Tinnitus management based on pre device use data and use data

Abstract

A method, including obtaining data indicative of a response to electrical stimulation to tissue of a human, evaluating the obtained data and based on the evaluation, determining fitting settings for a tinnitus treatment device.

Description

Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1 TINNITUS MANAGEMENT BASED ON PRE DEVICE USE DATA AND USE DATACROSS-REFERENCE TO RELATED APPLICATIONS[oooi] This application claims priority to U.S. Provisional Application No. 63 / 749,217, entitled TINNITUS MANAGEMENT BASED ON PRE DEVICE USE DATA AND USE DATA, filed on January 24, 2025, naming Patti TRAUTWEIN as an inventor, the entire contents of that application being incorporated herein by reference in its entirety.BACKGROUND

[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices 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 an embodiment, there is a method comprising any one or more of the actions detailed herein, such as, for example, obtaining data indicative of a response to electrical stimulation to tissue of a human, evaluating the obtained data, and based on the evaluation, determining fitting settings for a tinnitus treatment device.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1 BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Embodiments are described below with reference to the attached drawings, in which:

[0006] FIG. 1 is a perspective view of an exemplary prosthesis in which at least some of the teachings detailed herein are applicable;

[0007] FIGs. 1A-1C are quasi functional diagrams of an exemplary device to which some teachings herein may be applicable;

[0008] FIGs. 1D-2C present exemplary devices and / or systems that can be used to execute at least some of the teachings herein; and

[0009] FIGs. 4-11 provide exemplary flowcharts.DETAILED DESCRIPTION[ooio] Merely for ease of description, the techniques presented herein are described herein with reference by way of background to an illustrative medical device, namely a cochlear implant. However, it is to be appreciated that the techniques presented herein may also be used with a variety of other medical devices that, while providing a wide range of therapeutic benefits to recipients, patients, or other users, may benefit from setting changes based on the location of the medical device. For example, the techniques presented herein may be used to determine the viability of various types of prostheses, such as, for example, a vestibular implant and / or a retinal implant, with respect to a particular human being. And with regard to the latter, the techniques presented herein are also described with reference by way of background to another illustrative medical device, namely a retinal implant. The techniques presented herein are also applicable to the technology of vestibular devices (e.g., vestibular implants), 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, etc.

[0011] FIG. l is a perspective view of an exemplary multimodal (here, hybrid) prosthesis 200 attached to a person 99. The ear includes outer ear 201, middle ear 205, and inner ear 207, and are described next below, followed by a description of an implanted multimodal system 200. Multimodal system 200 provides multiple types of stimulation, i.e., acoustic, electrical, and / or mechanical. These different stimulation modes may be applied ipsilaterally or contralaterally. In the arrangement shown in FIG. 1, multimodal implant 200 provides acoustic and electrical stimulation, although other combinations of modes can be implemented in some arrangements.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1

[0012] It is also noted that arrangements are directed to a purely acoustic hearing aid. That said, arrangements are directed to non-hearing aid per se devices, but instead tinnitus treatment devices that utilize some aspects of acoustic (conventional) hearing aids, and in other arrangements, do not use such aspects. Indeed, some arrangements are directed to the use of pure tinnitus maskers (these can be devices that are conventional hearing aid based devices).

[0013] Shown in FIG. 1 is an acoustic pressure or sound wave 203 that is collected by outer ear 201 (auricle) and channeled into and through ear canal 206. Also seen is tympanic membrane 204 which vibrates in response to acoustic wave 203. This vibration is coupled to oval window, fenestra ovalis 215, through three bones of middle ear 205, collectively referred to as the ossicles 217 and comprising the malleus 213, the incus 209, and the stapes 211. Vibration sets up waves of fluid motion within cochlea 232. Also shown is the auditory nerve 238.

[0014] FIG. 1A provides a schematic of an exemplary conceptual sleep apnea system 1991. Here, this exemplary sleep apnea system utilizes a microphone 12 (represented conceptually) to capture a person’s breathing or otherwise the sounds made by a person while sleeping. The microphone is connected by leads 198 to the main unit 197, which includes a processor unit that can evaluate the signal from leads 198 or, in another arrangement, unit 197 is configured to provide that signal to a remote processing location via the Internet or the like, where the signal was evaluated. Upon an evaluation that an action should be taken by the system 1991, the unit 197 activates to implement sleep apnea countermeasures, which countermeasures are conducted by a hose 1902 sleep apnea mask 195.

[0015] FIGs. IB shows another conceptual sleep apnea system 1992. Electrodes 194 (which can be implanted in some arrangements) utilized to provide stimulation to the human who is experiencing a sleep apnea scenario. FIG. IB illustrates an external unit, and FIG. 1C illustrates the external unit 120 and an implanted unit 110 in signal communication via an inductance coil 707 of the external unit and a corresponding implanted inductance coil (not shown) of the implanted unit, according to which the teachings herein can be applicable. Implanted unit 110, can be configured for implantation in a recipient, in a location that permits it to modulate nerves of the recipient 100 via electrodes 194.

[0016] External unit 120 communicates with the implanted unit via inductive link. External unit 120 can include a processor unit 198 that is configured to control the stimulation executed by the implant unit 110.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1

[0017] Prosthesis 200 provides people with a hearing deficiency who may have some residual hearing the ability to perceive sound (but some devices only have a cochlear implant componentry, and is thus not a multimodal device). Prosthesis 200 may comprise an external component assembly 242 which is directly or indirectly attached to the body of the recipient, and an internal component assembly 244 which is temporarily or permanently implanted in the recipient. External component assembly 242 is also shown in FIG. ID. In some arrangements, components in the external assembly 242 may be included as part of the implanted assembly 244, and vice versa. Also, arrangements of the present invention may be used with implanted multimodal system 200 which are fully implanted.

[0018] External assembly 242 typically comprises a sound transducer 220 for detecting sound, and for generating an electrical audio signal. Sound transducer 220 is a microphone in this embodiment.

[0019] External assembly / external component 242 also comprises a signal processing unit, a power source 270, and an external transmitter unit 206. External transmitter unit 206 comprises an external coil 208 and, preferably, a magnet (not shown) secured directly or indirectly to the external coil 208. The signal processing unit processes the output of microphone 220 that is positioned, in the depicted arrangement, by outer ear 201 of the recipient. The signal processing unit generates coded signals using a signal processing apparatus (sometimes referred to herein as a sound processing apparatus), which can be circuitry (often a chip) configured to process received signals - because element 2130 contains this circuitry, the entire component 2130 is often called a sound processing unit or a signal processing unit. These coded signals can be referred to herein as a stimulation data signals, which are provided to external transmitter unit 206 via a cable 247 and to the receiver in the ear 250 via cable 252. In some arrangements, the signal processor (also referred to as the sound processor) may produce electrical stimulations alone, without generation of any acoustic stimulation beyond those that naturally enter the ear. While in still further arrangements, two signal processors may be used. One signal processor is used for generating electrical stimulations in conjunction with a second speech processor used for producing acoustic stimulations.

