Sensory medical device with extended feature

By designing a human balanced medical system that integrates nerve stimulators and environmental data collection, the problem that existing medical devices are difficult to adjust and optimize the surrounding environment in real time to assist human balance is solved, and efficient treatment effect on balanced damaged people is achieved.

CN120091849APending Publication Date: 2025-06-03COCHLEAR LIMITED +1
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Patent Information

Application Number
CN202380073434.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-08-30
Filing Date
2023-09-14
Publication Date
2025-06-03

AI Technical Summary

Technical Problem

Existing medical devices are difficult to effectively solve the problem of human balance, especially when balance is damaged. Traditional medical devices cannot adjust and optimize the surrounding environment in real time to assist human balance.

Method used

A human balanced medical system is designed, which includes a neural stimulator subsystem and an environmental data acquisition subsystem. By automatically obtaining data on the surroundings of the damaged person and controlling the neural stimulator subsystem based on this data, the system is able to adjust the stimulation mode in real time to assist the body in balance.

Benefits of technology

The system can significantly improve the balance of people with impaired balance, and provide more personalized and efficient treatment effects through real-time data-driven stimulation mode adjustment.

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Abstract

In one embodiment, a system includes a first subsystem configured to neuro-affect a person when activated and a second subsystem configured to provide an indication that the system is activated and / or not activated, where the system is a sensory management and / or sensory stimulation system.
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Description

[0001] Funding Statement

[0002] The project that generated this application has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No. 801127. Background Art

[0003] In recent decades, medical devices have provided a wide range of therapeutic benefits to recipients. Medical devices can include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., devices having external components that communicate with implantable components). Medical devices, such as traditional hearing aids, partially or fully implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful for many years in performing life-saving and / or lifestyle-improving functions and / or recipient monitoring.

[0004] Over the years, the types of medical devices and the range of functions performed by them have increased. For example, many medical devices sometimes referred to as "implantable medical devices" now typically include one or more instruments, devices, sensors, processors, controllers, or other functional mechanical or electrical components that are permanently or temporarily implanted within a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage diseases / injuries or their symptoms, or to study, replace, or modify anatomical structures or physiological processes. Many of these functional devices utilize power and / or data received from an external device that is part of or operates in conjunction with the implantable component. Summary of the Invention

[0005] In an exemplary embodiment, there is a system that includes: a first subsystem configured to have a neurological effect on a person when activated; and a second subsystem configured to obtain data based on the surroundings of the system, wherein the system is configured to control the first subsystem at least in part based on the obtained data; and the system is a human balance medical system.

[0006] In an exemplary embodiment, there is a method that includes: automatically obtaining data based on the changeable environment of a person with impaired balance; and at least in part controlling the input from the person's vestibular system to the person's brain based on the obtained data.

[0007] In an exemplary embodiment, there is a method that includes: obtaining data based on the surroundings of a person with impaired balance; changing the surroundings based on the obtained data; operating a balance-sensing medical device connected to the person based on the changed surroundings.

[0008] In an exemplary embodiment, there is a device that includes: one or more electrodes; a power source; a light capture device; and a control unit, where the device is configured such that the control unit controls the (multiple) electrical signals to the one or more electrodes to provide a balance treatment to a recipient of the device, and the device is further configured such that the control unit controls the (multiple) electrical signals based on an output from the light capture device.

[0009] In an exemplary embodiment, there is a human balance medical system that includes a nerve stimulator subsystem configured to affect nerve signals to the brain of a recipient of the human balance medical system to improve the recipient's balance; and a power source, where the nerve stimulator subsystem is powered by the power source, and the human balance medical system is an intelligent human balance medical system. In an embodiment, there is a prosthetic human balance medical device that includes:

[0010] at least one of the following:

[0011] (1) one or more external electrodes; or

[0012] (2) one or more implantable electrodes configured to be exposed to body fluids for at least 12 months;

[0013] a battery, where the battery is rechargeable or disposable;

[0014] a control unit configured to control the (multiple) electrical signals to one or more electrodes to provide a balance treatment to a recipient of the prosthetic medical device; and

[0015] a control circuit configured to provide an output from the device indicating an activation state and / or efficacy of the device.

[0016] In an exemplary embodiment, there is a prosthetic human balance medical system that includes:

[0017] at least one of the following:

[0018] (1) one or more external electrodes; or

[0019] (2) one or more implantable electrodes configured to be exposed to body fluids for at least 12 months;

[0020] a battery, where the battery is rechargeable or disposable;

[0021] An optoelectronic device configured to capture and / or be sensitive to ambient light, the optoelectronic device including one or more of (a plurality of) photosensitive regions, (a plurality of) photoresistors, (a plurality of) photodiodes, (a plurality of) photodetectors, (a plurality of) phototransistors, or a charge-coupled device; and

[0022] A control circuit configured to control (a plurality of) electrical signals to one or more electrodes to provide a balance therapy to a recipient of a prosthetic medical device and configured to control (a plurality of) electrical signals based on an output from the optoelectronic device to improve the balance of the recipient of the prosthetic medical device.

[0023] In an exemplary embodiment, there is a system including: a first subsystem configured to have a neurological effect on a human when activated; and a second subsystem configured to provide an indication that the system is activated and / or not activated, wherein the system is a sensory management and / or sensory stimulation system.

[0024] In an exemplary embodiment, there is a non-transitory computer-readable medium having recorded thereon a computer program for performing at least a portion of a method, the computer program including: code for automatically determining whether a system is operating and / or not operating and / or how well the system is operating and / or whether the system is capable of operating, wherein the system is a sensory management and / or sensory stimulation system; and code for providing an indication of whether the system is operating and / or not operating and / or how well the system is operating and / or whether the system is capable of operating and / or how well the system will operate in the future.

[0025] In an exemplary embodiment, there is a method including: operating a medical device connected to a human, the medical device being configured to stimulate the inner ear of the human; and automatically evaluating the efficacy of the medical device before, during, and / or after the operating action. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Embodiments are described below with reference to the drawings, in which:

[0027] Figure 1 is a perspective view of an exemplary hearing prosthesis;

[0028] Figure 2 presents a functional block diagram of an exemplary cochlear implant;

[0029] Figure 3A and Figure 3B and 3C presents an exemplary system for communication between devices;

[0030] Figure 4 illustrates an exemplary retinal prosthesis;

[0031] Figure 5 illustrates an exemplary vestibular implant;

[0032] Figure 6 and 7 provides details of another exemplary vestibular implant;

[0033] Figure 8 illustrates an exemplary external component;

[0034] Figures 9 - 12 illustrates an exemplary flowchart of an exemplary method;

[0035] Figure 13 illustrates an exemplary implant;

[0036] Figures 14 - 17 and 22 - 26 and 29 illustrate an exemplary flowchart of an exemplary method;

[0037] Figure 18 and 19 illustrates an anatomical structure;

[0038] Figure 20 illustrates another exemplary vestibular implant; and

[0039] Figure 21 illustrates the electrode insertion points of an exemplary embodiment;

[0040] Figure 27 and 28 illustrates an exemplary functional block diagram of an exemplary system;

[0041] Figure 30 and 31 illustrates an exemplary sensory impact system. Detailed Description

[0042] For ease of description only, the techniques presented herein are described herein by reference to an illustrative medical device in the background, namely a cochlear implant. This is because in some but not all embodiments, the characteristics of such an implant are generally and / or specifically applicable to a vestibular implant, which, in turn, is generally and / or specifically applicable to a balance prosthesis according to the teachings herein. However, it should be noted that the techniques presented herein can also be used with a variety of other medical devices that can benefit from setting changes based on the location of the medical device while providing a wide range of therapeutic benefits to a recipient, patient, or other user. In this regard, for example, as just mentioned, with respect to a particular individual, the techniques presented herein can be used with a vestibular implant and / or a balance medical device (such as a balance prosthesis) and / or a retinal implant. And with respect to the latter, the techniques presented herein are also described by reference to another illustrative medical device in the background (i.e., a retinal implant). But it should be clear that, where the two are not mutually exclusive, the techniques presented herein are directly applicable to the techniques of balance medical devices, vestibular devices (e.g., vestibular implants). Embodiments can also relate to vision devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and / or treating seizure events), sleep apnea devices, electroporation devices, etc.

[0043] Briefly, in an embodiment, a commercially available external component of a cochlear implant (the so-called sound processor) can be modified with respect to vestibular stimulation (e.g., by changing software and / or firmware and possibly changing a chip or some circuitry, but starting with the external cochlear implant component) to implement at least some of the teachings herein. In this regard, the implant can be an improved implantable portion of a cochlear implant. Note that these changes transform the initial device from a cochlear implant into a vestibular implant.

[0044] Again, as described below, some embodiments of a vestibular implant use at least some of the characteristics of a cochlear implant. Accordingly, we first describe the cochlear implant. Figure 1is a perspective view of a cochlear implant, designated cochlear implant 100, in an implant recipient, to which some of the embodiments and / or variants detailed herein are applicable. In particular, as will be detailed below, there are aspects of cochlear implants relevant to the use of vestibular implants, and thus there is utility in describing the features of cochlear implants in order to understand vestibular implants. In some embodiments, cochlear implant 100 is part of a system 10 that may include an external component, as will be detailed below. Additionally, it should be noted that the teachings detailed herein are also applicable to other types of hearing prostheses, by way of example and not limitation, such as bone conduction devices (transcutaneous, active transcutaneous, and / or passive transcutaneous), direct acoustic cochlear stimulators, middle ear implants, and conventional hearing aids, among others. In fact, it should be noted that the teachings detailed herein are also applicable to so-called multimodal devices. In an exemplary embodiment, these multimodal devices apply both electrical and acoustic stimulation to the recipient. In an exemplary embodiment, these multimodal devices evoke hearing perception via electroacoustic and bone conduction hearing.

[0045] In view of the foregoing, at least some of the embodiments and / or variants detailed herein relate to body-worn sensory augmentation medical devices (e.g., balance prostheses and / or vestibular prostheses (described in more detail below) or Figure 1 hearing prostheses (or devices that use at least one or more of these features). A balance device can supplement one or more senses that provide a sense of balance.

[0046] Some embodiments include applying the teachings detailed herein to any type of sensory augmentation medical device to which the teachings detailed herein can be usefully applied. In this regard, the phrase sensory augmentation medical device refers to any device that provides a sense to a recipient, regardless of whether the applicable natural sense is only partially impaired, completely impaired, or actually never existed.

[0047] Returning to Figure 1 , the recipient has an outer ear 101, a middle ear 105, and an inner ear 107. The components of the outer ear 101, middle ear 105, and inner ear 107 are described below, followed by a description of cochlear implant 100.

[0048] In a fully functional ear, the outer ear 101 includes the auricle 110 and the ear canal 102. Sound pressure or sound waves 103 are collected by the auricle 110, conducted into and through the ear canal 102. The tympanic membrane 104, which vibrates in response to the sound waves 103, is located at the distal end of the ear canal 102. This vibration is coupled to the oval window or fenestra ovalis 112 through three bones of the middle ear 105, which are collectively referred to as the ossicles 106 and include the malleus 108, incus 109, and stapes 111. The bones 108, 109, and 111 of the middle ear 105 are used to filter and amplify the sound waves 103 so that the oval window 112 pivots or vibrates in response to the vibration of the tympanic membrane 104. This vibration causes a fluid motion wave in the perilymph within the cochlea 140. This fluid motion in turn activates tiny hair cells (not shown) inside the cochlea 140. The activation of the hair cells causes appropriate nerve impulses to be generated and transmitted through the spiral ganglion cells (not shown) and the auditory nerve 114 to the brain (also not shown), where the sound is perceived in the brain.

[0049] As shown, the cochlear implant 100 includes one or more components that are implanted temporarily or permanently in a recipient. Figure 1 Shown is a cochlear implant 100 with an external device 142, which (along with the cochlear implant 100) is part of a system 10, and the external device is configured to provide power to the cochlear implant as described below, where the implanted cochlear implant includes a battery that is charged by the power provided from the external device 142.

[0050] In Figure 1 an illustrative arrangement, the external device 142 may include a power source (not shown) disposed in a behind-the-ear (BTE) unit 126. The external device 142 also includes components of a transcutaneous energy transfer link referred to as an external energy transfer assembly. The transcutaneous energy transfer link is used to transfer power and / or data to the cochlear implant 100. Various types of energy transfer (such as infrared (IR), electromagnetic, capacitive, and inductive transfer) can be used to transfer power and / or data from the external device 142 to the cochlear implant 100. In Figure 1 an illustrative embodiment, the external energy transfer assembly includes an external coil 130, which forms part of an inductive radio frequency (RF) communication link. The external coil 130 is typically a wire antenna coil composed of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire. The external device 142 also includes a magnet (not shown) positioned within the turns of the external coil 130. It should be understood that Figure 1 the external device shown is merely illustrative, and other external devices can be used with the embodiment.

[0051] The cochlear implant 100 includes an internal energy transfer component 132 that can be positioned in a recess of the temporal bone adjacent to the recipient's auricle 110. As detailed below, the internal energy transfer component 132 is part of a transcutaneous energy transfer link and receives power and / or data from an external device 142. In an illustrative embodiment, the energy transfer link includes an inductive RF link, and the internal energy transfer component 132 includes a primary internal coil 136. The internal coil 136 is generally a wire antenna coil formed of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire.

[0052] The cochlear implant 100 also includes a main implantable component 120 and an elongated electrode assembly 118. In some embodiments, the internal energy transfer component 132 and the main implantable component 120 are hermetically sealed within a biocompatible housing. In some embodiments, the main implantable component 120 includes an implantable microphone assembly (not shown) and a sound processing unit (not shown) to convert sound signals received by the implantable microphone in the internal energy transfer component 132 into data signals. That is, in some alternative embodiments, the implantable microphone assembly can be located in a separate implantable component (such as having its own housing assembly, etc.), and the separate implantable component (such as via leads between the separate implantable component and the main implantable component 120, etc.) is in signal communication with the main implantable component 120. In at least some embodiments, the teachings detailed herein and / or their variations can be used with any type of implantable microphone arrangement.

[0053] The main implantable component 120 also includes a stimulator unit (also not shown) that generates an electrical stimulation signal based on the data signal. The electrical stimulation signal is delivered to the recipient via the elongated electrode assembly 118.

[0054] The elongated electrode assembly 118 has a proximal end connected to the main implantable component 120 and a distal end implanted in the cochlea 140. The electrode assembly 118 extends from the main implantable component 120 through the mastoid bone 119 to the cochlea 140. In some embodiments, the electrode assembly 118 can be implanted at least in the basal region 116 and sometimes deeper. For example, the electrode assembly 118 can extend toward the apex of the cochlea 140, which is referred to as the cochlear apex 134. In certain cases, the electrode assembly 118 can be inserted into the cochlea 140 via the cochleostomy 122. In other cases, the cochleostomy can be formed through the round window 121, the oval window 112, the promontory 123, or through the apical turn 147 of the cochlea 140.

[0055] The electrode assembly 118 includes an array 146 of longitudinally aligned and distally extending electrodes 148 disposed along its length. As noted, the stimulator unit generates a stimulation signal that is applied to the cochlea 140 by the electrodes 148, thereby stimulating the auditory nerve 114.

[0056] Thus, as seen above, a variety of implantable devices rely on external components to provide certain functions and / or power. For example, a recipient of an implantable device may wear an external component that provides power and / or data (e.g., a signal representing sound) to the implanted portion to allow the implantable device to function. Specifically, the implantable device may not have a battery and may actually rely entirely on an external power source that provides continuous power for the implantable device to function. Although the external power source may provide power continuously, the characteristics of the power provided need not be constant and may fluctuate. Additionally, in the case where the implantable device is an auditory prosthesis such as a cochlear implant, the implantable device may not have its own sound input device (e.g., a microphone). Sometimes, it is practical to remove the external component. For example, a recipient of an auditory prosthesis typically removes the external portion of the prosthesis while sleeping. Doing so can result in a loss of function of the implanted portion of the prosthesis, which may prevent the recipient from hearing ambient sounds. This may not be very practical and may cause the recipient to be unable to hear while sleeping. The loss of function will also prevent the implanted portion from responding to signals representing streamed content (e.g., music streamed from a phone) or providing other functions such as providing tinnitus suppression noise.

[0057] As detailed above, the external component that provides power and / or data can be worn by the recipient. When the wearable external device is worn by the recipient, the external device is typically very close to and closely aligned with the implanted component. The wearable external device can be configured to operate under these conditions. Relatively speaking, in some cases, the non-worn device may generally be far from the implanted component and not as closely aligned with the implanted component. This can cause difficulties in the case where the implantable device depends on the external device for power and data (e.g., where the implantable device does not have its own battery and microphone), and the external device may need to provide power and data continuously and consistently in order to achieve continuous and consistent function of the implantable device.

[0058] Figure 2 is a functional block diagram of a cochlear implant system 200 that can be used in an embodiment. The cochlear implant system 200 includes an implantable component 201 configured to be implanted beneath the skin or other tissue 249 of a recipient (e.g., Figure 1 the implantable component 100) and an external device 240 (e.g., Figure 1 the external device 142).

[0059] The external device 240 can be configured as a wearable external device such that the external device 240 is worn by the recipient in very close proximity to the implantable component, which can enable the implantable component 201 to receive power and stimulation data from the external device 240. As Figure 1As described, the magnet can be used to facilitate the operative alignment of the external device 240 and the implantable component 201. In the case where the external device 240 and the implantable component 201 are extremely close, the transmission of power and data can be achieved by using near-field electromagnetic radiation, and the components of the external device 240 can be configured to be used with near-field electromagnetic radiation.

[0060] The implantable component 201 can include a transceiver unit 208, an electronic module 213 (which can be the stimulator assembly of a cochlear implant), and an electrode assembly 254 (which can include an array of electrode contacts disposed on Figure 1 the lead 118). The transceiver unit 208 is configured to receive power and / or data transcutaneously from the external device 240. As used herein, the transceiver unit 208 refers to any collection of one or more components that form part of a transcutaneous energy transfer system. In addition, the transceiver unit 208 can include or be coupled to one or more components that receive and / or transmit data or power. For example, this example includes a coil of a magnetic inductive device coupled to the transceiver unit 208. Other arrangements are possible, including antennas, capacitor plates, or any other practical arrangement for replacing an RF system. In an example, data modulates an RF carrier or a signal containing power. The transcutaneous communication link established by the transceiver unit 208 can transmit power and data to the implantable component 201 by time-interleaving power and data on a single RF channel or band. In some examples, the processor 244 is configured to cause the transceiver unit 246 to interleave power and data signals, such as described in U.S. Patent Publication No. 2009 / 0216296 to Meskens. In this way, the data signal is modulated by the power signal, and a single coil can be used to transmit power and data to the implant component 201. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive, and inductive transfer, can be used to transfer power and / or data from the external device 240 to the implantable component 201.

[0061] Aspects of the implantable component 201 may require a power source to provide functionality, such as receiving signals, processing data, or delivering electrical stimulation. A power source that directly powers the operation of aspects of the implantable component 201 can be described as operating power. There are two exemplary ways for the implantable component 201 to receive operating power: a power source inside the implantable component 201 (e.g., a battery) or a power source outside the implantable component. However, other methods or combinations of methods are possible. For example, the implantable component can have a battery but still receive operating power from an external component (e.g., to maintain the internal battery service life when the battery is fully charged).

[0062] The internal power source can be a power storage element (not depicted). The power storage element can be configured for long-term storage of electrical power and can include, for example, one or more rechargeable batteries. Electrical power can be received from an external source such as external device 240 and stored in the power storage element for long-term use (e.g., charging the battery of the power storage element). Then, the power storage element can supply electrical power to other components of the implantable component 201 over time as needed for operation, without an external power source. In this way, the electrical power from the external source can be considered charging power rather than operating power, since the electrical power from the external power source is used to charge the battery (which in turn provides operating power) rather than directly powering aspects of the implantable component 201 that require electrical power to operate. The power storage element can be a long-term power storage element configured as the primary power source for the implantable component 201.

[0063] In some embodiments, the implantable component 201 receives operating power from the external device 240 and the implantable component 201 does not include an internal power source (e.g., a battery) / internal power storage device. In other words, the implantable component 201 is powered only by the external device 240 or another external device, which provides sufficient electrical power to the implantable component 201 to allow the implantable component to operate (e.g., receive a data signal and take an action in response). The operating power can directly power the functions of the device rather than charging a power storage element of the external device for the implantable component 201. In these examples, the implantable component 201 can include incidental components that can store charge (e.g., a capacitor) or incidental components that can store a small amount of electrical power, such as a small battery (e.g., a motherboard CMOS battery) for keeping a volatile memory powered or powering a clock. However, such incidental components do not have sufficient power on their own to allow the implantable component to provide the primary functions of the implantable component 201 (e.g., receive a data signal and take an action in response thereto, such as providing stimulation), and thus even though the incidental components are indispensable for the operation of the implantable component 201, they cannot be said to provide operating power.

[0064] As shown, the electronic module 213 includes a stimulator unit 214 (e.g., which can correspond to Figure 1 the stimulator). The electronic module 213 can also include one or more other components for generating the electrical stimulation signal 215 or controlling the delivery of the electrical stimulation signal to the recipient. As described above with respect to Figure 1 described, a lead (e.g., Figure 1 the elongate lead 118) can be inserted into the cochlea of the recipient. The lead can include an electrode assembly 254 configured to deliver the electrical stimulation signal 215 generated by the stimulator unit 214 to the cochlea.

[0065] In Figure 2In the exemplary system 200 depicted, the external device 240 includes a sound input unit 242, a sound processor 244, a transceiver unit 246, a coil 247, and a power source 248. The sound input unit 242 is a unit configured to receive a sound input. The sound input unit 242 can be configured as a microphone (e.g., arranged to output audio data representing the surrounding sound environment), an electrical input (e.g., a receiver for a frequency modulation (FM) listening system), and / or another component for receiving a sound input. The sound input unit 242 can be or include a mixer for mixing together multiple sound inputs.

[0066] The processor 244 is a processor configured to control one or more aspects of the system 200, including converting a sound signal received from the sound input unit 242 into a data signal and causing the transceiver unit 246 to transmit power and / or data signals. The transceiver unit 246 can be configured to transmit or receive power and / or data 251. For example, the transceiver unit 246 can include circuit components for transmitting power and data through the coil 247 (e.g., inductively). The data signal from the sound processor 244 can be transmitted to the implantable component 201 using the transceiver unit 246 for providing stimulation or other medical functions.

[0067] The transceiver unit 246 can include one or more antennas or coils for transmitting power or data signals, such as the coil 247. The coil 247 can be a wire antenna coil having multiple turns of electrically insulated single-strand or multi-strand wire. The electrical insulation of the coil 247 can be provided by a flexible silicone molding. Various types of energy transfer, such as infrared (IR), radio frequency (RF) electromagnetic, capacitive, and inductive transfer, can be used to transfer power and / or data from the external device 240 to the implantable component 201.

[0068] Figure 3A An exemplary system 210 according to an exemplary embodiment is depicted, the exemplary system including: a hearing prosthesis 100, which corresponds to the cochlear implant 100 detailed above in the exemplary embodiment; and a portable body-worn device (e.g., a portable handheld device, a watch, a pocket device, etc., as Figure 2 seen in A) 2401, which is in the form of a mobile computer having a display 2421. The system includes a wireless link 230 between the portable handheld device 2401 and the hearing prosthesis 100. In an embodiment, the prosthesis 100 is an implant implanted in a recipient 99 (functionally represented by the dashed line of the block 100 in Figure 3A .

[0069] In an exemplary embodiment, system 210 is configured such that the hearing prosthesis 100 and the portable handheld device 2401 have a symbiotic relationship. In an exemplary embodiment, the symbiotic relationship is the ability to display data related to one or more functions of the hearing prosthesis 100 and, in at least some cases, the ability to control the one or more functions. In an exemplary embodiment, this can be achieved by the handheld device 2401 receiving data from the auditory prosthesis 100 via the wireless link 230 (but in other exemplary embodiments, other types of links, such as a wired link, etc., can be utilized). As will be detailed further below, this can be achieved by communicating with a geographically remote device that communicates via a link with the hearing prosthesis 100 and / or the portable handheld device 2401, by way of example but not limitation, such as an Internet connection or a cellular phone connection. In some such exemplary embodiments, system 210 may also include a geographically remote device. Again, additional examples in this regard will be described in more detail below.

[0070] As noted above, in an exemplary embodiment, the portable handheld device 2401 includes a mobile computer and a display 2421. In an exemplary embodiment, the display 2421 is a touchscreen display. In an exemplary embodiment, the portable handheld device 2401 also has the functionality of a portable cellular phone. In this regard, by way of example but not limitation, device 2401 can be what is commonly referred to as a smart phone. That is, in an exemplary embodiment, the portable handheld device 2401 includes what is still commonly referred to as a smart phone.

[0071] It should be noted that in some other embodiments, device 2401 need not be a computer device or the like. It can be a lower-tech recorder, or any device that can implement the teachings herein.

[0072] The phrase "mobile computer" includes a device configured to enable human-computer interaction, where the computer is expected to be moved away from a stationary position during normal use. Similarly, in an exemplary embodiment, the portable handheld device 2401 is what is commonly referred to as a smart phone. However, in other embodiments, less sophisticated (or more sophisticated) mobile computing devices can be utilized to implement the teachings detailed herein and / or variations thereof. In at least some embodiments, any device, system, and / or method that enables the teachings detailed herein and / or variations thereof to be practiced can be utilized. (As will be detailed further below, in some cases, device 2401 is not a mobile computer but a remote device (remote from the hearing prosthesis 100. Some of these embodiments will be described below).)

[0073] In an exemplary embodiment, the portable handheld device 2401 is configured to receive data from a hearing prosthesis and present, on a display, one of a plurality of different interface displays based on the received data. Exemplary embodiments will sometimes be described in terms of data received from the hearing prosthesis 100. However, it should be noted that any disclosure that applies to data sent from the handheld device 2401 to the hearing prosthesis is also covered by such disclosure (and vice versa), unless otherwise specified or otherwise incompatible with the relevant art.

[0074] It should be noted that in some embodiments, the system 210 is configured such that the cochlear implant 100 and the portable device 2401 have a relationship. By way of example only and not limitation, in an exemplary embodiment, the relationship is the ability of the device 2401 to act as a remote microphone for the prosthesis 100 via the wireless link 230. Thus, the device 2401 can be a remote microphone. That is, in an alternative embodiment, the device 2401 is a stand-alone recording / sound capture device.

[0075] It should be noted that in at least some exemplary embodiments, the device 2401 corresponds to an Apple Watch commercially available in the United States since January 10, 2021 TM Series 1 or Series 2. In an exemplary embodiment, the device 2401 corresponds to a Samsung Galaxy Gear commercially available in the United States since January 10, 2021 TM Gear 2. The device is programmed and configured to communicate with the prosthesis and / or to implement the teachings detailed herein.

[0076] In an exemplary embodiment, a telecommunications infrastructure can communicate with the hearing prosthesis 100 and / or the device 2401. By way of example only and not limitation, a telecoil 2491 or some other communication system (such as Bluetooth) is used to communicate with the prosthesis and / or the remote device. Figure 2 B depicts an exemplary quasi-functional schematic diagram depicting communication between an external communication system 2491 (e.g., a telecoil) and the hearing prosthesis 100 and / or the handheld device 2401 via links 277 and 279, respectively (it should be noted that Figure 3B bi-directional communication between the hearing prosthesis 100 and the external audio source 2491 and between the handheld device and the external audio source 2491 is depicted - in alternative embodiments, the communication is merely unidirectional (e.g., from the external audio source 2491 to the respective device)). It should be noted, however, that unless otherwise stated, Figure 3B the embodiments apply to any body-worn medical device / implantable device disclosed herein in some embodiments.

[0077] Figure 3CDepicts an exemplary external component 1440. The external component 1440 may correspond to the external component 142 of system 10 (which may also represent other body-worn devices / devices used with the implant portion herein). As can be seen, the external component 1440 includes a behind-the-ear (BTE) device 1426 connected to an exemplary head member 1478 by a cable 1472, and the head member includes an external inductive coil 1458EX, which corresponds to Figure 1 the external coil. As shown, the external component 1440 includes a head member 1478, which includes a coil 1458EX and a magnet 1442. This magnet 1442 interacts with the implanted magnet (or implanted magnetic material) of the implantable component to hold the head member 1478 on the skin of the recipient. In an exemplary embodiment, the external component 1440 is configured to transmit magnetic data and / or electrical power transcutaneously to and / or receive magnetic data from an implantable component including an inductive coil through the coil 1458EX. The coil 1458X is electrically coupled to the BTE device 1426 by a cable 1472. The BTE device 1426 may include, for example, at least some of the components of the external devices / components described herein.

[0078] Figure 4 Presents exemplary embodiments of a general neural prosthesis and particularly a retinal prosthesis and its usage environment, and in some teachings herein, its components may be used in whole or in part. In some embodiments of the retinal prosthesis, the retinal prosthesis sensor-stimulation device 10801 is positioned close to the retina 11001. In an exemplary embodiment, photons entering the eye are absorbed by the microelectronic array of the sensor-stimulation device 10801, which is hybridized with a glass piece 11201 containing, for example, an embedded micro-wire array. The glass may have a curved surface consistent with the inner radius of the retina. The sensor-stimulation device 108 may include a microelectronic imaging device, which may be made of thin silicon containing an integrated circuit system that converts incident photons into electron charges.

[0079] The image processor 10201 communicates signals with the sensor - stimulator 10801 via a cable 10401 that extends through a surgical incision 00601 in the eye wall (but in other embodiments, the image processor 10201 communicates wirelessly with the sensor - stimulator 10801). The image processor 10201 processes the input into the sensor - stimulator 10801 and provides control signals back to the sensor - stimulator 10801 so that the device can provide a processed output to the optic nerve. That is, in alternative embodiments, the processing is performed by components near or integrated with the sensor - stimulator 10801. The charge generated by the conversion of incident photons is converted into a proportional amount of electron current that is input into a nearby retinal cell layer. The cells are excited and signals are sent to the optic nerve, thus triggering visual perception.

[0080] The retinal prosthesis may include an external device disposed in a behind - the - ear (BTE) unit or in a pair of glasses, or any other type of component that may have practical value. The retinal prosthesis may include an external light / image capture device (e.g., located in / on the BTE device or a pair of glasses, etc.), and as noted above, in some embodiments, the sensor - stimulator 10801 captures light / images, and the sensor - stimulator is implanted in the recipient.

[0081] For the sake of compactness of the disclosure, any disclosure herein of a microphone or sound capture device corresponds to a similar disclosure of a light / image capture device such as a charge - coupled device. By extension, any disclosure herein of a stimulator unit that generates an electrical stimulation signal or otherwise imparts energy to tissue to evoke a hearing perception corresponds to a similar disclosure of a stimulator device for a retinal prosthesis. Any disclosure herein of a sound processor or the processing of captured sound, etc., corresponds to a similar disclosure of a light processor / image processor that has a similar function for a retinal prosthesis and processes captured images in a similar manner. In fact, any disclosure herein of a device for a hearing prosthesis corresponds to a disclosure of a device for a retinal prosthesis that has a similar function. Any disclosure herein of fitting a hearing prosthesis corresponds to a disclosure of fitting a retinal prosthesis using similar actions. Any disclosure herein of a method of using or operating a hearing prosthesis or otherwise working with a hearing prosthesis corresponds to a disclosure of using or operating a retinal prosthesis in a similar manner or otherwise working with a retinal prosthesis.

