Retention force monitoring in wearable devices

Abstract

Presented herein are techniques for monitoring a retention force associated with a magnetic wearable device configured to be worn by a recipient / user. The magnetic wearable device includes one or more magnet components configured to be magnetically coupled to one or more implantable magnetic components implanted in the recipient. The magnetic wearable device includes at least sensor configured to capture a pressure at the device-tissue interface and a processor configured to initiate one or more operations based on the pressure.

Description

RETENTION FORCE MONITORING IN WEARABEE DEVICESBACKGROUNDTechnical Field[oooi] The present disclosure relates generally to monitoring retention force associated with a wearable device configured to be magnetically coupled to a recipient.Related Art

[0002] Wearable devices, such as certain medical devices, have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices, for example, can include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). 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 in performing lifesaving and / or lifestyle enhancement functions and / or recipient monitoring for a number of years.

[0003] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and / or data received from external devices that are part of, or operate in conjunction with, implantable components.SUMMARY

[0004] In one aspect, a magnetic wearable device is provided. The magnetic wearable device comprises: a housing having a skin-facing surface configured to be positioned to abut skin of a recipient; at least one external magnetic component configured to magnetically couple the magnetic wearable device to at least one implantable magnetic component and retain the skinfacing surface abutting the skin of the recipient; at least one sensor configured to determine a pressure of the skin-facing surface against the skin of the recipient; and a processor configuredto initiate one or more operations based on the pressure of the skin-facing surface against the skin of the recipient.

[0005] In another aspect, a device is provided. The device comprises: a surface configured to abut skin of a recipient; an external magnetic component configured to magnetically couple the device to an implantable magnetic component configured to be implanted in the recipient to retain the surface of the device against the skin of the recipient; and at least one sensor configured to determine a pressure at an interface between the surface and the skin of the recipient.

[0006] In another aspect, a system is provided. The system comprises: at least one implantable magnetic component configured to be implanted in a recipient; and a device comprising: a surface configured to rest against skin of the recipient; at least one external magnetic component configured to magnetically couple to the at least one implantable magnetic component such that the surface is retained against the recipient; and a sensor configured to mechanically engage with the recipient to sense a pressure exerted by the device against the skin of the recipient.

[0007] In yet another aspect, a method is provided. The method comprises: positioning a device against a recipient such that a sensor of the device is in mechanical engagement with skin the recipient; sensing, via the sensor of the device, a pressure exerted by a surface of the device against the skin of recipient; and initiating, via a processor, one or more operations based on the pressure.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Embodiments of the present disclosure are described herein in conjunction with the accompanying drawings, in which:

[0009] FIG. 1A is a schematic diagram illustrating a cochlear implant system with which aspects of the techniques presented herein can be implemented;[ooio] FIG. IB is a side view of a recipient wearing a sound processing unit of the cochlear implant system of FIG. 1A;[ooii] FIG. 1C is a schematic view of components of the cochlear implant system of FIG. 1 A;

[0012] FIG. ID is a block diagram of the cochlear implant system of FIG. 1A;

[0013] FIG. 2 is a schematic view of a cochlear implant system with which aspects of the techniques presented herein can be implemented;

[0014] FIG. 3 is a schematic view of another cochlear implant system with which aspects of the techniques presented herein can be implemented;

[0015] FIG. 4 is a schematic view of yet another cochlear implant system with which aspects of the techniques presented herein can be implemented;

[0016] FIG. 5 is a schematic view of an external device of a cochlear implant system with which aspects of the techniques presented herein can be implemented;

[0017] FIG. 6 is a schematic diagram of an external device of a cochlear implant system with which aspects of the techniques presented herein can be implemented;

[0018] Each of FIGs. 7, 8, 9, and 10 are flowcharts of methods, in accordance with aspects of the techniques presented herein;

[0019] FIG. 11 is a schematic diagram illustrating a computing device configured to perform techniques presented herein;

[0020] FIG. 12 is a schematic diagram illustrating a vestibular stimulator system with which aspects of the techniques presented herein can be implemented; and

[0021] FIG. 13 is a schematic diagram illustrating a retinal prosthesis system with which aspects of the techniques presented herein can be implemented.DETAILED DESCRIPTION

[0022] Presented herein are techniques for determining / monitoring a retention-force associated with (e.g., applied by) a wearable device configured to be magnetically-coupled to a recipient. Wearable devices configured to be magnetically-coupled to a recipient are sometimes referred to herein as “magnetic wearable devices.” In general a magnetic wearable device comprises one or more magnetic components (e.g., one or more magnets) that are configured to magnetically couple with one or more implantable magnetic components, such as one or more implantable magnets (e.g., one or more permanent magnets), one or more non-magnetized magnetic components (e.g., ferromagnetic or ferrimagnetic materials), etc., implanted within the recipient. The magnetic coupling between the external magnetic component(s) and theimplantable magnetic component(s) retains the magnetic wearable device against the recipient (e.g., abutting the skin / tissue of the recipient).

[0023] Retention of a magnetic wearable device against the recipient exerts a force, sometimes referred to herein as a “retention force,” on the skin / tissue of the recipient. If the retention force is too low, then the magnetic wearable device may be more likely to fall off the recipient. If the retention force is too high, then there is a risk that the recipient may develop pressure sores or other medical complications from the force of the magnetic wearable device over the implant site. In general terms there is a trade-off to be made between providing sufficient retention to ensure the magnetic wearable device is held in place, while not introducing too much pressure such that skin sores or necrosis occurs. It is therefore useful to monitor / determine the retention force associated with (e.g., applied by) a magnetic wearable device. This information can be used, for example, to determine changes in a recipient’s magnetic wearable device retention over time so that the recipient, caregiver, clinician, or other user (collectively “user”) can remain informed of these changes and make necessary adjustments for better retention and comfort.

[0024] There are a number of different types of magnetic wearable devices in / with which embodiments of the present disclosure may be implemented. Merely for ease of description, the techniques presented herein are primarily described with reference to a specific magnetic wearable device in the form of a sound processor of a cochlear implant system. However, it is to be appreciated that the techniques presented herein may also be partially or fully implemented by any of a number of different types of magnetic wearable devices (e.g., other types of devices configured to be worn by a recipient via a magnetic coupling with one or more implantable magnetic components, including other types of hearing devices, other types of wearable medical devices, wearable consumer devices, etc. As used herein, the term “hearing device” is to be broadly construed as any device that acts on an acoustical perception of an individual, including to improve perception of sound signals, to reduce perception of sound signals, etc. In particular, a hearing device can deliver sound signals to a user in any form, including in the form of acoustical stimulation, mechanical stimulation, electrical stimulation, etc., and / or can operate to suppress all or some sound signals. As such, a hearing device can be a device for use by a hearing-impaired person (e.g., hearing aids, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electro-acoustic hearing prostheses, auditory brainstem stimulators, bimodal hearing prostheses, bilateral hearing prostheses, dedicated tinnitus therapy devices, tinnitus therapy device systems, combinationsor variations thereof, etc.), a device for use by a person with normal hearing (e.g., consumer devices that provide audio streaming, consumer headphones, earphones, and other listening devices), a hearing protection device, etc. In other examples, the techniques presented herein can be implemented by, or used in conjunction with, various implantable medical devices, such as visual 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 epileptic events), sleep apnea devices, electroporation devices, etc.

[0025] FIGs. 1A-1D illustrate an example cochlear implant system 102 with which aspects of the techniques presented herein can be implemented. The cochlear implant system 102 comprises an external component 104 that is configured to be directly or indirectly attached to the body of the user, and an intemal / implantable component 112 that is configured to be implanted in or worn on the head of the user. In the examples of FIGs. 1A-1D, the implantable component 112 is sometimes referred to as a “cochlear implant.” FIG. 1A illustrates the cochlear implant 112 implanted in the head 154 of a user, while FIG. IB is a schematic drawing of the external component 104 worn on the head 154 of the user. FIG. 1C is another schematic view of the cochlear implant system 102, while FIG. ID illustrates further details of the cochlear implant system 102. For ease of description, FIGs. 1A-1D will generally be described together.

[0026] In the examples of FIGs. 1A-1D, the external component 104 comprises a sound processing unit 106, an external coil 108, and generally, a magnet fixed relative to the external coil 108. The cochlear implant 112 includes an implantable coil 114, an implant body 134, and an elongate stimulating assembly 116 configured to be implanted in the user’s cochlea. In one example, the sound processing unit 106 is an off-the-ear (OTE) sound processing unit, sometimes referred to herein as an OTE component, which is configured to send data and power to the implantable component 112. In general, an OTE sound processing unit is a component having a generally cylindrically shaped housing 111 and which is configured to be magnetically coupled to the user’s head 154 (e.g., includes an integrated external magnet 150 configured to be magnetically coupled to an intemal / implantable magnet 152 in the implantable component 112). The OTE sound processing unit 106 also includes an integrated external (headpiece) coil 108 (the external coil 108) that is configured to be inductively coupled to the implantable coil 114.