[0020] Returning back to FIG. 1, internal component / implanted component 244 comprise an internal receiver unit 212, a stimulator unit 226 and an electrode assembly 218. Internal receiver unit 212 comprises an internal transcutaneous transfer coil (not shown), and preferably, a magnet (also not shown) fixed relative to the internal coil. Internal receiver unit 212 and stimulator unit 226 are hermetically sealed within a biocompatible housing. TheAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1internal coil receives power and data from external coil 208, as noted above. A cable or lead of electrode assembly 218 extends from stimulator unit 226 to cochlea 232 and terminates in an array 234 of electrodes 236. Electrical signals generated by stimulator unit 226 are applied by electrodes 236 to cochlea 232, thereby stimulating the auditory nerve 238.

[0021] In one arrangement, external coil 208 transmits electrical signals to the internal coil via a radio frequency (RF) link.

[0022] As shown in FIG. 1, multimodal system 200 is further configured to interoperate with a user interface 280 and an external processor 282 such as a personal computer, workstation, or the like, implementing, for example, a hearing implant fitting system. Although a cable 284 is shown in FIG. 1A between implant 200 and interface 280, a wireless RF communication may also be used along with remote 286.

[0023] While FIG. 1 shows a multimodal implant in the ipsilateral ear, in other arrangements, the multimodal implant may provide stimulation to both ears. For example, a signal processor may provide electrical stimulation to one ear and provide acoustical stimulation in the other ear.

[0024] With the above as a primer, arrangements are also directed to non-multimodal hearing aids utilizing behind the ear devices (traditional acoustic hearing aids using the teachings herein), and non-multimodal external components of cochlear implants utilizing behind the ear devices (traditional external components of such, embodied in a BTE apparatus, utilizing the teachings herein), and some arrangements are directed to multi-modal arrangements utilizing the teachings herein.

[0025] It is noted that the teachings detailed herein can be implemented with a non-totally implantable prosthesis or a totally implantable prosthesis (analogous to such for cochlear implants).

[0026] FIG. 2 A depicts an exemplary system 2110 according to an exemplary arrangement, including device 100, which can be a hearing prosthesis, or a tinnitus treatment device such as that disclosed below, or any device configured to provide stimulation to a recipient that can treat tinnitus in accordance with the teachings herein. In an exemplary arrangement, device 100 corresponds to the prosthesis of FIG. 1, or to any of the systems detailed below, etc. Also seen in the system is a portable body carried device (e.g. a portable handheld device as seen in FIG. 2A, a watch, a pocket device, etc.) 2140 in the form of a mobile computer (e.g., a smart phone) having a display 2142. The system includes a wireless link 2130 between the portableAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1handheld device 2140 and the hearing prosthesis 100 (often, 100 is referred to as a hearing prosthesis, and such reference corresponds to a disclosure of an alternate arrangement where such is one of the other devices herein). In an arrangement, the prosthesis 100 is a totally external prosthesis, such as where there is a processor and / or an internal power storage device (e.g., a battery), and where, for example, the implant can operate for at least 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 hours or more without signal communication from an external device, and in other arrangements, it includes an implanted portion implanted in recipient 99 (as represented functionally by the dashed lines of box 100 in FIG. 2 A).

[0027] In an exemplary arrangement, the system 2110 is configured such that the hearing prosthesis 100 or other device and the portable handheld device 2140 have a symbiotic relationship.

[0028] As noted above, in an exemplary arrangement, the portable handheld device 2140 comprises a mobile computer and a display 2142. In an exemplary arrangement, the display 2142 is a touchscreen display. In an exemplary arrangement, the portable handheld device 2140 also has the functionality of a portable cellular telephone and can be a smartphone.

[0029] FIG. 2B provides an exemplary tinnitus treatment system (a totally external device) which can be used in some arrangements. Here, the system is embodied in a self-contained tinnitus treatment device 2177. This device can correspond to the smart phone 2140 detailed above, or can be a dedicated device specifically designed for tinnitus treatment. Tinnitus treatment device 2177 includes an earbud jack to which is connected one or more earbuds 2155. The tinnitus treatment device 2177 outputs pressure waves (which could be a masking sound, and could be sub-threshold). In an exemplary arrangement, the tinnitus treatment device 2177 pressure waves that are utilized to prevent onset of tinnitus in the first place and / or to suppress tinnitus. Tinnitus treatment device 2177 includes display screen 2133. This can be the screen of a smart phone of an alternative arrangement (in an exemplary arrangement, device 2177 is a smart phone with earbuds, and in other arrangements, there are no earbuds - the speaker is utilized instead), or can be a dedicated screen of a dedicated tinnitus treatment device 2177. With respect to speaker 2166, this can also be used to provide pressure wave based treatment. The speaker can correspond to the speaker of a smart phone in some arrangements. There is also a microphone 2188. This can receive input from the user thereof and / or can receive input indicative of a portion of the ambient environment of the device, such as the audio environment.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1

[0030] Tinnitus treatment device 2177 includes a transceiver 2144 and / or a transmitter and / or a receiver that can communicate with another device, such as a remote device or a server that can be utilized to perform analysis and / or processing or to another such device 2177. In an exemplary arrangement, the treatment device can communicate with a remote device utilizing Bluetooth and / or utilizing cellular technology, etc. Alternatively, and / or in addition to this, tinnitus treatment device 2177 can utilize wired communications to communicate with remote devices etc. It is noted that tinnitus treatment device 2177 can communicate with a cell phone or a smart phone or with a hearing prosthesis, etc. Also, device 2144 can be utilized to communicate with a device that provides stimulation to a person to treatment tinnitus, such as by way of example, a wireless earbud system, or to the behind the ear device according to the embodiments above, or any other prosthesis that can enable the teachings detailed herein with a modicum of modification, etc. In an exemplary arrangement, tinnitus treatment device includes electronic circuitry and logic that can enable one or more or all of the method actions detailed herein as will be described in greater detail below.

[0031] Embodiments can include modifying the above and / or below devices that are hearing devices / used to assist people in hearing, as well as the above tinnitus devices, for use to implement the teachings herein. The above is a baseline from which the teachings herein relating to tinnitus can be applied to advance the art. Indeed, embodiments include any of the hearing prostheses / devices herein that further include tinnitus treatment features (hence embodiments where the above devices are modified to implement tinnitus treatment). Embodiments include utilizing any one or more of the features of the embodiments just described in a device utilized to treat tinnitus by way of example in the interest of textual economy.

[0032] In an exemplary embodiment, tinnitus treatment is affected utilizing a partially and / or a totally implantable device (the latter sometimes called a “fully implantable device”). In an exemplary embodiment, this device is more than minimally invasive. In an exemplary embodiment, the tinnitus treatment is affected utilizing an implantable portion of a cochlear implant, but positioned and / or modified for tinnitus treatment. In fact, in an exemplary embodiment, the implantable portion of a cochlear implant is not modified at all relative to that which would correspond to a cochlear implants implantable portion. In an exemplary embodiment, the cochlear implant electrode array is utilized to provide the tinnitus treatment, or more accurately, utilized to provide the output of the device to achieve the tinnitus treatment. In an exemplary embodiment, this can entail utilizing electrode array that is not located insideAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1the cochlea, but instead is located adjacent the cochlea, but close enough to the electrically activated tissue therein so that the electrical stimulation outputted by the electrode array can result in activation of that tissue so as to achieve tinnitus treatment. Still, in some embodiments, the electrode array can be placed inside the cochlea, albeit potentially at a different location than that which is normally the case for a cochlear implant. Note also that in some embodiments, not all of the electrode array need be placed into the cochlea. One or two or three or four or more electrodes can be placed in the cochlea, and the rest remaining outside. And further, in some embodiments, instead of the electrode array being the “output,” the so-called “hardball” could be the output and the electrode array could be the “return” (which is a reversal of the roles when used normally in a cochlear implant). Note also that the implant can be a dedicated tinnitus treatment device. Embodiments include utilizing a tinnitus implant to treat tinnitus.