[0082] Figure 5 An exemplary vestibular implant 500 according to one example is depicted. Using Figure 1The above cochlear implant is described in connection with various components to describe some specific features. In this regard, as described above, some features of the cochlear implant are used in the vestibular implant. That is, cross-technology is used in the embodiments herein. For economy of text and figures, the same numbers are used to refer to the various components of the vestibular implant that generally correspond to the components of the above cochlear implant. It should still be noted that some features of the vestibular implant 500 will be different from the features of the cochlear implant above. By way of example only and not limitation, there may be no microphone on the behind-the-ear device 126. Alternatively, sensors that are useful in the vestibular implant may be included in the BTE device 126. By way of example only and not limitation, a motion sensor may be located in the BTE device 126. There may also be no sound processor in the BTE device. Instead, other types of processors, such as those that process data obtained from sensors, will be present in the BTE device 126. A power source such as a battery will also be included in the BTE device 126. Consistent with the BTE device of the Figure 1 cochlear implant, the transmitter / transceiver will be located in the BTE device or otherwise in signal communication therewith.

[0083] The implantable component includes a receiver stimulator in a manner associated with the above cochlear implant. Here, the vestibular stimulator includes a main implantable component 120 and an elongated electrode assembly 1188 (where the elongated electrode assembly 1188 has some different features from the elongated electrode assembly 118 of the cochlear implant, and some of these features will be described later). In some embodiments, the internal energy transfer component 132 and the main implantable component 120 are hermetically sealed in a biocompatible housing. In some embodiments, the main implantable component 120 includes a processing unit (not shown) for converting data obtained by the sensor into a data signal, and the sensor may be an on-board sensor implanted in the receiver.

[0084] The main implantable component 120 also includes a stimulator unit (also not shown), and the stimulator unit generates an electrical stimulation signal based on the data signal. The electrical stimulation signal is delivered to the recipient via the elongated electrode assembly 1188.

[0085] It should be briefly noted that although Figure 5 the embodiments shown in represent a partially implantable vestibular implant, the embodiments may include a fully implantable vestibular implant, such as where a motion sensor is located in the implantable portion in a manner similar to the cochlear implant.

[0086] The elongated electrode assembly 1188 has a proximal end connected to the main implantable component 120 and extends through a hole in the mastoid 119 in a manner similar to the elongated electrode assembly 118 of a cochlear implant and includes a distal end extending into the inner ear. In some embodiments, the distal portion of the electrode assembly 1188 includes a plurality of leads 510 that branch from the body of the electrode assembly 118 to the electrodes 520. The electrodes 520 may be placed at the base of the semicircular canals, as Figure 5 shown. In an exemplary embodiment, one or more of these electrodes are placed near the branches of the vestibular nerve that innervate the semicircular canals. In some embodiments, the electrodes are located outside the inner ear, while in other embodiments, the electrodes are inserted into the inner ear. It should also be noted that while the present embodiment does not include an electrode array located in the cochlea, in other embodiments, one or more electrodes are located in the cochlea in a manner similar to a cochlear implant.

[0087] Embodiments may relate to, but are not limited to, humans and mammals who experience / suffer from vestibular dysfunction (including, for example, bilateral vestibular dysfunction). Embodiments may include using Figure 5 a device or a variant or related device thereof to treat BVD (unless otherwise indicated, any disclosure of BVD herein corresponds to an alternative disclosure of unilateral vestibular dysfunction and vice versa, or any vestibular dysfunction that may actually cause balance difficulties in humans or, in some embodiments, general balance difficulties). In certain cases, these individuals may exhibit postural instability and gait difficulties. Some embodiments include an implant that provides one or more stimulating electrodes for medium-term and / or long-term stimulation of one or more of the inferior vestibular nerves, and in some embodiments, for example, a sequence of constant electrical pulses (such as high-frequency electrical pulses) is delivered to one or more of these nerves by one or more of these electrodes. In an embodiment, a vestibular stimulator (such as Figure 5 a device) may deliver 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000 or more or fewer or any value or range of values in increments of 1 therebetween (e.g., 1111, 678, 1776, 1234 to 1818, etc.) of single-phase or biphasic pulses per second. Electrical stimulation may be provided by the electrodes at a location where, for example, the electrical stimulation positively stimulates the saccular afferent nerves (including the primary saccular afferent nerves).

[0088] Embodiments include providing electrical stimulation in a manner that can improve a person's postural stability and / or gait performance, which can be measured by computerized dynamic posturography (CDP) and dynamic gait index (DGI) to evaluate its efficacy (it is not required to implement the embodiments - this is a deterministic control that can be used by those skilled in the art to evaluate performance). Embodiments can "improve" peripheral vestibular function through stimulation. In some embodiments, the efficacy can be evaluated, i.e., the extent to which a person has a "need" or even requires assistance in walking and stabilizing themselves. It should be clear that embodiments can, but do not need to, be associated with the "otolith replacement" concept, and not all embodiments involve / cause a reduction or absence of otolith afferent activity that replaces the utricular macula with neural activity generated by electrical stimulation. In this regard, any device, system, and / or method that enhances balance, gait, or otherwise alters balance and / or gait through electrical stimulation or through chemical application can be used in some embodiments, as long as it can be achieved in the art, unless otherwise stated.

[0089] In fact, in view of the ability to improve postural stability and / or gait performance taught by at least some of the teachings detailed herein, embodiments can also involve utilizing one or more or all of the teachings detailed herein regarding treating mobility disorders and / or movement disorders other than balance disorders, at least in cases where the two are mutually exclusive or otherwise sufficiently exclusive to be considered independent diseases. In fact, embodiments include devices, systems, and / or methods for treating vestibular function impairment / disorders / including devices, systems, and / or methods for treating vestibular function impairment / disorders, regardless of the ultimate impact of the disease (such as balance or motor function impairment, etc.). Embodiments can include applying the electrical stimulation techniques detailed herein to reduce the amplitude of involuntary tremors (such as whole body or local, e.g., in the arm or hand or leg or foot, etc.) or otherwise control the tremors. These embodiments can utilize the connection that exists in certain medical scenarios, where vestibular function and motor function are linked or otherwise associated with each other.

[0090] In view of applying electrical stimulation (or other types of stimulation as supplemented herein in this regard) to tissue for treating movement disorders, for the sake of text brevity, any disclosure herein that implements the teachings herein for treating balance disorders corresponds to an alternative disclosure for treating movement disorders / dyskinesias, unless otherwise stated, as long as it can be implemented in the art. Moreover, for the sake of text brevity, any disclosure herein that implements the teachings herein for treating balance disorders corresponds to an alternative disclosure for treating vestibular function impairment / vestibular dysfunction. It should be clear that any device, system, and / or method disclosed herein can be applied respectively to devices, systems, and / or methods for treating movement disorders / dyskinesias / vestibular dysfunction in the human body, as long as it can be implemented in the art. By way of example only and not limitation, any disclosure of improving balance corresponds to an alternative disclosure of improving motor function and / or mobility function. In addition, any disclosure of improving balance corresponds to an alternative disclosure of improving posture and / or gait (which is movement, but a more specific type thereof). Also, any disclosure of improving balance corresponds to a disclosure of improving vestibular function. In this regard, any disclosure of a balance sensory medical device herein corresponds to an alternative disclosure of a vestibular function medical device, etc., and any method of treating balance corresponds to an alternative disclosure of a method of treating vestibular function.

[0091] It should be noted that embodiments can include devices, systems, and / or methods for controlling motor function and movement and additionally providing treatment to a person in a different and other manner by stimulating other parts of the body other than the vestibule, as detailed herein, and devices, systems, and / or methods for controlling motor function and movement and additionally providing treatment to a person in a different and other manner by stimulating other parts of the body other than the vestibule, as detailed herein. Accordingly, the embodiments disclosed herein relate to devices, systems, and / or methods for evaluating the efficacy of a medical device and / or providing an indication that a system / device is activated and / or not activated and / or determining whether a system / device is operating and / or not operating, etc., and associated teachings therearound, which correspond to an alternative disclosure of medical devices for stimulating parts of the body other than the vestibular system (e.g., the medical devices disclosed in the previous paragraph) and additional medical devices for addressing motor function impairments / movement disorders, etc., as long as it is achievable in the art, unless otherwise stated. In this regard, the aforementioned practical value associated with providing an indication to a recipient as to whether a stimulation device is operating, etc., can have practical value with respect to these other medical devices. For example, if a medical device for improving motor control is not operating in a situation where the recipient of the medical device is unaware that the system is not operating, a person relying on the device may harm themselves or others. By way of a more specific example, a person who is using a sharp knife to cut food believes that a medical device that at least partially treats a disease associated with motor control is operating, but in fact, the device is not operating or is otherwise operating at an efficacy level lower than expected, and he may accidentally cut himself or stab himself due to a decrease in motor function relative to the situation where the device is operating in an effective manner. This can also occur in driving, walking, and other activities detailed herein.

[0092] Some embodiments also use electrical stimulation to activate or otherwise stimulate the descending spinal pathways. Embodiments can include balloon stimulation as described above. Embodiments can include deep brain stimulation as long as this affects balance, such as stimulation of electrodes in / at the basal ganglia, the effect of which is to help relieve a person's symptoms regarding balance and / or gait. Embodiments can include also stimulating the spine as long as this has an effective impact on balance and / or gait. The above devices and / or improved devices or related devices can be used to provide such electrical stimulation.

[0093] Embodiments include applying electrical stimulation (including constant electrical stimulation) to a person's vestibular nerve (e.g., the inferior vestibular nerve) to improve or at least attempt to improve the balance and / or gait of a person suffering from balance and / or gait problems (including such problems due to vestibular dysfunction). Although the above embodiments relate to implantable devices, embodiments can include external devices that apply electrical stimulation from external electrodes to the surface of the skin (and can thus be non-implantable / non-implantable devices).

[0094] Embodiments include devices, systems, and methods that apply stimulation (electrical and / or chemical) to a person who may have vestibular dysfunction (bilateral or unilateral) (at least in some embodiments). In some of these people, there is at least some residual peripheral vestibular function, but the level has dropped below the internationally accepted criteria for vestibular dysfunction, such as the criteria for bilateral vestibular dysfunction. In an embodiment, the level is at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, or 80% or more of an acceptable criteria for function and / or normal level and / or normal results regarding postural stability and / or gait using DGI and / or CDP, etc., or any value or range of values decreasing in 1% increments therebetween (as long as there is some neurological problem that produces that result).

[0095] Embodiments can be implemented in a dedicated vestibular stimulation implant or a modified cochlear implant or an implant using electrodes of a modified cochlear implant and / or multiple electrodes or an array of modified cochlear implants. In an embodiment, the (multiple) electrodes are implanted on, at, or near a branch of the vestibular nerve in one or both ears. The exact position of the (multiple) electrodes can depend on specific anatomical considerations during the surgery. Embodiments can include implanting (multiple) electrodes / making the (multiple) electrodes be implanted very close to the inferior vestibular nerve that contains the afferent nerves from the macula of the saccule and the posterior semicircular canal. This can be verified from a CT scan or some other non-invasive examination protocol. Embodiments can position the (multiple) electrodes at 10, 9, 8, 7, 6, 5, 4, 3, 2.5, 2, 1.5, 1, 0.75, 0.5, 0.25, 0.2, 0.15, or 0.1 mm or less from the inferior vestibular nerve (e.g., the nerve that contains the afferent nerves from the macula of the saccule and the posterior semicircular canal), or any value or range of values in 0.01 mm increments therebetween. The (multiple) electrode positions can be on the otolith afferent nerve and / or the saccular afferent nerve. Embodiments can use vestibular stimulation and / or saccular stimulation. But any stimulation that can treat gait and / or postural and / or balance problems can be used in some embodiments.

[0096] Embodiments include devices, systems, and / or methods that apply a pulse sequence (e.g., a constant pulse sequence) at a high frequency or a medium frequency and continuously and / or semi-continuously maintain it while the recipient is engaged in walking activities and / or activities involving balance and / or coordination, etc. That is, in some embodiments, the application of the electrical stimulation can be applied only when needed / when it is valuable, and thus does not need to be continuous.

[0097] Embodiments may include a stimulation device, the stimulation device including 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 or more electrodes or any value or range of values (4 - 8, 2 - 8, etc.) in increments of 1 therebetween. The stimulation device (which again may be based on a cochlear implant / modified cochlear implant) or a vestibular device or any device capable of providing electrical stimulation to effectuate the teachings herein may provide single - phase and / or biphasic pulse trains, such as pulses of 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60 microseconds per phase or any value or range of values generated in increments of one therebetween, and may be delivered at any of the frequencies detailed above or any other frequency capable of effectuating the teachings detailed above. In an embodiment, one, two, three, four, five or more electrodes are activated such that the stimulation is substantially a constant pulse sequence. In an embodiment, electrical stimulation activates the vestibular afferents at a relatively high rate, thereby replicating the constant volley of action potentials that a normal person would receive.

[0098] Embodiments include providing stimulation to a human in a manner that affects the cerebellum which controls balance / movement and / or coordination. Embodiments may be applied in the presence of cerebellar injury and / or cerebellar absence in a human. Embodiments may be applied to humans who exhibit, for example, an excessive or diminished response to perturbations during movement of the torso and abnormal (statistically significant) sway, in the case of insufficient (e.g., poor) balance control. The patient may experience gait ataxia with unique characteristics, including variable foot positions, irregular foot trajectories, wide base of support, curvilinear movement paths, and abnormal inter - joint coordination. Embodiments include stimulating a human such that the central region of the cerebellum may integrate spinal input and vestibular input and affect the movement path of walking.

[0099] It should be noted that the various medical devices herein can be of the type that reconstruct the sense of balance / coordination, etc. through electrical signals and / or chemical stimuli, where the electrical signals and / or chemical stimuli are related to information collected using an accelerometer and / or gyroscope or other devices that enable the assessment / determination of the orientation of the recipient / person. It should be noted that the various medical devices herein can be of the type that inhibit or suppress the balance function / coordination function through electrical signals (e.g., unmodulated electrical signals) and / or chemical stimuli. Embodiments can include medical devices, implants, or other devices configured to perform one or both (a medical device can be a system, which is, for example, integrated and capable of determining whether one type of treatment is more practical or otherwise more effective than another, which can be determined automatically by the system or by a telehealthcare professional and / or by the person himself; the person can have a "feeling" about which type of treatment has a desired outcome for a given situation, and this can be based on experience and / or statistics and / or analytical data). In an embodiment, the devices detailed herein are configured to reconstruct the sense of balance in the recipient's body by using (a plurality of) electrical signals to stimulate the recipient's tissue and are configured to enhance and / or provide signals traveling from the vestibule (or elsewhere for that matter, as described above) to the brain by using (a plurality of) electrical signals to stimulate the recipient's tissue.

[0100] It should also be noted that the various medical devices detailed herein can be of the sensory substitution category. In an embodiment, there can be a device that generates an acoustic stimulus or some other stimulus related to information collected using a body-worn / carried device (e.g., including an accelerometer, gyroscope, or some other device capable of sensing a person's orientation, etc.).

[0101] Embodiments can include systems and methods for sensory substitution by suppressing one sensory channel and providing signals through another sensory channel. In one example, the system suppresses the dysfunctional vestibular system and provides substitute vestibular information via another sensory channel. The dysfunctional balance information from the recipient's vestibular system can be suppressed using electrical stimulation. The electrical stimulation can be provided to the otolith region, semicircular canals, vestibular nerve, or another part of the recipient's vestibular system. The balance information normally provided by a healthy vestibular system (e.g., how the recipient is oriented with respect to gravity, such as rotation along the pitch axis and roll axis) is provided by stimulating another sensory channel. This sensory channel can include the visual, auditory, or tactile sensory channels. For example, auditory perception can be generated by an auditory prosthesis (e.g., a cochlear implant that provides electrical stimulation in the recipient's cochlea). By suppressing one perception channel and providing stimulation via another, one sense can substitute for another. Although described mainly in the context of vestibular sensory substitution herein, sensory substitution can be extended to other sensory systems.

[0102] In fact, embodiments can include a medical device in which there is an architecture for combining an auditory system and a sensory substitution system. In an example, sensory substitution is delivered as a perceivable auditory cue provided via an intracochlear electrode. The sensory substitution cue can be provided via one or more dedicated intracochlear electrode channels rather than being superimposed on all hearing channels. In such examples, the remaining electrodes can deliver standard cochlear implant stimulation (e.g., to evoke auditory perception to compensate for a dysfunctional auditory system). Balance signals that can substitute for a dysfunctional vestibular system can originate from one or more accelerometers, magnetometers, other sensors, or combinations thereof that transmit pitch, roll, and yaw information to a balance signal generator. The balance signals that substitute for the dysfunctional vestibular system can then be injected into the cochlear stimulation signal processing path in a manner that does not interfere with (or is not interfered with by) other signal channels. Thus, although some sound processing paths can be shared between the balance signal and the sound input signal (e.g., from a microphone or other sound source), some processing paths can be dedicated to the balance input signal. In at least some examples, some processing paths can be dedicated to the sound input signal, and some processing paths can be shared by both the sound input signal and the balance input signal.

[0103] Various balance signals that can be used to substitute for a dysfunctional vestibular system include movement or position that is used as an indicator of the recipient's stability compared to gravity. This signal can be used to provide information that allows the recipient to quickly recover from a tripping or balance failure event, which can contribute to fall prevention. In another example, gait information is extracted from one or more sensors placed at different positions on the recipient's body (e.g., in a smartwatch, phone, gait monitor, pedometer, or another device having one or more sensors). The extraction of gait information can be used to predict falls. Fall prediction can be used in combination with fall prevention techniques by, for example, providing balance substitution when gait analysis indicates a risk of falling.

[0104] Figure 6 An exemplary system 1000 for treating a recipient's balance dysfunction is shown. The illustrated system 1000 includes a vestibular inhibitor 1100 and a stimulator 1200.

[0105] The vestibular inhibitor 1100 is a part of the system 1000 that is configured to inhibit the recipient's vestibular system. The vestibular inhibitor 1100 can include a vestibular inhibitor signal generator 1120 and an inhibition component 1140, which can be disposed in the same housing or separate housings.

[0106] The vestibular inhibitor signal generator 1120 can be a component that controls the stimulation provided by the inhibition component 1140, such as by or including one or more processors that provide signals. For example, the vestibular inhibitor signal generator 1120 can be configured to provide a stimulation signal to the inhibition component 1140.

[0107] The inhibition component 1140 can take any of a variety of forms. The inhibition component 1140 can include one or more stimulation electrodes. The inhibition component 1140 can be an implantable component or can include an implantable component configured to apply electrical stimulation to the otolith region, semicircular canals, other vestibular tissues, or a combination thereof of a recipient using one or more electrodes. The electrical stimulation can inhibit the signals provided by the vestibular system to reduce the perception of signals generated by a part of the vestibular system. For example, when there is a dysfunction in the recipient's vestibular system, the stimulation provided by the vestibular inhibitor 1100 can be sufficient to reduce or eliminate the recipient's perception of the dysfunction signals. In some examples, this is achieved by preventing the vestibular system from generating signals or by making the signals generated by the vestibular system noisy or otherwise having a nature that causes the signals to be ignored by the recipient.

[0108] Additional exemplary embodiments of a vestibular stimulator that can act as one or both of the vestibular inhibitor signal generator 1120 and the inhibition component 1140 are described in European Patent Application Nos. 19382629.4 and 19382632.8, both filed on July 24, 2019. The embodiments can include one or more or all of the features herein.

[0109] The stimulator 1200 is part of the system 1000 configured to cause a sensory perception (e.g., auditory, visual, or tactile perception) of a recipient. This sensory perception can be used, for example, to provide a balance compensation signal to the recipient through one or more non-vestibular sensory channels of the recipient. The balance compensation signal can be a signal that causes a sensory perception configured to compensate for a dysfunctional vestibular system. For example, the balance compensation signal can provide balance information regarding the perception that would otherwise be provided by a normally operating vestibular system, such as information regarding balance, equilibrium, and orientation in space and others.

[0110] The stimulator 1200 can be configured to utilize stimulation to act on one or more non-vestibular sensory channels of the recipient to convey balance information. The stimulator 1200 can include a balance signal generator 1220 and a stimulation component 1240 disposed in the same housing or separate housings.

[0111] The balance signal generator 1220 can be a component configured to generate one or more balance compensation output signals to cause stimulation via the stimulation component 1240. The balance compensation output signals can be configured to compensate for vestibular deficiencies, such as by providing a perception indicating balance information in a manner that bypasses the recipient's defective vestibular system.

[0112] The stimulation component 1240 can be a component configured to cause one or more sensory perceptions in the recipient's body based on the balance compensation output signals to provide balance information. For example, the sensory perceptions can provide balance information to the recipient through one or more non-vestibular sensory channels of the recipient. The one or more sensory channels can include, for example, a visual sensory channel, an auditory sensory channel, a tactile sensory channel, other sensory channels, or combinations thereof. Various characteristics of these sensory channels can be modified to convey different components of the balance information. For example, providing balance information about rotation around a first axis (e.g., a roll axis) can be performed using a first characteristic, and providing balance information about rotation around a second axis (e.g., a pitch axis) can be performed using a second characteristic. In another example, providing balance information about rotation around a first axis (e.g., a roll axis) can be performed using a first sensory channel, and providing balance information about rotation around a second axis (e.g., a pitch axis) can be performed using a second sensory channel.

[0113] When the sensory channel is a visual sensory channel, the stimulation component 1240 can be configured to cause the recipient to experience a visual perception that conveys balance information. The balance signal generator 1220 can provide a signal that changes the characteristics of the visual perception to the stimulation component 1240 to convey the balance information. The visual characteristics can include, for example, characteristics of the light provided by a set of one or more lights (e.g., LED lights) that make up the stimulation component 1240, such as color, brightness, blink frequency, position, pattern, other characteristics, or combinations thereof. In an example, the stimulation component 1240 includes a display (e.g., an LCD display) that can display the balance information in any of various forms (e.g., a visual graph or a text description). The stimulator 1200 can be configured to visually provide such information, for example, by setting one or more light-emitting elements of the stimulation component 1240 adjacent to the recipient's eyes such that the light-emitting elements are within the recipient's field of view. The stimulator 1200 can be configured as a wearable headpiece (e.g., shaped like a pair of glasses). In an example, the stimulator 1200 can directly stimulate parts of the recipient's visual system, for example, using a visual prosthesis. In this example, the stimulation component 1240 can be an implantable component configured to provide electrical stimulation to the recipient to cause a visual perception.

[0114] In the case where the sensory channel is the tactile sensory channel, the stimulation component 1240 can be configured to cause a tactile perception indicating balance information. In an example, the stimulation component 1240 can include one or more vibration actuators that vibrate the recipient's skin to convey balance information in a tactile manner. The balance signal generator 122 can provide a signal that changes the characteristics of the tactile perception to the stimulation component 1240 to convey balance information. The characteristics that can be modified to indicate balance information can include, for example, vibration intensity, vibration frequency, vibration position, and others.

[0115] In the case where the sensory channel is the auditory sensory channel, the stimulation component 1240 can be configured to cause an auditory perception indicating balance information in the recipient's body. In an example, the stimulation component 1240 can be a headpiece with a speaker. The stimulator 1200 can be a wearable or implantable auditory prosthesis medical device, such as a bone conduction device or a cochlear implant. In this example, the stimulation component 1240 can be a vibrating bone conduction actuator or an electrode assembly of a cochlear implant, or can include a vibrating bone conduction actuator or an electrode assembly of a cochlear implant. The balance signal generator 1220 can provide a signal that changes the characteristics of the auditory perception to the stimulation component 1240 to transmit balance information. The characteristics that can be modified to indicate balance information can include, for example, loudness, pitch, stimulation frequency, position (e.g., left or right), other characteristics, or a combination thereof. In addition to or instead of pitch, the audio perception can be an audio description, such as an audio description that can be provided by a text-to-speech system that describes the balance information.

[0116] A balance compensation signal can be generated to cause a perception that conveys balance information regarding movement about one or more of the pitch axis, roll axis, or yaw axis. Rotation about the pitch axis can involve the recipient's head tilting up or down (e.g., in a nodding motion). Rotation about the roll axis can involve the recipient's head tilting left or right. Rotation about the yaw axis can involve the recipient's head rotating left or right. For example, the implementation of the stimulator 1200 can provide an audio signal at a first frequency (e.g., corresponding to the pitch Di) to represent a positive rotation about the roll axis, and an audio signal at a second frequency (e.g., corresponding to the pitch CO) to represent a negative rotation about the roll axis. The degree of rotation can be represented by changing the volume of the provided audio signal. For example, when the rotation is approximately 0 degrees, the volume can be approximately 0 dB, and as the rotation approaches 90 degrees, it can increase to approximately 60 dB. When the recipient is accustomed to these signals indicating rotation, these signals can replace the recipient's dysfunctional vestibular system. In some examples, the stimulator 1200 can also include a sound processing path 5510. The balance signal generator 122 can be configured to inject a balance compensation output signal into the sound processing path 5510, such as herein with respect toFigure 5 described in more detail. Auditory perception can be any of the various ways that can provide this information. The stimulator 1200 can take any of various forms.

[0117] Although the system 1000 can be a single-purpose system (e.g., to uniquely treat balance dysfunction by suppressing the vestibular organs and providing balance signals), the system can be a multi-purpose system, for example, the stimulator 1200 provides sensory compensation for multiple sensory systems of the recipient. For example, in addition to compensating for the dysfunctional vestibular system, the stimulator 1200 can also cause stimulation to compensate for the dysfunctional visual or auditory system of the recipient. In this example, the balance signal generator 1220 can supplement the signal generator to treat sensory deficits. For example, the stimulator 1200 can be an auditory prosthesis configured to cause a hearing perception in the recipient's body indicating the auditory environment around the recipient. This stimulator 1200 can also include a sound processing path configured to convert an environmental sound input signal into an auditory stimulation signal to cause stimulation via the stimulation component 1240. The balance signal generator 1220 can inject a balance information output signal into the sound processing path to cause a hearing perception in the recipient's body indicating balance information.

[0118] As described above, the various components of the system 1000 can be disposed in the same housing or separate housings. As shown, the system 1000 can include a wearable housing 1020, and the vestibular suppressor signal generator 1120, the balance signal generator 1220, and the sound processing path 5510 are disposed in the wearable housing. The wearable housing 1020 can be configured to be worn by the recipient, for example, by a headband, magnetic connection, hairpin, or by another technique. As further shown, the system 1000 can include an implantable housing 1040. The implantable housing 1040 can at least partially include the suppression component 1140 and the stimulation component 1240. For example, the components 1140, 1240 can extend from the implantable housing 1040. The implantable housing 1040 can be constructed of a biocompatible material or coated with a biocompatible material. In some examples, the implantable housing 1040 also includes one or more of the vestibular suppressor signal generator 1120, the balance signal generator 1220, and the sound processing path 5510. Although the various components can be separated into the wearable housing 1020 and the implantable housing 1040, in some examples, the components can be entirely disposed in the wearable housing 1020 or the implantable housing 1040. For example, some embodiments can implement the vestibular suppressor 1100 and the stimulator 1200 as fully implantable devices.

[0119] As shown, a stimulator 1200 and a vestibular inhibitor 1100 are disposed on one side of a recipient's head. In other examples, the recipient may have multiple different stimulators 12000 and vestibular inhibitors 1100. In an example, there is a bilateral configuration with a left vestibular inhibitor and a right vestibular inhibitor 1100, as well as a left stimulator and a right stimulator 1200. Such components may be configured to stimulate the recipient's respective left and right vestibules or other tissues. In some examples, multiple components may cooperate with each other to provide substantially the same or different stimulations. In some examples, the laterality of the stimulation (e.g., the signal on one side is stronger than the signal on the other side) may indicate a particular balance state.

[0120] As shown, some examples of the system 1000 may also include one or more sensors 2420 disposed at various locations within the system 1000. The sensors 2420 may be, for example, one or more sensors for detecting balance or gait information, such as accelerometers, gyroscopes, piezoelectric sensors, other sensors, or combinations thereof. Additional exemplary sensors 2420 include physiological sensors, such as heart rate, galvanic skin response sensors, blood pressure sensors, electromyography sensors, other sensors, or combinations thereof. Yet some other examples of the sensors 2420 include microphones and light sensors, among others. The sensors 2420 may include components disposed within the components of the system 1000 or (e.g., via wired or wireless connections) connected to the components of the system. In some examples, the sensors 2420 include software sensors, such as software that obtains data from one or more sensors 2420 and generates additional data based thereon. For example, a software sensor may be configured to obtain data from one or more gyroscopes and accelerometers to generate gait data regarding the recipient. The gait data may relate to the way the recipient walks, runs, or otherwise moves. Such data may describe whether the recipient limps, staggers, or otherwise has an abnormal gait that may indicate a balance problem.

[0121] As further shown, some examples of system 1000 may also include a computing device 1300. The computing device 1300 may be a computing device associated with a recipient of the stimulator 1200. In many examples, the computing device 1300 is a mobile phone, a tablet computer, a smart watch, a pedometer, or a heart rate monitor, but the computing device 1300 may take other forms. Although described primarily in the context of a recipient, the computing device 1300 may be a computing device owned or primarily used by a parent or caregiver of the recipient. The computing device 1300 may have one or more processors configured to perform operations based on instructions stored in the memory of the computing device 1300. The computing device may also include one or more interfaces for interfacing with a user (e.g., via a touch screen) or other devices (e.g., a wireless transceiver). In the example shown, the computing device 1300 includes one or more sensors 2420 and a control application 1320.

[0122] The control application 1320 may be a computer program stored as computer-executable instructions in the memory of the computing device 1300 that, when executed, perform one or more tasks related to the system 1000. The control application 1320 may cooperate with one or both of the vestibular inhibitor 1100 and the stimulator 1200. For example, the control application 1320 may control the timing and manner in which inhibition is provided by the vestibular inhibitor 1100 and the timing and manner in which a signal is provided by the stimulator 1200. In some examples, this control of the operation of the components of the system 1000 may be performed automatically by the control application 1320 or based on input received from a user of the computing device 1300. The control application 1320 may also provide data of one or more signals from the sensors 242 of the computing device 1300 to the stimulator 1200 for use by the balance signal generator 1220. The computing device 1300 may be connected to one or both of the vestibular inhibitor 110 and the stimulator 1200 using, for example, a wireless radio frequency communication protocol (e.g., Bluetooth). The control application 1320 may transmit data through this connection or receive data from one or both of the vestibular inhibitor 1100 and the stimulator 1200. In the case where the stimulator 1200 includes a sound processing path 5510, the control application 1320 may be configured to stream audio as an input, for example, from a microphone of the sensor 2420 or an application running on the computing device 1300 (e.g., a video or audio application) into the sound processing path 5510. In other examples, another application running on the computing device 1300 may stream audio into the sound processing path 5510.

[0123] As described above, the components of the system 1000 may take any of a variety of forms. In Figure 7Exemplary devices that can be used to implement one or both of the vestibular inhibitor 1100 and the stimulator 1200 are described. And in this regard, Figure 7 FIG. Figure 7 is a functional block diagram of an exemplary device 2000 for implementing one or both of the vestibular inhibitor 1100 and the stimulator 1200. In the example shown, the device 2000 includes a first device 2020 acting as an external processor device and a second device 2500 acting as an implantable stimulator device. In the example, the second device 2500 is an implantable stimulator device configured to be implanted under the tissue (e.g., skin) of a recipient. In the example, the second device 2500 includes a biocompatible housing. The first device 2020 can be a device configured to be coupled (e.g., wirelessly) to the second device 2500 to provide additional functionality (e.g., stimulation control signals or charging). Although the device 2000 is shown as having both implantable and external components, the implementation of the device 2000 can be entirely external or entirely implantable.