[0027] It is to be appreciated that the OTE sound processing unit 106 is merely illustrative of the external devices that could operate with implantable component 112. For example, inalternative examples, the external component 104 may comprise a behind-the-ear (BTE) sound processing unit configured to be attached to, and worn adjacent to, the recipient’s ear. A BTE sound processing unit comprises a housing that is shaped to be worn on the outer ear of the user. In certain examples, the BTE is connected to a separate external coil assembly via a cable, where the external coil assembly is configured to be magnetically and inductively coupled to the implantable coil 114, while in other embodiments the BTE includes a coil disposed in or on the housing worn on the outer ear of the user. It is also to be appreciated that alternative external components could be located in the user’s ear canal, worn on the body, etc.

[0028] Although the cochlear implant system 102 includes the sound processing unit 106 and the cochlear implant 112, as described below, the cochlear implant 112 can operate independently from the sound processing unit 106, for at least a period, to stimulate the user. For example, the cochlear implant 112 can operate in a first general mode, sometimes referred to as an “external hearing mode,” in which the sound processing unit 106 captures sound signals which are then used as the basis for delivering stimulation signals to the user. The cochlear implant 112 can also operate in a second general mode, sometimes referred as an “invisible hearing” mode, in which the sound processing unit 106 is unable to provide sound signals to the cochlear implant 112 (e.g., the sound processing unit 106 is not present, the sound processing unit 106 is powered-off, the sound processing unit 106 is malfunctioning, etc.). As such, in the invisible hearing mode, the cochlear implant 112 captures sound signals itself via implantable sound sensors and then uses those sound signals as the basis for delivering stimulation signals to the user. Further details regarding operation of the cochlear implant 112 in the external hearing mode are provided below, followed by details regarding operation of the cochlear implant 112 in the invisible hearing mode. It is to be appreciated that reference to the external hearing mode and the invisible hearing mode is merely illustrative and that the cochlear implant 112 could also operate in alternative modes.

[0029] In FIGs. 1A and 1C, the cochlear implant system 102 is shown with an external device 110, configured to implement aspects of the techniques presented. The external device 110 is a computing device, such as a personal computer (e.g., laptop, desktop, tablet), a mobile phone (e.g., smartphone), a remote control unit, etc. The external device 110 and the cochlear implant system 102 (e.g., sound processing unit 106 or the cochlear implant 112) wirelessly communicate via a bi-directional communication link 126. The bi-directional communication link 126 may comprise, for example, a short-range communication, such as Bluetooth link, Bluetooth Low Energy (BLE) link, a proprietary link, etc.

[0030] Returning to the example ofFIGs. 1A-1D, the sound processing unit 106 of the external component 104 also comprises one or more input devices configured to capture and / or receive input signals (e.g., sound or data signals) at the sound processing unit 106. The one or more input devices include, for example, one or more sound input devices 118 (e.g., one or more external microphones, audio input ports, telecoils, etc.), one or more auxiliary input devices 128 (e.g., audio ports, such as a Direct Audio Input (DAI), data ports, such as a Universal Serial Bus (USB) port, cable port, etc.), and a short-range wireless transmitter / receiver (wireless transceiver) 120 (e.g., for communication with the external device 110), each located in, on or near the sound processing unit 106. However, it is to be appreciated that one or more input devices may include additional types of input devices and / or less input devices (e.g., the short- range wireless transceiver 120 and / or one or more auxiliary input devices 128 could be omitted).

[0031] The sound processing unit 106 also comprises the external coil 108, a charging coil, a closely-coupled radio frequency transmitter / receiver (RF transceiver) 122, at least one rechargeable battery 132, and an external sound processing module 124. The external sound processing module 124 can be configured to perform a number of operations that are represented in FIG. ID by a pressure sensing module 131 and a sound processor 133. Each of the pressure sensing module 131 and the sound processor 133 can be formed by one or more processors (e.g., one or more Digital Signal Processors (DSPs), one or more uC cores, etc.), firmware, software, etc. arranged to perform operations described herein. That is, the pressure sensing module 131 and the sound processor 133 can each be implemented as firmware elements, partially or fully implemented with digital logic gates in one or more applicationspecific integrated circuits (ASICs), partially or fully in software, etc. Although FIG. ID illustrates the pressure sensing module 131 and a sound processor 133 as being implemented / performed at the external sound processing module 124, it is to be appreciated that these elements (e.g., functional operations) could also or alternatively be implemented / performed as part of the implantable sound processing module 158, as part of the external device 110, etc.

[0032] Returning to the example of FIGs. 1A-1D, the implantable component 112 comprises an implant body (main module) 134, a lead region 136, and the stimulating assembly 116, all configured to be implanted under the skin (tissue) 115 of the user. The implant body 134 generally comprises a hermetically-sealed housing 138 that includes, in certain examples, at least one power source 125 (e.g., one or more batteries, one or more capacitors, etc.), in whichthe RF interface circuitry 140 and a stimulator unit 142 are disposed. The implant body 134 also includes the intemal / implantable coil 114 that is generally external to the housing 138, but which is connected to the RF interface circuitry 140 via a hermetic feedthrough (not shown in FIG. ID).

[0033] As noted, the stimulating assembly 116 is configured to be at least partially implanted in the user’s cochlea. The stimulating assembly 116 includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 144 that collectively form a contact array (electrode array) 146 for delivery of electrical stimulation (current) to the recipient’s cochlea. The stimulating assembly 116 extends through an opening in the recipient’s cochlea (e.g., cochleostomy, the round window, etc.) and has a proximal end connected to stimulator unit 142 via lead region 136 and a hermetic feedthrough (not shown in FIG. ID). Lead region 136 includes a plurality of conductors (wires) that electrically couple the electrodes 144 to the stimulator unit 142. The implantable component 112 also includes an electrode outside of the cochlea, sometimes referred to as the extra-cochlear electrode (ECE) 139.

[0034] As noted, the cochlear implant system 102 includes the external coil 108 and the implantable coil 114. The external magnet 150 is fixed relative to the external coil 108 and the intemal / implantable magnet 152 is fixed relative to the implantable coil 114. The external magnet 150 and the intemal / implantable magnet 152 fixed relative to the external coil 108 and the intemal / implantable coil 114, respectively, facilitate the operational alignment of the external coil 108 with the implantable coil 114. This operational alignment of the coils enables the external component 104 to transmit data and power to the implantable component 112 via a closely-coupled wireless link 148 formed between the external coil 108 with the implantable coil 114. In certain examples, the closely-coupled wireless link 148 is an RF link. However, various other types of energy transfer, such as infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer the power and / or data from an external component to an implantable component and, as such, FIG. ID illustrates only one example arrangement.

[0035] As noted above, the sound processing unit 106 includes the external sound processing module 124. The external sound processing module 124 is configured to process the received input audio signals (received at one or more of the input devices, such as sound input devices 118 and / or auxiliary input devices 128) and convert the received input audio signals into output control signals for use in stimulating a first ear of a recipient or user (i.e., the external sound processing module 124 is configured to perform sound processing on input signals received at the sound processing unit 106). Stated differently, the one or more processors (e.g., processingelement(s) implementing firmware, software, etc.) in the external sound processing module 124 are configured to execute sound processing logic in memory to convert the received input audio signals into output control signals (stimulation signals) that represent electrical stimulation for delivery to the recipient.

[0036] As noted, FIG. ID illustrates an embodiment in which the external sound processing module 124 in the sound processing unit 106 generates the output control signals. In an alternative embodiment, the sound processing unit 106 can send less processed information (e.g., audio data) to the implantable component 112, and the sound processing operations (e.g., conversion of input sounds to output control signals 156) can be performed by a processor within the implantable component 112.

[0037] In FIG. ID, according to an example embodiment, output control signals (stimulation signals) are provided to the RF transceiver 122, which transcutaneously transfers the output control signals (e.g., in an encoded manner) to the implantable component 112 via the external coil 108 and the implantable coil 114. That is, the output control signals (stimulation signals) are received at the RF interface circuitry 140 via the implantable coil 114 and provided to the stimulator unit 142. The stimulator unit 142 is configured to utilize the output control signals to generate electrical stimulation signals (e.g., current signals) for delivery to the user’s cochlea via one or more of the stimulating contacts 144. In this way, cochlear implant system 102 electrically stimulates the user’s auditory nerve cells, bypassing absent or defective hair cells that normally transduce acoustic vibrations into neural activity, in a manner that causes the recipient to perceive one or more components of the input audio signals (the received sound signals).