[0033] Thus, the implantable component 244 can be based on an implantable component of a cochlear implant, but positioned and / or modified for tinnitus treatment.

[0034] FIG. 2C shows an exemplary system using an implantable component 244 of a cochlear implant to affect tinnitus treatment and thus is a tinnitus treatment device. Here, there is an external component 2177 in communication by way of energy and / or data transfer link established by way of inductive RF link (or other types of RF can be used) with the implantable component 244. As seen, component 244 comprises a main implantable component 120 and an elongate electrode assembly 118 and a coil 137 encased in silicone 136, which collectively correspond to the implantable component 244. Implantable component 244 includes a magnet 160 that is surrounded by the coil 137 that is in two-way communication (although in other embodiments, the communication is one-way) with a stimulator unit 122, which in turn is in communication with the electrode assembly 118. Shown in FIG. 2C is the so-called “hardball” 198, which is traditionally used as a “return” electrode in a normal cochlear implant. In an embodiment, the hardball electrode 198 is located in an artificial blind hole in the promontory of the cochlea when implanted in a human, and electricity from the hardball 198 travels to the electrically activated tissue of the cochlea to affect tinnitus treatment, with the return being one or more of the electrodes of the electrode array 118. That said, in an exemplary embodiment, the return electrode could be the so-called “ECE plate” 197 of the cochlear implant or could be an electrode located on the electrical lead 196 for the hardball. In an embodiment, such as where there is a battery in the implantable component 244, the implantable component can be a totally implantable prosthesis / fully implantable prosthesis.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1

[0035] In this embodiment, implant 244 can be in signal communication with device 2178, which can correspond to any of the teachings above regarding tinnitus treatment device 2177 but instead of pressure waves or in addition to such, the output is a signal that is transcutaneous transmitted to the implant 244 in a manner analogous to how a cochlear implant operates and / or another type of implantable sensory prosthesis operates. Indeed, for the purposes of textual economy, an inductance coil assembly, such as that of device of FIG. ID, can be used in place of the earbuds 2155 (picture jack 221 attached where the earbuds were attached - and the lead could be longer to accommodate a non-BTE arrangement, or device 2177 could be a BTE device, and device 2177 could be in wireless communication with an inductance communication device that is in communication with the implant). Element 2178 can be the external device / BTE apparatus of FIG. 1.

[0036] Tinnitus treatment can be implemented by the device of figure 1, or at least the BTE device and the associated components in signal communication with the implantable device. This could be a modified cochlear implant adapted for use to treat tinnitus, such as by way of example only and not by way of limitation, a device that includes a tone generator or a signal generator that outputs one or more tones at one or more specific frequencies, which are then converted into a signal and provided to the implant in a manner that corresponds to how a signal that is based on sound captured by the microphone 220 of the BTE device is converted developed by the BTE device and / or otherwise provided to the implant. Indeed, in an exemplary embodiment, the cochlear implant can be utilized so that it receives a streamed signal, for example, from an MP3 or MP4 player, which signal contains various “sounds” that will be received by the BTE device and converted into a signal to be provided to the implant, where the implant is activated based on that signal in a manner analogous to how the implant will be activated if the sound from the MP3 or MP4 player was meant to evoke a hearing percept having meaning to the recipient. That is, the MP3 or MP4 player could include the underlying tinnitus mitigation sounds that are used by the implant. This is but one of many ways that a standard cochlear implant could be utilized to mitigate tinnitus.

[0037] Embodiments can include implant stimulation (or electrical stimulation) for tinnitus relief. In some embodiments, cochlear implant recipients are provided relief from the burden of tinnitus during active use of an implant which is based on sound input. But note that in some embodiments, cochlear implant recipients are also provided relief or alternatively provided relief by providing additional background stimulation which is in principle (or absolutely in other embodiments) not triggered by the ambient sound. Embodiments can include and canAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1exclude modulations of the background stimulation to be triggered by the modulations seen in the incoming sound.

[0038] Embodiments can utilize the device 2177 or 2178 detailed above in accordance with the teachings detailed herein. Any component disclosed herein can be combined with any other component disclosed herein if such can have utilitarian value providing that the art enables such. An overall control system can be utilized to control the combined components. Moreover, any one or more of the features of any one or more device and / or system disclosed herein can be combined with any one or more of the other features of any one or more other devices and / or systems disclosed herein providing that the art enables such, unless otherwise noted.

[0039] In an embodiment, without being bound by theory, the teachings detailed herein include providing background stimulation in one or both ears (a proxy for any one or more components of the respective ears of the two ears (outer, middle and inner)) that will induce neural activity and / or suppress in the auditory pathway, which is disrupted and causes tinnitus in some exemplary scenarios, and stimulate neural plasticity. Embodiments can include executing masking of tinnitus and / or introduction of unperceivable background activity. There is utilitarian value here in some embodiments in that there can be an improvement in tinnitus outcomes which is hypothesized as due to the restoration of disrupted neural activity and / or by further stimulating neural plasticity.

[0040] Embodiments can include the combined / coordinated (for example) use of a stimulation of the device(s) detailed herein that can be / is adjusted depending on the tinnitus characteristics of the particular human to reduce intrusive perception of tinnitus (e.g. related to loudness and / or or pitch) and related tinnitus burden. The stimulation can be modulated (e.g. current level (or magnitude (loudness whether absolute or perceived)), pulse width, pulse frequency, for example) to adapt to the tinnitus characteristics of each recipient.

[0041] In view of the above, it can be seen that embodiments can utilize both extra cochlear electrical stimulation and intra-cochlea electrical stimulation to treat tinnitus. With respect to the former, for example, embodiments include placing the hardball electrode into a bone bed in the promontory in the cochlea, which bone bed could be a circular hole having a diameter of 1 mm or three quarters of a millimeter or half a millimeter or less and a comparable depth, or at least a depth within 20 or 30 or 40 or 50% one way or the other of the diameter. Embodiments include applying stimulation that is sub threshold (e.g., not heard / perceived / Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1sensed directly (it could be that it is sensed indirectly and that the tinnitus is relieved)). In some embodiments, there is no data encoding, and thus relatively simple recurring pulse trains with predefined parameters are utilized.