[0124] In the example shown, the first device 2020 includes one or more sensors 2420, a processor 2440, a transceiver 2460, and a power source 2480. The one or more sensors 2420 can be units configured to generate data based on sensed activity. In an example where the stimulation system 200 is an auditory prosthesis system, the one or more sensors 2420 can include sound input sensors such as a microphone, a pickup coil, a wireless audio source (e.g., a Bluetooth transceiver), an electrical input for an FM hearing system, and / or another component for receiving sound input. In the case where the stimulation system 0200 is a visual prosthesis system, the one or more sensors 2420 can include one or more cameras or other visual sensors. The processor 2440 can be a component (e.g., a central processing unit) configured to control the stimulation provided by the second device 2500. The stimulation can be controlled based on data from the sensors 2420, a stimulation schedule, or other data. In the case where the stimulation system 2000 implements an auditory prosthesis, the processor 2440 can be configured to convert a sound signal received from the (one or more) sensors 2420 (e.g., acting as a sound input unit) into an external device signal 2510 using, for example, a sound processing path described elsewhere herein. The transceiver 2460 is a component configured to transmit the signal 2510 (e.g., a power signal, a data signal, other signals, or a combination thereof (e.g., by interleaving signals)). The transceiver 2460 can be configured to receive power or data. The stimulation signal can be generated by the processor 2440 and transmitted to the second device 2500 using the transceiver 2460 for providing stimulation.

[0125] In the illustrated example, the second device 2500 includes an electronic module 2100, a stimulator assembly 2300, a transceiver 2460, a power supply 2480, and a coil 2560. The second device 2500 also includes a hermetically sealed biocompatible housing that encloses one or more of the components.

[0126] The electronic module 2100 may include one or more other components for providing stimulation. In many examples, the electronic module 2100 includes one or more components for receiving signals and converting the signals into stimulation signals 215. The electronic module 2100 may also include a stimulator unit. The electronic module 2100 may generate the stimulation signals 215 or control the delivery of the stimulation signals to the stimulator assembly 230 to stimulate tissue adjacent to the stimulator assembly 2300. In an example, the electronic module 2100 includes one or more processors (e.g., a central processing unit) coupled to a memory component (e.g., flash memory) that stores instructions that, when executed, cause the performance of the operations described herein. In an example, the electronic module 2100 generates and monitors parameters associated with generating and delivering stimulation (e.g., output voltage, output current, or line impedance). In an example, the electronic module 2100 generates a telemetry signal (e.g., a data signal) that includes telemetry data. The electronic module 2100 may send the telemetry signal to the first device 2020 or store the telemetry signal in the memory for later use or retrieval.

[0127] The device 2000 may include one or more stimulator assemblies 2300, which may be one or more components configured to provide stimulation to a target tissue. In the illustrated example, there are two stimulator assemblies 2300, one corresponding to the implantable inhibition assembly 1140 and the implantable stimulation assembly 1240. Additionally, in the illustrated example, the stimulator assembly 2300 is an electrode assembly that includes an electrode array 2320 disposed on a lead configured to be inserted into the cochlea of a recipient. The stimulator assembly 2300 may be configured to deliver the stimulation signals 2150 (e.g., electrical stimulation signals) generated by the electronic module 2100 to the cochlea to cause a hearing perception in the recipient. In other examples, the stimulator assembly 2300 is a vibration actuator that is disposed inside or outside the housing of the second device 2500 and is configured to generate vibrations. The vibration actuator receives the stimulation signal 2150 and generates a mechanical output force in the form of vibrations based on the stimulation signal. The actuator may deliver the vibrations in a manner that produces movement or vibrations of the recipient's skull, thereby causing a hearing perception by activating hair cells in the recipient's cochlea via cochlear fluid movement. Additionally or alternatively, the actuator may deliver the vibrations to cause a tactile perception in the recipient.

[0128] The transceiver 2460 can be a component configured to receive and / or transmit signals 2510 (e.g., power signals and / or data signals) transcutaneously. The transceiver 2460 can be a collection of one or more components that form part of a transcutaneous energy or data transfer system to transfer signals 251 between a first device 202 and a second device 250. Various types of signal transmission, such as electromagnetic, capacitive, and inductive transmission, can be used to effectively receive or transmit signals 2510. The transceiver 2460 can include a coil 2560 or can be electrically connected to the coil.

[0129] The coil 2560 can be a component configured to generally receive or transmit signals 2510 via an inductive device formed by multiple turns of wire. In an example, other devices, such as an antenna or a capacitor plate, can be used in addition to or instead of the coil. A magnet 2340 can be used to align the respective coils 2560 of the first device 2020 and the second device 2500. For example, the coil 2560 of the second device 2500 can be arranged relative to the magnet 2340 (e.g., in a coaxial relationship therewith) to facilitate the orientation of the coil 2560 relative to the coil 256 of the first device 2020 via a magnetic connection 2350. The coil 256 of the first device 2020 can also be arranged relative to the magnet 2340 (e.g., in a coaxial relationship therewith).

[0130] The power supply 2480 of the respective device can be configured to provide operating power to other components. The power supply 2480 can be one or more rechargeable batteries or can include one or more rechargeable batteries. The power of the battery can be received from a power source and stored in the battery. Then, the power can be distributed to other components of the second device 2500 as needed for operation.

[0131] It should be understood that although specific components are described in conjunction with these, the techniques disclosed herein can be applied to any of a variety of situations. The foregoing discussion is not intended to imply that the disclosed techniques are only suitable for implementation within a system similar to that shown in and described with respect to the figures. In general, additional configurations can be used to practice the methods and systems herein, and / or some of the aspects described can be excluded without departing from the methods and systems disclosed herein. For example, although Figure 2 the second device 250 is shown implanted beneath the tissue of a recipient, the system 2000 can be formed without implanted components. Instead, for example, the stimulation assembly 2300 can be configured to be used externally / an external stimulator can be used.

[0132] The various components of the system 1000 can cooperate to compensate for balance dysfunction of the recipient of the system 1000. An exemplary process will now be described.

[0133] The process can include obtaining data from one or more sensors 2420. For example, one or both of the vestibular inhibitor 1100 (e.g., its vestibular inhibitor stimulator generator 1120) and the stimulator 1200 (e.g., its balance signal generator 1220) can obtain the data. The one or more sensors 2420 can be one or more balance sensors that obtain balance data. Such data can include, for example, accelerometer data, gyroscope data, or magnetometer data. The data can describe rotation about one or more axes (e.g., pitch axis, yaw axis, or roll axis). Obtaining data from the one or more sensors 2420 can include obtaining data from physiological sensors (e.g., heart rate, galvanic skin response sensor, electromyography sensor, or other sensors). In some examples, the one or more sensors 2420 are disposed remotely from the component obtaining the data. The obtaining operation can include wirelessly obtaining data from the remote sensors 2420. For example, in an example, the balance signal generator 122 obtains data from the computing device 1300. This process can include inhibiting the recipient's vestibular system. Such inhibition can include the vestibular inhibitor signal generator 1120 generating a signal that stimulates the recipient's vestibular system in a manner that inhibits the dysfunctional signals provided by the recipient's vestibular system to the stimulation assembly 1140. In various embodiments, the inhibition can be substantially constant, intermittent, performed in response to a schedule, or performed based on the sensor data obtained in operation 3200. Such inhibition can be controlled automatically or manually. For example, a user interface (e.g., a switch, button, touchscreen, or controls for a wireless connection) can be provided (e.g., at the computing device 1300) to allow the recipient or their caregiver to engage or disengage the inhibition. Such a user interface can also be used to modify the strength or other parameters of the inhibition provided.

[0134] In some examples, inhibiting the vestibular system can include deactivating tissue associated with the vestibular system, such as by ablating tissue associated with the vestibular system. In some examples, an agent is provided to the recipient that inhibits the vestibular system or the perception of signals provided by the vestibular system.

[0135] The process can include generating an inhibitory stimulation signal. The inhibitory stimulation signal can be generated using, for example, the processor 2440 or the electronic module 2100 associated with the inhibitor 1100. The generation of these signals can cause the inhibitory process to be substantially constant, intermittent, performed in response to a schedule, or performed based on sensor data. The inhibitory stimulation signal can be a signal available for controlling the delivery of the stimulation. For example, such inhibition can include electrically stimulating the vestibular system using one or more electrodes of the inhibition component 1140. The stimulation can be configured to mask naturally occurring signals generated by the vestibular system that can cause abnormal vestibular perception in the recipient. In some examples, such inhibition can include delivering the stimulation at approximately 500 Hz, approximately 900 Hz, or at less than 1 kHz.

[0136] The process can include applying an inhibitory stimulation based on the inhibitory stimulation signal. The techniques for applying the stimulation can vary according to the configuration of the stimulator component 2300 used. For example, in the case where the stimulator component 2300 is an electrode component, applying the stimulation can include using the stimulator component to electrically stimulate the recipient. The stimulation can be delivered to the otolith region, the semicircular canals, or other regions of the recipient's vestibular system to inhibit the vestibular system. In another example, the stimulation is delivered to the vestibular nerve.

[0137] The process can include ceasing to inhibit the vestibular system. For example, electrical stimulation or other stimulation of the vestibular system can be stopped. The stopping can be performed in response to any one of various events (e.g., detecting that the recipient is not walking or not otherwise moving). For example, it may be desirable to inhibit the vestibular system when the recipient is moving around and to stop the inhibition at other times (e.g., when the recipient is sitting or lying down). In some examples, the inhibition is stopped when the recipient is sleeping (e.g., which can be detected based on various factors such as the time of day, the recipient's movement, the detection by a light sensor of no light, other factors, or a combination thereof). In some examples, the inhibition can occur in response to detecting that the recipient has an abnormal gait or is falling or about to fall. The inhibition can be stopped in response to determining that such an event (e.g., an elevated fall risk) no longer occurs. And, note that any disclosure herein of stopping inhibition and / or starting inhibition (or suppression) corresponds to an alternative disclosure of stopping stimulation and / or starting stimulation with respect to embodiments regarding using stimulation for augmentation purposes and / or generating signals for brain purposes.

[0138] The process may include providing a balance compensation output signal to a recipient via one or more non-vestibular sensory channels of the recipient. The providing may include providing a first balance compensation output signal while suppressing the recipient's vestibular system. The providing may include providing a second balance compensation output signal when the suppression is stopped. The process may include generating one or more balance compensation output signals. The balance compensation output signals may be configured to compensate for a recipient's vestibular deficiency. The process may include obtaining a balance compensation input signal 2430 from one or more sensors 2420. Such balance compensation input signals 2430 may include, for example, signals related to rotation about one or more axes.

[0139] The process may include generating one or more balance compensation output signals based on the balance compensation input. The process may include encoding data regarding rotation about one or more axes using one or more characteristics. The process may include encoding data regarding rotation about a first axis, a second axis, and a third axis using a respective first characteristic, second characteristic, and third characteristic. In some examples, the axes are selected from a yaw axis, a roll axis, and a pitch axis. The axes may be with respect to the recipient such that rotation about a particular axis provides information regarding, for example, movement of the recipient's head. Rotation about the first axis may be determined based on, for example, a compensation input signal obtained from one or more sensors 2420. The characteristics may be characteristics of a perception that is ultimately perceived by the recipient. The encoding may include modifying a signal (e.g., the balance compensation output signal) such that the signal ultimately causes a perception to be detected by a recipient having those characteristics. These characteristics may vary based on a stimulation modality (e.g., tactile perception, audio perception, or visual perception). Additionally, the selected stimulation modality itself may be a characteristic that can be used to convey balance information. For example, in the case where the stimulation modality is audio, such audio characteristics that may be varied to indicate rotation about various axes may include: loudness, pitch, stimulation frequency, melody, rhythm, position (e.g., left or right), stereo effect (e.g., relative loudness or other differences between left playback and right playback), other characteristics, or combinations thereof. Further, the same characteristics may be used to indicate information regarding rotation about multiple axes.

[0140] In an example, pitch is used to encode rotation about a first axis and a second axis, and volume is used to encode the degree of rotation about these axes. For example, when a recipient rotates their head about a roll axis, a tone having a first pitch can be played at a first volume. When the recipient continues to rotate their head further, the first volume can increase while the pitch remains the same. Additionally, when the recipient rotates their head about a pitch axis, a tone having a second pitch can be played at a second volume. When the recipient continues to rotate their head further, the second volume can increase while the second pitch remains the same. These two tones can be played substantially simultaneously with each other. In some examples, a positive or negative rotation angle can be encoded based on on which side of the head the sound is played. The process can include applying a stimulus based on a balance compensation output signal. Applying the stimulus can include generating an electrical, vibratory, visual, or other type of stimulus based on the signals described herein, for example. Such a stimulus can be configured to provide balance compensation.

[0141] The process can include inducing an auditory perception. Inducing an auditory perception can include stimulating a recipient's auditory system such that the recipient perceives an audio event. The process can include electrically stimulating the recipient's cochlea. For example, one or more intracochlear electrodes can be used to stimulate the cochlea. Examples of cochlear implants that can be used to induce an auditory perception are described in Figure 4 The process can include applying a vibratory stimulus. The vibratory stimulus can include causing, for example, bone conduction or air conduction vibrations, such as from a bone conduction device or a consumer audio product, respectively. Such vibrations can enable the recipient to experience an auditory perception.

[0142] The process can include inducing a visual perception. Inducing a visual perception can include stimulating a recipient's visual system such that the recipient perceives a visual event. The process can include activating an LED (light-emitting diode) or an LCD (liquid crystal display) to induce a visual perception. The process can include directly stimulating the recipient's visual perception system via an electrical stimulus or other stimulus.

[0143] The process can include inducing a tactile perception. Inducing a tactile perception can include vibrating a recipient's skin with one or more vibration actuators to convey balance information haptically.

[0144] Note that various devices, systems, and methods have been described that can be used individually and / or jointly to compensate for balance / coordination dysfunctions or otherwise compensate for vestibular dysfunctions. Embodiments can utilize one or more or all of the teachings detailed herein individually and / or in combination in any manner capable of implementing the teachings herein. Also, note that the various devices described above have features that are related to each other in some cases. Thus, embodiments include any combination of one or more of the above teachings associated with the devices detailed above or alternatively any one or more of other teachings that replace the devices detailed above, unless otherwise stated, so long as they can be implemented in the art. In this regard, for the purpose of text brevity, some features and / or components and / or method acts associated with one type of device have not been presented because these features can, in some cases, be present in other devices.

[0145] In a person's normally functioning sensory system, there can be three sensory inputs that the human body utilizes to achieve balance. First, there is vestibular system input, which can provide equilibrium, spatial awareness, rotational, and linear force inputs. Second, there is also visual input, which requires vision. The third sensory input is proprioception, which requires touch and sensation. In a normally functioning person, these three sensory inputs are provided to the cerebellum, which coordinates, regulates postural movements, and balance. These three inputs can also be provided to the brainstem, which integrates sensory information and sorts it.

[0146] Most of the embodiments disclosed herein focus on the first sensory input, i.e., the vestibular. But note that embodiments can also include affecting vision and / or proprioception. Embodiments can relate to enhancing and / or suppressing or otherwise affecting the vestibular system in order to improve a person's balance and coordination. Again, as described above, there can be a system that reconstructs the sense of balance by using signals to provide stimulation, there can be a system that inhibits or suppresses the balance function, there can be a system that generates some other stimulation (e.g., acoustic stimulation), i.e., using the relevant information collected by a sensor system that can include an accelerometer and / or a gyroscope. Embodiments can include a combination of two or more or all of the systems.

[0147] The present inventor has determined that there can be practical value in controlling various systems for providing stimuli to a person to improve balance or additional systems that affect the vestibular function / system based on the state of the environment surrounding the person. As an example, with respect to the medical device for suppressing the vestibular balance function detailed above, once such a device begins to suppress in this way, the recipient of the device will need to use other sensory inputs for balance and coordination, such as the visual system. The present inventor has also determined that in such situations, depending on the environment, there can be practical value in increasing or otherwise initiating the provision of sensory substitution relative to what might otherwise occur. In this regard, in an exemplary embodiment, by way of example only, the embodiment can include evaluating the ambient light level to be used as a basis for whether the vestibular balance function should be suppressed or, alternatively, how much the vestibular balance function should be suppressed. For example, when there is a certain amount of ambient light, the visual sensory input operates optimally. Too little light, or in some cases, too much light will reduce the practical value of the visual sensory input relative to what might otherwise occur. Thus, in at least some exemplary situations, by way of example, suppressing the vestibular balance function at low light levels can have adverse effects. Accordingly, the embodiment includes the function of a medical device that enables the medical device to receive an input indicating the surrounding environment (such as the ambient light level). By way of example only and not by way of limitation, the medical device detailed above can include a light capture device capable of capturing light, such as a photodiode or a CCD. A light sensor can be used. A photoresistor can be used. Any combination of these sensors can be used, as long as it can be implemented in the art. In an embodiment, the light capture device approximates the human eye response. In an embodiment, the medical device includes a processor that is capable of evaluating a signal based on the captured light and determining or otherwise estimating the ambient light level. In an embodiment, there can be a device that is the same as or otherwise similar to a device capable of automatically determining whether to use flash for, for example, a digital camera. Control logic and / or its settings can be used in / with the medical device. In fact, in an exemplary embodiment, the medical device can signal communicate with a smartphone (such as the situation above Figure 3A ), the smartphone having a "camera phone" and having an application thereon capable of evaluating a signal from the light capture device (such as the CCD of the smartphone) and determining or otherwise estimating the ambient light level. The smartphone can provide a signal to the vestibular implant or other medical device (such as wirelessly, for example, via Bluetooth) that indicates the ambient light level, or alternatively provide a final control signal that determines whether the medical device should suppress the vestibular balance function and / or how much the vestibular balance function should be suppressed, all by way of example.

[0148] Note also that, in view of the cross - integration of the technologies described herein, such as the technology of using a cochlear implant in combination with a vestibular stimulation device, embodiments can include, in some embodiments, a light - capturing device and circuitry (at least some thereof) of a retinal implant as the light - capturing device of a balance - sensing device.

[0149] Thus, in one embodiment, there is a medical device (e.g., a vestibular implant) that includes a light - capturing device on an external device (e.g., a BTE device, or an off - ear device for example) that can capture ambient light. The device is capable of measuring the ambient light level. In an embodiment, the vestibular implant only begins to stimulate and suppress vestibular function when it determines that there is sufficient ambient light in the recipient's environment. Thus, referring Figure 8 , the external component 840 of the vestibular implant can include a behind - the - ear (BTE) device 826 connected to an exemplary head member 1478 via a cable 1472, the head member including an external inductive coil 1458EX, which corresponds to Figure 5 the external coil of. As can be seen, there are three (3) CCD sensors 888. In an embodiment, the element 888 can be the lens of a smartphone, such as a wide - angle lens, or any other lens capable of implementing the teachings detailed herein. In some embodiments, any off - the - shelf light - capturing device capable of capturing light or otherwise sensing light and outputting a signal (an electrical signal or an optical fiber signal or other signal) can be used, and the signal can be fully utilized to evaluate the ambient light level. And, in this regard, the signal output by the light - capturing device is provided to a computer chip or a processor or some other arrangement of electronics (e.g., a logic circuit) that receives this signal and analyzes this signal to evaluate the ambient light level based on this signal. The electronics can have circuitry configured to determine or otherwise evaluate the amplitude and / or frequency of the light (which can be such that the wavelength of the ambient light can be used to determine whether to implement vestibular balance function suppression or otherwise at which level to operate). The circuitry can include a high - pass filter or a low - pass filter.

[0150] The external component (implantable component - some embodiments may relate to a so-called fully implantable vestibular implant, similar to a fully implantable cochlear implant) may include circuitry (e.g., a processor or computer chip) capable of evaluating based on signals of ambient light levels received from a light capture device. More specifically, the external component (implantable component - hereinafter, any disclosure of the external component corresponds to an alternative disclosure of the implantable component and vice versa, unless otherwise stated, as long as it can be implemented in the art) may include a look-up table with pre-stored values. The values in the look-up table may be compared with relevant values associated with the signals received by the electronics of the external component from the light capture device. The values in the look-up table may correspond to light levels indicating good light levels or bad light levels or otherwise light levels indicating that the vestibular balance function should be suppressed (or not suppressed). These values may be based on empirical values and / or analytical values. All of this may be performed in an automated manner.

[0151] Briefly noted, the vestibular implant may be configured with a switch or otherwise configured with an input kit that may enable the recipient to activate and deactivate the light level feature of this exemplary embodiment. In this regard, it may be the case that the recipient knows that the ambient light level is high enough to implement other teachings detailed herein, but for one reason or another, the sensor 888 is not able to adequately capture the true ambient light. This may be because the recipient is wearing a wide-brimmed hat or, for some reason, the recipient's hair extends in front of the sensor 888. That is, the embodiment may include the ability to cover or otherwise disable the light capture feature of the implant so that the implant functions as it normally does in the absence of the innovative features associated with the surrounding environment sensor.

[0152] Figure 9An exemplary flowchart of an advanced exemplary method according to an exemplary embodiment is presented. The method begins at method act 910, where a user initiates vestibular stimulation by activating the vestibular stimulation function on their vestibular stimulation implant. In this exemplary embodiment, the vestibular stimulation implant has been implanted and is additionally powered on and waiting to be actuated. Prior to method act 910, the implant is turned off, or at least the implant is in a sleep mode or a mode where the implant is not stimulating the recipient's vestibular system. In this embodiment, even if the user activates the vestibular stimulation function of the implant, the device does not begin stimulation. Instead, the device moves to method act 920, where the device automatically checks the ambient light level. In this regard, this can be considered a precautionary or potential override measure regarding the actions of the user / recipient. This can be similar to the lane keeping function of an advanced automobile. By inference, in at least some exemplary embodiments, the user / recipient can override this feature, whether before method act 920 or after method act 920. In fact, in an exemplary embodiment, the vestibular implant is configured such that the logic circuitry bypasses method act 920 and goes directly to method act 940, the features of which are described below. Still, regarding method act 920, here, the logic circuitry of the device, whether part of the external portion of the implant or not, evaluates the signal from the light capture device 888 to check the ambient light level. If it is determined that the light level is not high enough, the algorithm proceeds to method act 930, which is to prevent the device from performing vestibular stimulation. Conversely, if it is determined that the light level is high enough, the algorithm proceeds to method act 940, which is to begin / perform vestibular stimulation.

[0153] As mentioned above, the user can override the environmental sensor feature of the implant. This is represented by the dashed line 945, which extends from the action where the user activates vestibular stimulation to act 940, which requires the beginning of vestibular stimulation. In an exemplary embodiment, a dedicated switch 871 can be provided on the device 840, and the recipient can press this switch to activate and / or deactivate the environmental sensor function of the implant. The switch 871 can be configured to open or close a circuit that leads to the logic circuitry of the system in order to enable and / or disable the environmental sensor function.

[0154] Figure 10 Shows Figure 9 a continuation of the algorithm. Here, when it is determined that vestibular stimulation at act 940 should begin, the vestibular implant periodically (including continuously) checks the ambient light level. When it is determined that the ambient light level is high enough, there is essentially a continuous do loop. Conversely, when it is determined that the light level is not high enough, the method proceeds to method act 1020, where vestibular stimulation is stopped. Thus, by Figure 10The method represented is a method that is operated or otherwise carried out when the vestibular stimulation implant is stimulating the vestibular system or at least enabled to stimulate the vestibular system, because the ambient light was previously determined to be high enough, but the ambient light level is repeatedly checked, and when it is determined that the light level is not high enough, the function is substantially overridden. Note that in an exemplary embodiment, an indication that the implant is operating may be provided to the recipient according to any one or more circumstances. For example, if the implant is operating to provide vestibular stimulation because there is sufficient light, the implant can provide some form of notification to the recipient, whether by way of an audio chirp or verbal sound in this regard, or light or some form of tactile output. Conversely, if the implant stops providing vestibular stimulation because the light is insufficient (or does not provide such stimulation in the first case), the implant also provides some form of notification to the recipient.

[0155] Figure 9 and 10 The embodiments of and

[0155] use a binary logic system in cases where the light level is high enough or not high enough. There is no intermediate case in this exemplary embodiment. Moreover, the function is applied as an all-or-nothing function at least with respect to the surrounding environment, because the vestibular stimulation is either initiated / activated, or the vestibular stimulation is blocked. As will be described below, in an alternative embodiment, the light level is evaluated on a sliding scale, and the functionality of the implant is based on different levels of perceived / perceivable light.

[0156] Figure 11Presents another exemplary flowchart that also starts at method action 940. Here, the system again performs method action 1010. If the light level is the same as or greater than before (e.g., again, there can be a situation where too much light causes problems, so the check can be to check that the light is within a certain range, where being below or above that range is the cause for stopping the stimulation, or as is the case here, at least notify the recipient to pay attention), then the system continues to provide vestibular stimulation. And, when it is determined that the light level has changed such that it is not high enough, or at least has decreased by a certain amount (which may still keep the light level high enough, where the light level decrease indicates a need for some form of action), then the implant proceeds to method action 1160, which requires the implant to notify the recipient of the light level change and / or instruct the recipient to take an action, such as at least being careful or turning on the light, etc. In this exemplary algorithm, after the notification, the method returns back to checking the ambient light level. If the light level does not change, or more precisely, if the light level does not decrease further, then the system can remain in a continuous loop, and if it does decrease further, then the system may re-notify the recipient that the light level has decreased further. Similarly, in the exemplary embodiment, when the light level is the light level decrease, the implant can periodically remind the recipient of this situation, or otherwise periodically instruct the recipient to take certain actions. The recipient can override this repeated warning or otherwise cancel the repeated message by providing an input into an external device (e.g., by pressing switch 871 as an example).

[0157] Figure 12Presents another exemplary flowchart, which also starts at method action 940. Here, the system again performs method action 1010. If the light level is the same as or greater than before, the system continues to provide vestibular stimulation. And, upon determining that the light level has changed such that it is not high enough, or at least has decreased by a certain amount, the implant proceeds to method action 1260, which requires the implant to notify the overall system (e.g., the Internet of Things and / or its specific devices) to take an action. In this embodiment, by way of example, the action is to automatically adjust the state of the lights in the area around the recipient. For example, the implant can signal communicate with one or more devices of the Internet of Things via Bluetooth communication or some other wireless communication scheme, and can convey a command signal to the Internet of Things to turn on one or more lights that are currently off, or increase the output of one or more lights that are currently on but at a low output level. Alternatively, the output can simply be the value of the light level determined by the implant, or even the raw data from the light capture device, and then the Internet of Things can make a determination as to whether or how to adjust the ambient lighting. This process can be iterative in at least some exemplary embodiments. Additionally, it should be noted that although this embodiment focuses on brightening the ambient lighting, in some embodiments, according to the teachings above, there can be a situation where if the light level increases beyond the upper limit of a given value range for that light level, the lighting is actually decreased.

[0158] And, although the embodiments herein focus on light level, in some embodiments, it can be other characteristics of the surrounding environment, such as noise level or even temperature for that matter. In some embodiments, any surrounding environment characteristic that can improve the efficacy of the teachings detailed herein can be used. Also, although the above focuses on light level, again as briefly noted above, it can be the frequency of the light that can be adjusted or otherwise controlled to improve the efficacy of the teachings herein.

[0159] In view of the foregoing, it can be seen that in an embodiment, there is a system (e.g., a medical system) that includes a first subsystem and a second subsystem, the first subsystem being configured to have a neurological effect on a human when activated, and the second subsystem being configured to obtain data based on the surroundings of the system. In this embodiment, the system is configured to control the first subsystem at least in part based on the obtained data, and the system is a medical system for human balance. In combination with the teachings above, the first subsystem can be a vestibular nervous system stimulation device. The first subsystem can provide an electrical signal directly or indirectly to the vestibular nervous system of a human (again, in some cases, the embodiment can be a completely external device without any implanted components, where the electrodes of the system are located, for example, on the skin). The first subsystem can be a therapeutic substance delivery subsystem, such as a device that releases a chemical substance into the human body. This can be a subcutaneous implant device that can have, for example, a catheter that is in fluid communication with the (multiple) vestibular ducts and can inject a fluid (e.g., a chemical substance) that can have a neurological effect on a human therein. Figure 13 Exemplary implantable components of a vestibular stimulation device - Device 1300 are presented. The device includes a receiver 1310 and logic / control circuitry 1320 that is connected by electrical leads to a therapeutic substance electromechanical actuator syringe 1330 having a terminal 1340. Briefly, Device 1300 can generally correspond to the implantable components of a cochlear implant and / or a vestibular implant as detailed above. Implant 1300 can receive control signals transcutaneously from an external component, and these control signals are related to control circuitry 1320. This control circuitry converts these control signals into electrical signals that are supplied by the electrical leads to electromechanical syringe 1330. Terminal 1340 extends into a vestibular duct or another component of the middle ear. Depending on the signals received from the external component, electromechanical syringe 1330 can inject a therapeutic substance into the middle ear when it determines that it can be used to obtain practical value with respect to the treatment protocols detailed herein.

[0160] In combination with the teachings detailed above, the first subsystem configured to have a neurological effect on a human when activated can be a conventional vestibular implant that provides or otherwise reconstructs a sense of balance by stimulating using signals related to information collected by an accelerometer and / or a gyroscope. It can also be a device that at least partially suppresses or inhibits the operation of the vestibular system. It can also be a device that provides a sensory stimulation substitute as detailed above. It can be a combination of any of these. However, in an embodiment, the first subsystem is a vestibular implant.

[0161] In some exemplary embodiments, any device and / or system that can implement the teachings detailed herein and that can have a neurological effect on a human when activated to treat balance and / or coordination problems in a human or a mammal can be used.

[0162] In combination with the teachings above, the second subsystem can be a light capture subsystem. Alternatively, or in addition, the second subsystem can be a sound sensor subsystem.

[0163] In more practical terms, the overall system can be a system configured to suppress sensory input to a person's brain in different ways. In this regard, in an exemplary embodiment, the system can be configured to suppress and / or inhibit the vestibular balance function. As described above, some people may suffer from diseases in which the vestibular balance function relative to a normally operating vestibular system causes the person to become unbalanced or otherwise uncoordinated. Thus, suppressing and / or inhibiting the vestibular balance function can have practical value. In some embodiments, this can be achieved by applying an electrical signal to the vestibular nervous system. This may require applying the electrical signal directly to the inner ear, or applying the electrical signal directly to another part of the person (such as the brain), to the spine, or some other part of the person, as long as this can inhibit and / or suppress the vestibular balance function. Of course, as described above, the signals may be provided from outside the body, so these signals can be indirectly applied to one or more of the various body parts just mentioned. Thus, in at least some exemplary embodiments, the electrical signal is not necessarily applied to the person's ear system. Any signal application that can be of practical value in light of the teachings detailed herein can be utilized in at least some exemplary embodiments. Note that in some embodiments, the system is configured to enhance and / or provide sensory input to a person's brain in different ways, the sensory input being, for example, input from the vestibule, and / or to fully reconstruct the output of the vestibular system (regardless of the location, whether from the vestibular system or elsewhere - any stimulus regarding balance at any location can be used in at least some embodiments). Similarly, the devices herein are configured to enhance and / or provide signals traveling from the vestibule to the brain by using (a)n electrical signal to stimulate the tissue of the recipient.