[0038] As detailed above, in the external hearing mode, the cochlear implant 112 receives processed sound signals from the sound processing unit 106. However, in the invisible hearing mode, the cochlear implant 112 is configured to capture and process sound signals for use in electrically stimulating the user’s auditory nerve cells. In particular, as shown in FIG. ID, an example embodiment of the cochlear implant 112 can include a plurality of implantable sound sensors 165(1), 165(2) that collectively form a sensor array 160, and an implantable sound processing module 158. Similar to the external sound processing module 124, the implantable sound processing module 158 may comprise, for example, one or more processors and a memory device (memory) that includes sound processing logic. The memory device may comprise any one or more of: Non-Volatile Memory (NVM), Ferroelectric Random Access Memory (FRAM), read only memory (ROM), random access memory (RAM), magnetic diskstorage media devices, optical storage media devices, flash memory devices, electrical, optical, or other physical / tangible memory storage devices. The one or more processors are, for example, microprocessors or microcontrollers that execute instructions for the sound processing logic stored in memory device.

[0039] In the invisible hearing mode, the implantable sound sensors 165(1), 165(2) of the sensor array 160 are configured to detect / capture input sound signals 166 (e.g., acoustic sound signals, vibrations, etc.), which are provided to the implantable sound processing module 158. The implantable sound processing module 158 is configured to convert received input sound signals 166 (received at one or more of the implantable sound sensors 165(1), 165(2)) into output control signals 156 for use in stimulating the first ear of a recipient or user (i.e., the implantable sound processing module 158 is configured to perform sound processing operations). Stated differently, the one or more processors (e.g., processing element(s) implementing firmware, software, etc.) in the implantable sound processing module 158 are configured to execute sound processing logic in memory to convert the received input sound signals 166 into output control signals 156 that are provided to the stimulator unit 142. The stimulator unit 142 is configured to utilize the output control signals 156 to generate electrical stimulation signals (e.g., current signals) for delivery to the user’s cochlea, thereby bypassing the absent or defective hair cells that normally transduce acoustic vibrations into neural activity.

[0040] It is to be appreciated that the above description of the so-called external hearing mode and the so-called invisible hearing mode are merely illustrative and that the cochlear implant system 102 could operate differently in different embodiments. For example, in one alternative implementation of the external hearing mode, the cochlear implant 112 could use signals captured by the sound input devices 118 and the implantable sound sensors 165(1), 165(2) of sensor array 160 in generating stimulation signals for delivery to the user.

[0041] According to the techniques of the present disclosure, the external sound processing module 124 may also include an inertial measurement unit (IMU) 170. The IMU 170 is configured to measure the inertia of the user's head, that is, motion of the user's head. As such, the IMU 170 comprises one or more sensors 175 each configured to sense one or more of rectilinear or rotatory motion in the same or different axes. Examples of sensors 175 that may be used as part of inertial measurement unit 170 include accelerometers, gyroscopes, inclinometers, compasses, and the like. Such sensors may be implemented in, for example,micro electromechanical systems (MEMS) or with other technology suitable for the particular application.

[0042] As also illustrated in FIG. ID, in certain examples, a second IMU 180 including one or more sensors 185 is incorporated into implantable sound processing module 158 of implant body 134. The second IMU 180 may serve as an additional or alternative inertial measurement unit to the IMU 170 of external sound processing module 124. Eike sensors 175, sensors 185 may each be configured to sense one or more of rectilinear or rotatory motion in the same or different axes. Examples of sensors 185 that may be used as part of inertial measurement unit 180 include accelerometers, gyroscopes, inclinometers, compasses, and the like. Such sensors may be implemented in, for example, MEMS or with other technology suitable for the particular application. For hearing devices that include an implantable sound processing module, such as implantable sound processing module 158, that includes an IMU, such as the IMU 180, the techniques presented herein may be implemented without an external processor. Accordingly, a hearing device that includes an implant body 134 and lacks an external component 104 may be configured to implement the techniques presented herein.

[0043] In use, the magnetic coupling between the external magnet 150 and the implantable magnet 152 results in a retention force that pulls the sound processing unit 106 towards / against the skin / tissue (e.g., epidermis, hair, etc.) of the recipient. That is, a skin-facing surface 169 of the sound processing unit 106 is pulled such that it abuts the skin of the recipient. As noted above, if the retention force is too low, then the sound processor 106 may be more likely to fall off the implant. If the retention force is too high, then there is a risk that the recipient may develop pressure sores from the force of the sound processor 106 over the implant coil site. Therefore, there is a trade-off to be made between providing sufficient retention to ensure that the sound processor 106 is held in place, while not introducing too much pressure such that skin sores or necrosis occurs. Presented herein are techniques to determine or monitor the pressure exerted by the sound processing unit 106 caused by the retention force to ensure that the pressure is appropriate (e.g., determine whether the sound processing unit 106 is securely coupled to the cochlear implant 112 and / or whether the arrangement of the sound processing unit 106 on the recipient provides sufficient comfort to the recipient). For example, it is desirable for the sound processing unit 106 to exert a threshold amount of pressure to be retained against the recipient without causing discomfort (e.g., pain) at the area in which sound processing unit 106 is positioned on the recipient (e.g., provide a retention force that is betweena minimum retention force at which the sound processing unit 106 can be easily decoupled and a maximum retention force that can damage the recipient’s skin / tissue).

[0044] To this end, the pressure sensing module 131 is configured to determine, measure, sense, or otherwise monitor the pressure exerted by the sound processing unit 106, namely the skin-facing surface 169 of the external sound processing unit 106 against the recipient. Stated differently, the pressure sensing module 131 can operate to determine a pressure of the skinfacing surface 169 of the sound processing unit 106 against the skin of the recipient (e.g., determine the pressure at the device-tissue interface). The pressure sensing module 131 can also perform one or more subsequent operations based on the pressure, including determining or suggesting adjustments that can adjust / alter the retention force (and thus adjust / alter the applied pressure). The pressure sensor module 131 operates with at least one sensor 168 (e.g., a pressure sensor) that is in mechanical contact with the skin-facing surface 169 of the sound processing unit 106. For example, the at least one sensor 168 is disposed at the skin-facing surface 169. In certain arrangements, the least one sensor 168 is disposed on the skin-facing surface 169.

[0045] The techniques are generally described herein with reference to the recipient’s “skin” and “skin-facing surfaces” of magnetic wearable devices. It is to be appreciated that reference to a recipient’s skin is merely for convenience / ease of description and that the term “skin,” as used herein, can refer to any tissue of a recipient / user, including the recipient’s epidermis, hair, etc.

[0046] As noted, FIGs. 1A-1D, have been primarily described with reference to the use of magnetic wearable devices that comprises one or more external magnets (one or more external permanent magnets) that are configured to magnetically couple with one or more implantable magnets (one or more implantable permanent magnets). It is to be appreciated that the use of external magnets and implantable magnets is merely illustrative and the embodiments presented herein can be implemented with other magnetic arrangements. For example, in alternative embodiments, the one or more implantable magnets and / or the one or more external magnets can instead comprise one or more non-magnetized magnetic components (e.g., ferromagnetic or ferrimagnetic materials), etc. In general, as used herein, the term “magnetic component” should be understood to include permanent magnets, as well as non-magnetized magnetic components (e.g., ferromagnetic or ferrimagnetic materials) that can be magnetically coupled to a permanent magnet. It should also be noted that a magnetic component can be used with other retention components to augment retention (e.g., increase the retention force).

[0047] FIG. 2 is a schematic view of a simplified cochlear implant system 250. The cochlear implant system 250 includes an implantable device 252 (e.g., the cochlear implant 112) implanted within a recipient, such as underneath skin of the recipient, and an external device 254 (e.g., the external component 104) positioned external to the recipient. The implantable device 252 and the external device 254 are configured to magnetically couple to one another. To this end, the implantable device 252 includes at least one implantable magnetic component 256, and the external device 254 includes at least one external magnetic component 258. The implantable magnetic component 256 and the external magnetic component 258 are configured to magnetically couple with / to one another. The magnetic coupling of the external magnetic component 258 with the implantable magnetic component 256 retains the external device 254 against the recipient, such as abutting skin / tissue 260, including the epidermis, hair, or any other part of the recipient exposed to an external environment.

[0048] The external device 254 includes a housing / enclosure 262 that contains the external magnetic component 258, thereby shielding the external magnetic component 258 from an external environment. Magnetic coupling of the external magnetic component 258 with the implantable magnetic component 256 places a wall 264 of the housing 262 against the recipient. That is, the external magnetic component 258 is positioned within the housing 262 adjacent to the wall 264 to provide a magnetic force through the wall 264 for engagement with the implantable magnetic component 256. Thus, the external magnetic component 258 biases / urges a surface 266 (e.g., a skin-facing surface) of the wall 264 toward the implantable device 252 to rest on the recipient. As a result, the surface 266 exerts pressure on the skin 260.