[0042] Embodiments also include screening humans who are afflicted with tinnitus to forecast / predict utility in using a tinnitus treatment device to treat the tinnitus of the particular human. Screening has utilitarian value with respect to avoiding unnecessary expenditures for devices that will not work or may not work, and also with respect to providing a general prediction as to the efficacy of an implant, which is an invasive device. Herein, any device that is permanently implanted, and / or any device that requires, for example, bone excavation or bone drilling, is considered an invasive device. This as opposed to, for example, a minimally invasive device, which could entail a temporary device and / or a device where, for example, the electrode inserted through a puncture in the tympanic membrane and held against the promontory of the cochlea for example, or the round window for example, with or without adhesive. In an exemplary embodiment, candidates for a tinnitus treatment device can be screened in a clinic utilizing trans tympanic promontory stimulation by way of example. This procedure is executed before progressing to the surgery that is required for the implantable device / the invasive device. This procedure is typically executed days or weeks or months before implantation of the device. Again, this is often a screening technique that is implemented to predict the efficacy of the device that is ultimately used, including an implantable device. Non screening tests as detailed herein can also be executed using these techniques.

[0043] And while the above example of screening has been presented in terms of utilizing a minimally invasive procedure where the electrode is placed through a puncture of the tympanic membrane (a trans-tympanic probe is placed through the membrane) to reach the outer wall of the cochlea or bone that is sufficiently close to the cochlea so that the electrical stimulation from the electrode can stimulate electrically sensitive tissue to cause a reaction that can treat the tinnitus or otherwise impact the recipient’s perception of tinnitus by however little or however much that might be, other embodiments utilize a procedure that does not require incising or puncturing skin of the recipient, such as, for example, placing an electrode against the tympanic membrane.

[0044] Any device, system, and / or method of screening and / or testing a person afflicted with tinnitus that can have utilitarian value with respect to the teachings detailed herein can be utilized in at least some exemplary embodiments, providing that the art enables such, unlessAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1otherwise noted. And in this regard, there can be utilitarian value with respect to utilizing data that is obtained during a screening exercise or multiple screening exercises, and utilizing such with respect to methods and implementations beyond / other than predicting or forecasting the efficacy of a given tinnitus treatment device. By way of example only and not by way of limitation, embodiments include capturing data that is obtained during the screening process which can be utilized to “fit” the tinnitus treatment device. That is, this data obtained by a clinician or a non-clinician or however the data is obtained that is developed as a result of the screening process is utilized in some embodiments to develop settings of the tinnitus treatment device that will be utilized at the inception of device usage to treat tinnitus. This temporal concept is known as “switch-on.” This is the first activation of the device to provide stimulation to a human for its purpose, here, to treat tinnitus. In an exemplary embodiment, a personalized map / profile is generated based on some or all of the screening data, and this map is utilized by the tinnitus treatment device at switch-on. This map could also be based on other data unrelated to the screening or otherwise data based on statistically significant populations for example. By “based on,” it does not mean that all features of the given map must have a basis from the screening data. That said, in some embodiments, the map that is utilized at switch on is not entirely based on the screening data.

[0045] In some embodiments, the map is a set of control parameters that are uploaded to the device. In other embodiments, the map constitutes individual settings that are stored in the device that are adjusted one by one. This as opposed to, for example, volume. In an exemplary embodiment, map data as used herein corresponds to map data of a cochlear implant. In an exemplary embodiment, map data includes threshold and / or comfort levels. Other features can be included in map data, some of which will be described below. The fitting based on the screening data is automated or semi-automated, or at least automated in part.

[0046] One or more parameters associated with the stimulation provided to the candidate recipient during the screening process form the basis of at least some control settings of the device that will ultimately be used to treat the person’s tinnitus during the out periods (the periods following the screening). To be clear, this does not require that there be a one to one relationship between the parameters and the control settings or the map data. If for example the frequency utilized during the screening process that was found to have efficacious results is X, a scaling factor can be applied to X to develop the frequency that will be utilized by the device to treat the tinnitus, and thus the control settings can be set to have the device produceAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1that frequency, where the frequency is different from the frequency utilized during the screening.

[0047] Any one or more of the following data is developed during the screening process and / or during one or more other tests prior to device selection and / or device implantation or otherwise prior to switch-on of the device. To be clear, in an exemplary embodiment, the following data is developed utilizing a system or apparatus that is different from the device that is and / or will be utilized to treat tinnitus in the out periods. The device is different in design, not just by serial number (same make and model). Embodiments include utilizing a minimally invasive device and / or a non-invasive device during the screening or otherwise during the preimplantation process or otherwise the pre-switch-on process. (Testing can be extended after screening, and post screening test data can be used / developed, such as once the candidate for the device has been deemed suitable.) That said, some embodiments do not include utilizing screening data. The candidate has been deemed suitable, and then additional tests are implemented. The pre-switch-on data that is utilized to fit the tinnitus treatment device or otherwise develop control settings therefore or otherwise to develop a treatment regime is developed for the sole purpose of developing fitting data to be utilized at switch-on. The data that is utilized can actually exclude any screening data that exists. Indeed, there may not be any screening data that exists. The data obtained can be obtained during screening and / or, at least some of the data, perioperative and / or even at switch-on, or in close proximity thereto.

[0048] The data can be any one or more of minimum and / or maximum and / or average (mean, median and / or mode) current levels. The data can be electrical impedance data, which can be obtained at screening, perioperatively and / or at switch-on (which is something that “maximum current” is not conducive to do at switch-on and thus is data that will be developed from the pre-switch-on data). The data can be a duration (minimum, maximum, mean, median, and / or mode) of the stimulation that is needed and / or statistically significantly has shown to suppress the tinnitus.

[0049] With respect to current levels, data can be collected on the magnitude of the current applied by the test stimulation device (hereinafter, “test stimulation device” will be used as shorthand for any of the non-implanted devices used to develop data that is used for the control and / or use (e.g., the therapy regime) of the device that will be used to treat the tinnitus. This can be in amperage or standardized values (“current levels”). For example, if an electrode inserted through the tympanic membrane and placed against the wall of the cochlea showed that a minimum current level of X applied thereto had efficacy and / or a current level of Y alsoAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1applied thereto has efficacy, but was the maximum current level that could be applied without causing discomfort for example, or evoking a hearing percept for example, those values are collected / recorded, and then used to develop the control data and / or the treatment regime data for the device that will be used for the treatment in the out periods. In an exemplary embodiment, because the electrode is located further away from the interior of the cochlea than that which will be the case with respect to the device that will be implanted, and / or because the resistance between the current and tissue of the human could be higher than that which will be the case with respect to the device when implanted (e.g., because there is no bone excavation during the testing / the device is minimally invasive), the current settings that are utilized for the implanted device can be scaled down by a certain factor so as to avoid overstimulation by the implanted device. Hereinafter, we will often refer to the device that is utilized in the out periods as the “implanted device” for purposes of textual economy. While many if not most embodiments will be directed towards implementation of the teachings herein to an implanted device, some embodiments may not necessarily utilize such. Any disclosure herein of an implanted device corresponds to an alternate disclosure of a non-implanted device in the interest of textual economy, providing that the art enables such, unless otherwise noted.