[0164] Regarding suppressing sensory input to a person's brain, some embodiments can include using the first subsystem in a way that completely shuts off the person's vestibular balance function or otherwise renders the vestibular balance function meaningless. Regarding inhibiting sensory input to the brain, some embodiments can include using the first subsystem in a way that restricts the vestibular balance function or otherwise reduces the impact of the vestibular balance function on the person. This can occur to different degrees, as will be described in more detail below. The point here is that not all embodiments always completely eliminate the vestibular balance function or otherwise render this function completely ineffective. Embodiments can include simply restricting the impact of this function. Briefly, as will be described in more detail below, changes in light levels can be correlated with the level of suppression (controlled suppression) of the vestibular balance function.

[0165] And, in some embodiments, the system is configured to limit the level of effect of the first subsystem on the person based on data obtained from the second subsystem. In this regard, again, with respect to situations where there are various light levels, in bright or other well-lit environments, the system allows the first subsystem to operate at its maximum capacity or fully function, which may completely offset the vestibular balance function, or may limit the vestibular balance function to the maximum extent expected by the subsystem. For example, if the vestibular implant is designed to suppress the vestibular balance function to a level of 35% relative to normal function when the first subsystem is operating at its full capacity, the system may instead operate the first subsystem so that the vestibular balance function is suppressed to a level of, for example, 50% or 60% or 70% relative to normal function. For example, if the vestibular implant is designed to suppress vestibular balance function to a level of 0% relative to normal function (completely ineffective) when the first subsystem is operated at its full capacity, the system may instead operate the first subsystem so that the vestibular balance function is suppressed to a level of, for example, no more than 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75% or 80% relative to normal function, or any value or range of values ​​therebetween in increments of 1%.

[0166] The concept is that a cost-benefit analysis may reveal that inhibiting or suppressing vestibular balance function when the environment is a low light environment may have less practical value, or may even have deleterious consequences, relative to allowing vestibular balance function to affect the person without inhibition and / or suppression. The low light level situation may sufficiently deprive the recipient of sufficient visual sensory input that the deleterious effects of vestibular balance function are best exerted on the person because this is less deleterious than the consequences of inhibiting or suppressing vestibular balance function in a reduced visual sensory input situation. Stated another way, the cost-benefit analysis weighs the effects of reducing vestibular sensory input against reducing visual sensory input. If there is sufficiently reduced visual sensory input, then the reduction of vestibular sensory input will be limited or prevented, even if the vestibular sensory input itself is capable of causing material consequences.

[0167] Such embodiments may have practical value in ensuring or otherwise increasing the chances that visual sensory input is sufficient to supplement reduced vestibular sensory input. In this regard, determining that there is a sufficient light level for the recipient to see or otherwise adjusting the implementation of the first subsystem based on the light level may provide better results in providing balance and / or coordination to the person relative to operating the first subsystem without regard to the environment (here, the light environment) in which the person is located.

[0168] Embodiments include methods. Figure 14An algorithm for an exemplary method (i.e., method 1400) is shown, the method including method act 1410, which includes the act of automatically obtaining data based on the changeable environment of a person with impaired balance. This can be the person's potential environment or the person's acoustic environment or the person's vibrational environment. Any aspect of the environment that can have practical value can be utilized in at least some exemplary embodiments. In one of these embodiments, method act 1410 can be performed using a light capture device of an external component of the vestibular system. In another embodiment, alternatively and / or in addition, method act 1410 can be performed using a smart phone or the like, where the smart phone can have an application that can activate the smart phone camera or other light capture device of the smart phone (the smart phone has a configuration that can adjust the brightness of the display based on ambient light, and embodiments can use this to evaluate the ambient light level, and it should be noted that some embodiments include an external component of the implant, such as a BET device or an off-ear device, which has hardware and software and firmware and circuitry built into the device (e.g., the light capture device of the smart phone that implements light detection to adjust the screen brightness and its logic circuitry can be present in the BET or OTE device)). In embodiments where the light capture device is based on a smart phone, the smart phone can communicate with the implant signals in accordance with the teachings detailed above. Note that in some embodiments, the smart phone can have an accessory that enables long-range wireless electric field sensing such that the smart phone can communicate with the implant without the external component of the implant. By extension, instead of a smart phone, some other form of portable hand-held or body-worn device that can sense the ambient light level can be used, where the portable hand-held or body-worn device is not part of the implant system itself but is an accessory thereto.

[0169] Furthermore, it can be the Internet of Things or the like that can be used to provide data based on the changeable environment of a person. A device that senses the light level in a consumer electronic device located in a home or an environment where a person lives or works or otherwise spends a lot of time (such as the interior of a car) can provide data or otherwise generate data automatically obtained in method act 1410. As an example, a camera of a personal computer can capture light, and there can be a program on the personal computer that is capable of evaluating the captured light and determining the ambient light level in the room or in the area near the laptop computer otherwise. A television set that automatically adjusts its brightness according to the light level can be incorporated into the system loop to provide data automatically obtained in method act 1410. Although the above embodiments focus on sensors that capture light, in alternative embodiments, latent variables can be used to evaluate the light level. As an example, whether one or more or all of the lights in a given room are on, or whether the lights in a house or a certain area / environment are on and / or the power consumption can be used to estimate the light level in the environment. The power consumption can be used as a latent variable to determine the setting of a light (e.g., a three-way light bulb). In an embodiment, the Internet of Things or otherwise the house or building or infrastructure where a person is located can communicate with the implant or with an accessory device to provide data based on the changeable environment of a person. The data obtained in method act 1410 can vary and can originate from various sources as long as these can implement method 1400. In fact, in some embodiments, the act of automatically obtaining data in method act 1410 can be performed with a microphone or the like, which is part of the implant or part of the accessory device, where the microphone picks up a voice statement indicating the brightness of a person with impaired balance. For example, a person with impaired balance may claim that the room is dark, or the room is not very bright, or even make an uncertain statement that indicates the ambient light level (e.g., it is difficult to see clearly). The microphone can automatically capture the voice and thus perform method act 1410.

[0170] Speaking of microphones, again in embodiments where the environment is a sound environment, the microphone of the vestibular implant can pick up the sound in the environment and thus automatically obtain data based on the changeable environment of a person. A vibration sensor can be used to automatically obtain this data. A humidity and / or temperature sensor can be used to automatically obtain this data, where the data is based on local climate values. In fact, the level of wind may affect the balance and / or coordination of a person with impaired balance. In a system including an implant, there can be a wind speed and / or wind direction sensor. And again note that the device for automatically obtaining this data may not necessarily be a direct part of the implant. It can be an accessory device, such as a smartphone.

[0171] Note that although the foregoing and the following generally focus on the brightness of the environment, the characteristics of the environment related to the visual input of a person used in some embodiments can be broader than the general light level. In fact, an environment with many moving objects or other objects that move relatively fast or in a disorganized manner can be an environment that affects the visual perception that can affect balance. And in this regard, the actions related to the characteristics that affect visual perception associated with the environments detailed herein can be applied not only to the light level, but also to the entire visual "scene" or to a specific part of the visual "scene" that may affect a person with impaired balance. Consider a scene where objects are moving in a disorderly manner in different directions, such as a group of children playing on a playground (or an American football game or a non-North American rugby game or a basketball game) or a group of dogs running in a dog park (consider the corgis of Queen Elizabeth II running between the legs of various staff members). The environment may be fully illuminated, i.e., the maximum possible illumination for seeing the surrounding environment (up to the frequency of pupil dilation, brightness, etc.), but these movements may affect visual perception in a way that is harmful to balance. And it is possible that these movements are more organized or even random, and this may also affect visual perception. For example, if a person with impaired balance is exposed to a succession of cars all moving in one direction, if this person relies more extensively on visual perception than otherwise, such as if the stimulation device does not suppress or inhibit the vestibular balance function, then this may affect the balance sense of the person with impaired balance. When this is not the case, the person with impaired balance may have a sense of leaning in the direction of the movement of the cars. And note that this may not necessarily be associated with the pattern of the moving objects or the lack thereof. The simple fact that the objects are moving rather than stationary may cause the person with impaired balance to have a more difficult balance experience. Thus, the characteristics associated with the visual environment are not limited to the more generalized characteristics of similar levels and / or frequencies.

[0172] By inference, a person with impaired balance may have more balance problems in an environment where the objects are less defined relative to each other than in an environment where the objects are more defined. As an example, compared to observing features with less natural and more clearly defined boundaries (e.g., linear objects or sharp boundary objects), a person with impaired balance may have more difficulty with balance in a forest or when observing thick foliage (nature does not run in straight lines).

[0173] Note that the obtaining action in method 1410 does not require an action to formulate the obtained data, although method action 1410 does not preclude such an action. The data can be formulated by a third party (such as a remote database) and then provided to the implant or the user of the implant or any medical device that implements the teachings detailed herein. In fact, in an exemplary embodiment, a room or building or infrastructure where a person with balance impairment lives or spends time can be "wired" to a sensor or device that captures light, and the light level can be evaluated or analyzed at a remote location via an Internet connection or the like. This remote location can provide the data or otherwise give the data such that it can be accessed by the implant or the user of the implant. The data can be data indicating the light level, or the data can be command data or instructions that cause the implant or the recipient of the implant to take an action. And the data obtained in method action 1410 is not necessarily strictly developed. In this regard, in an exemplary embodiment, a caregiver or healthcare provider or friend or partner of a person with balance impairment can provide information about the environment that can be changed (e.g., stating that a certain room is dark or a certain room is darker than another room, etc., or that it is dark outside), and this can be information that is the data obtained in method action 1410.

[0174] Method 1400 also includes method action 1420, which includes at least partially controlling the input from a person's vestibular system to the person's brain based on the obtained data. This may require using any one or more of the devices or their variants detailed herein to reconstruct the sense of balance by stimulating with signals related to the information collected by an accelerometer or gyroscope or some other position capture device, orientation capture device. Thus, the action of at least partially controlling the input to the brain includes initiating artificial stimulation of a person's vestibular nervous system. This can be done using a vestibular implant or some form of external device detailed herein that applies an electric current to a person's skin as long as it artificially stimulates the person's vestibular nervous system. This can also be achieved by providing a chemical substance as described above. And note that the chemical substance provided can be directly provided to the inner ear using Figure 13 a device (as an example), or can be provided in a less invasive manner (such as a transdermal lumen or injection, etc.).

[0175] This can also be an inhibition or suppression of vestibular balance function. Thus, in an embodiment, the action of at least partially controlling the input to the brain includes restricting vestibular function, which encompasses both the actions of inhibition and suppression. And this can also be, for example, sensory substitution. Any device, system, and / or method for at least partially controlling the input from the vestibular system to a person's brain can be used in some embodiments as long as the input is obtained from method action 1410.

[0176] Figure 15Another exemplary flowchart of an exemplary method (i.e., method 1500) is provided. This method reviews the teachings of the exemplary embodiments above regarding actions recommended for persons with impaired balance or other prosthesis recipients, which actions can be useful in at least reducing the likelihood that a person with impaired balance may harm themselves. Thus, method 1500 includes method 1510 (which requires the execution of method 1400), and also includes method action 1520, which includes the action of automatically providing instructions to a person with impaired balance based on the data obtained in method action 1410.

[0177] Returning to method action 1420, in an exemplary embodiment, the action of at least partially controlling the input to the brain includes stopping the artificial stimulation of the person's vestibular system. In this regard, note that there are various types of prosthetic devices that suppress or dampen the balance function by stimulating the person's nervous system (e.g., by non-modulated signals). These types of prosthetic devices must rely more on other sensory inputs that inject balance, such as vision. If the light level is considered too low such that the visual sense cannot adequately compensate for the attenuated vestibular portion of the input, then the artificial stimulation of the vestibular system that suppresses or dampens the balance function is stopped. The idea here is that even with a defective vestibular system, the recipient is better off using its full effect than using a more restricted vestibular system that enhances the reliance on visual input because the light level is below the level that is otherwise sufficient for practical use. Thus, it is to be understood that controlling the input to the brain can be performed by stopping the provision of electrical stimulation (distinguished from not providing electrical stimulation - this action alone is not covered by the control action in method action 1420 - doing nothing is not control, but changing what is being done is control). From this, it follows that method action 1420 can require at least partially controlling the input to the brain by changing the artificial stimulation of the brain's vestibular system. The artificial stimulation can be changed rather than stopped. For example, if the suppression of the balance function causes the vestibular balance function to be reduced to 50% relative to the situation where there is no suppression, then the artificial stimulation can be changed such that the vestibular balance function is reduced to 75% relative to the original situation or some other value. And note that the action of changing the artificial stimulation does not necessarily need to result in alleviating the "attenuation" of the vestibular balance function. If the light level has been considered to have increased or is otherwise considered to be better than the previous situation, then the artificial stimulation can be changed to reduce the suppression of the balance function such that the impact of the balance function on the person with impaired balance is lower than the previous situation. In this regard, if the light level is better than before, then the stimulation treatment can be more aggressive in suppressing the balance function.

[0178] In another exemplary embodiment, method act 1420 can be performed by beginning artificial stimulation of a person's vestibular system. This occurs when the vestibular system has not been artificially stimulated previously. In an exemplary embodiment, if the light level increases, inhibitory and / or suppression acts of an implant or other prosthetic device can be initiated that were not previously initiated. In an exemplary embodiment, the act of beginning artificial stimulation occurs when there has been no artificial stimulation for the past 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 120, 150, 180, 250, 300, 350, 400, 500, or 600 or more minutes or any value or range of values in one-minute increments therebetween. In an exemplary embodiment, acts associated with method 1400 and / or 1500 can be performed automatically. In fact, note that unless otherwise stated, any act detailed herein can be performed automatically by a prosthesis or by a remote device (such as a smart phone) or any other device detailed herein (such as a laptop or desktop computer or a remote device remote from the recipient / balance-impaired person), as long as it can be achieved in the art, unless otherwise stated. And any method act detailed herein can be performed manually or by a person in a non-automatic manner, unless otherwise stated, as long as it can be performed by a person.

[0179] Much of the above focuses on vestibular prostheses that inhibit or suppress vestibular balance function. Note that many of the above features of the method can also be practiced by other types of vestibular prostheses or other balance prostheses. For example, the act of beginning artificial stimulation of a person's vestibular system can be performed by a type of vestibular implant that reconstructs a sense of balance based on some artificial device (such as an accelerometer and / or gyroscope). This is also the case with regard to varying and ceasing artificial stimulation. Thus, any disclosure herein that utilizes a device that inhibits or suppresses vestibular balance function corresponds to an alternative disclosure in which the vestibular system is stimulated by a stimulating device to achieve improved balance and / or improved coordination and / or improved psychological well-being of a person. Any disclosure herein of vestibular stimulation by a medical device corresponds to a disclosure of suppression / inhibition and an alternative disclosure of stimulation to provide a sense of balance and / or enhance vestibular balance function and vice versa.

[0180] Figure 16Another exemplary algorithm of another exemplary method (method 1600) is presented. Here, method 1600 includes method act 1610, which includes an act of obtaining data based on the surroundings of an impaired person (e.g., a person with impaired balance or impaired motor function). (For the sake of brevity of the text, most of the descriptions herein will relate to a person with impaired balance and / or the vestibular sensory system, but again, as described above, any disclosure of these corresponds to an alternative disclosure of a person with impaired motor function, etc., and vice versa, as long as it can be implemented in the art.) Different from method act 1410 above, this does not need to be performed automatically, although it can be performed automatically, and by inference, in a variant of method 1400, method act 1410 in this variant is not performed automatically.

[0181] To briefly point out, the phrase based on the surroundings includes data directly related to the measured or analyzed property (e.g., light level), and data based on data directly related to the measured or analyzed property (e.g., the overall characterization of the measured or analyzed property). For example, the data based on the surroundings can be the defined condition that the surroundings are bright, which is based on a measured value indicating that the surroundings at the sensor for capturing light have, for example, Y lumens. As long as there is a connection with the surroundings, the data is based on the surroundings.

[0182] Method 1600 further includes method act 1620, which includes an act of changing the surroundings based on the data obtained in method act 1610. Returning again to such a scenario: the surroundings of an impaired person (e.g., a person with impaired balance) are at a very low light level, low enough that it may not be sufficient for the impaired person to see their surroundings or otherwise not sufficient in a timely and / or accurate manner such that their visual sense can provide compensation for the reduced vestibular function (e.g., reduced vestibular balance function) to process the visual input of their surroundings.

[0183] Of course, it is possible that the surrounding environment is so bright that the input regarding the ultimate purpose of the motor functions used to achieve balance and / or improvement reduces the efficacy of the visual input. In this regard, this phenomenon can be well understood in the following situation: sunlight is so bright that people sometimes wear sunglasses, which actually limits the amount of light reaching the human eye but improves the sensations associated with vision relative to other situations. The deduced phenomenon is that a person walks out of a relatively dark area into a much brighter area, for example, from a house illuminated by electric lights at noon to an area outside without clouds or trees. The human eye takes time to adjust. And in this regard, note that the teachings detailed herein are essentially time-related, and in some embodiments, there can be devices, systems, and methods that are essentially dynamic and take into account the fact that the eyes of a person with impaired balance must take time to adapt to a changing environment and this applies to environmental changes from dark to bright (relatively) and from relatively bright to relatively dark. The eyes of a person with impaired balance will adjust over time, so the surrounding environment that may be problematic for a person with impaired balance at a first time location may not be problematic or otherwise problematic at a later time location. Therefore, the teachings regarding the surrounding environment detailed herein may not be a hard requirement or an absolute teaching in some cases because it can depend on changing circumstances. Thus, embodiments include taking into account a person's ability to adapt to a changing environment over time. Thus, embodiments include taking into account the time nature of the changing environment. In an exemplary embodiment where, for example, the ambient light decreases from a first value to a second value, where the second value is initially so problematic that, for example, some form of action needs to be taken regarding the implant, after a certain amount of time, the second value may no longer be a big problem so that any action taken in a first time period can be cancelled or otherwise relaxed in a second time period.

[0184] Therefore, the action of changing the surrounding environment may initially require increasing or decreasing the brightness of the surrounding environment and then at least partially reversing this increase or decrease more slowly (in fact, decreasing the brightness from an increased brightness is actually increasing the brightness from a decreased brightness, all over time). Thus, when the surrounding environment is the ambient light level, the change in the surrounding environment may be decreasing the light level or increasing the light level (the latter including turning on the lights).

[0185] Inferences from the above are that method acts associated with method 1400 and with adjusting a vestibular implant or other balance prosthesis based on the obtained human-alterable environment data may further include readjusting or periodically providing further adjustments to the prosthesis to account for the fact that the human body adapts to the initial environmental exposure, even if the environment no longer changes or otherwise does not change. And note that a changing environment does not necessarily mean that something is happening in the environment. It could be that a person with impaired balance moves from one environment to another, such as from inside a house to outside the house and into bright sunlight (or into a dark environment - the human body adapts to both over time). Thus, embodiments include devices, systems, and methods having algorithms that account for the adaptability of the human body. This can be based on human factors data for a statistically significant population of which the balance-impaired person is a part, which is based on subjective / individual data particularly relevant to the observable characteristics of a particular balance-impaired person. Note that the use of such data for setting or adjusting or otherwise refining the teachings detailed herein is not limited to physical adaptation. Embodiments can include using human factors and / or subjective, specific observable characteristics of a person as a basis for implementing one or more of the teachings detailed herein, as long as it is achievable in the art.

[0186] In any case, regardless of whether the surrounding environment is dim or too bright, take some form of action to change the surrounding environment. Method 1600 also includes method act 1630, which includes operating a sensory medical device (e.g., a balance sensory medical device or a motor function medical device connected to an impaired person (balance impaired and / or motor function impaired)) based on the altered surrounding environment. Here, there can be, for example, an automatic determination by the prosthesis or a prosthesis attachment / assistive device or by some other device that the now-altered surrounding environment is in a state sufficient to operate the medical device (if only in some way). This can be increasing the level of suppression of vestibular balance function or suppressing vestibular function (e.g., vestibular balance function). This can also provide more or less sensory substitution, or sensory substitution in the first case. And this can also be starting to apply stimulation or adjusting stimulation that reconstructs, for example, a sense of balance or otherwise improves motor function.

[0187] Method act 1630 can also be performed manually, for example, by activating a suppression or suppression function or by raising, for example, a suppression function.

[0188] Again, although the embodiments have focused on light, it should be noted that the surrounding environment can have other characteristics that can affect the overall efficacy of the teachings herein, such as the sound level of the type of sound in the environment, etc. Some sounds can be distracting or otherwise confusing, and may additionally have reverberation characteristics that can "deceive" a person with impaired balance into perceiving a position and / or sense of balance that is inconsistent with reality. Thus, in an embodiment, the surrounding environment is sound. Thus, a change in the surrounding environment can be a reduction in the sound level (volume) or a change in the frequency of the surrounding sounds, or a change in the direction of the sound source (e.g., to address reverberant sounds).

[0189] Figure 17 Another exemplary flowchart of an exemplary method (Method 1700) is shown. Method 1700 includes method action 1710, which includes performing the method actions of Method 1600. Method 1700 also includes method action 1720, which includes the action of obtaining data indicative of a person's comfort level. The person's comfort level can be related to the impact of the surrounding environment on a person with impaired balance. A noisy environment can be distracting, as can a bright or dark environment. In fact, as described above, an environment with many moving objects or other objects that move relatively fast or in a disorganized manner can be an environment that affects a person's comfort level. A very bright environment can be uncomfortable.

[0190] Embodiments can include apparatuses, systems, and methods for automatically determining a person's comfort level or at least data indicative of a person's comfort level. This can be based on latent variables such as a person's body temperature or heart rate or blood pressure, or the way a person speaks (a fast speaking rate may indicate agitation, or a mispronunciation of words may indicate that the person is uncomfortable, etc.). The prosthesis can be equipped with body sensors such as a temperature monitor (e.g., an infrared monitor capable of detecting skin temperature and thus extrapolating from that body temperature), an eye movement monitor, an EKG and / or EEG monitor, and a microphone can be part of the prosthesis or the microphone of a smartphone or an accessory / auxiliary device or an Internet of Things microphone, which can be used to capture speech (which can also be used to capture sounds in embodiments where the environment is evaluated as a sound environment). In fact, a visual camera (e.g., the camera of a smartphone) can be used to sense facial features. All of these can be used to obtain data indicative of a person's comfort level. The various apparatuses herein can be configured with electronics and / or processors and / or computer chips and / or firmware or software or circuitry that are capable of, for example, receiving data indicative of a person's comfort level from the various sensors just detailed, and then analyzing the data to obtain an estimate of the person's current comfort level.

[0191] Data indicative of a person's comfort level can be used in method act 730, which includes controlling the actions of a balance-sensing medical device based on the obtained data indicative of the person's comfort level. Here, even if environmental factors indicate that an event may be problematic for a person with impaired balance, the balance-sensing medical device may be set at a more aggressive level than otherwise if the person with impaired balance is relatively comfortable in that environment. For example, in the case of a vestibular implant that suppresses and / or inhibits vestibular balance function, the suppression and / or inhibition function may be reactivated because the person with impaired balance is comfortable in that environment. By inference, if the person with impaired balance is considered agitated or otherwise uncomfortable or otherwise experiences symptoms indicating such a condition, the vestibular implant that suppresses and / or inhibits vestibular balance function may be deactivated or its aggressiveness may be reduced. All of this may be because the comfort level can be associated with being distracted or not distracted, or otherwise with the person's sensory system's ability to qualitatively, quantitatively, and / or over a sufficient period of time process visual inputs that play a role in human balance function. Thus, by obtaining data indicative of a person's comfort level and controlling a balance-sensing medical device based on the obtained data indicative of the person's comfort level, more effective results can be obtained from using the balance-sensing medical device.

[0192] Embodiments include a method where method act 1730 includes adjusting / changing the output of a balance-sensing medical device based on a changed surrounding environment and operating the balance-sensing medical device with the adjusted / changed output. By way of example only and not limitation, the output level of the balance-sensing medical device can be increased or decreased. By way of example only and not limitation, the output level of the medical device can relate to the magnitude of a stimulation current, the rate / frequency of the stimulation current, and / or the pulse length / width. Adjusting the output level may require adjusting one or more or all of these characteristics. Adjusting the output level may require adjusting the stimulation current but not the rate and not the pulse length. Adjusting the output level may require adjusting the pulse rate without adjusting the stimulation current and without adjusting the pulse length. Adjusting the output level may require adjusting the pulse length but not the other two. Adjusting the output level may require two of the three just mentioned above but not the third or all three.

[0193] Embodiments include an analysis of which types of adjustments to a given human experience analysis may have practical value with respect to various environmental conditions and / or variations. Embodiments may also include the use of a statistically significant data set from people with balance impairments in similar situations (e.g., people with balance impairments who fall into a specific subset of human factors engineering that is statistically significant or otherwise statistically relevant to the person being discussed). Thus, for a particular individual, it may be the rate of environmental change or perceived environmental adjustment stimuli that is considered, while for another individual, it may be the adjustment of the stimulus current or pulse length. It may be changing the stimulus current amplitude without changing the other two, or changing the stimulus current and pulse length without changing the rate, or changing the rate and the stimulus current level without changing the pulse length, etc. Any possible permutation with respect to adjusting the output may be used in at least some exemplary embodiments. The idea is that different people may respond differently with respect to the output of a balance-sensing medical device, at least when associated with different environmental situations, and the teachings detailed herein include operating a balance-sensing medical device in a manner customized for a particular balance-impaired person (whether based on a strict subjective analysis or statistically significant data for a group of similarly situated individuals or a combination of both).

[0194] Note that adjusting the output level may include completely stopping the stimulation according to some of the embodiments above. Any one or more exemplary features of the stimulation may be increased or decreased according to the situation. For example, in an embodiment where there is insufficient lighting, it may be reducing the stimulus current, including stopping altogether, while if the lighting increases to a more sufficient or fully sufficient lighting level, the stimulus current may be increased, at least for a balance-sensing medical device configured to suppress vestibular balance function. This may also be the case for the rate or the pulse or a combination of two or all three of them. Still, with respect to embodiments focused on the suppression of vestibular balance function, in a situation of insufficient lighting, the output level will generally be reduced.

[0195] In an exemplary embodiment, an action of operating a balance-sensing medical device includes operating the device in a manner that is different from a previous operation based on an altered surrounding environment to achieve an increased treatment aggressiveness. This increased level of aggressiveness can correspond to operating the device at an increased output level in accordance with the teachings above. That is, in some cases, the increased aggressiveness can be achieved by actually decreasing the output level of one or more of the various variables detailed above. Aggressiveness refers to the overall intended result of operating a balance-sensing medical device in a certain manner. For example, with respect to embodiments where the balance-sensing medical device is configured to suppress and / or inhibit vestibular balance function, a more aggressive treatment can be to more greatly inhibit the vestibular balance function. It can also be to more greatly temporarily suppress the vestibular balance function. In this regard, it can be that at a given setting, the vestibular balance function is sometimes suppressed, but not all the time, and the increased aggressiveness will suppress the vestibular balance function such that the likelihood of non-suppression periods is lower than otherwise.

[0196] In an exemplary embodiment, an increase in treatment aggressiveness can be a result of an increase in the restoration of the sense of balance, and / or can be an increase in sensory stimulation, or more precisely an increase in the outcome (effect) on a person. Conversely, an action of operating a balance-sensing medical device can include operating the device in a manner that is different from a previous operation based on an altered surrounding environment to achieve a decreased treatment aggressiveness. This may require completely ceasing stimulation, or may require adjusting one or more of the above variables such that the effect of the balance-sensing device on the person is decreased relative to a previous situation.

[0197] The above embodiments focus on the concept that there may be certain light levels that are insufficient to operate at least some embodiments of a balance-sensing prosthesis relative to other light levels (e.g., a dark surrounding light environment). The embodiments also focus on the concept of a "too bright" environment, and the embodiments briefly focus on the concept of a slightly changing environment. By extension, there may be other surrounding light environments that are perfectly fine for a person to continue receiving treatment, for example, but it is the change itself that creates a level of discomfort that requires a change in balance treatment. In this regard, the inventors have found that when the ambient light level changes, at least when it changes by a certain amount, a person with impaired balance may experience a balance challenge that they may not experience if the light level has been present for a sufficient amount of time previously. Note that this is not a phenomenon based on the fact that the eyes take time to adjust to the brightness change, although it can be part of this phenomenon or can at least partially cause this phenomenon. This is more of a physiological phenomenon that can generally affect balance and can affect the efficacy of a balance-sensing prosthesis / medical device in particular. Therefore, Figure 22Presents an exemplary flowchart of an exemplary method, which includes repeatedly checking the ambient light level. Method actions 940 and 1010 are as described above. If the ambient light level has not changed, the routine continues, but if there is a change, the routine proceeds to method action 3020, which requires actions to reduce and / or apply a minimum stimulus and / or stop the stimulus. Here, if the change is a valid change (valid means having an impact on a person or statistically likely to have an impact on a person, whether this is based on the empirical results of a specific person or the statistically significant data of a group of people of which the person is a part), the balance sensing device will be adjusted or operated differently. In some cases, or if certain types of recipients are special recipients, the different operation may be to stop all stimuli or reduce the stimulus or respond to a minimum stimulus level, or at least reduce the aggressiveness of the treatment to a minimum level, as is known in advance regarding the given person being discussed. In an exemplary embodiment, a change in lighting (whether an increase or a decrease) may cause balance problems because the person's visual sense may not be as effective as in the previous situation before the change, and thus, it may be of practical value regarding reducing and / or eliminating the amount of suppression of the vestibular balance function.

[0198] In an exemplary embodiment, when the change in light level is less than, greater than, and / or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200 lux (lux) or any value or range of values in increments of 0.1 lux therebetween, Figure 22 the method proceeds from method action 1010 to method action 4020, and does not proceed if the change in light level is not less than, not greater than, and / or not equal to the above values. In an embodiment, the change occurs within 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 210, 250, 300, 350, 400, 450, 500, 600, or 700 seconds or more or any value or range of values in increments of 0.1 second therebetween.

[0199] Also note that method act 4020 can also include or alternatively include the act of applying a supplementary stimulus to the prosthesis as described above and otherwise providing sensory substitution (e.g., in the form of acoustic stimulation) while applying a form of alternative stimulus different from the vestibular stimulus. Also note that "and / or" is meaningful in all cases. In some embodiments, method act 4020 includes the act of applying only other stimuli different from the vestibular stimulus. That is, no vestibular stimulus is applied, and the stimulus applied is other stimuli. Also note that applying other stimuli different from the vestibular stimulus requires some form of affirmative act beyond the case of normal or ambient stimuli. This may be to modify the normal or ambient stimulus in some way such that this would not occur without such modification. By way of example only and not limitation, according to the teachings detailed herein, this may be additional stimulus input, such as noise stimulation.

[0200] Figure 23 Another exemplary algorithm of an exemplary method is presented, again, where method act 1010 remains the same as above, but method 9400 is to stop / reduce vestibular stimulation (for whatever reason, including that the light level has changed such that this operation is required). Here, there is a qualifying condition of an ambient light presence value of Z lux. In some embodiments, Z can be 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, 300, 350 or 400 lux or any value or range of values therebetween in increments of 0.1 lux. According to the teachings above / herein, the value of Z can be selected in a preset manner based on empirical and / or statistical data and / or a combination of both. Note that for all embodiments, the value of Z need not be the same. For the sake of brevity in the text, Z is used herein. Any Z can be used for one embodiment, and a different Z can be used in another embodiment.