[0049] It is desirable for the pressure exerted by the external device 254 to be sufficient for coupling with the implantable device 252 without causing discomfort to the recipient. For example, exerting pressure above a low threshold firmly retains the external device 254 against the recipient. Additionally, exerting pressure below a high threshold avoids causing discomfort to the recipient in the area where the external device 254 is positioned. Thus, in certain embodiments, it is desirable for the magnetic coupling between the implantable magnetic component 256 and the external magnetic component 258 to cause the external device 254 to exert pressure between the first threshold and the second threshold against the recipient.

[0050] The cochlear implant system 250 includes a sensor 268 (e.g., a pressure sensor) configured to sense, determine, detect, or measure the pressure exerted by the external device 254 against the recipient. To this end, the sensor 268 is positioned in mechanical engagement with the skin 260 against which the surface 266 is retained. For example, the mechanicalengagement of the sensor 268 against the skin 260 enables the pressure exerted between the skin 260 and the external device 254 to transfer to the sensor 268. The sensor 268 is then able to sense the received pressure for determining the pressure exerted by the external device 254 against the recipient. In the illustrated embodiment, the sensor 268 is positioned at least partially within the housing 262 such that the housing 262 encloses and shields a portion of the sensor 268. However, the sensor 268 extends through the wall 264 (e.g., via an opening formed through the wall 264) to be exposed to an external environment. Thus, part of the sensor 268 is positioned at the surface 266. Consequently, retaining the surface 266 against the skin 260 also abuts the sensor 268 against the skin 260 to mechanically engage the sensor 268 with the skin 260. The abutment of the sensor 268 against the skin 260 enables the pressure to be transmitted directly from the skin 260 to the sensor 268.

[0051] In some embodiments, the cochlear implant system 250 also includes a controller 270 (e.g., the pressure sensing module 131) configured to perform one or more operations based on the pressure sensed by the sensor 268. To this end, the controller 270 is communicatively coupled to the sensor 268 and is configured to receive data from the sensor 268, the data including the pressure sensed by the sensor 268. The controller 270 is configured to operate to enable the external device 254 to be appropriately retained against the recipient. For example, the controller 270 compares the pressure received from the sensor 268 to a first threshold associated with securement of the external device 254 against the recipient. For instance, a pressure below the first threshold indicates that the external device 254 is not securely retained against the recipient and is therefore more susceptible to magnetically disengaging from the implantable device 252. Thus, the controller 270 determines whether the pressure exceeds the first threshold, which indicates the external device 254 is securely retained against the recipient. The controller 270 also compares the pressure received from the sensor 268 to a second threshold that is greater than the first threshold. For example, in certain embodiments, the second threshold is associated with comfort and / or to avoid medical complications of the recipient while the external device 254 is in contact with the recipient. As an example, the pressure exceeding the second threshold indicates that the external device 254 is exerting an excessive amount of pressure that can cause discomfort to the recipient. Alternatively, the second threshold may be associated with a point at which harm can occur to the recipient. In such examples, the threshold (limit) may be associated with properties of the skin in the location of the device. For example, the limit at which blood flow is reduced leading, in the long term, to skin damage / necrosis. Defining the limit in this way may be beneficial in that therecipient may be able to self-report that a comfort limit is exceeded but may be unaware that a harm limit is exceeded.

[0052] As such, the controller 270 determines whether the pressure is below the second threshold, which indicates that the external device 254 is not causing discomfort to the recipient. In certain implementations, the thresholds are determined during a fitting operation (e.g., a calibration phase) of the cochlear implant system 250 with the recipient. Additionally or alternatively, the recipient defines the thresholds based on their own comfort / experience. In either case, the thresholds may differ between different recipients to provide customized arrangements that are more suitable for the recipients.

[0053] The controller 270 is configured to output a signal to initiate one or more operations based on the comparison of the pressure with the first threshold and / or with the second threshold. In some embodiments, the controller 270 is configured to provide a notification based on the comparison. As an example, in response to the pressure being below the first threshold and / or exceeding the second threshold, the controller 270 is configured to provide the notification to prompt adjustment of the external device 254. For instance, based on the pressure being below the first threshold, such a notification can prompt a user (e.g., the recipient, a caretaker, a clinician) to increase the magnetic strength of the external magnetic component 258, to replace the external device 254 (e.g., having an external magnetic component 258 with a more suitable magnetic strength), and / or to adjust positioning of the external device 254 (e.g., to better align the external magnetic component 258 with the implantable magnetic component 256) to increase magnetic coupling of the external device 254 with the implantable device 252. Based on the pressure being above the second threshold, such a notification can prompt the user to reduce the magnetic strength of the external magnetic component 258 and / or to treat the area at which the external device 254 is retained against the recipient (e.g., by providing a treatment substance, such as topical medication) to increase comfort of the recipient. As another example, in response to the pressure being below the first threshold and / or exceeding the second threshold, the controller 270 is configured to directly adjust the magnetic strength of the external magnetic component 258. To this end, the controller 270 is communicatively coupled to an actuator 272 used to adjust the magnetic strength of the external magnetic component 258. By way of example, the controller 270 is configured to operate the actuator 272 to maintain the magnetic strength of the external magnetic component 258 between the first threshold and the second threshold. As such, the controller 270 is configured to instruct the actuator 272 increase the magnetic strength of theexternal magnetic component 258 to increase the pressure toward the first threshold in response to determining the pressure is below the first threshold and to reduce the magnetic strength of the external magnetic component 258 to reduce the pressure toward the second threshold in response to determining the pressure is above the second threshold. In this manner, the controller 270 can automatically adjust the pressure exerted by the external device 254 against the recipient, which can reduce an amount of time in which the external device 254 is inappropriately retained against the recipient and / or reduce latency associated with adjusting the magnetic coupling of the external device 254 with the implantable device 252 based on the pressure exerted by the external device 254 against the recipient.

[0054] FIG. 3 is a schematic view of a cochlear implant system 350 that includes an implantable device 352 and an external device 354 that are configured to magnetically couple to one another via an implantable magnetic component 356 of the implantable device 352 and an external magnetic component 358 of the external device 354. The magnetic coupling between the implantable device 352 and the external device 354 retains the external device 354 against a recipient, such as by placing a wall 364 of a housing 362 of the external device 354 against skin 360 of the recipient. Consequently, a surface 366 of the wall 364 exerts pressure onto the skin 360.

[0055] The external device 354 includes a sensor 368 configured to sense the pressure exerted by the external device 354 onto the skin 360. The sensor 368 is positioned over (e.g., in overlap with) the external magnetic component 358 to sense the pressure exerted by a particular portion 366A of the surface 366 against the skin 360. For example, the portion 366A overlaps with the external magnetic component 358, and the magnetic force provided by the external magnetic component 358 is greatest through the portion 366A. As such, the pressure at the portion 366A is more indicative of the magnetic coupling of the external device 354 with the implantable device 352 as caused by the magnetic force provided by the external magnetic component 358. In this manner, positioning the sensor 368 over the external magnetic component 358 enables the sensor 368 to receive and sense such a pressure exerted at the portion 366A for determining the securement of the external device 354 against the recipient more accurately. Additionally, because the external magnetic component 358 provides the greatest magnetic force at the portion 366A, the pressure exerted by the surface 366 at the portion 366A may be relatively greater (e.g., in comparison to another portion of the surface 366 that is more distal to the portion 366A) and therefore may be more susceptible to causing discomfort to the recipient.As such, the pressure sensed by the sensor 368 can also more readily indicate potential discomfort to the recipient.

[0056] In some embodiments, the sensor 368 is entirely contained within the housing 362. That is, the sensor 368 may not extend out of the housing 362 (e.g., through the surface 366) for contact with the skin 360. Instead, the sensor 368 extends between the external magnetic component 358 and a surface 374 (e.g., an internal surface), opposite the surface 366, of the wall 364. For this reason, pressure can still transfer from the skin 360, through the wall 364, and to the sensor 368 for sensing. That is, the sensor 368 is mechanically engaged with the recipient via the wall 364 to sense pressure exerted by the external device 354 against the recipient. Such an arrangement of the sensor 368 within the housing 362 increases shielding of the sensor 368, which can increase a useful lifespan of the sensor 368.

[0057] The sensor 368 is communicatively coupled to a controller 370 configured to perform one or more operations based on the pressure sensed by the sensor 368. For example, the controller 370 can provide a notification based on the pressure and / or adjust a magnetic strength of the external magnetic component 358 (e.g., via an actuator 372) based on the pressure, such as based on a comparison of the pressure to one or more thresholds.

[0058] FIG. 4 is a schematic view of a cochlear implant system 450 that includes an implantable device 452 and an external device 454 that are configured to magnetically couple to one another via an implantable magnetic component 456 of the implantable device 452 and an external magnetic component 458 of the external device 454. The magnetic coupling between the implantable device 452 and the external device 454 retains the external device 454 against a recipient, such as by placing a wall 464 of a housing 462 of the external device 454 against skin 460 of the recipient. Consequently, a surface 466 of the wall 464 exerts pressure onto the skin 460.