[0050] Frequency of the electrical stimulation (in the macro - analogous to the frequency of sound - a 60 Hz power line when grounded makes a distinctive buzz sound - this as opposed to for example frequency use of the device - more on the latter below) can be one of the data collected or otherwise utilized for the implanted device (again, in the interests of textual economy, we will dispense with the longform phrase of developing the map and / or control settings and / or treatment regime utilizing the device, and instead will refer to utilized for the device). Note that frequencies can be sub-threshold (subjectively, but the average person cannot hear frequencies below 10 or 20 Hz), within the hearing range (again, subjectively), or ultrasonic (subjectively, which is typically above 20 kHz for normal hearers). In an exemplary embodiment, it can be determined that, for example, a frequency of 1300 Hz is effective to suppress and / or eliminate the perception of tinnitus. That could be the frequency that is utilized by the implanted device, or the frequency could be scaled for example. In an exemplary embodiment, there can be two or more frequencies that are found to be effective. Note also that ranges could be found to be effective, and all of this data which is developed prior to switch on of the implanted device can be utilized for the implanted device. And note that these may not necessarily be absolute values. It can be that a certain frequency or frequency range provides efficacy for a certain amount of time, and then that efficacy ceases or otherwise isAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1reduced, but a change to another frequency or another frequency range results in efficacy for a certain period of time, and so on. This is an example of data that can be developed prior to switch-on.

[0051] Electrical impedance data can be developed utilizing data from the testing. In some exemplary embodiments, the electrical impedance data can be developed based on latent variables for example. This is another example of a variable that might have utility with respect to being scaled or otherwise weighted (e.g., to take into account that the implanted device will have less impedance because of the better electrical contact of the electrodes and the tissue / bone and / or because of the different location of the implanted electrode). The duration of stimulation shown to have efficacy to treat (e.g., suppress, including eliminate) tinnitus is another example of data that does not lend itself to data collection at switch-on, and will instead be developed from pre-switch-on data. The duration is the continuous stimulation that exists between periods of non-stimulation. These are effective periods of stimulation and nonstimulation. For example, it could bet that a treatment regime stimulates for five seconds and then halts for five seconds, and so on. That is all continuous stimulation. Conversely, if there is continuous stimulation followed by a period of scores of minutes or more, the period of the continuous stimulation would be the duration of stimulation.

[0052] Here again this is an example of data that could be scaled or otherwise weighted owing to the fact that the implant device will likely be more effective than the test device when a per unit basis, or more accurately, the implant device should be able to more effectively treat the tinnitus than the test device. That said, the duration data can be utilized on a one to one basis in some other embodiments. Note also, it could be that in fact a longer duration is implemented based on statistical data developed relating to a given cohort or simply based on the overall average results.

[0053] Data from the screening tests or other tests used for the implant can be stimulation characteristics, which can include one or more of frequency, pulse width or pulse amplitude data of the stimulation outputted by the device used to implement the testing. Again, this data may or may not be scaled or weighted.

[0054] Also, other types of data can be used. For example, evoked physiological responses can be monitored, and the data can be used for the implant. This data can be developed during screening or subsequent tests, developed during peri-operative testing and / or can be developed at switch-on. Any objective measurements can be used. Evoked compound action potentialAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1data can be developed. This data can be developed during any one or more of the just-noted events.

[0055] Obj ective measures can be used to translate stimulation screening data for use in fitting. For example, changes in impedance and / or ECAP threshold can be used to scale stimulation current levels. Indeed, with respect to utilizing the obtained data that is obtained from the screening and / or testing or other sources for that matter, embodiments include utilizing objective measures to translate that stimulation data for use in the fitting of the device and / or the development of a tinnitus treatment regime, or otherwise to develop parameters that will be utilized with the device or otherwise to control the device (e.g., the just noted use of ECAP or changes in impedance for scaling purposes). The translation can be executed in an automated or semiautomated fashion.

[0056] With respect to obtaining changes in impedance and / or the ECAP thresholds for example, this can be done over a series of tests that are temporally spaced out over sufficient periods of time to identify a meaningful change or more accurately, for a meaningful change to occur. That said, in an exemplary embodiment, the data obtained during what say for example a screening process can be utilized for comparison to data that is obtained intra-operatively and / or at switch-on (or just before switch-on). Any of the afforementioned time periods associated with the testing can be utilized in at least some exemplary embodiments if such is utilitarian value, providing that the art enables such. Note further that in some exemplary embodiments, post switch-on testing can be utilized to develop data. More on this in a moment with respect to monitoring and updating various parameters after the recipient has begun using the tinnitus treatment device. But here, for the moment, it can be that the impedance values can be measured after switch on and can be utilized for comparison purposes to prior impedance values so as to identify a change, which change can be utilized with respect to developing the parameter’s detailed herein. In this regard, in an exemplary embodiment, the implant can be configured to measure or otherwise collect data indicative of impedance with respect to the electrical current applied to the human. In an exemplary embodiment, the impedance values can be collected hours or days or weeks or even months after switch on.

[0057] Data relating to the presence and / or duration of residual tinnitus inhibition can be developed, and this can occur during screening or in other tests as can be efficaciously executed, such as tests dedicated to developing data for the implant (irrespective of screening test data). In this regard, the stimuli outputted by the tinnitus treatment device can be provided continuously without variation and / or can be discontinuous (at temporally different times thanAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1any continuously provided stimuli). The discontinuation of providing of stimuli can be based on environmental conditions, such as, for example, if the sound input from the environment is already providing the relief, stimulus can be halted or not even started (and this can be logged per the below and used to develop a treatment regime). If prior sound in the ambient environment has reduced its tinnitus by a desired amount, whatever amount that is, there can be utilitarian value in stopping or otherwise halting further stimulation and / or not starting stimulation, at least if the tinnitus does not return in a relatively quick manner or otherwise in a time period that is deemed unacceptable to the human. Put another way, a regime where stimulation is provided discontinuously can be implemented where the stimulation has an effect of reducing the tinnitus. If the human indicates that the tinnitus is gone, the stimulation would be halted. This indication could be provided by way of example into a remote device such as a smart phone or smart device that is in communication with the other components of the system. Conversely, in some instances, it is that the testing develops data indicating that after a certain amount of time or otherwise after a certain amount of stimulation or otherwise after certain actions are taken utilizing the treatment detailed herein, the tinnitus is reduced to an acceptable level, which can include completely eliminated, at least with respect to perception, and thus the system can be “programmed” to act on that data. This data can be developed prior to switch on in accordance with the teachings herein. And in an alternate embodiment, it could be that the system is not programmed for example or otherwise control settings etc. are not developed based on this data. Instead, a treatment regime is prescribed or otherwise developed that takes into account the concept of residual inhibition. More on this below.

[0058] In view of the above, there is an exemplary method, such as that represented by way of example by the flowchart 300 of FIG. 3. Here, there is method action 310, which includes the action of obtaining data based on data based on a response to electrical stimulation to tissue of a human. In an exemplary embodiment, method action 310 can be executed by providing the stimulation to the human and determining the efficacy or otherwise the results of the electrical stimulation with respect to, for example, mitigating tinnitus in a human. This can be done in accordance with any of the teachings detailed herein, such as, for example, by way of the trans tympanic probe during a screening operation, or a minimally invasive testing procedure or two or more procedures, to develop the data that forms the basis of method action 310. Conversely, method action 310 can be executed by obtaining the data where some other party performed the test. Namely, to execute method action 310, the party need not perform the actual testing. The test data could be transmitted electronically or by mail or handed to the entity executingAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1method action 310. And by data based on data based on a response to electrical stimulation, this can be data directly related to the response (e.g., this current level was utilized and this was the result), which would be data based on the response, but also could be data that is modified or otherwise manipulated prior to the action of obtaining (e.g., scaling the current level that was utilized, and here is the result with the current that was utilized, where the current that was utilized is not specifically told).