[0201] Figure 24 Another exemplary flowchart of an exemplary method is presented, where method acts 940 and 1010 are as described above, and the trigger for the ambient light level can be based on the variable Z as described above, where method act 4040 can correspond to method act 4020 above, except that the adjustment of the stimulus can include turning off the stimulus.

[0202] Figure 23 And / or embodiments of 24 can be a case of adjusting the stimulus, whether this may be adjusting the stimulus to a minimum output power or actually increasing the stimulus, depending on the case or the practical value for a given person with balance impairment.

[0203] Returning to the device concept of the innovative features in this document, in an exemplary embodiment, there is a device that includes one or more electrodes, a power source, a light capture device, and a control unit. In an exemplary embodiment, the electrode can be an implantable electrode of a vestibular implant, or can be an extra-skin electrode, or any electrode capable of implementing the teachings detailed herein. In an exemplary embodiment, the power source can be a rechargeable battery, or can be a capacitor (e.g., a supercapacitor or multiple capacitors), or can be a non-rechargeable battery, and its arrangement with the power source located externally and the electrode implanted in the human body can have practical value. The light capture device can be any light sensor detailed herein, and can be a photodiode or a complex CCD (a camera is not a light sensor as a light sensor is a less complex device). The control unit can be the electronic devices detailed herein, and / or a processor or a chip or any microprocessor component capable of implementing the teachings detailed herein. In an exemplary embodiment, the control unit can be the control unit of a vestibular implant, which can be an off-the-shelf device or can be a modified device, such as by adding firmware and / or hardware, such as adding a memory chip to a logic chip, etc.

[0204] In an exemplary embodiment, the device is configured such that the control unit controls the (multiple) electrical signals to one or more electrodes to provide balance therapy and / or movement therapy to the recipient of the device, and the device is further configured such that the control unit controls the (multiple) electrical signals based on the output from the light capture device. According to the above teachings, the device can vary the stimulation or otherwise control the stimulation from the electrode based on the light level or other visual scenes associated with the environment in which the user of the device is located. In embodiments where the system provides movement therapy, this can provide stimulation to stop and / or limit and / or control tremors or shakes (as an example). In an embodiment, this can provide fine motor function beyond what would otherwise be the case. In an embodiment, all other things being equal, relative to a situation without the teachings in this document, the teachings in this document (e.g., the applied stimulation) can increase the scores of the Peabody Developmental Scale and / or the Purdue Pegboard Test and / or the Box and Blocks Test and / or the Strength-dexterity test by 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45% or 50% or any value or range of values in increments of 1% therebetween.

[0205] Embodiments of the stimulations detailed herein can provide an improved spatial orientation perception of a recipient. Accordingly, embodiments include a spatial orientation perception system and a method of improving spatial orientation, as well as a spatial orientation perception device, such as those that rely on tissue stimulation.

[0206] In an exemplary embodiment, again in accordance with the teachings above, the device is configured to inhibit and / or suppress signals traveling from the vestibule to the brain by using (a)n electrical signal(s) to stimulate the tissue of a recipient. Thus, in an embodiment, the operating principle of the device is at least the operating principle of a vestibular prosthesis that inhibits or suppresses balance function by stimulation. Note that this is not mutually exclusive, and the device may also have functionality and associated hardware for reconstructing a sense of balance and / or providing sensory substitution. That is, the functionality may be mutually exclusive. The device may be a device that only inhibits and / or suppresses signals or may be a device that only reconstructs the sense of balance of the recipient of the device, etc. Thus, in an embodiment, the device is configured to provide a recipient with another type of stimulation different from the stimulation provided by one or more electrodes to provide balance therapy to the recipient, thereby supplementing the reduced and / or eliminated stimulation caused by a phenomenon detected by a light capture device that meets a set criterion from the electrodes (e.g., a certain number of moving objects in the field of view as perceived by the recipient, a light level below or above a threshold, the visual scene does not include sharp images or is otherwise an inarticulate scene, the light level has changed rapidly or otherwise changed a specific amount over a certain time period, etc.). The set criterion may be fixed or may be set by the recipient or by a caregiver or healthcare provider. For example, a given light level used as a criterion may be set based on ergonomic data or may be set based on subjective data associated with a particular recipient. The light level criterion may be adaptively modified over time based on changing expectations or the comfort level of the recipient. The criterion may be set using artificial intelligence or machine learning algorithms, where various changes made by the recipient to the prosthesis based on their expectations regarding the changing environment may be correlated with the criterion used by the device as the set criterion.

[0207] Note that the concept of setting a criterion can be used in other embodiments in other situations, such as determining whether to suppress or inhibit the vestibular balance function and by how much, etc. Any of the teachings detailed herein associated with changing or otherwise controlling a balance medical device may be applied to triggering or controlling a medical device using a criterion (e.g., a set criterion), as long as it is achievable in the art, unless otherwise stated.

[0208] In an exemplary embodiment, the device is configured to provide a notification to a recipient based on an output from a light capture device, the notification indicating at least one of a light-based environmental characteristic (such as a light level (qualitative and / or quantitative)) or an action recommended for the recipient of the device to take. These have been discussed above, only briefly. In an embodiment, the notification can be that the ambient light is X lumens, or is considered dark or is considered too bright to be problematic or is considered acceptable or unacceptable for using the device as currently set up. The notification can be that the visual environment has many moving objects, or can be a notification that can affect the balance of the recipient (or some other notification that conveys a goal without insulting the recipient's intelligence but also in a concise manner). And note that the device does not necessarily need to provide the notification. In fact, the device can initiate the notification. In this regard, the device can provide a signal indicating that the notification should be given to an accessory device / auxiliary device or to a smartphone, etc., and the smartphone or the auxiliary device can provide the notification. This can have practical value in embodiments where the notification is a text message or an audible message using voice in cases where the device does not include a speaker but the smartphone does. That is, the speaker can be built into the device (such as a behind-the-ear device) and can be configured to output an oral message.

[0209] The notification can be a recommended action. In this regard, as briefly pointed out above, the notification can be a cautionary warning. The notification can be more specific, such as walk slower or more carefully or take smaller steps or watch out for stationary objects (depending on the complexity, the device can identify objects - embodiments can include a laser device that can illuminate a "target" and notify the recipient that they should focus their line of sight on that restricted target). The notification can be to make an adjustment to the device, such as in embodiments where the recipient wants some control over the device and the device does not automatically adjust its performance (including activation and deactivation) based on the environment. For example, if the device determines that the light level has dropped sufficiently to a potentially problematic level, the device can provide the recipient with an incentive to deactivate the device until a subsequent recommendation notified by the device.

[0210] In an embodiment, the device is configured such that a control unit, based on an output from a light capture device, performs at least one of the following: increase the activation threshold of an electrode, increase the stimulation rate of an electrode, or increase the amplitude of an (a) electrical signal(s). In an embodiment, the device is configured such that a control unit, based on an output from a light capture device, performs at least one of the following: decrease the activation threshold of an electrode, decrease the stimulation rate of an electrode, or decrease the amplitude of an (a) electrical signal(s).

[0211] Embodiments include a human balance medical system that includes a nerve stimulator subsystem configured to affect nerve signals to the brain of a recipient of the human balance medical system to improve the recipient's balance. The system includes a power source, such as any of those detailed herein. The nerve stimulator subsystem of the system is powered by the power source, and the human balance medical system is an intelligent human balance medical system. Regarding the "intelligent" aspect of the human balance medical system, this can be achieved by embodiments described herein regarding controlling prosthetic components based on the surrounding environment and / or based on the recipient's comfort level or alternatively the recipient's physiological state. Regarding the latter, note that any embodiment disclosed herein regarding the recipient's comfort level can correspond to a disclosure of the recipient's more generalized physiological state. In this regard, for example, various sensors for obtaining data on latent variables associated with the comfort level can be used in at least some embodiments to evaluate various physiological characteristics of a person. In an embodiment, in accordance with the teachings detailed above and just mentioned, the intelligent human balance medical system is configured to control the nerve stimulator subsystem based on an input into the system indicative of the system's surrounding environment. In an embodiment, the intelligent human balance medical system is configured to automatically adjust the system's environment to improve the efficacy of the nerve stimulator subsystem. This can be implemented in accordance with any of the teachings herein. But briefly, note that in an exemplary embodiment, the human balance medical system can signal communicate with another system (such as a home system or a workplace system or an automotive system or some other transportation system), and the other system can be controlled based on a signal from the human balance medical system. Embodiments of the system can be controlled by other means, such as by some other intelligent system associated with that other system. For example, a home can include a system where lights can be adjusted based on the presence or absence of a person, which can be detected by a sensor subsystem of the system. In a similar convertible vehicle, the system can be adapted to be used with the intelligent human balance medical system. The intelligent human balance medical system can provide control instructions to other systems. That is, in different embodiments, the intelligent human balance medical system can only provide data regarding the environment, etc. and / or data regarding the recipient's physiological state or the recipient's comfort level, and another system can analyze the data and take action accordingly. The use of the Internet of Things concept can enable these embodiments in at least some cases.

[0212] In some embodiments, the intelligent human balance medical system is configured to automatically adjust the functionality of the nerve stimulator subsystem based on ambient light and / or noise levels. The intelligent human balance medical system can be configured to automatically adjust functionality based on other variables that are not mutually exclusive. And in accordance with the teachings above, in an embodiment, the intelligent human balance medical system is configured to automatically stop the functionality of the nerve stimulator subsystem based on ambient light level and / or ambient noise level or any of the other "trigger" events detailed herein. With respect to stopping functionality, this can be, for example, an embodiment of inhibition and / or suppression of vestibular balance function, stopping the application of an electrical signal or otherwise stopping the inhibition and / or suppression of vestibular balance function by the prosthesis.

[0213] In an embodiment, the intelligent human balance medical system is configured to automatically check the ambient light level and, based on the checked ambient light level, selectively and automatically perform the following:

[0214] (i) Adjust the functionality of the nerve stimulator subsystem;

[0215] (ii) Stop the functionality of the nerve stimulator subsystem; or

[0216] (iii) Provide information and / or recommendations to the recipient to improve the recipient's balance.

[0217] This captures the various features detailed above with respect to at least some of the various arrangements herein. In short, adjusting the functionality of the nerve stimulator subsystem can include decreasing or increasing the inhibition of vestibular balance function. The act of stopping functionality can include stopping the electrical stimulation from suppressing vestibular balance function. Providing information and / or recommendations to the recipient can include the above information and recommendations or any other recommendations or information that may have practical value. In an embodiment, the intelligent human balance medical system is configured to collect (a) latent variable(s) that may affect the recipient's cognitive load and, based on the collected (a) latent variable(s), selectively and automatically perform the following:

[0218] (i) Adjust the functionality of the nerve stimulator subsystem;

[0219] (ii) Stop the functionality of the nerve stimulator subsystem; or

[0220] (iii) Provide information and / or recommendations to the recipient to improve the recipient's balance.

[0221] Latent variables can be those variables detailed above, such as body temperature or EEG or EKG values, as well as ambient light levels or the presence of objects moving around a person with impaired balance, etc. Anything that can indicate the recipient's cognitive load or can affect the recipient's cognitive load can be utilized. Speech rate and pronunciation can be used (the idea being that a person who speaks unclearly or inaccurately may have a cognitive burden).

[0222] Embodiments thus include a device and / or system configured to receive an input indicative of a latent variable, etc., where the latent variable indicates that the recipient is becoming, for example, tired, the recipient is less cognitively capable than in a previous situation, and / or the sounds and / or light to which the recipient is exposed require more effort to understand. In an exemplary embodiment, the device and / or system can correlate inputs regarding the latent variable and can train itself to automatically take an action when there is data indicating that an action should be taken (since the action has been repeatedly taken when such data is present).

[0223] Embodiments can use any one or more teachings of U.S. Patent Application Publication No. 2017 / 0304620, published on October 26, 2017, by Dr. Sean Lineaweaver and John Michael Heasman, to evaluate / determine the cognitive load and / or capture / sense latent variables that can be used to evaluate / determine the cognitive load, or to determine characteristics of the environment that can be used to make one or more determinations regarding how to affect a person's vestibular balance function, etc. For example, embodiments can include utilizing any one or more features of the patent application related to determining / estimating the cognitive load and using it as a basis / trigger condition for taking any one or more actions related to adjusting / using the balance prosthesis detailed herein.

[0224] As described above, embodiments can include positively controlling the environment of a person with impaired balance. In this regard, embodiments are not limited to controlling balance sensing devices, but can include adjusting the surrounding environment, possibly excluding controlling balance sensing devices. In short, note that by using the Internet of Things (by way of example), medical devices can be used to control or otherwise prompt environmental changes to improve the efficacy of the medical device (here, a balance sensing device). In an exemplary embodiment, this can include increasing or decreasing the surrounding light level. In fact, in some embodiments, a less bright environment may have a more calming effect or otherwise make the recipient feel more comfortable. Embodiments can include adjusting vestibular stimulation based on previous outputs / settings. For example, the vestibular stimulation output (measured, e.g., by current level, pulse length, frequency, or any combination thereof) can be increased by 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 80%, 90%, 100%, 150%, 200%, 250%, 300%, 350%, or 400% or more or any value or range of values in increments of 0.1% therebetween and accompanied by a light decrease, e.g., 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, or 70% or more or any value or range of values in increments of 0.1% therebetween and / or 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65 lux, 70 lux, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, or 300 lux or more lux or any value or range of values in increments of 0.1 lux therebetween.The light reduction can occur in 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 210, 250, 300, 350, 400, 450, 500, 600 or 700 seconds or any value or range of values in increments of 0.1 second therebetween.

[0225] Also note that embodiments can include the reverse situation, such as reducing the stimulation output and increasing the illumination by any of the amounts above (but in reverse). Embodiments can include reducing the stimulation output and reducing the illumination, increasing the stimulation output and increasing the illumination, etc., such increase or decrease being according to the values above (for the purpose of text brevity, any disclosure of a decrease or increase corresponds to the disclosure of the opposite value, unless otherwise stated, as long as it can be achieved in the art). Any combination of adjustments that can have practical value can be practiced as long as it can be achieved in the art.

[0226] In an exemplary embodiment, there is an implementation of a method where, by way of example, the output stimulation level is increased by 5% or 10%, accompanied by a decrease in light from 300 Lux or 250 Lux to 150 Lux or 125 Lux. This may have a subjective effect on a person with impaired balance, making the person with impaired balance feel more comfortable than before these arrangements. Conversely, it may be that if the light level is decreased too much, for example, by way of example, to below 100 Lux or below 50 Lux or 70 Lux or 60 Lux, the person with impaired balance may start to feel uncomfortable. And this may result in little or no efficacy even if the stimulation is increased. In fact, other types of stimulation that may be more effective can be applied. This other stimulation can be, for example, the acoustic stimulation detailed above. In these embodiments, there may be practical value with respect to the power management of the medical device. In this regard, relative to other types of medical devices (such as hearing aids in general), these devices may be power-consuming due to the electrical stimulation of tissue. There may be practical value in limiting the power output or otherwise refraining from electrical stimulation when the stimulation will have little or no benefit. In this regard, it may have practical value to increase the lifespan of the medical device with respect to the time period between recharging or replacing the battery. By inference, a full increase in stimulation, such as operating the balance sensing device at maximum output, can quickly discharge the battery, or more precisely, more quickly than in the case of a lower output level. If this output level achieves an effective result, then this may be reasonable. If this output level does not achieve a practical result, then it is not needed and is additionally wasteful, and affects the overall efficacy of the treatment, because the balance sensing device will discharge faster than otherwise, thus reducing its overall practical value at least in the short term.

[0227] Accordingly, embodiments include using the surrounding environment as a latent variable to evaluate the efficacy of the stimulation and controlling the stimulation or otherwise controlling the balance sensing device based on what efficacy its use will achieve during a given situation. This concept may be somewhat counterintuitive because the purpose of a medical device is typically to operate and operate in all cases. But the present inventors have determined that there is practical value not only with respect to preventing harmful effects, in terms of limiting or stopping the effect of the balance prosthesis on a person (such as suppressing the vestibular balance function in a low light environment), but also in controlling the balance prosthesis based on the efficacy of the device in the first case. Put another way, the former uses the ultimate goal of the person's outcome as a control (such as which action can be taken to increase the balance level felt by the human body), and the latter uses the fact that the person's outcome is essentially fixed and correspondingly adjusts the balance sensing device, for example, by extending the battery life beyond what it would otherwise be, to achieve the greater goal of maintaining compliance.

[0228] Figure 25Another exemplary flowchart of an exemplary method is shown, where method action 1010 is as described above. Here, if the light level meets or exceeds a certain value, the method proceeds to method action 9400, which corresponds to method action 4020 above. If the light level is below a certain value, the method proceeds to method action 4040, which is as described above. It should be briefly noted that although the same qualification is presented on the right side of the flowchart, in an embodiment, the qualification can be on the left side (right / left is used as a shorthand).

[0229] Figure 25 Embodiments can consider the fact that at certain light levels, such as light levels below 50 Lux or 40 Lux or 30 Lux, etc., statistics show that stimulation from a balance sensory prosthesis provides little to no increase in balance performance. This is compared to, for example, no stimulation at all. That is, no stimulation at all can provide the same result as stimulation at the maximum possible output. And in this regard, although method action 9400 includes various scenarios and method action 4040 includes various scenarios, in Figure 25 an exemplary embodiment of the flowchart, method action 9400 can simply turn on or otherwise activate the implant and start stimulation from a situation where there was no previous stimulation, and method action 4040 may need to simply turn off the stimulator or otherwise stop stimulation, where there was stimulation before.

[0230] Still, embodiments can include a sliding scale where an increase in output can be considered to have little improvement, so an adjustment in method action 4040 would reduce the stimulation to a level that is considered to have practical value for that light level.

[0231] Figure 26 Another exemplary flowchart is presented that is similar to the Figure 25 flowchart, except that instead of there being method action 19400, that method action includes actions of notifying the user and / or the Internet of Things to turn off or shut down the device or not notifying the user and / or the Internet of Things.

[0232] It should be briefly noted that although Figure 25 and 26 the flowcharts of the methods do not indicate the current state of the balance sensory device, the balance sensory device can be in a stimulated state or a non-stimulated state depending on the situation. And it should also be briefly noted that although many of the above methods indicate the presence of "start stimulation" in method action 940, it can also include situations where vestibular stimulation is already in progress. That is, any disclosure of starting stimulation corresponds to an alternative disclosure of being in a stimulated state, and vice versa, as long as it can be implemented in the art, unless otherwise stated, all for the purpose of text brevity.

[0233] Figure 26Embodiments can have utility in situations where acoustic noise can also be of practical value. As an example, the acoustic noise can act like a linear response between output level and balance performance in a noisy environment. There can be situations where an improvement in balance is obtained linearly proportional to the reduction of environmental noise. The reverse also applies. And note that in some embodiments, in exemplary embodiments, the response can be non-linearly related. Also, the point is that in some exemplary embodiments, turning off the radio or television or performing some form of noise cancellation can improve the efficacy of the balance sensing prosthesis. Further, in some embodiments, this can be the case whether or not adjustments are made to the balance sensing prosthesis or even whether the balance sensing prosthesis is providing stimulation to the recipient. Merely as an example and not by way of limitation, there can be situations where the light level is low enough such that the stimulation would have no utility and thus, the stimulation is turned off. However, the device can still notify the user and / or notify the Internet of Things or any device in the system that is controlled by or based on an input from the medical device to take some form of action to improve balance. Thus, even though the light level may justify turning off the stimulation, the medical device can still improve balance by performing these other auxiliary features. This is consistent with the concept of providing alternative stimulation. But this is also consistent with the concept of providing noise cancellation and / or reducing the sound level in the environment.

[0234] And it should be briefly noted that, as used herein, the act of applying other stimuli different from vestibular stimuli also includes adjusting that other stimulus, such as adjusting the noise level.

[0235] Regarding noise cancellation, embodiments can include using hearing aid technology to cancel noise. In an exemplary embodiment, in a situation where the recipient does not have a hearing problem or otherwise does not itself require a hearing aid, an ear device can be used to transpose sound to the recipient. The hearing aid may actually operate in reverse so as to attenuate / diminish sound for at least some frequencies. As a result, the ear device can be useful because it can at least partially occlude the ear canal. Embodiments can replace this and / or supplement this, including speakers, etc., that output sound having noise cancellation and that can be located, for example, on a behind-the-ear device.

[0236] However, embodiments include instructing the user and / or the Internet of Things or some other device to take action to change the environment so as to improve balance or at least not further detract from balance, whether or not vestibular stimulation is present.

[0237] The embodiments also include treating oscillopsia. In this regard, one or more or all of the teachings detailed herein may be applicable to treating a person experiencing oscillopsia. Any disclosure herein of a person with impaired balance or a general person corresponds to an alternative disclosure of a person suffering from or otherwise experiencing oscillopsia (and the two are at least not mutually exclusive in all cases). In an embodiment, a combination of light level control and stimulus control is used to treat oscillopsia. In an embodiment, this treatment may be directed to children or young adults or infants. In an exemplary embodiment, this treatment is directed to a person less than 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5 or 4 years old or any value or range of values therebetween in one-month increments. In this regard, there may be a light level that is more comfortable for a person than other light levels, and there may be an interrelationship between balance and other vestibular-related features (such as eye movement and eye movement tracking) and the ambient light level. The embodiments include determining a useful combination of ambient light level and stimulus for a particular person, whether strictly subjective or based on statistical values of a larger population or a combination thereof, to treat oscillopsia. The embodiments may involve improving or otherwise achieving a comfort level, where the comfort level may change or otherwise affect a person's real-time cognitive level. Without being bound by theory, in at least some exemplary embodiments, the efficacy of vestibular stimulation using the medical devices herein and their variants and other medical devices may be enhanced if a person has a lower cognitive load relative to the original situation. Put another way, if a person is not concentrating on other things or otherwise suffering from a high cognitive load, the results of vestibular stimulation may be excellent. Accordingly, the embodiments include reducing the cognitive load of a recipient in combination with applying a stimulus for treatment. This reduction of cognitive load may be carried out at least in part using the teachings of the above patent application of Dr. Sean Lynne Weaver, for example, by way of example but not limitation, using the various teachings therein to determine or otherwise estimate the cognitive load, and / or using the various teachings therein to reduce the cognitive load.

[0238] In short, embodiments include using a vestibular stimulation device to attenuate vestibular balance function. Embodiments include ceasing attenuation or limiting attenuation relative to an original situation according to the environment. In an embodiment, the balance sensing device is configured to attenuate the vestibular function by at least and / or equal to 5%, 20%, 25%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% or any value or range of values in increments of 1% therebetween. Thus, embodiments of an adjustable balance sensing medical device can change from any one or more of the percentages just mentioned to any one or more of the percentages just mentioned based on the environment. This accounts for increases and decreases. Similarly, embodiments can decrease the output level (one or more of the aforementioned characteristics of the electrical stimulation) by 5%, 20%, 25%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% or any value or range of values in increments of 1% therebetween according to the changing environment. The reverse also applies, except that the upper limit is not defined as 100% because the increase can be greater, such as increasing to 200%, 300%, 400% or 500% or any value or range of values in increments of 1% therebetween. Embodiments can also be classified by the power consumed by the stimulation. This can be a proxy for the output. Thus, the above percentages can apply to the power required for the stimulation (as distinct from the power required to maintain the implant, for example, above a preset voltage and / or standby voltage, or to provide return telemetry, etc.). This is the power required for the stimulation / the power required to move current out of the electrode (and into the electrode of the AC system). Thus, in an embodiment, the stimulation power can be reduced and / or increased by the above percentages.

[0239] Any reference to a vestibular stimulation device refers to a single device that applies stimulation to one ear, a single device that applies stimulation to both ears, and multiple devices that apply stimulation to both ears, and vice versa, unless otherwise stated.

[0240] In an exemplary embodiment, there are devices, systems, and / or methods for providing an indication that the sensory management and / or sensory stimulation systems and their variations detailed herein and / or other types of systems including medical devices (which may be other types of sensory management and / or sensory stimulation systems and / or may be other types of systems for medical devices (not sensory stimulation and / or sensory management systems)) are activated and / or not activated. In an exemplary embodiment, this indication is provided automatically by the system, which may be provided by a prosthesis and / or a body-worn device constituting a medical device and / or another component (e.g., a smartphone or a smartwatch) that works in conjunction with the prosthesis or a dedicated remote control for the prosthesis (or a non-dedicated remote control, which may be a handheld device of system 210 (by way of example only, more will be described below)). In an embodiment, there are devices, systems, and / or methods for providing an indication that the foregoing system is being implemented in an effective manner and / or providing an indication of the level of effectiveness of the implementation, as an alternative or supplement to the indication that the system is activated or otherwise has been activated.

[0241] In an embodiment, there is a system, such as Figure 27 the system shown in, which includes a first subsystem 2710 configured to have a neurological effect on a human when activated. The system includes a second subsystem 2720 configured to provide an indication that the system is activated and / or not activated. As will be briefly described below, the system may include a third subsystem, and / or one of the first subsystem and / or the second subsystem may be configured to make a determination as to whether the system has been activated, and this determination may be made automatically. The two subsystems communicate with each other via a radio frequency link 2727 as shown, which may be a wired link in some other embodiments. In an exemplary embodiment, Figure 27 the system corresponds to system 210, where subsystem 2710 may be prosthesis 100, and subsystem 2720 may be smartphone 2410 or may be some other smart or non-smart device, such as a dedicated remote control. In an exemplary embodiment, the prosthesis 100 used in the arrangement as in Figure 27 may be a cochlear implant and / or may be a vestibular stimulation system as detailed above and / or a tinnitus management device as will be described below. In some embodiments, the vestibular stimulation system may include the foregoing environmental sensing devices, which may include the (multiple) light sensors detailed above. That is, in some exemplary embodiments, the vestibular stimulation system does not include, for example, a light sensor, or the environmental sensing device, at least not utilized as detailed above according to the teachings above.

[0242] Figure 28Another exemplary system is presented, in which two subsystems are included in a single prosthetic device 2810, which can be, for example, a vestibular stimulation system, a balance-sensing medical device, or a tinnitus management / mitigation device. Subsystem 2805 can be a subsystem configured to have a neurological effect on a person when activated, and subsystem 2820 can correspond to subsystem 2720 detailed above. As can be seen, the two subsystems can communicate with each other, here in a wired / printed circuit form and / or via optical communication, although in other embodiments the communication can be wireless. In Figure 28 In an exemplary embodiment of the embodiment of Figure 28 , both subsystems are included in a single housing (which can be an implantable housing), and thus both subsystems are implanted (and in some embodiments, this can include the subsystem that makes the above activation determination). In an alternative embodiment, the subsystems are located in separate components of the prosthesis, for example, the first subsystem in an implantable component and the second subsystem in an external component. In some embodiments, the first subsystem and the second subsystem are located in an external component (and depending on the system, there may be no implantable component, or vice versa). It should also be noted that the individual subsystems can be divided among the various components. By way of example only and not limitation, a part of the second subsystem can be located in the implantable component, and a part of the second subsystem can be located in the external component (and the first subsystem).

[0243] In short, Figure 30 is a perspective view of a tinnitus treatment implant, called implant 1000, in an implant recipient. As shown, implant 1000 includes one or more components that are implanted in the recipient either temporarily or permanently. Implant 1000 is shown in FIG. 1000, where external device 142 can in principle correspond to the external device detailed above, but modified / different for tinnitus treatment, the details of which are not elaborated for the sake of brevity.

[0244] In short, implant 1000 can be generally based on a cochlear implant (partially implantable or fully implantable). The arrangement of implant 1000 can receive power and / or data in a manner similar and / or identical to or otherwise modified to implement tinnitus treatment and convert it into an electrical stimulation signal that is ultimately delivered to tissue. As detailed herein, some arrangements may or may not have an implant processor. In some embodiments, any arrangement that can be used to provide electrical stimulation to electrodes to stimulate tissue to treat tinnitus (or for treating epilepsy, more about which is described below) can be used.

[0245] In Figure 30In an illustrative arrangement, the external device 142 (again based on the device above, but for a tinnitus treatment device) may include a power source (not shown) disposed in a behind-the-ear (BTE) unit 126. The implant 1000 includes an internal energy transfer assembly 132 that may be positioned in a recess of the temporal bone adjacent to the recipient's auricle 110. As detailed below, the internal energy transfer assembly 132 is a component of a transcutaneous energy transfer link and receives power and / or data from the external device 142.

[0246] The implant 1000 also includes a main implantable component 120 and an elongated electrode assembly 118.

[0247] As described above, in an exemplary embodiment, the implant 1000 is a fully implantable device that includes a power source (e.g., a battery) and is configured to operate in a manner similar to a fully implantable hearing prosthesis modified for tinnitus treatment.

[0248] The elongated electrode assembly 118 has a proximal end connected to the main implantable component 120 and a distal end that includes electrodes positioned adjacent to the cochlea 140. In Figure 30 the illustrated embodiment, the electrodes (not shown) are located in a drilled partial bore 122. The electrode assembly 118 extends from the main implantable component 120 through the mastoid bone 119 to the cochlea 140, reaching the osseous capsule.

[0249] As noted, the implant 1000 may include a fully implantable prosthesis capable of operating for at least a period of time without the external device 142. Accordingly, the implant 1000 also includes a rechargeable power source (not shown) that stores the power received from the external device 142. For example, the power source may include a rechargeable battery. Alternatively, a long-term non-rechargeable power source that is implanted and remains implanted may be used. During operation of the implant 1000, the power stored by the power source may be distributed to various other implanted components as needed. The power source may be located in the main implantable component 120 or disposed in a separate implant location.

[0250] As seen in the figure, there is a return electrode / reference electrode at the end of the lead 162. This provides a return / reference for the electrodes at the end of the electrode assembly 118.

[0251] Embodiments include treating tinnitus by using an implant 100, for example, by applying an electric current to the ear system of a person suffering from tinnitus. By way of example only and not limitation, in an exemplary embodiment, one or more electrodes are placed on or otherwise in electrical communication with tissue (e.g., bone) of the otic capsule / osseous labyrinth, etc. In an exemplary embodiment, by way of example, one or more electrodes are placed on or otherwise in electrical communication with the round window of the cochlea. The concept here is that the electric current supplied by or otherwise conducted from the electrodes to the tissue will stimulate the inner ear nerves or otherwise stimulate the auditory nervous system in a manner that can be used to treat and / or otherwise mitigate the effects of tinnitus.

[0252] Embodiments include using the teachings herein to indicate the activation / functionality / efficacy of a tinnitus treatment / masking implant 1000.

[0253] Another exemplary arrangement in which the techniques detailed herein can be used is an epilepsy monitoring and / or treatment device. Figure 31 An exemplary embodiment of an EEG system (which can be an epilepsy monitoring system) in an implant recipient is provided, where read / sensing electrodes 2202 are arranged inside the recipient's head and communicate signals with a coil 2102 via electrical leads. In this embodiment, the implantable device does not have recording / storage capabilities, and an external device is required to receive signals from the implanted inductive coil 2102 in order to retrieve the signals therefrom in real time. The implantable component that converts the electricity sensed by the sensor / read electrodes into... is not shown

[0254] As detailed herein, again unless otherwise stated, as long as it can be achieved in the art.