[0059] The external device 454 includes a sensor 468 configured to sense the pressure exerted by the external device 454 onto the skin 460. The sensor 468 is contained entirely within the housing 462 to shield the sensor 468 from an external environment. Additionally, a mechanical linkage 476 (e.g., a spring, a piston, mechanical joints and segments, a gauge) extends from the sensor 468, through the wall 464, and into contact with the skin 460. Retention of the surface 466 of the external device 454 against the recipient also places the mechanical linkage 476 against the recipient. In some embodiments, placement of the mechanical linkage 476 against the recipient moves / deforms (e.g., compresses, retracts) the mechanical linkage 476.The sensor 468 is configured to determine the pressure exerted between the external device 454 and the recipient based on such movement of the mechanical linkage 476. Additionally or alternatively, placement of the mechanical linkage 476 against the recipient transfers pressure from the recipient, through the mechanical linkage 476, and to the sensor 468. In either case, the mechanical linkage 476 mechanically engages the sensor 468 with the skin 460 to enable the sensor 468 to determine the pressure of the surface 466 against the skin 460.

[0060] In further embodiments, the sensor 468 is configured to determine the pressure exerted between the skin 460 and the surface 466 using any other suitable mechanism. By way of example, the external magnetic component 458 is configured to move within the housing 462 based on the magnetic coupling with the implantable magnetic component 456, and the sensor 468 is configured to determine the pressure based on such movement of the external magnetic component 458. For instance, increased magnetic coupling, which corresponds to greater pressure exerted onto the recipient, moves the external magnetic component 458 by a greater amount toward the surface 466. In one example, the sensor 468 is positioned against the external magnetic component 458 (e.g., between the external magnetic component 458 and the wall 464, between the external magnetic component 458 and an opposite wall 478).

[0061] In any case, the sensor 468 is communicatively coupled to a controller 470 configured to perform one or more operations based on the pressure sensed by the sensor 468. For example, the controller 470 can provide a notification based on the pressure and / or adjust a magnetic strength of the external magnetic component 458 (e.g., via an actuator 472) based on the pressure, such as based on a comparison of the pressure to one or more thresholds.

[0062] FIG. 5 is a schematic view of an external device 554 of a cochlear implant system. The external device 554 is configured to magnetically couple to an implantable device implanted within a recipient, thereby retaining the external device 554 against the recipient, such as by placing a wall 564 of a housing 562 against skin of the recipient. Consequently, a surface 566 of the wall 564 exerts pressure onto the skin.

[0063] The external device 554 includes a sensor 568 configured to sense the pressure exerted by the external device 554 onto the skin. In particular, the sensor 568 is disposed at the surface 566 such that positioning of the surface 566 against the skin transfers pressure to the sensor 568. The sensor 568 includes a strain gauge configured to deform upon receiving the transferred pressure. In some embodiments, the sensor 568 is configured to contact the recipient such that positioning the external device 554 against the recipient transfers pressure directlyfrom the recipient to the sensor 568 to deform the sensor 568. In additional or alternative embodiments, the sensor 568 is positioned in contact with the wall 564 such that positioning the external device 554 against the recipient transfers pressure to the sensor 568 via the wall 564 to deform the wall 564, and deformation of the wall 564 also deforms the sensor 568. In either case, the sensor 568 is configured to sense pressure based on its deformation. As an example, increased pressure of the surface 566 against the skin increases the deformation of the sensor 568.

[0064] In the illustrated embodiment, the wall 564 includes a shaped-surface portion 580, and the sensor 568 is positioned at the shaped-surface portion 580. The shaped-surface portion 580 facilitates deformation upon engagement of the wall 564 with the recipient. Therefore, the sensor 568 can more easily detect pressure based on deformation upon engagement of the wall 564 with the recipient. For example, the shaped-surface portion 580 includes a recess.

[0065] The sensor 568 is communicatively coupled to a controller 570 configured to perform one or more operations based on the pressure sensed by the sensor 568. For example, the controller 470 can provide a notification based on the pressure and / or adjust a magnetic strength of the external magnetic component (e.g., via an actuator) based on the pressure, such as based on a comparison of the pressure to one or more thresholds.

[0066] FIG. 6 is a schematic diagram of an external device 654 of a cochlear implant system. The external device 654 includes multiple sensors 668 forming an array. Each sensor 668 is positioned at a different portion of the external device 654. Thus, each sensor 668 is configured to determine a pressure exerted between a different portion of the external device 654 and a recipient. In this manner, the different pressures monitored by the sensor 668 can indicate a distribution of pressure exerted across a surface 682 of the external device 654. For example, the sensors 668 are positioned in a certain arrangement to monitor a particular distribution of pressure, such as at the same distance 684 from one another to determine the pressure distribution more evenly. The pressures can be collectively analyzed to determine the positioning of the external device 654 against the recipient.

[0067] As an example, in some embodiments, an average of the pressures is determined to compare to one or more thresholds. By way of example, the average of the pressures can indicate positioning of the external device 654 against the recipient more accurately as compared to usage of a single (e.g., local) pressure measurement. For instance, although the pressure at one portion of the external device 654 can be undesirable / inappropriate (e.g., belowa first threshold associated with securement of the external device 654, above a second threshold associated with discomfort provided to the recipient), the pressure at remaining portions of the external device 654 being desirable / appropriate can indicate that the external device 654 is still correctly positioned against the recipient, such as at sufficient securement without causing discomfort to the recipient. Therefore, the pressure sensed at multiple portions of the external device 654 can better indicate the positioning of the external device 654 against the recipient. However, in such embodiments, a certain amount of pressure sensed by one of the sensors 668 can also indicate the external device 654 is positioned incorrectly / inappropriately against the recipient. For instance, the pressure at one of the sensors 668 being outside of a pressure range (e.g., a pressure range extending beyond the first threshold and the second threshold to which the average of the pressures is compared) indicates undesirable positioning of the external device 654 regardless of the pressures and / or the average of the pressures sensed by the sensors 668. In other words, even though the pressures sensed by the remaining sensors 668 and / or the average of the pressures sensed by the sensors 668 indicates the external device 654 is positioned appropriately against the recipient, a determination is made that the external device 654 is positioned inappropriately against the recipient based on the pressure sensed by one of the sensors 668 being outside of the pressure range. Additionally or alternatively, a ratio between two pressure measurements from two of the sensors 668 is determined, and the ratio exceeding a threshold indicates the external device 654 is positioned inappropriately against the recipient.

[0068] In additional or alternative embodiments, the distribution of pressures can indicate an alignment of the external device 654 to an internal device. For instance, the pressures at a first subset of the sensors 668 being desirable and the pressures at a second subset of the sensors 668 being undesirable can indicate the first subset of sensors 668 is aligned with the implantable magnetic component of the internal device (e.g., and therefore is in sufficient magnetic coupling with the internal device) and the second subset of sensor 668 is misaligned with the implantable magnetic component (e.g., and therefore is not in sufficient magnetic coupling with the internal device). Thus, the pressures sensed at multiple portions of the external device 654 can be used to determine which part of the external device 654 may be aligned or misaligned with the internal device.

[0069] Although the illustrated external device 654 includes four sensors 668 positioned equidistant from one another, it should be noted that any suitable quantity of sensors 668 can be implemented and positioned at any suitable arrangement with respect to one another. Indeed,the sensors 668 can be positioned at different distances from one another and / or in any suitable pattern, such as along the same row / column or in a random distribution across the surface of the external device 654.

[0070] Each of FIGs. 7-10 discussed below illustrates a method for operating a magnetic wearable device, such as a sound processor of a cochlear implant system, in accordance with embodiments presented herein. In some embodiments, each method is performed by the same device / entity (e.g., a controller, a pressure sensing module). In additional or alternative embodiments, different entities perform operations of different methods. It should be noted that the operations of each method can be performed differently than depicted. For example, an additional operation can be performed, and / or the depicted operation of any of the methods can be performed differently, performed in a different order, and / or not performed. Furthermore, the operations of the respective methods can be performed in any suitable manner with respect to one another, such as sequentially (e.g., in response to) and / or concurrently with one another.

[0071] FIG. 7 is a flowchart of a method 750, in accordance with embodiments presented herein. Method 750 begins at block 752 where a sensor of a magnetic wearable device is configured to sense a pressure at an interface between a surface (e.g., a skin-facing surface) of a device and the skin of the recipient. In particular, the magnetic wearable device includes at least one external magnetic component that, when the magnetic wearable device is worn by the recipient, is magnetically coupled to at least one implantable magnetic component implanted within the recipient. The magnetic coupling of the device with the implantable magnetic component positions the device against the recipient, such as against skin of the recipient, thereby causing the surface of the device to rest and exert a pressure against the recipient. The sensor is configured to sense such a pressure.