[0059] The obtained data is a response to extra-cochlea electrical stimulation implemented by a temporary device temporarily placed into electrical communication with the human. Again, this could be the probe detailed above. The obtained data can be obtained (or is obtained, if the person executing action 310 is the person taking the test) with a non-implantable device and / or minimally invasive device. To be clear, the device could be permanently in electrical communication with the human. Indeed, in an embodiment, a cochlear implant already present could be used to develop at least some of the test data.

[0060] The obtained data includes current levels. These could be the minimum levels and / or the maximum levels or any of those detailed herein that provide tinnitus relief in part or in total. Any of the above-noted or below noted variables (e.g., impedance values, frequency, pulse width, amplitude, etc.) can be included in the data and can be used in whole or in part (and some data can be disregarded, not used, depending on the situation / circumstances).

[0061] Method 300 includes method action 320, which includes analyzing the data obtained in method action 310. This is done automatically, such as utilizing a product of machine learning, while in other embodiments, this is done by a clinician or other trained personnel. This can be a mix of the two, where the clinician utilizes “big data” or statistical information to analyze the data.

[0062] Method 300 also includes method action 330, which includes, based on the evaluation of method action 320, determining fitting settings for a tinnitus treatment device. In an embodiment, this includes developing, at least in part, a map for the device. This can be analogous to a map for a cochlear implant, or can be the same thing in some embodiments, albeit in some embodiments, a scaled down map.

[0063] The teachings herein can have utilitarian value with respect to overcoming or mitigation or at least reducing some of the following issues. Programming of therapeutic devices for tinnitus treatment utilizing stimulation, including electrical stimulation, is often challenging or otherwise time-consuming. This can be because the typical patient tends to experience anAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1exasperation of their condition, along with considerable frustration, when they are asked to participate in a clinical fitting session which requires them to focus on their tinnitus. The teachings herein have utilitarian value with respect to developing an optimum stimulation protocol or at least a working stimulation protocol or adequate stimulation protocol, or at least something better than an educated guess at the beginning, sooner rather than later, such as developing such for use at switch on. The teachings herein can be utilized to reliably predict at least part of postoperative stimulation program based on preoperative screening measures and / or based on preoperative screening testing. These measures of testing can often include trends to electrical stimulation.

[0064] In some embodiments, frequency characteristics can be correlated from preoperative data in accordance with the teachings above and / or below. In an exemplary embodiment, a range of stimulation amplitudes are reliably correlated from preoperative data in combination with data relating to patient and / or surgeon variability. In an exemplary embodiment, other stimulation parameters can be correlated as detailed herein. Embodiments can reduce the “programming burden” on patients and thus encourage earlier acceptance of intervention, which has utilitarian value with respect to long-term success.

[0065] In an exemplary embodiment, the teachings detailed herein with respect to determining fitting settings or determining control regimes and / or developing tinnitus therapy prescriptions for the human can be executed with a reliability result in total (across all or mean, median, and / or mode) or with respect to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,1 1, 12, 13,1 4, 15,1 6, 17, 18, 19, or 20, or more, or any values or range of values therebetween in 1 increments settings or features or parameters that equals or exceeds 70, 75, 80, 85, 90, 95, or 100%, or any value or range of values therebetween in 1% increments confidence and / or equals or is less than 35, 30, 25, 20, 15, 10, 5, or 0%, or any value or range of values therebetween in 1% increments (in an embodiment, that means that the resulting parameter has a value that, if adjusted subsequently after switch-on, is adjusted by a value that would meet any of the aforementioned percentages where the final adjusted value is the base number / denominator (if current level is set at 22 units, and the adjustment at the end is 25 units, that would be (3 / 25 x 100)).

[0066] FIG. 4 shows another flowchart for an exemplary method, method 400. This method includes method action 410, which includes executing method action 310. In an embodiment, this is part of method 300. In an embodiment, this can be executed before or after method action 320 for example. In this regard, figure 5 shows an exemplary flowchart for an exemplary method, method 500, which includes executing the methods of method 400, along with theAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1actions of executing method actions 320 and 330 of method 300 detailed above. And to be clear, while the flowchart of figure 500 shows that method action 320 and 330 are executed after method action 420, in an exemplary embodiment, this may not necessarily be the case. Again, method action 320 could be executed before method action 420. Any disclosure herein of any method action can be executed in any order relative to one or more other method actions unless otherwise noted, providing that the art enables such, in the interest of textual economy.

[0067] FIG. 6 shows another exemplary flowchart for an exemplary method, method 600, that includes method action 610, which includes executing method 300. Method 600 also includes method action 620, which includes determining non-fitting data related to operation of the device. This can be considered “device parameters” as opposed to fitting parameters. For example, this can be the selection of what electrode will be used for the return. For example, the hardball or the so-called ECE plate (or which plate out of multiple plates, or a combination of the plates used simultaneously), or one or more or all of the electrodes of the electrode array in the case where the hardball is used as the main output of the device. In fact, it could be that the testing data reveals that multiple hardballs should be used to provide stimulation, or one is used as the return and the other is used as the output. Other features that are unrelated, at least directly, to fitting data that are related to operation of the device can be developed, such as, for example, whether back-telemetry will be provided from the implant automatically, for example. The compliance voltage for example could be determined based on the test data (or more accurately, based on an evaluation of the test data). In some embodiments, method action 620 is executed based on the data developed in method action 310. Method action 620 could be based on the evaluation of method action 320. In other embodiments, this is executed without reliance on such data (the data may be available, it is simply not used in the determination).

[0068] The tinnitus treatment device has not been previously switched on to treat the human at the time of determining the fitting settings of method action 330. Method actions 310, 320, and / or 330 can be executed less than, greater than and / or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 or 24 hours or any value or range of values therebetween in 0.1 hour increments (e.g., 2.2 hours, 22.5 hours, 4.3 hours to 21.1 hours, etc.) and / or less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 250, or 300 days, or more, or any value or range of values therebetween in 0.1 day increments before commencement of an incision into the human as part of the main operation to implant the device into the human (e.g., an incision in the skin behind the pinna) and / or excavation of boneAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1for that operation and / or switch-on to treat the tinnitus with the device (as opposed to activating the device for non-treatment purposes). Note that the just-noted time periods need not be the same, and in some embodiments simply cannot be the same, for each of the various scenarios just described. Instead, these time periods are presented in one fell swoop for purposes of textual economy. This is the case for all of the teachings detailed herein unless provided otherwise, providing that the art enables such. Note also that any of these temporal periods can be periods that separate any one or more of the method actions herein from the other, all in the interests of textual economy.