[0255] According to the teachings detailed above, in an exemplary embodiment, the system is a human balance medical system, which can correspond to (wholly or partially) the exemplary embodiment detailed above, but can also be a variant thereof or a different embodiment of another human balance medical system. Embodiments can include devices and / or systems configured to provide and / or determine an indication and / or methods of providing an indication and / or determining that the system is activated / not activated and / or its effective operation and / or its functional state. In an embodiment, the system is configured to provide this indication to a signal transmitted by an inductive coil. In an exemplary embodiment, Figure 31 The sensor arrangement seen therein is an implantable EEG sensor arrangement.

[0256] Embodiments include using the teachings herein to indicate Figure 31 the activation / functionality / efficacy of an epilepsy treatment system.

[0257] Embodiments can also be used in a sleep apnea treatment system.

[0258] For the sake of brevity, any disclosure in this document of using one or more of the teachings described herein for a balance sensory system or a tinnitus treatment system and / or an epilepsy treatment system and / or any medical device detailed herein corresponds to an equivalent disclosure of using those teachings for any one of the other systems, unless otherwise stated, as long as it can be implemented in the art. It is to be understood that the embodiments include devices, systems, and / or methods, where one or more of the teachings detailed herein are used for one or more medical device users of the system, such as the recipient of a prosthetic device that is part of the system. In an exemplary embodiment, the system is configured to provide this indication to a third party with respect to the recipient / patient / user of the system (the person directly affected by the system), such as a caregiver or guardian of the recipient of a prosthetic device, by way of example. The indication may be provided to a third-party monitoring company. By way of example only and not limitation, the third party may monitor activation rate and / or efficacy and / or functionality, etc., based on the indication provided to it. In an exemplary embodiment, this may have practical value with respect to the following: enabling a professional organization or a company otherwise versed in the subject matter associated with the system to evaluate the foregoing phenomena to determine whether there are "issues" with the system and / or the recipient / user of the system when determining whether an intervention may be practical. By way of example only and not limitation, a human balance medical system may make the recipient of the system feel nauseous. This may then result in the recipient of the system using the system for less time than they might or otherwise should, and thus create a potentially dangerous situation for that person's life. This data may be used by a professional third party to determine or otherwise evaluate settings and, by way of example, remotely adjust the system.

[0259] However, embodiments may focus on providing instructions to the recipient and / or the direct caregiver of the person affected by the system. The instructions may be (by way of example only and not limitation) visual instructions, such as activation and / or deactivation of a light-emitting diode (LED), or a change in its color, or the presentation of a given LED activation sequence and / or a change in the LED activation sequence or its blinking change (from non-blinking) or blinking in a first mode relative to a second mode, etc. The visual instructions may be on an external component of the prosthesis (e.g., a BTE device), which is part of the system, or on a component remote from the prosthesis (in embodiments where the system uses the prosthesis), such as a handheld smartphone or smart device. The visual instructions may be on the remote control unit of the system (e.g., a handheld remote control unit for any of the prostheses detailed herein). The visual instructions may be a message (a smartphone text message or an email) or a status indicator on any of these devices. By way of example only and not limitation, the message or status indicator may be displayed on the screen 2421 of the handheld component 2401, where the system corresponds to the system 210 detailed above or a variant thereof (e.g., the second subsystem may be part of the handheld component 2401).

[0260] The instructions may be audible instructions in the form of beeps or tones, which may be triggered by an external trigger such as a smartphone command. The instructions may be computer-generated or prerecorded voice statements from the speaker of the prosthesis or device or smartphone or remote control.

[0261] The indication can be electrical stimulation of the recipient / user's organization, such as stimulation of a nerve (e.g., for the auditory nerve for a cochlear implant, by way of example only, and thus nerve stimulation for indication purposes is different from the stimulation of the nerve(s) for vestibular stimulation / balance improvement / maintenance). In fact, in an exemplary embodiment, the stimulation can be a stimulation similar to or otherwise analogous to (at least generally) the stimulation resulting from cochlear implant stimulation. In some embodiments, the electrodes of the implant are also located in or at least adjacent to the inner ear (and in some embodiments, in the cochlea), and can provide at least a basic form of stimulation to the auditory system, which can generally be perceived as a hearing perception, and specifically can be an oral hearing perception. That is, in an exemplary embodiment, the stimulation can be in the form of a series of pulses similar to a Morse code signal or can be a single tone or a varying tone, anything that can convey an indication to the recipient of the system based on the hearing perception. The embodiment can also be configured to provide a "hi-stimulation" relative to the stimulation normally provided by the system, the hi-stimulation being sufficient to stimulate the auditory nerve using electrodes located outside and / or remote from the cochlea. In this exemplary embodiment, the system includes, for example, a vestibular stimulation device, and its electrodes are located remote from the cochlea, and the current to these electrodes can be increased and / or the voltage can be increased by a relatively large amount compared to the amount used to stimulate, for example, the vestibular system, and this amount may be sufficient to cause the current to stimulate the auditory nerve in a manner that produces a certain kind of hearing perception sufficient to implement the teachings herein. The frequency and / or pulse and / or other electrical characteristics used in this exemplary embodiment can be such that the vestibular system is not stimulated in a way that affects a person's balance but will be perceived as sound by the cochlea.

[0262] In an embodiment, tactile indication / feedback can be used to convey an indication. The embodiment can include a system that includes a vibration device, such as the vibrator of a portable telephone or the vibrator of a bone conduction device. The vibration output can be triggered by an external trigger (e.g., a smartphone command). In an exemplary embodiment, the vibration can be presented in a manner similar to the LED presentation described above, where a sequence that conveys a certain indication can be provided by way of example. A pattern or intensity or frequency or any combination of these can be used to convey an indication. This is the case for optical indication or sound indication or tactile indication, etc.

[0263] Any device, system, and / or method that can provide / transmit an indication with practical value can be used, as long as it can be implemented in the art. It is to be understood that the embodiments include a device and / or system configured to provide an indication of delivery, and / or a method of delivering an indication by any one or more or all of the following: a smart device (e.g., a smartphone or a tablet or a smartwatch, or a remote control of a medical device), a dumb device (e.g., a digital watch or a neck pendant, e.g., having a receiver that receives a signal from another component of the system indicating the state of the system (e.g., the system is activated and / or not activated), which may also include a device that provides an indication when no signal is received from another component of the system), a BET or OTE or ITE device, an automotive communication system, an infrastructure, the Internet of Things, etc. The embodiments include a device and / or system configured to provide an indication of delivery, and / or a method of delivering an indication by an audio arrangement, a video arrangement, a tactile arrangement, an electrical arrangement, which may include vibrating a recipient or otherwise providing, for example, a "zap" or at least a "tingling sensation" to the recipient's tissue.

[0264] Regarding the indication(s), in an exemplary embodiment, a second subsystem is configured to provide an indication that the system is on and / or the system is off. In an exemplary embodiment, the system turns on when its "on" button (which may be an on / off button) is pressed as needed to turn on the device, and the final state of the system is on as expected and desired (when the system is operating correctly - again, this is based on the operation of the button). This may be, for example, a button on an external component of a cochlear implant, which may be on a BTE device or on its OTE device. As an example, this may also be when an on signal is provided from a portable handheld device (e.g., a smartphone or a remote control), and the portable handheld device communicates with the cochlear implant. This does not necessarily require a button in the traditional sense, as a touch screen can be utilized. Of course, the source can also be a verbal input. The system turns off when, for example, its "off" button is pressed to turn off the system or at least turn off the final stimulation device, and the final state of the system is off as expected and desired (when operating correctly), again referring to the above conditions, although regarding turning off rather than turning on.

[0265] This does not mean that when the system is on, the system is operating in a practical manner and / or in an effective manner. By analogy, a car can start, but if traffic is disrupted, the car will not work as expected. The air conditioner may work, but the car will not move forward or backward.

[0266] Accordingly, in view of the foregoing, the second subsystem can be configured to provide an indication to a recipient of the system via a stimulus applied internally by the system. In an exemplary embodiment, in accordance with the teachings above, the second subsystem can be configured to provide an indication to a recipient of the system via a stimulus applied externally by the system. In an embodiment, the second subsystem can be configured to provide both a stimulus applied internally and a stimulus applied externally. Of course, there can be a third subsystem that can provide a stimulus from outside the recipient while the second subsystem provides a stimulus from inside the recipient.

[0267] In an embodiment, the second subsystem is configured to directly provide an indication to a recipient of the system from a body-worn portion of the system. In an embodiment, by way of example, this can be a vestibular stimulation system or a cochlear implant or a BET device of a tinnitus management system. In an embodiment, this can be from a smartwatch. With respect to the BET device, this can also be a second subsystem that is configured to directly provide an indication to a recipient of the system from a body-worn portion of the device, and while the smartwatch is part of the system, it is not part of the vestibular stimulation implant / device. In an embodiment, the feature of directly providing an indication to the recipient can be achieved using the haptic-limited audible described in detail above. In an exemplary embodiment, this can also be visual, but this may require, for example, the recipient to remove the BTE device from their ear so that the device can be moved to see, for example, an LED. Of course, embodiments can include using a mirror, or having another person tell the recipient that, for example, there is a light flashing on their BTE device. But these would indirectly provide an indication to the recipient. These would directly provide information to a third party (such as a caregiver) who can see the BET device while the BTE device is on the recipient's ear. Accordingly, embodiments include a second subsystem that is configured to directly provide an indication to a third party with respect to the recipient.

[0268] In short, note that the embodiment is configured such that the second subsystem provides an indication that the system is activated. This can be a periodic indication to the recipient (by way of example). For instance, every five minutes or 10 minutes, an indication can be provided. The idea is to give the indication in an effective manner without overwhelming or even annoying the recipient with a "constant" reminder. More description on this is provided below. Conversely, the embodiment includes a system where the second subsystem provides an indication that the system is not activated. In some cases, this may be more practical from the perspective of the annoyance or tolerance of the recipient in implementing the teachings herein. The system will notify or otherwise provide the indication when the system is not activated. It is assumed that if this indication is not provided, the system is activated. Of course, the embodiment can provide both. In an embodiment, the recipient can select a mode where the indication is that the system is activated, and then select another mode where the indication is that the system is not activated (and the reverse does not occur / is excluded). In an embodiment, there can be a third mode where, in the third mode, the second subsystem provides both an indication that the system is activated and an indication that the system is not activated depending on the situation. Moreover, in an embodiment, the system can be configured such that the recipient or a third party can set the trigger time or the manner of triggering the indication. For example, if the recipient selects the mode where the indication is that the system is activated, the recipient can set the timing of this indication, such as providing the indication every five minutes or every 10 minutes or for example every half hour. This can be a preference of the recipient based on the frequency at which the recipient is comfortable being notified.

[0269] In fact, embodiments include adjusting triggers based on the recipient's lifestyle actions. For example, if the recipient is driving a vehicle, the indication may be provided more frequently than when the recipient is lying in bed reading a book. The idea is that it is more important for the recipient to know whether the system is activated or not when the recipient is driving a vehicle compared to when the recipient is lying in bed. The recipient may very much want to know that the system is activated every minute (or every second or continuously) while they are driving the vehicle. In fact, embodiments can be implemented where the system is constantly providing (e.g., a constant tone or some other constant type of stimulus) an indication. For example, when the recipient is engaged in a given activity, such as driving a vehicle, the recipient may be satisfied with a low-frequency or high-frequency constant tone or a mid-frequency constant tone that is constantly on or otherwise constantly "playing". In this exemplary scenario, the recipient is participating in an activity where they believe they need continuous notification that the balance device is activated. Of course, this can be a more periodic arrangement where the indication is provided every 10 seconds or 20 seconds or 30 seconds or one minute or two minutes, etc. Also note that the indication does not have to be as monotonous as a tone or some other noise itself. The indication can be that music or a radio station is being streamed to the output of the medical device and is constantly played when the device is activated (e.g., the recipient can hear the result), and when the device is deactivated, the content being played is stopped, and this stop can be the indication, provided that the recipient understands this and is otherwise informed that this is how the device operates. This can alternatively be, for example, a car radio where the system interfaces with the car entertainment system or the communication system outputs the radio station that the recipient has tuned their radio to.

[0270] Thus, the indication can be provided via the infrastructure.

[0271] Again, regarding the opposite of constant indication, in an alternative embodiment, the indication only appears when the system is no longer activated. This can also be achieved via an infrastructure such as a car entertainment system.

[0272] Still, returning to the concept of the indication mode or sub - mode selected by the user, the user, caregiver, etc. can select the frequency at which the indication will be provided and under what circumstances the indication will be provided. Although the scenarios above focused on the concept that the system is activated and the indication is delivered periodically, in an alternative embodiment, there can be a lag between when the system is deactivated or otherwise stops being activated and the time of the indication. For example, the user can set the system such that, by way of example, the indication is provided only after 15 seconds or 30 seconds of inactivity or after multiple (a predetermined number) determinations that the system is inactive. That is, in an embodiment, the device itself can have a built - in lag time, where the device checks again or three times to determine that it has been deactivated or otherwise. There is an activation or non - activation for more than a certain period of time. In some embodiments, this can be much shorter than the aforementioned 15 seconds or 30 seconds. This can be a time sufficient to ensure that there are no random signals indicating "false positives" or "false negatives" (by way of example). That is, the software is configured to reduce the probability that an indication is provided incorrectly or unnecessarily.

[0273] Embodiments include using a subsystem that is configured to provide an indication that the system is activated and / or not activated in combination with the teachings above, where the system includes a subsystem configured to obtain data based on the surroundings of the system, and where, in this embodiment, the system includes a third subsystem that includes a light sensor. As described above, at least some systems are configured to control the first subsystem at least in part based on data obtained from a subsystem configured to obtain data based on the surroundings. Aspects associated therewith can be combined with or otherwise used together with the teachings herein regarding indications, and / or vice versa. By way of example only and not limitation, there are scenarios where the system can stop or otherwise inhibit the amount of stimulation provided by a medical device based on the surroundings. By way of example only and not limitation, as described above, if the system determines that the ambient light level is insufficient or otherwise the place where the recipient is located is dark, the system can automatically limit or stop the stimulation of the vestibule. In some embodiments, this may result in the deactivation of the system, by way of example, at least in cases where the system does not provide any stimulation at all. Thus, providing an indication to the recipient or caregiver or a party that the system no longer provides stimulation to a person or otherwise no longer has a neurological effect on a person can have practical value.

[0274] In fact, in an exemplary embodiment, the system is configured to limit the level of impact of the first subsystem on a person based on the obtained data regarding the surrounding environment. Thus, the system configured to provide an indication to a person can be configured to automatically provide an indication to the person when the level of impact of the first subsystem is limited, which, if the limitation of the impact on the first subsystem corresponds thereto, can correspond to an indication that the system is not activated. By inference, an indication can be provided when the system is providing a stimulus based on the surrounding environment. Thus, for example, if the system determines that there is sufficient light in the surrounding environment to effect the stimulus, the system can provide an indication that the system has been activated. And note that although the embodiments focus on activation and non-activation, the embodiments can also focus on reactivation and deactivation. Any disclosure herein associated with activation corresponds to an alternative disclosure of reactivation, and any disclosure herein associated with non-activation corresponds to any disclosure of deactivation, unless otherwise stated, so long as the art can effectuate it.

[0275] In view of the foregoing, it is to be understood that any disclosure herein of managing a medical device system based on the surrounding environment and / or managing a system based on any of the phenomena detailed herein corresponds to a disclosure of using the teachings associated with providing an indication thereto, and vice versa, unless otherwise stated, so long as the art can effectuate it. Thus, any disclosure of any embodiment associated with controlling a first subsystem or otherwise configured to have a neurological impact on a person when activated corresponds to a disclosure of an apparatus and / or system and / or method for providing an indication based on a result or otherwise based on a characteristic associated with that management. By way of example only and not limitation, the system can include a fourth subsystem that analyzes the state of the system to determine whether the first subsystem is being controlled based on data obtained by a second subsystem, and this fourth subsystem can control the second subsystem in accordance with the teachings detailed herein to provide an indication(s).

[0276] In an embodiment, the indication can be controlled or otherwise associated with other phenomena. By way of example only and not limitation, the system can be configured to provide an indication when the recipient starts moving, even if the trigger for the indication should have occurred earlier. For example, in a situation where low light levels in the surrounding environment cause the stimulator of the balance system to deactivate, the system can be configured to delay the action of providing the indication until the time point when the recipient starts moving. The idea is that the recipient does not necessarily need to know that the system is in a deactivated state until they start moving. As an alternative and / or addition to this, the system can evaluate whether the recipient is sitting or standing or lying in bed, etc. If the recipient is lying in bed, the system can retain the indication even if the recipient is moving (the idea being that the movement is just the recipient rolling in bed, for example). If the recipient is sitting in a chair, the system can retain the indication until a movement occurs that indicates the recipient stands up or otherwise significantly moves their position in the seat. Conversely, if the recipient is moving while standing, for example, the indication can occur immediately or otherwise as soon as possible.

[0277] In an embodiment, the system is configured to provide an indication that the system is not activated within XYZ seconds (including XYZ) or more seconds or within a range of any values of 0.05 seconds or more seconds after the system enters an inactive state. XYZ can be 0.1, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55, 60, 75, 80, 85, 90, 120, 150, 210, 350, 300, 350, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500 seconds or more seconds. In an embodiment, the recipient and / or caregiver can adjust the timing of the indication and / or the device can be adjusted by a professional and possibly only by a professional to adjust the timing (the adjustment may require, for example, reprogramming or uploading new settings - with regard to user / caregiver adjustment, this can be performed, for example, by the recipient or caregiver pressing buttons on the BTE device in a given sequence or in a specific manner to adjust the timing and / or can be achieved by entering the timing into a smart device or remote control unit that signals with the prosthetic component or body-worn component of the medical device. In some embodiments, a special GUI menu is provided on the display screen of the handheld device, and the special GUI menu allows the recipient to enter the desired timing.

[0278] Note also that the timing described above can be the timing for the indication of the system activity and / or inactivity. Regarding the former, it is envisioned that the timing can be longer than that detailed above, or at least longer than the timing of the indication that the system is not activated (it is envisioned that the case where the system is not activated is a case that the recipient wishes to know earlier than other cases). In any case, regardless of the scenario, in at least some exemplary embodiments, the timing described above can be lengthened by 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 4, 5, 6, 7, 8, 9, or 10 times or any value or range of values with an increment of 0.05 therebetween in some embodiments.

[0279] Note also that embodiments include a recipient or third party inspection arrangement, where the recipient or other caregiver queries the system regarding whether the system is activated and / or not activated. By way of example only and not limitation, the recipient can press a button on, for example, a BTE device, where the system is configured to interpret the pressing of the button as a query from the recipient regarding the status or operating mode, etc. of the system (or the manner in which the button is pressed - if the button is pressed three times continuously within, for example, two seconds, the system will interpret this as a query regarding the activation status, and if the button is pressed only twice within two seconds, the system can interpret this as a desire to adjust another functionality of the system (by way of example) - this is a long - winded way of saying that the teachings detailed herein can be applied to a single - input device component or a limited - input device component). Thus, in an exemplary scenario, this indication is given only in response to an affirmative action by the recipient, and the affirmative action constitutes a query by the recipient regarding whether the system is activated and / or whether the system is not activated.

[0280] Still, embodiments can include an arrangement where the system evaluates the activation status of the system, or at least provides stimulation or otherwise manages the activation status of a part that manages the recipient's body functions or otherwise manages the recipient's medical characteristics, and provides an indication to the recipient or user or third party when the system is in an unactivated state. It is envisioned that, regardless of other features, the recipient may prefer the feature of providing the indication when the system is not activated.

[0281] Embodiments include a non-transitory computer-readable medium having stored thereon a computer program for performing at least a portion of a method, the computer program including code for: automatically determining whether a system is operating and / or not operating and / or how well the system is operating and / or whether the system is capable of operating and / or how well the system will operate in the future, where the system is a sensation management and / or sensation stimulation system. Note that in some other embodiments, this functionality may alternatively be obtained by a device or system configured to perform this operation, or in addition by a device or system configured to perform this operation. In an embodiment, the code is configured to implement a checksum of certain data of the system, or alternatively to evaluate the current and / or voltage of the system at a particular node or other utility node in the overall circuitry of the system. The code may include logic for determining a functional level of the system based on this determination. Thus, in an embodiment, the code is code for an algorithm that, for example, receives data indicative of a voltage at a certain location in a circuit over a particular period of time and / or over discrete periods of time, and then determines whether the voltage is present for a sufficient period of time and / or has an amplitude sufficient to cause the device to operate (at least at a certain level). By way of example only and not limitation, the algorithm may utilize voltage readings over a certain period of time (e.g., one second or five seconds or 10 seconds), and if the average (mean, median, and / or mode) of the voltage drops below a threshold, the algorithm includes logic for determining that the system is not operating at a desired level. Additional embodiments by way of example will be described below.

[0282] In an exemplary embodiment, the code for automatically determining whether the system is operating and / or not operating and / or how well the system is operating and / or whether the system is capable of operating and / or how well the system will operate in the future is code that performs a functional check that is distinct from whether the system is activated and / or deactivated. By analogy, many central air conditioning systems and houses include electrostatic air filters. Charge is used to attract dust particles and adhere them to the filter. However, it is often difficult to determine whether the electrostatic system is operating or otherwise how well it is operating. The system may be turned on, but the electrostatic system of the air handling system may be in a state where the electrostatic feature does not operate to attract and / or adhere dust particles to the filter (the basic filter is capturing dust in the same manner as in the case where there is no electrostatic feature), or otherwise operates, but at a level that is meaningful and even significantly lower than its expected operating level. One may not be able to figure out by visual inspection whether the electrostatic system is operating. Instead, measurement of current and / or voltage and / or even assessment of the electrostatic field generated by the system can provide an indication of whether the system is operating or how well the system is operating. Similarly here, there can be code that performs a functional check. In an embodiment, this is code that is executed when the system is turned on / the code herein can be executed when the system is turned on.

[0283] Conversely, the code may be executed when the system is turned off. In this regard, a turned-off system can correspond to a system in an inactive state, and for all intents and purposes, to any external observer or recipient, the system is turned off (e.g., the stimulator portion is deactivated / will not stimulate, for example, but consider the test stimulation below). In fact, in this arrangement, when in the off state, the system will not be able to provide stimulation or sensation management, etc., or one or more or all of the functionalities detailed herein associated with the interface with the recipient or user of the medical device. However, the system is still capable of operating at a basic level to perform diagnostic features or otherwise perform at least some features associated with determining whether the system is capable of operating and / or how well the system is operating, etc. And note that in some embodiments, even when the system is "off", the system may provide some form of output. The output can be an output at a certain threshold level, or otherwise can be an output of limited duration where the recipient is not aware of the presence of the stimulation or otherwise where the vast majority of recipients of the device or system are unlikely to be aware of the presence of the stimulation, or even if they are aware, the effect is negligible. Thus, jumping briefly ahead, in an exemplary embodiment of evaluating the efficacy of a medical device as will be described in further detail below, the efficacy evaluation is based on the stimulation provided to the recipient's tissue when the device is turned off and / or on.

[0284] Embodiments include using code for providing an indication in conjunction with code for automatically obtaining data on an alterable environment for an impaired person (such as a person with impaired balance and / or impaired mobility and / or impaired vestibular function) as detailed above, and code for at least partially controlling the input from a person's vestibular system to the person's brain based on the obtained data. In some such embodiments, the code for automatic determination is code that makes a determination based on how the input to the brain is controlled (where, for example, the control can be stopped and thus the system does not operate, or the system is restricted in its functionality and thus the system does not operate with its full functionality). In an embodiment, as described above, at least partially controlling the input to the brain includes stopping artificial stimulation of a person's vestibular system, and thus the indication can be that the system, for example, does not operate. In an embodiment, there is code for automatically evaluating the obtained data and determining that the light level is at and / or below a threshold level, where the action of at least partially controlling the input to the person's brain includes stopping stimulation based on the determination.

[0285] In view of the foregoing paragraphs, it can again be seen that embodiments associated with controlling the input from a person's vestibular system to the person's brain based on data on an alterable environment for an impaired person (such as impaired balance and / or impaired mobility and / or impaired vestibular function, etc.) can be combined with the indication teachings detailed herein, and according to the above disclosure, any one of these features can be combined with another feature to provide an indication to a recipient that the system operates or does not operate according to environment-based control.

[0286] In view of this, it can be seen that there is a method of providing an indication to a recipient or user or to a third party that the system, for example, has a problem, or that the system will not operate or will otherwise operate in some way that may be different from what is desired or expected. Providing this indication to the user recipient can be utilized by the user recipient to adjust their actions and / or adjust the medical device system based on knowledge of whether the system is operating or will operate or the way the system operates or will operate. By way of rough analogy, in the case where the system is, for example, a balance system, the system can operate at a level that enables the recipient to walk around a room (including up and down stairs at a desired safety level), but not at a level that would enable the recipient to drive a car on a winding road during rush hour or at least would provide the recipient with a notice that they should be more careful than otherwise.

[0287] In short, a system that is being attended to is different from a system that is activated. As described above, an activated system can be a powered-on system, but this does not mean that the system is in a state where it can provide an output and / or a meaningful / useful output. In contrast, a system that is running is a system that is providing, for example, some form of output and generally a useful output. This requires that, in at least most conceivable embodiments, the system be powered on and, additionally, activated. But running implies operating at a certain level. Note, however, that there are several levels of functionality. By way of example only and not limitation, an embodiment in which the battery level is starting to get low may not operate at the same level as it would when the system has a fully charged battery. By way of example only and not limitation, certain subroutines or functions may be trimmed due to a low battery state. By way of example only and not limitation, it may be the case that the system automatically reduces the current output of one or more electrodes and, instead, lengthens the amount of time that the current is applied. In fact, the current output level may be reduced only if all other conditions remain the same. The key is that there are different levels of functionality. In this regard, features that are associated with how well the system operates can include the system providing certain stimulation levels / management only relative to other levels.

[0288] In an exemplary embodiment, there is also code for providing an indication of whether the system is running and / or not running and / or how well the system is running. By way of example only and not limitation, the code can be code that is used to render a GUI interface of a smart phone that has been modified to have a specific display to present the indication. In an exemplary embodiment, the code can be code for allowing current to flow into a red-colored LED that lights up to indicate that the system is not running. In this regard, the code can be code that evaluates a signal (output from a detector that can be digital and that represents the presence or state of the signal) from, for example, code that makes a determination of a functional level, and when no such signal is received, since the code that makes the determination has determined that the system is not operating at the given level under discussion and thus stops outputting the signal to an algorithm for providing an indication, the code for providing the indication, when performing a checksum or otherwise evaluating the current level or voltage of the signal, or more precisely the current and / or voltage is zero or minimal, or alternatively the output of the detector has a binary string corresponding to the system not operating, provides an indication on the GUI that the medical device is not operating and / or not operating at the desired level. Of course, the reverse applies in the case where a signal or alternatively a binary character indicates functionality, or at least functionality at the desired level, and the code controls the GUI to provide an indication that the system is operating at least in the desired manner. This indication can be a graphic or text string indicating that the system is operating in the desired manner, or a text string indicating that the system is not operating in the desired manner or for that matter not operating at all, etc. The graphic can be a simple graphic such as a thumbs up or thumbs down image presented on the screen of a smart phone.

[0289] According to the above, the code for automatic determination includes code for performing a self - assessment of the system. This self - assessment can be performed according to the teachings just mentioned above. Again, this can be performed by monitoring the voltage and / or current of one or more parts of the system. In an embodiment, the code is code for monitoring the voltage of the battery of the system or the voltage of an electrical energy storage device or the voltages of a plurality of electrical energy storage devices. Again, in an exemplary embodiment, a voltage detector can be positioned in series with the output of the battery, and this detector can output a digital signal indicating the voltage or at least one characteristic of the voltage, and a digital signal that can be evaluated by the code, for example, by comparing the data represented by the digital signal with a look - up table of certain values associated with the voltage, and if the look - up table indicates for this value that the voltage is at a level indicating that the system is not operating according to expectations or otherwise not operating in a useful manner, then the code can make a determination in an automated manner. Again, other types of arrangements can be used, where, for example, a detector is provided at other locations on the circuit, which monitors voltage, current, etc., and outputs a digital signal that is evaluated by the code (e.g., based on threshold techniques or look - up table techniques).

[0290] In an embodiment, the code for automatic determination includes code for performing the following operations: evaluating a feature indicative of the output of the system and determining, based on the evaluation of the feature, whether the system is operating and / or not operating and / or how well the system is operating. In an embodiment, this feature may be, by way of example, the voltage of the (one or more) electrodes and / or the current supplied to the (one or more) electrodes. In an embodiment, with respect to cochlear implant technology, the voltage of the electrodes and / or the current supplied to the electrodes can be measured using standard techniques for measuring them. In an embodiment, there is a current detector that detects the current supplied to the electrodes. The current detector outputs a digital signal that is evaluated by software (e.g., via a look-up table) to compare the output with the data in the look-up table to determine whether the current indicates an operating system or a non-operating system and / or to determine how well the system is operating. In an embodiment, there may be another sensor separate from the output that evaluates the internal physiological characteristics of the recipient to determine whether the system is operating. By inference, this can be used to determine whether the system is providing efficacy and / or the level thereof. More description thereof is provided below. In an embodiment, the feature indicative of the output may be the length of the electrical pulse of the output or the length of time there is a voltage difference relative to other times, etc. In an embodiment, latent variables may be used as a basis, where sensors can detect these latent variables and provide a digital output to the software, where the output is compared with, for example, a look-up table. Any device, system, and / or method for capturing or otherwise determining a feature indicative of the output of the system and / or for evaluating a feature indicative of the output of the system may be used in at least some exemplary embodiments, as long as it is achievable in the art, unless otherwise stated. Note also that more than one feature indicative of the output of the system may be used, which is an insurance method or a redundancy method. Alternatively, these features may be compared with each other. If these features establish a first set of features, a determination may be made that the system is operating, and if these features establish a second set of features, a determination may be made that the system is not operating and / or multiple sets of features may be used to determine how well the system is operating and in some embodiments there may be a determination of code therefor.

[0291] Note that the feature indicative of the output is different from whether a component is operating. Just because an engine is running does not mean the engine is propelling a vehicle, for example, if the vehicle's transmission is damaged, by way of example. It should be clear that the embodiments also include evaluating the operational aspects of the components of the system. These aspects may be related to the output. But just because a component is not working and thus there is no output does not mean the evaluation of that component corresponds to the evaluation of the feature itself indicative of that output.

[0292] In an embodiment, the code for providing an indication is code for providing a warning that the system is not operating and / or will not operate and / or is operating at a particular level and / or below a particular level and / or will only operate at a particular level and / or below a particular level. And note the use of the term "level" here is quite loose. This does not require, for example, a level of "77%", although this level can be included within that level. Put another way, the level can be qualitative and / or a qualitative level. Any indication of a particular level that will provide utility value to a recipient or user or third party can be used in some embodiments, as long as it can be implemented in the art, unless otherwise stated.