[0072] In some embodiments, the sensor is positioned at the surface of the device such that positioning the surface against the recipient also abuts the sensor against the recipient to mechanically engage the sensor directly with the recipient. As a result, pressure between the device and the recipient is directly transferred onto the sensor to enable sensing of the pressure via the sensor. In additional or alternative embodiments, another component mechanically engages the sensor with the recipient. For instance, a mechanical linkage extends from the sensor to the recipient to transfer pressure from the recipient to the sensor. In either case, the pressure exerted onto the sensor (e.g., a strain gauge, a micro-electromechanical system sensor) can deform the sensor, and the sensor senses the pressure based on the deformation. In further embodiments, the sensor is configured to sense pressure based on movement of a portion ofthe device. By way of example, a magnet of the device used to magnetically couple to the implantable magnetic component is configured to move based on the magnetic coupling to the implantable magnet. The sensor is configured to determine movement of the magnet and sense pressure based on such movement.

[0073] In any case, at block 754, one or more operations can be initiated (e.g., by outputting a signal) based on the pressure. In certain embodiments, the operation includes providing a notification to prompt a user to adjust the external device and / or the internal device based on the pressure. In additional or alternative embodiments, the operation includes adjusting a magnetic strength of the external device and / or of the internal device and / or adjusting a relative placement (e.g., relative proximity) between the external device and the internal device. The operation can improve positioning of the external device against the recipient, such as by enabling the external device to sufficiently couple to the internal device without causing discomfort to the recipient.

[0074] FIG. 8 is a flowchart of a method 800 in accordance with certain embodiments presented here. At block 802, a pressure of a surface of a device positioned against a recipient is sensed, the device being magnetically coupled to an implantable magnetic component implanted within the recipient. At block 804, the pressure is compared to a threshold pressure, which indicates desirable positioning of the device against the recipient. In some embodiments, the threshold pressure is provided by an input from a user, such as the recipient, a clinician, a caretaker (e.g., during fitting of device and / or during usage of the device). At block 806, one or more operations are initiated to adjust the pressure toward the threshold pressure. Because a user defines the threshold pressure in certain embodiments, the user can manually change the threshold pressure and correspondingly initiate the operation.

[0075] In certain embodiments, the threshold pressure indicates an amount of pressure exerted while the device is securely positioned against the recipient. For example, a pressure below such a threshold pressure indicates the device may be susceptible to decoupling from the implantable magnet. Thus, the operation initiates to increase the pressure toward the threshold pressure in response to the pressure being below the threshold pressure. Additionally or alternatively, the threshold pressure indicates an amount of pressure exerted by the device that can cause discomfort to the recipient. Thus, a pressure exceeding such a threshold pressure indicates the device may be causing discomfort to the recipient. As such, the operation initiates to reduce the pressure toward the threshold pressure in response to the pressure exceeding the threshold pressure.

[0076] In some embodiments, the operation includes providing a notification, which then prompts a user to adjust (e.g., manually adjust) the pressure toward the threshold pressure. In additional or alternative embodiments, the operation includes automatically adjusting the pressure toward the threshold pressure. For example, an actuator is instructed to adjust the magnetic strength of a magnet of the device to adjust coupling of the device to the implantable magnet, thereby adjusting the pressure exerted by the device against the recipient.

[0077] FIG. 9 is a flowchart of a method 850 in accordance with embodiments presented herein. At block 852, a change in pressure of a surface of a device positioned against a recipient is sensed, the device being magnetically coupled to an implantable magnetic component implanted within the recipient. The change in pressure can indicate a change in magnetic coupling of the device to the implantable magnet.

[0078] At block 854, one or more operations are initiated based on a rate of the change in pressure. For example, a first pressure at a first time (e.g., during one day) is sensed, a second pressure at a second time (e.g., during the same day) after the first time is sensed, a pressure differential between the first pressure and the second pressure is determined, and the pressure differential over a difference between the first time and the second time is calculated to determine the rate of change in pressure. In some embodiments, the operation is initiated based on the rate of the change exceeding a threshold rate. By way of example, certain anatomical changes in the recipient can gradually change the coupling of the device to the implantable magnet. For instance, a change in thickness of the skin (e.g., during recovery from a surgical procedure, due to hair growth) of the recipient can change the magnetic force passing through the skin to change coupling of the device to the implantable magnetic component (e.g., an increase in thickness reduces the magnetic force passing through the skin). The change in magnetic force can then change the coupling of the device with the implantable magnetic component and correspondingly change the pressure of the device exerted against the recipient. However, anatomical changes that gradually change the pressure may not warrant any action to be performed. Indeed, the pressure of the device may remain desirable after changing such that no additional operations (e.g., to adjust the pressure of the device) are to be performed.

[0079] However, the rate of change in the pressure exceeding the threshold rate can indicate that an additional action is to be performed. As an example, a sudden decrease in the pressure can indicate that magnetic coupling of the device with the implantable magnetic component has deteriorated. For instance, the device has become misaligned with the implantable magnetic component and / or the implantable magnetic component and / or the device magnet has becomedemagnetized (e.g., after performing a magnetic resonance imaging operation on the recipient). As another example, a sudden increase in the pressure can indicate an undesirable change in the magnetic coupling of the device with the implantable magnet, such as an immune system response (e.g., inflammation, swelling) by the recipient. Forthis reason, one ormore operations are initiated based on the rate of the change in pressure exceeding the threshold rate. Such an operation, including providing a notification and / or adjusting a magnetic strength, is performed to address the rate of the change, such as to prompt a user to inspect positioning of the device against the recipient, to improve coupling of the device with the implantable magnet, and / or to seek medical intervention / treatment.

[0080] FIG. 10 is a flowchart of a method 900 using multiple pressures, in accordance with certain embodiments presented herein. At block 902, a plurality of sensors is configured to sense pressures at different portions of a surface of a device positioned against a recipient . For example, the device includes multiple sensors configured to sense pressure, and each sensor is positioned at a different portion of the surface device to sense the pressure at the different portions of the surface. The plurality of pressures can therefore indicate a distribution of pressure exerted across the surface.

[0081] At block 904, one or more operations are initiated based on the plurality of pressures. In some embodiments, an average of the plurality of pressures is determined, and the average is compared to a threshold pressure. The operation is then performed based on comparison of the average with the threshold pressure, such as to adjust the average toward the threshold pressure (e.g., in response to the average exceeding or being below the threshold pressure). In additional or alternative embodiments, the pressures of the plurality of pressures are compared with one another to determine a difference in the pressures (e.g., by subtracting the pressures from one another to provide a differential, by dividing the pressures from one another to provide a ratio) and to compare the difference with a threshold value. For instance, the difference exceeding the threshold value indicates an uneven distribution of pressure across the surface, such as that the device is not properly aligned with the implantable magnet. As such, the operation is performed to address the uneven distribution of pressure across the surface, such as to present the pressures at the different portions to the recipient to indicate a manner in which the positioning of the device is to be adjusted to provide more evenly distributed pressures (e.g., and better coupling with the implantable magnet).

[0082] It should be noted that any other suitable method can be performed in addition to or as an alternative to those presented herein to operate the cochlear implant system and position adevice appropriately against the recipient. Indeed, any of the methods can be performed along with other operations to initiate one or more operations accordingly. As an example, a frequency in which undesirable positioning of a device is determined (e.g., based on comparison of a pressure with a threshold pressure, based on comparison of a rate of a change in pressure with a threshold rate), such as a frequency in which the device is determined to be magnetically disengaged from the implantable magnet, and one or more operations can be performed based on the frequency. For instance, an operation to increase the pressure can be performed based on the frequency exceeding a threshold frequency (e.g., to indicate the device is constantly being decoupled from the implantable magnet), even though the pressure exerted while the device is positioned against the recipient is desirable. As another example, user activity is sensed (e.g., via a motion sensor, via biometric data) to determine the pressure (e.g., a change in pressure) in correlation with certain amounts of recipient activity. One or more operations can then be initiated to adjust the pressure based on recipient activity, such as to mitigate or offset an undesirable pressure change caused by the recipient activity (e.g., by increasing the pressure above a threshold during a physical activity to make the device more secure and / or exceeding the threshold value for short durations, if desired). Therefore, one or more operations can be initiated to provide better positioning of the device in different contexts and situations, including before an actual pressure exerted by the device against a recipient is sensed.

[0083] FIG. 11 is a block diagram illustrating one example arrangement for an external computing device 200 configured to perform one or more operations in accordance with certain embodiments presented herein. As shown in FIG. 11, in its most basic configuration, the external computing device 200 includes at least one processing unit 183 and a memory 184. The processing unit 183 includes one or more hardware or software processors (e.g., Central Processing Units) that can obtain and execute instructions. The processing unit 183 can communicate with and control the performance of other components of the external computing device 200. The memory 184 is one or more software or hardware-based computer-readable storage media operable to store information accessible by the processing unit 183. The memory 184 can store, among other things, instructions executable by the processing unit 183 to implement applications or cause performance of operations described herein, as well as other data. The memory 184 can be volatile memory (e.g., RAM), non-volatile memory (e.g., ROM), or combinations thereof. The memory 184 can include transitory memory or non-transitory memory. The memory 184 can also include one or more removable or non-removable storagedevices. In examples, the memory 184 can include RAM, ROM) EEPROM (Electronically- Erasable Programmable Read-Only Memory), flash memory, optical disc storage, magnetic storage, solid state storage, or any other memory media usable to store information for later access. By way of example, and not limitation, the memory 184 can include wired media, such as a wired network or direct-wired connection, and wireless media, such as acoustic, RF, infrared, other wireless media, or combinations thereof. In certain embodiments, the memory 184 comprises logic 195 that, when executed, enables the processing unit 183 to perform aspects of the techniques presented.