[0069] In an embodiment, any one or more of the methods detailed herein further include applying the developed fitting settings to the tinnitus treatment device prior to switch on (and this can be any of the just-noted temporal periods in the interests of textual economy), wherein those settings are used by the device at switch-on of the device (although in some embodiments, the settings may not be stored in the device, but instead can be used by a remote device or another device to control the tinnitus treatment device so that will operate in accordance with the settings). And here again, the time period between this action and another action, such as implanting the device and / or switch-on, can be any of the temporal periods detailed herein.

[0070] In an embodiment, there is at least and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, or 34, or any value or range of values therebetween in 1 increment distinct settings that are developed, based totally or at least in part, on screening data and / or testing developed prior to switch-on. In an embodiment, the method also includes storing any number or ranges of numbers of the aforementioned settings in or otherwise setting the settings of the tinnitus treatment device so that, when in use at switch on, the device will utilize those settings to treat the tinnitus. That said, embodiments also include developing a map and / or a group of settings that are stored in the device but not utilized in the device at switch on. These can be alternate maps or settings that can be adopted when utilitarian. For example, there could be two or more maps stored into the device, where only one map is utilized at switch on, and the other map is stored as a backup or otherwise stored for use in alternate situations. By way of example only and not by way of limitation, the screening data or testing data detailed herein could be developed in a quiet situation on the one hand, and then the screening data or testing data could also be developed for a noisy situation or another environmental situation where the nature of the tinnitus and / or the nature of a utilitarian treatment might be different than the first situation. Accordingly, the screening data can provide a basis for more than one map and / or group ofAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1settings that will be respectively used depending on a given situation, where the testing and / or screening data is specifically directed for such a scenario. And note that there could be submaps or sub setting groups that can be ultimately used and not used and / or switch out for others may be utilitarian. This substitution could be automatic or manual. Note also that there could be different maps and / or setting groups, etc., for severity of tinnitus. For example, one map could be used if tinnitus is severe and the other map could be used if tinnitus is less severe, for example. At switch on, depending on the severity of the tinnitus at the time, the specific map could be selected and utilized by the device to treat the tinnitus.

[0071] Methods include developing a recipient profile for switch-on from the testing (e.g., the screening data, etc.).

[0072] In an embodiment, a therapy is developed for the person / recipient. For example, the frequency of use (a period of stimulation to treat tinnitus bounded by periods of discontinued stimulation). By way of example only and not by way of limitation, the recommended therapy could entail recommending or otherwise instructing the recipient to utilize the device to apply continued stimulation every few days or on a daily basis or every two or three or four hours or six hours, etc. This could be implemented by way of automatic operation of the device, especially in the case of where the device is a totally implantable device that includes an onboard power storage device, such as a battery, that can enable stimulation without an external component. This could have utilitarian value where the recommended period of stimulation occurs every day or every other day or even later for example, and thus the recipient need not wear the external device for periods beyond that which is needed (e.g., for charging the implant for example). In an embodiment, the aforementioned temporal periods can be for waking periods for the human.

[0073] Embodiments include developing duration time periods from the data developed during the tests. Also, embodiments include identifying when the stimulation should commence and / or should be being applied, such as, for example, during the morning or around noon or afternoon or in the evening, etc.

[0074] Note in an embodiment, the development of duration data and / or frequency data can be extrapolated from the expected residual tinnitus suppression for that particular person. Indeed, an embodiment includes developing an expected residual inhibition data set or forecast or otherwise expectation based on the test data / screening data. In an embodiment, this expected residual inhibition data can be utilized to develop a map or otherwise to fit the prosthesis to theAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1recipient. In other embodiments, this can be utilized to develop the therapy regime / instructions for the recipient.

[0075] In an exemplary embodiment, the aforementioned frequency and / or duration periods, or other data developed in accordance with the teachings detailed herein, are based on the test data and / or the screening data as noted above, in an exemplary embodiment, the amount of test data and / or screening data is limited to the temporal periods of the testing. This could be as short as 15 or 30 minutes or an hour of testing. In an exemplary embodiment, the data upon which the method actions detailed herein are developed is test data that was developed over less than, greater than and / or equal to 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 120, 150, 200, 250, 300, 350, 400, 450, 500, 600 or 700 or more minutes or any value or range of values therebetween in one minute increments of stimulation (continuous stimulation -collectively - there could be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, or 30, or more, or any value or range of values therebetween in 1 increments periods of continuously stimulation, collectively resulting in the just-noted times) applied to the candidate / recipient / human.

[0076] In an embodiment, stimulation parameters can be developed from the test data, for example. As noted above, the amplitude can be developed, which can have utility for determining where the subthreshold current level will be for a given person. Again, this could be scaled in an exemplary embodiment owing to the fact that the actual implant will likely provide greater sensation for a given current level than that which is the case for the test devices / data collection devices. Accordingly, in an embodiment, there are methods of determining the current levels that correspond to subthreshold current levels, or otherwise the current level that would evoke (or not evoke) a hearing percept or otherwise a sensory percept beyond the tinnitus mitigation / relief. Embodiments include creating a map or otherwise a profile for the tinnitus treatment device that will be utilized that switch on. In an exemplary embodiment, stimulation parameters that can be developed could be the frequency of the stimulation signal. Note also that there could be multiple frequency ranges that have utilitarian value, and these frequencies can be utilized to develop the map data (i.e., the frequency at which the device will stimulate) or the regime of treatment, where, for example, the individual human could adjust the frequency on his or her own. Note also that while not necessarily map data, it could be that there is a range of frequencies that can be utilized to treat the tinnitus, and thus the device could be programmed or otherwise controlled to operate within a given range of frequencies and not operate outside these frequencies for example. The device can be set so that the device cannot operate outside this frequency even if the recipient tries to adjust theAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1frequency outside that range, at least not without some form of required override that affirmatively indicates to the recipient that the frequency ranges are outside the set ranges or otherwise the range is identified as having utilitarian value.

[0077] Concomitant with the above, embodiments include providing guardrails / limitations, hard (which cannot be changed by the recipient, but only by a professional) and / or soft (which can be overridden by the recipient), on the device and / or the treatment / therapy regime, based on the testing. In an embodiment, there could be limits on the current levels that are output by the device, analogous to the threshold and / or comfort levels of a cochlear implant, albeit reversed, in the sense that for a cochlear implant, the goal is to hear the sound, and thus the current levels are set at a level so that the recipient will hear something, and thus set at a threshold level or above the threshold level, whereas for a tinnitus treatment device, the current levels would be set below the threshold level so that a hearing percept is not evoked, even at the highest output set (unless there is some other reason that such is desired, in which case limit settings would be adjusted or overridden). Still, it could be that the recipient, in at least some instances, finds it acceptable to experience a hearing percept, and thus the recipient could increase the output current level or the clinician could allow an increase in the current level.