[0293] The embodiment includes a method. Figure 29 An exemplary flowchart of an exemplary method (method 2900) according to an exemplary embodiment is shown. Method 2900 includes method act 2910, which includes the act of operating a medical device connected to a person, where the medical device is configured to stimulate the inner ear of the person. The stimulation can be direct stimulation or indirect stimulation. In an exemplary embodiment, the medical device can be a vestibular medical device. In an exemplary embodiment, the device can be a tinnitus masking device. The device can be a cochlear implant. In this regard, by way of example, the device can also be a bone conduction device, as this indirectly stimulates the inner ear. The method further includes method act 2920, which includes the act of automatically evaluating the efficacy of the medical device before, during, and / or after the operating act. Here, the efficacy can be in the context of whether the medical device is turned off, in which case it will have no efficacy. At the other extreme, the efficacy can be how well the medical device operates according to its intended purpose. By way of example only, in the example where the medical device is a vestibular medical device, the efficacy can be in terms of how well the medical device helps the recipient of the medical device maintain balance. This can also be how well the medical device will help the recipient maintain balance. Based on empirical data collected by the medical device when connected to the person, this can be completely subjective for the recipient. The efficacy of the medical device can be evaluated based on, by way of example, feedback from the recipient. The medical device can be configured to receive this feedback and automatically evaluate it. The efficacy of the medical device can be based on the voltage difference between electrodes. By way of example, if the voltage difference is very high, this can indicate a high impedance between the electrodes, thus indicating that the efficacy will be very low. This is in contrast to, for example, evaluating the level of current provided to the electrodes to achieve a particular result and evaluating whether there is "a lot" of current relative to the original situation. This can be evaluating the efficacy of the medical device. If the medical device can operate in an effective manner even if a high level of current is required, then this is simply an inefficient device. However, if a high level of current indicates that the device has no efficacy level relative to another level, then this will be different, and thus the efficacy of the medical device will be automatically evaluated.

[0294] However, embodiments can focus on using the state of a system of which a medical device is a part as a basis for evaluating efficacy, off state, inactivity state, low battery state, reduced functionality state, etc. Here, this can be subjective or objective or both subjective and objective. In an exemplary embodiment, the evaluation of efficacy is based on whether the device is off. This of course will not provide efficacy. This action can be performed by a device separate from the medical device. Thus, this will not require the device to be able to operate when the device is turned off in a conventional manner (understood as disconnected) to evaluate efficacy. That is, the device will not require some form of routine that operates even when the device is turned off for all intents and purposes with respect to the operating characteristics desired by the user (e.g., to provide stimulation for balance purposes). By way of example only and not limitation, a portable handheld device (such as a smartphone) that is part of the system can be used to perform the action of automatically evaluating the efficacy of the medical device. Additionally, embodiments include methods where the evaluation action is performed by the medical device when the medical device is off. Additionally, embodiments include the situation where the automatic evaluation action is performed when the device / system is on and the recipient would otherwise consider the device to be operating in an effective manner. And, this is a practical feature - to determine that there is an abnormal situation or other situation that does not meet the recipient's expectations or desires, in a situation where the recipient may not necessarily be aware that this is the case.

[0295] In accordance with the teachings herein, in an embodiment, the medical device is a balance sensory medical device, and the efficacy is based on how well the device improves a person's balance performance. This can be based on subjective data specific to the person. In an exemplary embodiment, there can be a system that can be configured to automatically evaluate, for example, a person's movements and compare these movements to a baseline that can be stored in a memory. Based on this comparison, an evaluation can be made as to how well the device improves the person's balance performance. In an exemplary embodiment, there can be one or more gyroscopes or inertial sensors, etc., that can capture data regarding a person's movements (or the person not moving, indicating that the person may be experiencing dizziness), and provide an output that is evaluated by code that is configured to evaluate this data by comparing it to, for example, a look-up table. In an alternative embodiment, the system can receive feedback from the recipient, such as that they are feeling dizzy, etc., and this feedback can be the basis for the evaluation. This input can be verbal and / or can be an input into the system through a smart device touchscreen or a direct input into a BTE device of the balance medical device (by way of example) (such as tapping the device a number of times, indicating the degree of dizziness).

[0296] Additionally, embodiments associated with feedback from a recipient based on the recipient's observations defeat the concept of another system such as the efficacy or functionality of a self-checking system or an automated assessment system in order to provide an indication that serves as a warning or otherwise notifies the recipient or user that the device is not operating in the manner that he or she might think it is operating or otherwise should be operating. That is, the embodiments relate to notifying the recipient that he or she should not rely entirely on a medical device as he or she might otherwise have relied on it, where in some embodiments the recipient may have little or no reason to think that this is the case. This is somewhat analogous to the electrostatic air purifier analogy detailed above. This is an indication that there is a problem, or at least a situation that is occurring but is not readily apparent or otherwise may be difficult for the recipient to detect. Accordingly, embodiments include devices, systems, and / or methods for performing the assessments detailed herein in the absence of at least direct input from the recipient and / or in the absence of input from the recipient based on the recipient's assessment or otherwise the recipient's judgment. Embodiments include devices, systems, and / or methods for performing the assessments that do not require any action on the part of the recipient other than to use the medical device to the greatest extent possible as in normal use.

[0297] As described above, the act of automatically evaluating the efficacy of a medical device can be performed while the device is operating or before or after the device is operated or in all three cases. In an exemplary embodiment, the evaluation act is performed during and / or before (including at least before) and / or after (including at least after) any of the above time periods, which are not repeated here for the sake of brevity of the text but are included by reference. Thus, for example, the act of automatically evaluating efficacy can be performed for 120 seconds or at least 120 seconds before operating the medical device. This can have practical value in terms of giving, for example, the recipient of a balance-sensing prosthesis time to change or adjust their intended actions based on how the efficacy of the medical device will operate or is otherwise operating or has been operating. For example, if the medical device is operating at a high efficacy level, the recipient can determine to engage in activities that require a high level of balance or otherwise where the recipient loses their balance, and the consequences may be more severe than other activities the recipient would engage in. That is, this can achieve an excellent level of risk management relative to what might otherwise be the case. (It is not reasonable to have the recipient of a balance-sensing prosthesis avoid walking across a hard asphalt parking lot at all times. This is not risk management. This is risk avoidance. Determining when or whether the recipient should walk across a hard asphalt parking lot is risk management.) In any case, in accordance with the teachings detailed above, embodiments include evaluating the efficacy of a medical device while the medical device is being operated. However, also in accordance with the teachings detailed above, the act of automatically evaluating the efficacy of a medical device can also be implemented when the device is stopped operating, and this can be a very practical time to evaluate efficacy because this can be used as a basis for communicating to the recipient that the efficacy of the medical device is low (including no efficacy). And embodiments include performing an efficacy evaluation within a short time after stopping operation.

[0298] Also note that any disclosure of a time trigger when the device described herein is not activated or not operating or turned off corresponds to an alternative disclosure of the device changing efficacy levels or states, etc. Unless otherwise stated, any status change / new status that requires an indication to the recipient or a third party can apply to any of the time triggers detailed herein, all for the sake of brevity of the text. Regarding arrangements where it is not known whether the device is turned on or off, in an exemplary embodiment, the efficacy is based on whether the device is providing tissue stimulation to a person regardless of whether the device is turned off. Again, this can be providing stimulation to the recipient at a sub-threshold level when the device is turned off, and the stimulation is provided for the diagnostic purposes detailed herein.

[0299] Based on the above disclosure regarding the combined use of indicative features and other features with embodiments of the altered surrounding environment, in an exemplary embodiment of the exemplary method, the action of automatically evaluating efficacy is based on the medical device being operated based on the altered surrounding environment. By way of example only and not limitation, in an embodiment where the medical device is a balance-sensing medical device, the method may include obtaining data based on the surrounding environment of a person with balance impairment. The method may also include experiencing a change in the surrounding environment, such as when, for example, the lights in a living room are turned off. The method further includes restricting the operation of the balance-sensing medical device connected to the person based on the altered surrounding environment. In an exemplary embodiment, the action of automatically evaluating the efficacy of the medical device in method act 2920 is based on the medical device being restricted from operating based on the altered surrounding environment. Conversely, in an exemplary embodiment, the method may also include experiencing a change in the surrounding environment where the lighting in a room is increased to a level at which the balance-sensing medical device is useful, such that the balance-sensing medical device is activated from a deactivated state (by way of example). Here, the method includes restricting the operation of the balance-sensing medical device based on the altered surrounding environment, or alternatively, for example, activating the balance-sensing medical device from a deactivated state, or alternatively increasing the level of functionality of the medical device.

[0300] In accordance with the teachings detailed above, embodiments may include providing an indication of a restriction and / or removal of a restriction to a recipient of a medical device, or a third party, etc.

[0301] In an exemplary embodiment, the system and / or device is configured to perform a check of the activation and / or functionality and / or efficacy of the system and / or device every XYZ seconds or any value or range of values therebetween in increments of 0.05 seconds and / or in a range of XYZ seconds or any value or range of values therebetween in increments of 0.05 seconds during a 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, or 100 minute period or any value or range of values therebetween in increments of 0.1 minute, and the method of performing includes the checks described above, and the timing between the executions during these time periods (e.g., during a 30 minute period, the device may perform the check every 5 seconds for 18 minutes and then every 3 seconds for 12 minutes) need not be the same. The reason for using is that the recipient is engaged in an activity that is life threatening in the event of a temporary decline in efficacy even for a short period relative to other activities. Thus, embodiments include a method in which an automatic assessment action is periodically performed by a medical device / system when the device is connected to a person and / or when the medical device / system is in a state where its recipient believes the device is operating normally / system is operating normally or otherwise operating in a desired manner (uniform or different timing between assessments). The method further includes periodically and automatically providing an indication to the person that the device is operating in an effective manner based on the results of the automatic assessment. The periods need not coincide or be temporally related in a consistent manner, but they can be. Returning to embodiments of the medical device for balance sense, the automatic assessment action can be periodically performed by the balance sense medical device when the device is connected to a person and / or when the medical device / system is in a state where its recipient believes the device is operating normally / system is operating normally or otherwise operating in a desired manner, and the method further includes automatically providing an indication to the person that the device is operating in a less effective manner based on the results of the automatic assessment.

[0302] For purposes of text brevity, the disclosures herein generally refer to one feature without explicitly referring to another feature. By way of example only and not limitation, some of the disclosures herein refer to activation, while other portions of the disclosure refer to functionality, and other portions of the disclosure refer to efficacy. For purposes of text brevity, note that any disclosure of a feature related to activation and / or non - activation corresponds to an alternative disclosure related to functionality and / or non - functionality and / or its various levels and / or efficacy or non - efficacy or a change in its level, so long as the art can implement, unless otherwise stated. Unless otherwise stated, any feature of an embodiment can be combined with any other embodiment and / or any feature of any embodiment can be excluded from use with any feature of any other embodiment, so long as the art can implement.

[0303] And although the embodiments focus on the detailed arrangements associated with features associated with assessment and functionality and / or activation and / or efficacy, the embodiments also include basic implementations where the system provides an indication of a given state of the system and / or its subsystems (such as a first subsystem) to a recipient or its user, including whether the system and / or a part of the system (such as a stimulator device for a prosthesis, for example) is on and / or off and / or whether it is operating at a baseline level and / or not operating (e.g., the system may be turned on, but the battery is weak such that it cannot adequately or consistently stimulate the vestibular system to achieve the desired efficacy). By way of example only and not limitation, a portable handheld device (such as a smartphone) may provide an indication that the balance sensing medical device is off or otherwise not turned on or otherwise not operating and / or that the balance sensing medical device is on or otherwise turned on or otherwise operating. In an embodiment, the system is configured to detect the voltage and / or current provided to or that can be provided to a stimulator unit of a given prosthesis under discussion, and output a signal (such as a digital signal) that can be read by the code of the system and / or evaluated by a processor of the system, etc., by comparing the voltage and / or current with the voltage and / or current of a look-up table when determining whether the system is capable of operating or is operating, etc. In an embodiment, the system is configured to detect the switch state of the stimulator, which may correspond to assessing the state of a switch that turns the system on and / or off, etc., and this detection may be the basis for determining the state of the system.

[0304] To reiterate, in view of the foregoing, there can be practical value in using the teachings detailed herein to provide an indication to a recipient and / or caregiver of the system as to whether the system is operating and / or not operating, etc. This may reduce the likelihood of situations where the recipient or caregiver has false confidence in the system or otherwise the results of the system relative to the original situation. In a simple scenario, a recipient with a balance disorder who is using a balance sensing medical device will realize practical value in knowing the state of the system before and / or during activities that require balance or at least when the outcome of a lack of balance may be worse relative to other situations (e.g., driving a vehicle relative to lying in bed or walking across a hard asphalt parking lot relative to walking across the topsoil of a mowed lawn with one or both feet, etc.).

[0305] As described above, embodiments include a method that includes automatically evaluating the efficacy of a medical device. This can be accomplished using logic circuitry and / or software that analyzes certain characteristics of a system of which the medical device is a part. These characteristics can be latent variables associated with, for example, the efficacy of the medical device, or can be more directly associated therewith. The component that performs the automatic evaluation action is not merely a simple switch indicator. In fact, merely indicating whether the medical device is on or off is not an evaluation. This is the conveyance of information. Conversely, as an example, automatically evaluating whether a system is in an activated state of an excitation electrode, a logic circuit specifically designed and implemented to perform the teachings herein can correspond to a circuit for implementing some of the method acts detailed herein. If the circuit also includes an output that can control the activation / deactivation of, for example, an LED that indicates whether the system is on, for example, these characteristics are ancillary to the logic circuit for automatically evaluating whether the system is operating, etc. Note also that the component used to perform some of the method acts detailed herein can utilize existing circuitry in the system, such as that providing control of the aforementioned LED. Merely as an example and not by way of limitation, if the medical device is configured to supply current to an LED to indicate that the device is turned on, some embodiments include monitoring that current and using the detection or non-detection of that current as an indicator when performing at least some of the exemplary method acts. That is, the system can include a more complex arrangement where the circuitry used to controllably generate the current is also used as a basis for implementing at least some of the method acts, or at least the output from this circuitry is used as a basis for making determinations regarding some of the method acts detailed herein. It is to be clear that merely an on / off indicator / its use does not constitute an evaluation of efficacy or a determination of whether the system is operating or not operating or how well the system is operating / whether the system is capable of operating, etc.

[0306] Some additional details of vestibular stimulation will now be described. Figure 18 For a schematic illustration of the general anatomy of the vestibular system, Figure 19 For a more detailed illustration of the semicircular canals and associated structures. Referring Figure 18 to, there is a vestibular system 2000. Three semicircular canals 2002 are shown, each arranged in a generally mutually perpendicular manner. Each canal is filled with endolymph fluid, and when the head rotates with a movement component in the appropriate direction, it causes the fluid to move within the canal. Ampullae 2004 and associated cristae 2006 are at the base of each canal. Cupulas 2008 are within cristae 2006, and the cupulas contain hair bundles 2110 that are connected to hair cells 2112 and in turn to nerve fibers 2114. When the fluid moves, the hair cells 2112 are stimulated and corresponding nerve signals are generated. Referring Figure 19, more particularly illustrates the position and orientation of the vestibular labyrinth relative to selected structures of the cranial nerves VII and VIII and the inner and middle ear. Illustrated are the vestibular nerve 1, cochlear nerve 2, intermediate facial nerve 3, geniculate ganglion 4, chorda tympani nerve 5, cochlea 6, semicircular canals 7, malleus 8, tympanic membrane 9, and ear canal 10. The illustrative embodiments to be described can be used in a relatively simple and constant stimulation system. This is intended to be operable by a user when they determine that they have symptoms indicating the onset of an attack or alternatively when in a prophylactic mode, in which the operating device prevents the onset of an attack. In another embodiment, the system can be implemented in a manner connected to a monitor, and the system automatically enables / disables stimulation and / or adjusts it according to the above. Embodiments can include directly electrically stimulating the vestibular system by non-invasively implanting an electrode array into one or more of the semicircular canals.

[0307] A vestibular stimulation device (such as those presented above and / or Figure 20 described more hereinbelow (more will be said about them shortly)) can include an external processor (or an implantable processor), a transmission coil (transcutaneous link), and an implant and electrode array. The stimulation device 40 and the associated external power / stimulation controller can be a modified conventional cochlear implant stimulator device with a customized electrode array.

[0308] Figure 20 An enlarged view of the array is shown, which shows electrodes 31, 32, 33 with reinforcement 34.

[0309] Once implanted, the electrodes of the electrode array (although the embodiments use a single electrode on each branch) receive stimulation signals from the stimulator unit. The stimulator unit is typically electrically connected to the electrode array by electrical leads. The stimulator unit is located within a housing implantable within the patient's body and is typically implanted in a recess in the bone behind the mastoid process behind the ear. When implanted, in addition to the stimulator unit, the housing can also include a receiver unit adapted to receive signals from a controller. In this example, the controller is mounted externally on the body behind the patient's auricle such that the signals are transmitted transcutaneously through the skin of the recipient.

[0310] These signals travel from the controller to the receiver unit and vice versa. The receiver unit includes a receiver antenna (such as an antenna coil), which is adapted to receive radio frequency (RF) signals from a corresponding transmitter antenna (such as an antenna coil) worn outside the body. The RF signals can include frequency modulation (FM) signals, but alternatively can be modulated in any suitable manner using analog or digital techniques with amplitude, frequency, or phase. Generally, the modulation can be selected to maximize both the data and power efficiency of the link. It should be recognized that the receiver antenna can also transmit signals, and the transmitter antenna can receive such signals. The transmitter antenna coil is preferably held in a position adjacent to the implanted position of the receiver antenna coil by a corresponding attracting magnet (not shown) mounted in the middle of the coil or at at least some other position relative to the coil.

[0311] In this example, the external controller includes a processor (not shown, but can correspond to the aforementioned processor(s)), which is adapted to encode a suitable stimulation signal, e.g., in response to any one or more of the triggers detailed herein. This signal can include data defining, for example, the stimulation pattern, current level, and which electrodes are to be stimulated. Since the implant can use three separate electrode arrays, the stimulation can occur simultaneously or alternately, sequentially on more than one array. The encoded sequence is transmitted to the implanted receiver / stimulator unit using the transmitter antenna and the receiver antenna. The implanted receiver / stimulator unit demodulates the signal and distributes electrical pulses to the appropriate electrodes. The external controller can also include a power source (not shown). The power source can include one or more rechargeable batteries. The transmitter antenna and the receiver antenna are used to provide power to the implanted receiver / stimulator unit and the electrode arrays via transcutaneous induction.

[0312] Embodiments of the implant can be configured to deliver both or either or neither monopolar and bipolar stimulation. Bipolar stimulation occurs when current flows from one electrode to another electrode in the same array (i.e., in the same tube). Monopolar stimulation occurs when current flows between an electrode inside the tube and an electrode outside the tube (e.g., a separate implanted electrode outside the tube). Depending on the stimulation current required to elicit a response, bipolar may be advantageous in minimizing interaction with adjacent semicircular canals. At least two channels are also required for neural response telemetry (usually one inside the tube and one between tubes), which has been shown to be important during surgery for electrode placement.

[0313] When not moving, the normal vestibular system generates a constant regular activity, i.e., neurons in the semicircular canals fire at a constant rate. In some embodiments, the target of the stimulation can be to stimulate this constant firing by delivering an electric current to evoke efferent neural activity. According to some embodiments, this can be unmodulated. However, other embodiments are contemplated to be modulated, e.g., modulated in frequency or amplitude, in order to provide a more complex user perception. Compared to auditory stimulation, the electrical stimulation that can be used can have a lower complexity and a lower rate pulse sequence. For example, the electrical stimulation can be provided as biphasic pulses at 100 - 200 Hz, 400 μs phase width, 8 μs phase gap, and a current of 20 - 100 uA. These numbers are merely indicative, and embodiments can use other parameters.

[0314] In an embodiment, the electrode array is designed to enter each semicircular canal while preserving any residual vestibular function. This is achieved using a suitable size (e.g., a diameter of less than 150 microns for a circular array). Other specific characteristics related to length, stops to limit penetration, and stiffness contribute to this goal, as will be further explained below.

[0315] Embodiments can alternatively be located outside the canal or in two places.

[0316] (A plurality of) arrays can be surgically placed into any one, two, or all of the semicircular canals.

[0317] (A plurality of) illustrative arrangements of electrode arrays can allow one electrode array to be placed in one semicircular canal and the remaining electrode arrays to be safely placed in the mastoid resection cavity for future implantation into the remaining semicircular canals. In this case, only the implanted array is used for stimulation. The remaining electrode arrays can also be used for possible otolith stimulation through vestibular implantation, possibly through the round window or oval window access or through the common crus.

[0318] Figure 21 Suitable surgical openings 55, 55A, 55B in the posterior semicircular canal 51, anterior semicircular canal 51B, and lateral semicircular canal 51A are shown through which the electrode array 26 can be implanted. In each case, the corresponding ampulla 50, 50A, 50B can be seen.

[0319] The array can be surgically placed within the labyrinth while preserving vestibular function / sensitivity, but providing robust electrical stimulation to the vestibular periphery.

[0320] Each array can have a sufficient number of electrodes to allow both monopolar and bipolar stimulation and to provide sufficient redundancy in case of individual electrode failure. A suitable reference electrode can also be provided as the return path for monopolar stimulation.

[0321] Some embodiments include ampullary implantation away from the outer tube.

[0322] Embodiments may include electrode placement near the ampulla of the semicircular canal for activation of the vestibular system.

[0323] Embodiments include implementing at least some of the teachings detailed herein using machine learning algorithms or what is otherwise referred to as artificial intelligence. In an exemplary embodiment, these machine learning algorithms may be implemented to evaluate an environment (e.g., light level or visual scene, etc.), make a determination based on that evaluation, such as, by way of example only, whether to suppress or inhibit vestibular balance function according to the teachings detailed above. Some brief examples of the implementation of machine learning techniques will now be described, but note also that in an exemplary embodiment, the analysis / decision making detailed herein may be performed by a microprocessor or a chip or other electronic circuitry having logic circuitry configured to analyze data and make decisions thereon.

[0324] At least some exemplary embodiments according to the teachings detailed herein utilize advanced techniques to analyze data obtained by a system / device and / or data used in a method. An exemplary data processing technique is what is referred to as a deep neural network (DNN). At least some exemplary embodiments utilize a DNN (or any other advanced learning data processing technique) to process data, and the processed data is used to evaluate electrodes according to the teachings herein. At least some exemplary embodiments require training a data processing algorithm to process data so as to implement at least some of the exemplary methods herein. That is, some exemplary methods utilize a learning algorithm or scheme or system (such as a DNN) or any other system that may have practical value, where this would otherwise enable the teachings detailed herein to analyze data.

[0325] Embodiments include utilizing what is referred to as a “neural network,” which may be a particular type of machine learning system. Any disclosure herein of the species “neural network” constitutes a disclosure of the genus “machine learning system.” While embodiments herein focus on various species of neural networks, note that other embodiments may utilize other species of machine learning systems. Thus, any disclosure herein of a neural network constitutes a disclosure of any other species of machine learning system capable of implementing the teachings detailed herein and their variations. For clarity, at least some embodiments according to the teachings detailed herein are embodiments having the ability to learn without being explicitly programmed. Thus, with respect to some embodiments, any disclosure herein of an apparatus or system constitutes a disclosure of an apparatus and / or system having the ability to learn without being explicitly programmed, and any disclosure of a method constitutes actions enabling learning without being explicitly programmed therefor.

[0326] The embodiments include method acts associated with the process of training DNNs so that these DNNs can be used to perform at least some of the method acts detailed herein.

[0327] It should be noted that in at least some exemplary embodiments, a given ability to evaluate / process data detailed herein is implemented using a DNN or a product from machine learning or the like. In some cases, for the purpose of language economy, apparatuses and / or systems that perform acts and the like will be disclosed, and in some cases, the structures that produce the act or enable the performance of the act will be disclosed. Any method act detailed herein or any function detailed herein or any structure having a function as disclosed herein corresponds to the disclosure in an alternative embodiment of a DNN or a product from machine learning or the like that produces the function in use, unless otherwise indicated or unless such method act or function cannot be implemented in the art.

[0328] Exemplary embodiments include implementing or otherwise performing at least one or more of the method acts detailed herein using a trained neural network, and thus the embodiments include a trained neural network configured to do so. Exemplary embodiments also utilize the knowledge of the trained neural network / information obtained from implementing the trained neural network to implement or otherwise perform at least one or more of the method acts detailed herein, and thus the embodiments include apparatuses, systems, and / or methods configured to utilize such knowledge. In some embodiments, these apparatuses may be processors and / or chips configured using the said knowledge. In some embodiments, the apparatuses and systems herein include apparatuses that imprint or otherwise impart the knowledge to the neural network.

[0329] As described above, in some embodiments, s...

Claims

1. A system, comprising: a first subsystem configured to have a neurological effect on a human when activated; and a second subsystem configured to obtain data based on the surroundings of the system, wherein the system is configured to control the first subsystem at least in part based on the obtained data, and the system is a human balance medical system.

2. The system according to claim 1, wherein: the first subsystem is a vestibular nervous system stimulation device.

3. The system according to claim 1, wherein: the first subsystem is a therapeutic substance delivery subsystem.

4. The system according to claim 1, 2 or 3, wherein: the second subsystem is an optical capture subsystem.

5. The system according to claim 1, wherein: the first subsystem is a vestibular implant.

6. The system according to claim 1, 2, 3, 4 or 5, wherein: the system is configured to limit the level of influence of the first subsystem on the human based on the obtained data.

7. The system according to claim 1, 2, 3, 4, 5 or 6, wherein: the first subsystem is configured to suppress and / or inhibit sensory input to the brain of the human in different ways.

8. A method, comprising: obtaining data based on the surroundings of an impaired human; changing the surroundings based on the obtained data; and operating a sensory medical device connected to the human based on the changed surroundings to affect the balance of the human and / or affect the motor function of the human.

9. The method according to claim 8, wherein: the surroundings is the ambient light level.

10. The method according to claim 8, wherein: the surroundings is sound.

11. The method according to claim 8, wherein: the surroundings is the ambient light level; and changing the surroundings is reducing the light level.

12. The method according to claim 8, 9, 10 or 11, further comprising: increasing the output level of the sensory medical device based on the changed surroundings and operating the sensory medical device at the increased output level, wherein the sensory medical device is a balance sensory medical device and the human is a human with impaired balance.

13. The method according to claim 8, 9, 10, 11 or 12, further comprising: obtaining data indicating the comfort level of the human; and controlling the sensory medical device based on the obtained data indicating the comfort level of the human.

14. The method according to claim 8, 9, 10, 11, 12 or 13, further comprising: increasing the aggressiveness of treatment by operating the sensory medical device differently from a previous operation based on the changed surroundings, wherein the sensory medical device is a balance sensory medical device and the human is a human with impaired balance.

15. The method according to claim 8, 9, 10, 11, 12, 13 or 14, further comprising: reducing the aggressiveness of treatment by operating the sensory medical device differently from a previous operation based on the changed surroundings.

16. The method according to claim 8, 9, 10, 11, 12, 13, 14 or 15, wherein: the method is a method for treating oscillopsia.

17. The method according to claim 8, 9, 10, 11, 12, 13 or 14, 15 or 16, wherein: the action of changing the surrounding environment includes reducing environmental noise.

18. The method according to claim 8, 9, 10, 11, 12, 13, 14, 15 or 16, wherein: the action of changing the surrounding environment includes reducing environmental noise; and the action of operating the sensory medical device based on the changed surrounding environment includes reducing the stimulation level of the medical device, wherein the sensory medical device is a balance sensory medical device, and the person has impaired balance.

19. The method according to claim 8, 9, 10, 11, 12, 13, 14, 15 or 16, wherein: the action of changing the surrounding environment includes reducing environmental noise; and the action of operating the sensory medical device based on the changed surrounding environment includes increasing the stimulation level of the medical device, wherein the sensory medical device is a balance sensory medical device, and the person has impaired balance.

20. The method according to claim 8, 9, 10, 11, 12, 13, 14, 15 or 16, wherein: the action of changing the surrounding environment includes increasing environmental noise, wherein the sensory medical device is a balance sensory medical device, and the person has impaired balance.

21. A non - transitory computer - readable medium having recorded thereon a computer program for performing at least a part of a method, the computer program comprising: code for automatically obtaining data on the changeable environment of a person with impairment; and code for at least partially controlling the input from the person's vestibular system to the person's brain based on the obtained data.

22. The medium according to claim 21, wherein: at least partially controlling the input to the brain includes restricting vestibular function.

23. The medium according to claim 21 or 22, wherein: at least partially controlling the input to the brain includes starting artificial stimulation of the person's vestibular nervous system.

24. The medium according to claim 21, 22 or 23, further comprising: code for automatically providing instructions to the person based on the obtained data.

25. The medium according to claim 21, 22, 23 or 24, wherein: at least partially controlling the input to the brain includes stopping the artificial stimulation of the person's vestibular system.

26. The medium according to claim 21, 22, 23, 24 or 25, wherein: at least partially controlling the input to the brain includes changing the artificial stimulation of the person's vestibular system.

27. The medium according to claim 21, 22, 23, 24, 25 or 26, wherein: at least partially controlling the input to the brain includes starting the artificial stimulation of the person's vestibular system.

28. The medium according to claim 21, 22, 23, 24, 25, 26 or 27, further comprising: code for automatically evaluating the acquired data and determining that the light level is at and / or below a threshold level, wherein the action of at least partially controlling the input to the brain of the person includes stopping the stimulation based on the determination.

29. The medium according to claim 21, 22, 23, 24, 25, 26, 27 or 28, further comprising: code for automatically evaluating the acquired data and determining that the light level is at and / or above a threshold level, wherein the action of at least partially controlling the input to the brain of the person includes stopping the stimulation based on the determination.

30. An apparatus, comprising: one or more electrodes; a power supply; a light capture device; and a control unit, wherein the apparatus is configured such that the control unit controls the (multiple) electrical signals to the one or more electrodes to provide balance and / or movement therapy to a recipient of the apparatus, and the apparatus is further configured such that the control unit controls the (multiple) electrical signals based on an output from the light capture device.

31. The apparatus according to claim 30, wherein: the apparatus is configured to inhibit and / or suppress signals traveling from the vestibule to the brain by stimulating the tissue of the recipient using the (multiple) electrical signals.

32. The apparatus according to claim 30 or 31, wherein: the apparatus is configured to reconstruct the recipient's sense of balance by stimulating the tissue of the recipient using the (multiple) electrical signals.

33. The apparatus according to claim 30, 31 or 32, wherein: the apparatus is configured to provide to the recipient another type of stimulation different from the stimulation provided by the one or more electrodes to provide balance therapy to the recipient, thereby supplementing the reduced and / or eliminated stimulation caused by a phenomenon detected by the light capture device from the electrodes that meets a set criterion.

34. The apparatus according to claim 30, 31, 32 or 33, wherein: the apparatus is configured to reconstruct the recipient's sense of balance by stimulating the tissue of the recipient using the (multiple) electrical signals, and is configured to suppress and / or inhibit signals traveling from the vestibule to the brain by stimulating the tissue of the recipient using the (multiple) electrical signals.

35. The apparatus according to claim 30, 31, 32, 33 or 34, wherein: the apparatus is configured such that the control unit performs at least one of the following based on an output from the light capture device: increasing the activation threshold of the electrode, increasing the stimulation rate of the electrode, or increasing the amplitude of the (multiple) electrical signals.

36. The apparatus according to claim 30, 31, 32, 33, 34 or 35, wherein: the apparatus is configured to perform at least one of the following based on an output from the light capture device: initiating or providing to the recipient a notification indicating at least one of a light-based environmental characteristic or a recommended action.

37. The device according to claim 30, 31, 32, 33, 34, 35 or 36, wherein: the device is configured to provide to the recipient another type of stimulus different from the stimulus provided by the one or more electrodes to provide balance therapy to the recipient, thereby supplementing the reduced and / or eliminated stimulus caused by the phenomenon detected by the light capture device from the electrodes that meets the set criteria.