[0084] In the illustrated example of FIG. 11, the external computing device 200 further includes a network adapter 186, one or more input devices 187, and one or more output devices 188. The external computing device 200 can include other components, such as a system bus, component interfaces, a graphics system, a power source (e.g., a battery), among other components. The network adapter 186 is a component of the external computing device 200 that provides network access (e.g., access to at least one network 189). The network adapter186 can provide wired or wireless network access and can support one or more of a variety of communication technologies and protocols, such as Ethernet, cellular, Bluetooth, near-field communication, and RF, among others. The network adapter 186 can include one or more antennas and associated components configured for wireless communication according to one or more wireless communication technologies and protocols. The one or more input devices187 are devices over which the external computing device 200 receives input from a user. The one or more input devices 187 can include physically-actuatable user-interface elements (e.g., buttons, switches, or dials), a keypad, keyboard, mouse, touchscreen, and voice input devices, among other input devices that can accept user input. The one or more output devices 188 are devices by which the external computing device 200 is able to provide output to a user. The output devices 188 can include a display 190 (e.g., a liquid crystal display (LCD)) and one or more speakers 191, among other output devices for presentation of visual or audible information to the recipient, a clinician, an audiologist, or other user.

[0085] It is to be appreciated that the arrangement for the external computing device 200 shown in FIG. 11 is merely illustrative and that aspects of the techniques presented herein can be implemented at a number of different types of systems / devices including any combination of hardware, software, and / or firmware configured to perform the functions described herein. For example, the external computing device 200 can be a personal computer (e.g., a desktop or laptop computer), a hand-held device (e.g., a tablet computer), a mobile device (e.g., asmartphone), a surgical system, and / or any other electronic device having the capabilities to perform the associated operations described elsewhere herein.

[0086] Although the present disclosure primarily discusses techniques implemented for a cochlear implant system, it should be noted that the techniques can be implemented in any other suitable device that is retained against a recipient using a magnetic coupling feature (e.g., to magnetically couple to / with an implantable magnet). For example, the techniques may be implemented in a bone conduction devices, charging devices (e.g., off-the-ear chargers), or any other magnetic wearable device.

[0087] Furthermore, as previously described, the technology disclosed herein can be applied in any of a variety of circumstances and with a variety of different devices. Example devices that can benefit from technology disclosed herein are described in more detail in FIGS. 12 and 13. The techniques of the present disclosure can be applied to other devices, such as neurostimulators, cardiac pacemakers, cardiac defibrillators, sleep apnea management stimulators, seizure therapy stimulators, tinnitus management stimulators, and vestibular stimulation devices, as well as other medical devices that deliver stimulation to tissue. Further, technology described herein can also be applied to consumer devices. These different systems and devices can benefit from the technology described herein.

[0088] FIG. 12 illustrates an example vestibular stimulator system 1002, with which embodiments presented herein can be implemented. As shown, the vestibular stimulator system 1002 comprises an implantable component (vestibular stimulator) 1012 and an external device / component 1004 (e.g., magnetic wearable device in the form of external processing device, battery charger, etc.). The external device 1004 comprises a transceiver unit 1060. As such, the external device 1004 is configured to transfer data (and potentially power) to the vestibular stimulator 1012.

[0089] The vestibular stimulator 1012 comprises an implant body (main module) 1034, a lead region 1036, and a stimulating assembly 1016, all configured to be implanted under the skin / tissue 1015 of the recipient. The implant body 1034 generally comprises a hermetically- sealed housing 1038 in which RF interface circuitry, one or more rechargeable batteries, one or more processors, and a stimulator unit are disposed. The implant body 1034 also includes an intemal / implantable coil 1014 that is generally external to the housing 1038, but which is connected to the transceiver via a hermetic feedthrough (not shown).

[0090] The stimulating assembly 1016 comprises a plurality of electrodes 1044( l)-(3) disposed in a carrier member (e.g., a flexible silicone body). In this specific example, the stimulating assembly 1016 comprises three (3) stimulation electrodes, referred to as stimulation electrodes 1044(1), 1044(2), and 1044(3). The stimulation electrodes 1044(1), 1044(2), and 1044(3) function as an electrical interface for delivery of electrical stimulation signals to the recipient’s vestibular system.

[0091] The stimulating assembly 1016 is configured such that a surgeon can implant the stimulating assembly adjacent the recipient’s otolith organs via, for example, the recipient’s oval window. It is to be appreciated that this specific embodiment with three stimulation electrodes is merely illustrative and that the techniques presented herein may be used with stimulating assemblies having different numbers of stimulation electrodes, stimulating assemblies having different lengths, etc.

[0092] In operation, the vestibular stimulator 1012, the external device 1004, and / or another external device can be configured to implement the techniques presented herein. That is, the vestibular stimulator 1012, possibly in combination with the external device 1004 and / or another external device, can include an evoked biological response analysis system, as described elsewhere herein.

[0093] FIG. 13 illustrates a retinal prosthesis system 1101 that comprises an external device 1110 (magnetic wearable device) configured to communicate with an implantable retinal prosthesis 1100 via signals 1151. The retinal prosthesis 1100 comprises an implanted processing module 1125, and a retinal prosthesis sensor-stimulator 1190 is positioned proximate the retina of a recipient. The external device 1110 and the processing module 1125 can communicate via coils 1108, 1114.

[0094] In an example, sensory inputs (e.g., photons entering the eye) are absorbed by a microelectronic array of the sensor-stimulator 1190 that is hybridized to a glass piece 1192 including, for example, an embedded array of microwires. The glass can have a curved surface that conforms to the inner radius of the retina. The sensor-stimulator 1190 can include a microelectronic imaging device that can be made of thin silicon containing integrated circuitry that convert the incident photons to an electronic charge.

[0095] The processing module 1125 includes an image processor 1123 that is in signal communication with the sensor-stimulator 1190 via, for example, a lead 1188 that extends through surgical incision 1189 formed in the eye wall. In other examples, processing module1125 is in wireless communication with the sensor-stimulator 1190. The image processor 1123 processes the input into the sensor-stimulator 1190 and provides control signals back to the sensor-stimulator 1190 so the device can provide an output to the optic nerve. That said, in an alternate example, the processing is executed by a component proximate to, or integrated with, the sensor-stimulator 1190. The electric charge resulting from the conversion of the incident photons is converted to a proportional amount of electronic current which is input to a nearby retinal cell layer. The cells fire and a signal is sent to the optic nerve, thus inducing a sight perception.

[0096] The processing module 1125 can be implanted in the recipient and function by communicating with the external device 1110, such as a BTE unit, a pair of eyeglasses, etc. The external device 1110 can include an external light / image capture device (e.g., located in / on a behind-the-ear device or a pair of glasses, etc.), while, as noted above, in some examples, the sensor-stimulator 1190 captures light / images, in which sensor-stimulator 1190 is implanted in the recipient.

[0097] As should be appreciated, while particular uses of the technology have been illustrated and discussed above, the disclosed technology can be used with a variety of devices in accordance with many examples of the technology. The above discussion is not meant to suggest that the disclosed technology is only suitable for implementation within systems akin to that illustrated in the figures. In general, additional configurations can be used to practice the processes and systems herein and / or some aspects described can be excluded without departing from the processes and systems disclosed herein.

[0098] This disclosure described some aspects of the present technology with reference to the accompanying drawings, in which only some of the possible aspects were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible aspects to those skilled in the art.

[0099] As should be appreciated, the various aspects (e.g., portions, components, etc.) described with respect to the figures herein are not intended to limit the systems and processes to the particular aspects described. Accordingly, additional configurations can be used to practice the methods and systems herein and / or some aspects described can be excluded without departing from the methods and systems disclosed herein.[ooioo] According to certain aspects, systems and non-transitory computer readable storage media are provided. The systems are configured with hardware configured to execute operations analogous to the methods of the present disclosure. The one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.[ooioi] Similarly, where steps of a process are disclosed, those steps are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular sequence of steps. For example, the steps can be performed in differing order, two or more steps can be performed concurrently, additional steps can be performed, and disclosed steps can be excluded without departing from the present disclosure. Further, the disclosed processes can be repeated.