38. A human body balance medical system, comprising: a nerve stimulator subsystem configured to affect nerve signals of the brain of the recipient of the human body balance medical system to improve the balance of the recipient; and a power supply, wherein the nerve stimulator subsystem is powered by the power supply, and the human body balance medical system is an intelligent human body balance medical system.

39. The system according to claim 38, wherein: the intelligent human body balance medical system is configured to control the nerve stimulator subsystem based on an input into the system indicating the surrounding environment of the system.

40. The system according to claim 38 or 39, wherein: the intelligent human body balance medical system is configured to automatically adjust the environment of the system to improve the efficacy of the nerve stimulator subsystem.

41. The system according to claim 38, 39 or 40, wherein: the intelligent human body balance medical system is configured to automatically adjust the functionality of the nerve stimulator subsystem based on ambient light and / or noise level.

42. The system according to claim 38, 39, 40 or 41, wherein: the intelligent human body balance medical system is configured to automatically stop the functionality of the nerve stimulator subsystem based on ambient light level and / or ambient noise level.

43. The system according to claim 38, 39, 40, 41 or 42, wherein: the intelligent human body balance medical system is configured to automatically check the ambient light level and selectively and automatically perform the following operations based on the checked ambient light level: (i) Adjust the functionality of the nerve stimulator subsystem; (ii) Stop the functionality of the nerve stimulator subsystem; or (iii) Provide information and / or recommendations to the recipient to improve the balance of the recipient.

44. The system according to claim 38, 39, 40, 41 or 42, wherein: the intelligent human body balance medical system is configured to collect (a plurality of) latent variables that can affect the cognitive load of the recipient, and selectively and automatically perform the following operations based on the collected (a plurality of) latent variables: (i) Adjust the functionality of the nerve stimulator subsystem; (ii) Stop the functionality of the nerve stimulator subsystem; or (iii) Provide information and / or recommendations to the recipient to improve the balance of the recipient.

45. The system according to claim 1, 2, 3, 4, 5 or 6, wherein: the first subsystem is configured to enhance and / or provide sensory input to the brain of the person in different ways.

46. The device according to claim 30, wherein: The device is configured to enhance and / or provide signals traveling from the vestibule to the brain by stimulating the tissue of the recipient using the (one or more) electrical signals.

47. The device according to claim 30, 31, 32 or 33, wherein: The device is configured to reconstruct the sense of balance of the recipient by stimulating the tissue of the recipient using the (one or more) electrical signals, and is configured to enhance and / or provide signals traveling from the vestibule to the brain by stimulating the tissue of the recipient using the (one or more) electrical signals.

48. A system, comprising: A first subsystem configured to have a neurological effect on a human when activated; and A second subsystem configured to provide an indication that the system is activated and / or not activated, wherein The system is a sensory management and / or sensory stimulation system.

49. The system according to claim 48, wherein: The system is a human balance medical system.

50. The system according to claim 48, wherein: The system is an epilepsy management system.

51. The system according to claim 48, wherein: The system is a tinnitus management system or a sleep apnea system.

52. The system according to claim 48, wherein: The second subsystem is configured to provide an indication that the system is turned on.

53. The system according to claim 48, wherein: The second subsystem is configured to provide an indication that the system is turned off.

54. The system according to claim 48, wherein: The second subsystem is configured to provide the indication to the recipient of the system.

55. The system according to claim 48, wherein: The system is configured to provide the indication to a caregiver and / or guardian of the recipient of the system.

56. The system according to claim 48, wherein: The second subsystem is configured to provide the indication to the recipient of the system, and the indication is visual.

57. The system according to claim 48, wherein: The second subsystem is configured to provide the indication to the recipient of the system by stimulation applied internally by the system.

58. The system according to claim 48, wherein: The second subsystem is configured to directly provide the indication to the recipient of the system from a body-worn part of the system.

59. The system according to claim 48, wherein: The second subsystem is configured to provide an indication that the system is activated.

60. The system according to claim 48, wherein: The second subsystem is configured to provide an indication that the system is not activated.

61. The system according to claim 48, wherein: The system is configured to provide an indication that the system is not activated within 30 seconds of being deactivated.

62. The system according to claim 48, further comprising a light sensor.

63. The system according to claim 48, further comprising: A third subsystem configured to obtain data based on the surroundings of the system, wherein The system is configured to control the first subsystem at least in part based on the acquired data. The system is a human balance medical system.

64. The system according to claim 63, wherein: The second subsystem is an optical capture subsystem.

65. The system according to claim 63, wherein: The system is configured to limit the level of influence of the first subsystem on the person based on the acquired data; and The second subsystem is configured to automatically provide an indication to the person when the level of influence of the first subsystem is limited.

66. A non-transitory computer-readable medium having recorded thereon a computer program for performing at least a part of a method, the computer program comprising: Code for automatically determining whether a system is operating and / or not operating and / or how effective the operation of the system is and / or whether the system is capable of operating, wherein the system is a sensory management and / or sensory stimulation system; and Code for providing an indication of whether the system is operating and / or not operating and / or how effective the operation of the system is and / or whether the system is capable of operating and / or how effective the future operation of the system will be.

67. The medium according to claim 66, wherein: The code for automatically determining includes code for performing a self-assessment of the system.

68. The medium according to claim 66, wherein: The code for automatically determining includes code for performing the following operations: evaluating characteristics indicating the output of the system and determining based on the evaluation of the characteristics whether the system is operating and / or not operating and / or how effective the operation of the system is and / or whether the system is capable of operating and / or how effective the future operation of the system will be.

69. The medium according to claim 66, wherein: The code for automatically determining is at least code for providing an indication that the system is not operating.

70. The medium according to claim 66, wherein: The code for automatically determining is at least code for providing an indication of how effective the operation of the system is.

71. The medium according to claim 66, wherein: The system is a human balance medical system.

72. The medium according to claim 66, wherein: The code for automatically determining is code for performing a functional check that differentiates whether the system is activated and / or deactivated.

73. The medium according to claim 66, wherein the code for providing an indication is code for providing a warning that the system is not operating and / or will not operate and / or is operating at a particular level and / or below a particular level and / or will only operate at a particular level and / or below a particular level.

74. The medium according to claim 66, further comprising: Code for automatically obtaining data on the changeable environment of a person with impaired balance; and Code for at least partially controlling the input from the person's vestibular system to the person's brain based on the acquired data, wherein The code for automatic determination is code that makes the determination based on the manner of controlling the input to the brain.

75. The medium according to claim 74, wherein: At least partially controlling the input to the brain includes stopping the artificial stimulation of the person's vestibular system.

76. The medium according to claim 74, further comprising: Code for automatically evaluating the acquired data and determining that the light level is at and / or below a threshold level, wherein The action of at least partially controlling the input to the person's brain includes stopping the stimulation based on the determination.

77. A method, comprising: Operating a medical device connected to a person, wherein the medical device is configured to stimulate the person's inner ear; and Automatically evaluating the efficacy of the medical device before, during, and / or after the operation action.

78. The method according to claim 77, wherein: The efficacy-related perspective is whether the device is on and / or off.

79. The method according to claim 77, wherein: The evaluation action is performed by a device separate from the medical device.

80. The method according to claim 77, wherein: The evaluation action is performed by the medical device when the medical device is turned off.

81. The method according to claim 77, wherein: The medical device is a balance sensory medical device; and The efficacy-related perspective is how well the device improves the person's balance.

82. The method according to claim 77, wherein: The efficacy-related perspective is based on whether the device is providing tissue stimulation to the person, regardless of whether the device is on or off.

83. The method according to claim 77, wherein: The medical device is a balance sensory medical device; and The automatic evaluation action is periodically performed by the balance sensory medical device when the device is connected to the person, regardless of whether the device is being operated.

84. The method according to claim 77, wherein: The automatic evaluation action is performed when the device is on and the recipient would otherwise consider the device to be operating in an effective manner.

85. The method according to claim 77, wherein: The automatic evaluation action is periodically performed by the medical device when the device is connected to the person; and Based on the result of the automatic evaluation, an indication that the device is operating in an effective manner is automatically provided to the person periodically.

86. The method according to claim 77, wherein: The medical device is a balance sensory medical device; The automatic evaluation action is periodically performed by the balance sensory medical device when the device is connected to the person; and The method further includes automatically providing an indication to the person that the device is operating in a less effective manner based on the result of the automatic evaluation.

87. The method according to claim 77, wherein: The medical device is a balance sensory medical device; The method includes obtaining data based on the surroundings of a person with impaired balance; The method includes subjecting the surroundings to a change; and Operating the balance sensory medical device connected to the person based on the changed surroundings.

88. The method according to claim 77, Wherein: The action of automatically evaluating the efficacy is based on the medical device being operated based on the changed surrounding environment.

89. The method according to claim 77, Wherein: The medical device is a balance-sensing medical device; The method includes obtaining data based on the surrounding environment of a person with impaired balance; The method includes subjecting the surrounding environment to a change; and Restricting the operation of the balance-sensing medical device connected to the person based on the changed surrounding environment.

90. The method according to claim 77, Wherein: The action of automatically evaluating the efficacy is based on the medical device being restricted from operating based on the changed surrounding environment.

91. The medium according to claim 21, 22, 23, 24, 25, 26, 27, 28 or 29, Wherein: The impaired person is a person with impaired balance.

92. The medium according to claim 21, 22, 23, 24, 25, 26, 27, 28 or 29, Wherein: The impaired person is a person with impaired mobility.

93. The medium according to claim 21, 22, 23, 24, 25, 26, 27, 28 or 29, Wherein: The impaired person is a person with impaired vestibular function.

94. The method according to claim 8, 9, 10, 11, 13, 15, 16 or 17, Wherein: The sensing medical device is a balance-sensing medical device, and the person is a person with impaired balance.

95. The method according to claim 8, 9, 10, 11, 13, 15, 16 or 17, Wherein: The sensing medical device is a motor function medical device, and the person is experiencing motor impairment.

96. The device according to claim 30, 31, 32, 33, 34, 35, 36 or 37, Wherein: The device is configured to provide balance therapy to the recipient of the device.

97. A prosthetic human balance medical device, Comprising: At least one of the following: (1) One or more external electrodes; Or (2) One or more implantable electrodes configured to be exposed to body fluid for at least 12 months; A battery, wherein the battery is rechargeable or disposable; An optoelectronic device configured to capture ambient light and / or be sensitive to ambient light, wherein the optoelectronic device includes one or more of (a plurality of) photosensitive regions, (a plurality of) photoresistors, (a plurality of) photodiodes, (a plurality of) photodetectors, (a plurality of) phototransistors or charge-coupled devices; And A control circuit configured to control (a plurality of) electrical signals to one or more electrodes to provide balance therapy to the recipient of the prosthetic medical device, and configured to control (a plurality of) electrical signals based on the output from the optoelectronic device to improve the balance of the recipient of the prosthetic medical device.

98. A prosthetic human balance medical device, Comprising: At least one of the following: (1) One or more external electrodes; Or (2) One or more implantable electrodes configured to be exposed to body fluid for at least 12 months; A battery, where the battery is rechargeable or disposable; A control unit configured to control (a) plurality of electrical signals to one or more electrodes to provide a balancing treatment to a recipient of a prosthetic medical device; And A control circuit configured to provide an output from the device indicating the activation state and / or efficacy of the device.

99. A device and / or system, where at least one of the following holds: The device and / or system includes one or more electrodes; The device and / or system includes a power source, such as a rechargeable or non-rechargeable battery; The device and / or system includes a light capture device; The device and / or system includes a control unit; The device and / or system is configured such that the control unit controls (a) plurality of electrical signals to the one or more electrodes to provide a balancing treatment to a recipient of the device and / or system, and the device and / or system is further configured such that the control unit controls the (a) plurality of electrical signals based on an output from the light capture device; The device and / or system is configured to inhibit and / or suppress signals traveling from the vestibule to the brain by stimulating tissue of the recipient using the (a) plurality of electrical signals; The device and / or system is configured to reconstruct a sense of balance of the recipient by stimulating tissue of the recipient using the (a) plurality of electrical signals; The device and / or system is configured to reconstruct a sense of balance of the recipient by stimulating tissue of the recipient using the (a) plurality of electrical signals, and is configured to suppress and / or inhibit signals traveling from the vestibule to the brain by stimulating tissue of the recipient using the (a) plurality of electrical signals; The device and / or system is configured such that the control unit performs at least one of the following based on an output from the light capture device: increasing an activation threshold of the electrode, increasing a stimulation rate of the electrode, or increasing an amplitude of the (a) plurality of electrical signals; The device and / or system is configured to perform at least one of the following based on an output from the light capture device: initiating or providing a notification to the recipient indicating at least one of a light-based environmental characteristic or a recommended action; The device and / or system is configured to provide to the recipient another type of stimulation different from the stimulation provided by the one or more electrodes to provide a balancing treatment to the recipient, thereby supplementing reduced and / or eliminated stimulation caused by a phenomenon detected by the light capture device that meets a set criterion from the electrodes; The device and / or system includes a first sub-device and / or system configured to have a neurological effect on a human when activated; The device and / or system includes a second sub-device and / or system configured to obtain data based on the surroundings of the device and / or system, where The device and / or system is configured to control the first sub-device and / or system at least in part based on the obtained data; The device and / or system is a human balance medical device and / or system; The first sub-device and / or system is a vestibular nerve device and / or system stimulator; The first sub-device and / or system is a therapeutic substance delivery sub-device and / or system; The second sub-device and / or system is a light capture sub-device and / or system; The first sub-device and / or system is a vestibular implant; The device and / or system is configured to limit the level of influence of the first sub-device and / or system on the person based on the acquired data; The first sub-device and / or system is configured to suppress and / or inhibit sensory input to the person's brain in different ways; The nerve stimulator sub-device and / or system is configured to affect nerve signals in the brain of the recipient of the body balance medical device and / or system to improve the balance of the recipient; The device and / or system includes a power supply; The nerve stimulator sub-device and / or system is powered by the power supply; and The body balance medical device and / or system is an intelligent body balance medical device and / or system; The intelligent body balance medical device and / or system is configured to control the nerve stimulator sub-device and / or system based on an input into the device and / or system indicating the surrounding environment of the device and / or system; The intelligent body balance medical device and / or system is configured to automatically adjust the environment of the device and / or system to improve the efficacy of the nerve stimulator sub-device and / or system; The intelligent body balance medical device and / or system is configured to automatically adjust the functionality of the nerve stimulator sub-device and / or system based on ambient light and / or noise levels; The intelligent body balance medical device and / or system is configured to automatically stop the functionality of the nerve stimulator sub-device and / or system based on ambient light level and / or ambient noise level; The intelligent body balance medical device and / or system is configured to automatically check the ambient light level and, based on the checked ambient light level, selectively and automatically perform the following: (i) Adjust the functionality of the nerve stimulator sub-device and / or system; (ii) Stop the functionality of the nerve stimulator sub-device and / or system; Or (iii) Provide information and / or recommendations to the recipient to improve the recipient's balance; The intelligent body balance medical device and / or system is configured to collect (a plurality of) latent variables that can affect the recipient's cognitive load and, based on the collected (a plurality of) latent variables, selectively and automatically perform the following: (i) Adjust the functionality of the nerve stimulator sub-device and / or system; (ii) Stop the functionality of the nerve stimulator sub-device and / or system; Or (iii) Provide information and / or recommendations to the recipient to improve the recipient's balance; The system and / or device includes a first subsystem configured to have a neurological effect on the system and / or device, including a person, when activated; The system and / or device includes a second subsystem configured to obtain data based on the surrounding environment of the system; The system is configured to control the first subsystem at least in part based on the acquired data; The system is a human balance medical system; The first subsystem is a vestibular nervous system stimulation device; The first subsystem is a therapeutic substance delivery subsystem; The second subsystem is a light capture subsystem; The first subsystem is a vestibular implant; The system is configured to limit the level of influence of the first subsystem on the person based on the acquired data; The first subsystem is configured to suppress and / or inhibit sensory input to the person's brain in different ways; The device and / or system is configured to perform an action of automatically acquiring data on the changeable environment of a person with impaired balance; The device and / or system is configured to perform an action of at least partially controlling the input from the person's vestibular system to the person's brain based on the acquired data; The device and / or system is configured to perform an action of at least partially controlling the input to the brain, including restricting vestibular function; The device and / or system is configured to perform an action of at least partially controlling the input to the brain, including initiating artificial stimulation of the person's vestibular nervous system; The device and / or system is configured to perform an action of automatically providing instructions to the person based on the acquired data; The device and / or system is configured to perform an action of at least partially controlling the input to the brain, including stopping the artificial stimulation of the person's vestibular system; The device and / or system is configured to perform an action of at least partially controlling the input to the brain, including changing the artificial stimulation of the person's vestibular system; The device and / or system is configured to perform an action of at least partially controlling the input to the brain, including initiating the artificial stimulation of the person's vestibular system; The device and / or system is configured to perform an action of automatically evaluating the acquired data and determining that the light level is at and / or below a threshold level; The action of at least partially controlling the input to the person's brain includes stopping the stimulation based on the determination; The device and / or system is configured to perform an action of automatically evaluating the acquired data and determining that the light level is at and / or above a threshold level; The action of at least partially controlling the input to the person's brain includes stopping the stimulation based on the determination; The device and / or system is configured to perform an action of acquiring data on the surrounding environment of a person with impaired balance; The device and / or system is configured to perform an action of changing the surrounding environment based on the acquired data; The device and / or system is configured to perform an action of operating a balance sensory medical device connected to the person based on the changed surrounding environment; The surrounding environment is the ambient light level; The surrounding environment is sound; The surrounding environment is the ambient light level; Changing the surrounding environment is reducing the light level; The device and / or system is configured to perform an action of increasing the output level of the balance sensory medical device based on the changed surrounding environment and operating the balance sensory medical device at the increased output level; The device and / or system is configured to perform an action of acquiring data indicating the comfort level of the person; The device and / or system is configured to perform an action of controlling the balance-sensing medical device based on the obtained data indicating the comfort level of the person; The device and / or system is configured to perform an action of increasing the aggressiveness of treatment by operating the balance-sensing medical device differently based on the changed surrounding environment compared to the previous operation; The device and / or system is configured to perform an action of reducing the aggressiveness of treatment by operating the balance-sensing medical device differently based on the changed surrounding environment compared to the previous operation; The device and / or system is configured to perform an action of treating oscillopsia; The action of changing the surrounding environment includes reducing environmental noise; The action of changing the surrounding environment includes reducing environmental noise; and The action of operating the balance-sensing medical device based on the changed surrounding environment includes reducing the stimulation level of the medical device; The action of changing the surrounding environment includes reducing environmental noise; The action of operating the balance-sensing medical device based on the changed surrounding environment includes increasing the stimulation level of the medical device; The device and / or system includes an implantable or external receiver stimulator; The device and / or system is configured to treat BVD; The device and / or system is configured to treat unilateral vestibular dysfunction; The device and / or system is configured to improve gait and / or relieve gait difficulties; The device and / or system is configured to provide medium-term and / or long-term stimulation to one or more inferior vestibular nerves; The device and / or system is configured to provide long-term stimulation to one or more inferior vestibular nerves; The device and / or system is configured to deliver 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000 or more or fewer or any value or range of values incremented by 1 therebetween of monophasic or biphasic pulses per second; The device and / or system is configured to provide stimulation to the saccular afferents, including primarily stimulating the saccular afferents; The device and / or system is configured to activate or otherwise stimulate the recipient's descending spinal pathways using electrical stimulation; The device and / or system is configured to apply electrical stimulation, including constant electrical stimulation, to a person's vestibular nerve, such as the inferior vestibular nerve, to improve or at least attempt to improve the balance and / or gait of the person suffering from balance and / or gait problems, including such problems caused by vestibular dysfunction; The stimulation is provided subcutaneously; The device and / or system includes 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 or more electrodes or any value or range of values incremented by 1 therebetween of electrodes; The device and / or system includes an improved cochlear implant; The device and / or system is capable of providing a series of monophasic and / or biphasic pulses, such as pulses having 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60 microseconds or any value or range of values produced incremented by one therebetween per phase; The device and / or system is configured so that one, two, three, four, five or more electrodes are activated so that the stimulation is a substantially constant sequence of pulses; The device and / or system is configured to assess the ambient light level to be used as a basis for whether the vestibular balance function should be suppressed or otherwise how much the vestibular balance function should be suppressed; The device and / or system is a fully implantable vestibular implant; The device and / or system is configured to enable a recipient to activate and deactivate a light level feature of the device and / or system; The device and / or system provides the ability to override or otherwise disable the light capture features of the device and / or system so that the implant functions as it normally would in the absence of an ambient environment sensor; The device and / or system is configured to automatically control one or more aspects of the surrounding environment; The device and / or system is configured to limit the level of impact of the first subsystem on the person based on data obtained from the second subsystem; The device and / or system is configured such that in the presence of various light levels, in a bright or otherwise well-lit environment, the device and / or system allows the first subsystem to operate at its maximum capacity or fully function, which can completely offset the vestibular balance function, or can limit the vestibular balance function to the maximum extent expected by the subsystem; The device and / or system is configured such that its vestibular implant is designed to suppress the vestibular balance function to a level of no more than 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75% or 80% relative to normal function when the first subsystem is operating at its full capacity; The device and / or system is configured to evaluate the light level using a latent variable; The device and / or system is configured to determine or assess based on latent variables whether one or more or all lights in a given room are on or whether lights in an area are on can be used to estimate the light level in the environment; The device and / or system is configured to assess light levels using the Internet of Things; The device and / or system is configured such that when the light level changes by less than, greater than, and / or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, or 200 lux or any value or range of values in increments of 0.1 lux therebetween, the device and / or system automatically takes any one or more of the above actions, and when the light level does not change by less than, not greater than, and / or not equal to the above values, does not take the action and / or takes the action only when the change occurs within 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 210, 250, 300, 350, 400, 450, 500, 600, or 700 seconds or more seconds or any value or range of values in increments of 0.1 second therebetween; The device and / or system is configured such that if the light level is 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, 300, 350, or 400 lux or any value or range of values in increments of 0.1 lux therebetween, it takes one or more of the above actions; The device and / or system is configured such that if the light level is 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, 300, 350, or 400 lux or any value or range of values in increments of 0.1 lux therebetween, it does not take the above actions; The device and / or system is configured to inhibit and / or suppress signals traveling from the vestibule to the brain by using the (multiple) electrical signals to stimulate the tissue of the recipient; The device and / or system is configured such that the operating principle of the device and / or system is at least the operating principle of a vestibular prosthesis that inhibits or suppresses the balance function by stimulation; The device and / or system is configured to enable the functionality and associated hardware to reconstruct the sense of balance and / or provide sensory substitution; The device and / or system is configured to only inhibit and / or suppress signals from the vestibular system; The device and / or system is configured to only reconstruct the sense of balance of the recipient of the device and / or system; The device and / or system is configured to use a given light level as a criterion that can be set based on ergonomic data or can be set based on subjective data associated with a particular recipient; The device and / or system is configured to enable the modification of the light level criterion over time based on the changing expectations or comfort of the recipient; The device and / or system is configured to enable the criterion to be set using artificial intelligence or machine learning algorithms, where the recipient makes various changes to the prosthesis based on their expectations regarding the changing environment; The device and / or system is configured to actively control the environment of a person with impaired balance; The device and / or system is configured to adjust vestibular stimulation according to previous outputs / settings; The device and / or system is configured such that the vestibular stimulation output (measured, e.g., by current level, pulse length, frequency, or any combination thereof) can increase by 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 80%, 90%, 100%, 150%, 200%, 250%, 300%, 350%, or 400% or more, or any value or range of values in increments of 0.1% therebetween, and is accompanied by a light reduction, e.g., 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, or 70% or more, or any value or range of values in increments of 0.1% therebetween, and / or 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, or 300 lux or more lux, or any value or range of values in increments of 0.1 lux therebetween. Optionally, the light reduction occurs within a range of 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 210, 250, 300, 350, 400, 450, 500, 600, or 700 seconds, or any value or range of values in increments of 0.1 second therebetween, and / or vice versa; The SoC is configured to use hearing aid technology to eliminate noise in the environment; The device and / or system is configured to use a vestibular stimulation device to attenuate the vestibular balance function; The device and / or system is configured to stop attenuating or limit the attenuation of the vestibular balance function according to the environment relative to the original situation; The device and / or system is configured to reduce the vestibular function by at least and / or equal to 5%, 20%, 25%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% or any value or range of values in increments of 1% therebetween; The device and / or system is configured to reduce the output level (one or more of the above characteristics of the electrical stimulation) by 5%, 20%, 25%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% or any value or range of values in increments of 1% therebetween according to the changing environment, and / or increase these percentages; The device and / or system is a prosthetic human balance medical device; The device and / or system includes one or more external electrodes; The device and / or system includes one or more implantable electrodes configured to be exposed to body fluids for at least 12 months; The device and / or system includes a battery, where the battery is rechargeable or disposable; The device and / or system includes a photoelectric device configured to capture ambient light and / or be sensitive to ambient light, where the photoelectric device includes one or more of (a plurality of) photosensitive regions, (a plurality of) photoresistors, (a plurality of) photodiodes, (a plurality of) photodetectors, (a plurality of) phototransistors or charge-coupled devices; The device and / or system includes a control circuit configured to control the (multiple) electrical signals to the one or more electrodes to provide balance therapy to the recipient of the prosthetic medical device, and configured to control the (multiple) electrical signals based on the output from the photoelectric device to improve the balance of the recipient of the prosthetic medical device; The device and / or system includes a non-transitory computer-readable medium on which a computer program for executing at least a part of a method is recorded; The device and / or system includes code for automatically obtaining data on the changeable environment of a person with impaired balance; and The device and / or system includes code for at least partially controlling the input from the person's vestibular system to the person's brain based on the obtained data; The device and / or system includes code for automatically providing instructions to the person based on the obtained data; The device and / or system includes code for automatically evaluating the obtained data and determining that the light level is at and / or below a threshold level; The device and / or system includes code for automatically evaluating the obtained data and determining that the light level is at and / or above a threshold level; The system includes a third subsystem configured to provide an indication that the system is activated and / or not activated; The system is a sensory management and / or sensory stimulation system; The system is a human balance medical system; The system is an epilepsy management system; The system is a tinnitus management system or a sleep apnea system; The third subsystem is configured to provide an indication that the system is turned on; The third subsystem is configured to provide an indication that the system is turned off; The third subsystem is configured to provide the indication to a recipient of the system; The system is configured to provide the indication to a caregiver and / or guardian of a recipient of the system; The third subsystem is configured to provide the indication to a recipient of the system, and the indication is visual; The third subsystem is configured to provide the indication to a recipient of the system through a stimulus applied internally by the system; The third subsystem is configured to directly provide the indication to a recipient of the system from a body-worn part of the system; The third subsystem is configured to provide an indication that the system is activated; The third subsystem is configured to provide an indication that the system is not activated; The system is configured to provide an indication that the system is not activated within 30 seconds of being deactivated; The system is configured to control the first subsystem at least in part based on data obtained from the second subsystem; The system is a human balance medical system; The second subsystem is a light capture subsystem; The system is configured to limit the level of influence of the first subsystem on the person based on the obtained data; The third subsystem is configured to automatically provide an indication to the person when the level of influence of the first subsystem is limited; The system is configured to automatically determine whether the system is operating and / or not operating and / or how effective the system's operation is and / or whether the system is capable of operating, where the system is a sensory management and / or sensory stimulation system; The system is configured to provide an indication of whether the system is operating and / or not operating and / or how effective the system's operation is and / or whether the system is capable of operating and / or how effective the system will operate in the future; Automatically determining includes performing a self-assessment of the system; automatically determining includes evaluating characteristics indicative of the output of the system and determining based on the evaluation of the characteristics whether the system is operating and / or not operating and / or how effective the system's operation is and / or whether the system is capable of operating and / or how effective the system will operate in the future; Automatically determining is at least to provide an indication that the system is not operating; Automatically determining is at least to provide an indication of how effective the system's operation is; Automatically determining is at least to perform a functional check that is distinct from whether the system is activated and / or deactivated; Where providing an indication is to provide a warning that the system is not operating and / or will not operate and / or is operating at a specific level and / or below a specific level and / or will only operate at a specific level and / or below a specific level; Automatically determining makes a determination based on the manner in which the input to the brain is controlled; At least partially controlling the input to the brain includes stopping the artificial stimulation of the person's vestibular system; Automatically evaluating the obtained data and determining that the light level is at and / or below a threshold level; At least partially controlling the input to the brain of the person includes stopping the stimulation based on the determination; The system and / or device is configured to be operated when connected to a person, wherein the medical device is configured to stimulate the inner ear of the person; The system and / or device is configured to automatically evaluate the efficacy of the medical device before, during, and / or after an operation; The efficacy-related perspective is whether the device is on and / or off; The system and / or device is configured such that the evaluation is performed by a device separate from the medical device; The system and / or device is configured such that the evaluation is performed by the medical device when the medical device is turned off; The medical device is a vestibular medical device; and The efficacy-related perspective is how well the device improves the balance of the person; The efficacy-related perspective is based on whether the device is providing tissue stimulation to the person, regardless of whether the device is on or off; The system and / or device is configured to automatically evaluate whether the device is being operated by the vestibular medical device periodically performing when the device is connected to the person; The system and / or device is configured to automatically evaluate when the device is on and the recipient would otherwise consider the device to be operating in an effective manner; The system and / or device is configured to be automatically evaluated periodically by the medical device when the device is connected to the person; The system and / or device is configured to automatically provide an indication to the person that the device is operating in an effective manner periodically based on the results of the automatic evaluation; The automatic evaluation action is performed periodically by the vestibular medical device when the device is connected to the person; The system and / or device is configured to automatically provide an indication to the person that the device is operating in a less effective manner based on the results of the automatic evaluation; The system and / or device is configured to operate the vestibular medical device connected to the person based on a changed surrounding environment; The system and / or device is configured to automatically evaluate the efficacy based on the medical device being operated based on a changed surrounding environment; The system and / or device is configured to limit the operation of the vestibular medical device connected to the person based on a changed surrounding environment; The system and / or device is configured such that the action of automatically evaluating the efficacy is based on the medical device being limited in operation based on a changed surrounding environment; The system is configured to provide an indication that the system is not activated for XYZ (including XYZ) seconds or more, or any value or range of values within 0.05 seconds therebetween, where XYZ can be 0.1, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55, 60, 75, 80, 85, 90, 120, 150, 210, 350, 300, 350, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500 seconds or more; The system is configured to enable a user to adjust the timing of the indication; The system includes a special GUI menu on the display screen of a handheld device, and the special GUI menu allows the recipient to input a desired timing; The system is configured to evaluate the activation state of the system, or at least provide the stimulation or otherwise manage the activation state of a part of the recipient's body functions or otherwise manage the recipient's medical characteristics, and provide an indication to the recipient or user or a third party when the system is in an inactive state; It is envisioned that regardless of other features, the recipient may like the feature of providing the indication when the system is not activated; The system and / or device is configured to perform an inspection of the activation and / or functionality and / or efficacy of the system and / or device during a period of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90 or 100 minutes, or any value or range of values in increments of 0.1 minute therebetween, and / or every XYZ seconds or any value or range of values in increments of 0.05 seconds therebetween and / or within XYZ seconds or any value or range of values in increments of 0.05 seconds therebetween; The system is a motion therapy system; Or The system affects the person's balance and / or affects the person's motor function.

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