[0102] Although specific aspects were described herein, the scope of the technology is not limited to those specific aspects. One skilled in the art will recognize other aspects or improvements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative aspects. The scope of the technology is defined by the following claims and any equivalents therein.

[0103] It is also to be appreciated that the embodiments presented herein are not mutually exclusive and that the various embodiments may be combined with another in any of a number of different manners.

Claims

CLAIMSWhat is claimed is:

1. A magnetic wearable device, comprising: a housing having a skin-facing surface configured to be positioned to abut skin of a recipient; at least one external magnetic component configured to magnetically couple the magnetic wearable device to at least one implantable magnetic component and retain the skin-facing surface abutting the skin of the recipient; at least one sensor configured to determine a pressure of the skin-facing surface against the skin of the recipient; and a processor configured to initiate one or more operations based on the pressure of the skin-facing surface against the skin of the recipient.

2. The magnetic wearable device of claim 1, wherein the at least one sensor is in mechanical contact with the skin-facing surface.

3. The magnetic wearable device of claim 2, wherein the at least one sensor is disposed at the skin-facing surface.

4. The magnetic wearable device of claim 2, wherein the at least one sensor is disposed on the skin-facing surface.

5. The magnetic wearable device of claim 1, 2, 3, or 4, wherein the at least one sensor comprises a strain gauge.

6. The magnetic wearable device of claim 1, 2, 3, or 4, wherein the at least one sensor comprises an array of sensors, and wherein each sensor of the array of sensors is configured to determine a respective pressure of the skin-facing surface against the skin of the recipient.

7. The magnetic wearable device of claim 6, wherein the processor is configured to determine an average of the respective pressures and initiate the one or more operations based on the average of the respective pressures.

8. The magnetic wearable device of claim 6. wherein the processor is configured to determine a difference between the respective pressures and initiate the one or more operations based on the difference between the respective pressures.

9. The magnetic wearable device of claim 1, 2, 3, or 4, wherein the processor is configured to transmit a signal based on the pressure of the magnetic wearable device against the skin of the recipient.

10. The magnetic wearable device of claim 9, wherein the processor is configured to transmit the signal to at least one of provide a notification or adjust a magnetic strength of the at least one external magnetic component.

11. The magnetic wearable device of claim 9, wherein the processor is configured to: compare the pressure with a threshold pressure; and transmit the signal in response to the pressure exceeding the threshold pressure.

12. The magnetic wearable device of claim 1, 2, 3, or 4, further comprising: a sound processor configured to convert an input sound signal into a processed signal for transmission to an implantable component configured to be implanted in the recipient.

13. A device, comprising: a surface configured to abut skin of a recipient; an external magnetic component configured to magnetically couple the device to an implantable magnetic component configured to be implanted in the recipient to retain the surface of the device against the skin of the recipient; and at least one sensor configured to determine a pressure at an interface between the surface and the skin of the recipient.

14. The device of claim 13, further comprising a processor configured to output a signal based on the pressure at the interface between the surface and the skin of the recipient.

15. The device of claim 14, wherein the processor is configured to determine a change in the pressure at the interface between the surface and the skin of the recipient, and to transmit the signal based on a rate of the change of the pressure.

16. The device of claim 15, wherein the processor is configured to: compare the rate of the change of the pressure with a threshold rate; and transmit the signal in response to the rate of the change of the pressure exceeding the threshold rate.

17. The device of claim 14, wherein the processor is configured to: determine a threshold pressure; and transmit the signal in response to the pressure exceeding the threshold pressure.

18. The device of claim 17, wherein the processor is configured to: receive a user input; and determine the threshold pressure based on the user input.

19. The device of claim 13, 14, 15, 16, 17, or 18, wherein the at least one sensor is disposed over the implantable magnetic component.

20. The device of claim 13, 14, 15, 16, 17, or 18, wherein the at least one sensor comprises a plurality of sensors disposed on the surface of the device, wherein each sensor of the plurality of sensors is configured to determine a respective pressure at the interface between a portion of the surface and the skin of the recipient.

21. The device of claim 20, wherein the plurality of sensors are positioned equidistant from one another.

22. The device of claim 20, further comprising a processor, wherein the processor is configured to determine an average of the respective pressures and initiate one or more operations based on the average of the respective pressures.

23. The device of claim 20, further comprising a processor, wherein the processor is configured to determine a difference between the respective pressures and initiate one or more operations based on the difference between the respective pressures.

24. The device of claim 13, 14, 15, 16, 17, or 18, wherein the at least one sensor is disposed adjacent the surface configured to abut skin of a recipient.

25. The device of claim 13, 14, 15, 16, 17, or 18, wherein the at least one sensor is disposed on the surface configured to abut skin of a recipient.

26. The device of claim 13, 14, 15, 16, 17, or 18, wherein the at least one sensor is mechanically coupled to the surface configured to abut skin of a recipient.

27. The device of claim 13, 14, 15, 16, 17, or 18, wherein the at least one sensor comprises a strain gauge.

28. A system, comprising: at least one implantable magnetic component configured to be implanted in a recipient; and a device comprising: a surface configured to rest against skin of the recipient; at least one external magnetic component configured to magnetically couple to the at least one implantable magnetic component such that the surface is retained against the recipient; and a sensor configured to mechanically engage with the recipient to sense a pressure exerted by the device against the skin of the recipient.

29. The system of claim 28, wherein the sensor is disposed over the least one implantable magnetic component.

30. The system of claim 28, comprising a plurality of sensors including the sensor, each sensor of the plurality of sensors being configured to determine a respective pressure exerted by the device against the skin of the recipient, and the plurality of sensors is positioned so that sensors of the plurality of sensors are equidistant from one another.

31. The system of claim 28, wherein the sensor is positioned between the at least one external magnetic component and the surface.

32. The system of claim 28, wherein the device comprises a wall having the surface, and the sensor is positioned against the wall.

33. The system of claim 28, wherein the surface comprises a shaped-surface portion, and the sensor is positioned at the shaped-surface portion.

34. The system of claim 33, wherein the shaped-surface portion comprises a recess.

35. The system of claim 28, 29, 30, 31, 32, 33, or 34, wherein the device comprises a processor configured to initiate one or more operations based on the pressure sensed by the sensor.

36. The system of claim 28, 29, 30, 31, 32, 33, or 34, wherein the device comprises a housing that encloses the at least one external magnetic component and the sensor.

37. A method, comprising: positioning a device against a recipient such that a sensor of the device is in mechanical engagement with skin the recipient; sensing, via the sensor of the device, a pressure exerted by a surface of the device against the skin of recipient; and initiating, via a processor, one or more operations based on the pressure.

38. The method of claim 37, wherein positioning a device against a recipient such that a sensor of the device is in mechanical engagement with skin the recipient comprises: magnetically coupling an external magnetic component of the device and an implantable magnetic component implanted within the recipient.

39. The method of claim 37 or 38, further comprising: determining, via the processor, a change of the pressure; andinitiating, via the processor, the one or more operations based on the change of the pressure.

40. The method of claim 39, further comprising: initiating, via the processor, the one or more operations based on a rate of change of the pressure.

41. The method of claim 40, further comprising: comparing, via the processor, the rate of change of the pressure with a threshold rate; and initiating, via the processor, the one or more operations in response to the rate of change of the pressure exceeding the threshold rate.

42. The method of claim 37 or 38, further comprising: determining, via the processor, a threshold pressure; and initiating, via the processor, the one or more operations in response to the pressure exceeding the threshold pressure.

43. The method of claim 42, further comprising: receiving, via the processor, a user input; and determining, via the processor, the threshold pressure based on the user input.

44. One or more non-transitory computer readable storage media comprising instructions that, when executed by at least one processor, are configured to: obtain, via a sensor of a device positioned against a recipient, a pressure measurement indicative of a pressure exerted by a surface of the device against the skin of recipient; and initiating, via a processor, one or more operations based on the pressure.

45. The one or more non-transitory computer readable storage media of claim 44, further comprising instructions that, when executed by the at least one processor, are configured to: determine a change of the pressure; and initiate the one or more operations based on the change of the pressure.

46. The one or more non-transitory computer readable storage media of claim 45, further comprising instructions that, when executed by the at least one processor, are configured to: initiate the one or more operations based on a rate of change of the pressure.

47. The one or more non-transitory computer readable storage media of claim 46, further comprising instructions that, when executed by the at least one processor, are configured to: compare the rate of change of the pressure with a threshold rate; and initiate the one or more operations in response to the rate of change of the pressure exceeding the threshold rate.

48. The one or more non-transitory computer readable storage media of claim 46, further comprising instructions that, when executed by the at least one processor, are configured to: determine a threshold pressure; and initiate the one or more operations in response to the pressure exceeding the threshold pressure.

49. The one or more non-transitory computer readable storage media of claim 48, further comprising instructions that, when executed by the at least one processor, are configured to: obtain a user input; and determine the threshold pressure based on the user input.

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