[0078] Also, in an exemplary embodiment, the teachings herein are directed towards providing stimulation in a continuous manner, such as any of the above-noted temporal periods just detailed, even in the complete absence of sound. This is the opposite of how a cochlear implant typically works, where there is no stimulation in the events of the recipient being located in an area where there is no sound, or at least the sound is below that which would be deemed utilitarian to evoke a hearing percept based thereon, and the device can be configured to do so (which could entail bypassing certain features or purposely triggering a feature, such as with a standard artificial sound input, such as from a noise generator or tone generator). And in this regard, it is noted that in embodiments where the recipient / human / patient is enabled to adjust the stimulation features, or at least one or more of the stimulation features, such is different than that which is the case for a cochlear implant, where the recipient can increase or decreasing volume for example. The adjustment of the current level is different than the adjustment of volume for a cochlear implant, even though the end results with respect to the latter is an increase or decrease in the current level that is applied for a given input. In this regard, the ability for the tinnitus sufferer to adjust the current level can be distinguished from adjustment of a volume in a cochlear implant in that there is no input into the system per se that results in the output having a current level. In an embodiment, there is no sound input into the tinnitusAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1treatment device, at least not that which is utilized to form the basis of the output. It could be that a cochlear implant being utilized to treat tinnitus is capturing sound and could potentially even be processing the sound. It is simply that that captured sound and / or the processed sound is not utilized as a basis for the output. That said, in some other embodiments, such as where the tinnitus treatment is adjusted based on the presence of a sound, it could be that the tinnitus treatment device is utilizing an input such a sound to establish a basis for the output. But the ability of the tinnitus treatment device to do so is still different than this general concept under explanation, where the recipient can adjust the current level or other stimulation feature, such as the frequency, so that the device will provide output irrespective of any input. In an embodiment, the microphone is not utilized and / or does not exist on the device, or is permanently deactivated, or temporarily deactivated during any one or more of the method actions herein / or in any system or device herein. In an embodiment, the input into the recipient is totally independent of the sound environment. Conversely, some embodiments could take into account the sound environment in a blended concept with one or more of the teachings herein, where, for example, certain sound environments are known to encourage tinnitus, and thus the device might only activate or automatically activate during such. Still, embodiments can be totally agnostic to the sound environment.

[0079] As noted above, there could be hard limits placed on the device, which can be considered a safety feature for example. It could be that there is always a comfort level that is established irrespective of the threshold level. In some embodiments, this comfort level cannot be changed by the recipient, even if the current level that is output can be adjusted to be at a level above a threshold level. Accordingly, in an exemplary embodiment, the device is configured to affirmatively prevent an adjustment by the recipient that causes a painful or otherwise irritating sound to be output by the device, or more accurately, the cause the device to evoke a hearing percept that is painful. Corollary to this concept is that hard limits could be placed on the pulse width of the output, so as to ensure that the fundamental utilitarian value of utilizing alternating current is maintained.

[0080] In view of the above, in an embodiment, there is a method, such as method 700, as represented by the flowchart of FIG. 7, which includes method action 710, which includes obtaining data indicative of a response to electrical stimulation to tissue of a human. This can correspond to any of the teachings herein for such. Method 700 also includes method action 720, which includes evaluating the data and this can be done in accordance with any of the teachings herein for evaluating such data.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1

[0081] Method 700 also includes method action 730, which includes, based on the evaluation, developing a tinnitus therapy prescription for the human. The phrase prescription is utilized herein in a manner that describes actions to be taken by the tinnitus sufferer with or without additional instructions or guidance from a healthcare professional. This can also describe actions that require additional input from a healthcare professional. With respect to the former, the entity that executes method action 730 could be the “end interface” with the tinnitus sufferer or a caregiver for the tinnitus sufferer or guardian in the case of a child for example, where the prescription corresponds to the full-fledged treatment regime that will be or at least is intended to be adopted by the tinnitus sufferer. With respect to the latter, this could be guidelines or otherwise instructions to a healthcare professional who in turn will evaluate that information and develop the treatment regime for the particular person.

[0082] Briefly, it is noted that the response in accordance with at least some embodiments to the electrical stimulation is an immediate response to the stimulation. In an embodiment, the response can be a latent response to the stimulation. In an exemplary embodiment, the response is a response that is identified or otherwise considered present less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, or 2000, or more seconds or 0.5, 0.6. 0.7, 0.8, 0.9, 1, 1.25, 2.5, 2.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, or 90 or more hours, or any value or range of values therebetween in 0.1 second or 0.05 hour increments, respectively at the beginning and / or end and / or middle of the stimulation.

[0083] In an embodiment, the prescription can include the duration and / or frequency of use, time of use, etc., of the stimulation to be applied by the tinnitus stimulation device. Note that these parameters can be set for the beginning and / or the end of the use. And by beginning of use, it is meant the commencement of the continuous stimulation, and the end of use it is meant the discontinuity of the stimulation.

[0084] The prescription can have any of the use profiles or treatment profiles or settings or parameters detailed herein, such as those detailed above or below that are based on the testing, whether such as for the initial screening or specific testing beyond screening or unrelated to screening.

[0085] In an embodiment, the prescription can be for a tinnitus treatment device, whether that device is an implantable device or a non-implantable device the prescription can include anyAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1one or more of the map settings for example as detailed herein, to be utilized with that implantable device. For that matter, the prescription may not necessarily specify that the recipient obtain a given device, where instead, the device that the recipient will use has already been determined, and thus the prescription is directed to control settings or the like or how that device will be utilized by the recipient to treat tinnitus.

[0086] In an embodiment, the prescription provides for residual inhibition implementation utilizing the device. In this regard, as noted above, it can be that the recipient might experience residual inhibition of tinnitus after stimulation is discontinued. This prescription could by way of example only, the duration of stimulation and / or the timing of the commencement of stimulation could be identified for the prescription based on the recognition of the temporal periods of the residual inhibition that should result for the particular recipient. This as opposed to a prescription that does not take into account or otherwise does not provide for residual inhibition implementation utilizing the device. A prescription could be developed that provides for non-continuous stimulation, but such does not necessarily take into account residual inhibition.

[0087] Accordingly, screening metrics can be developed, such as for example, the stimulation that is “needed” or otherwise has shown to be “required” for suppression, whether that be total or partial, and / or the extent of residual inhibition (temporal length and / or quality thereof - the inhibition could be total for example, and then the tinnitus could come back with a vengeance, while in other scenarios, the inhibition could be potentially total, and then the inhibition could be say 90% of the untreated amount, and then 80% in an 70%, etc. over a period of time from the cessation of the stimulation - in an embodiment, it could be that the treatment parameters are provided to rely on inhibition for scenarios where, for example, 70% of the tinnitus is inhibited (the perception is only 30% of that which occurs after the total end of any inhibition for example, however that can be quantified). Again, consistent with the teachings herein, the screening metrics can be adapted to create therapy recommendations or otherwise to develop a therapy regime for the individual person, this would be a personalized profile for the individual as opposed to a statistically based profile or a standard profile that would be applied simply because the person falls into a given cohort. And note that while the above refers to “screening metrics” in other embodiments, the metrics may be “test metrics.”

[0088] Concomitant with the teachings above, in an embodiment, the electrical stimulation of method action 710 can be minimally invasive stimulation or otherwise a result of a minimally invasive procedure. The prescription can be for use of an invasive stimulation device. This isAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1consistent with the concept detailed above where a different type of device is utilized to collect the data than that which is utilized to treat the tinnitus.

[0089] In view of the above, FIG. 8 shows an exemplary flowchart for an exemplary method, method 800, that includes method action 810, which includes obtaining an implantable tinnitus management device. This can be any of the devices detailed herein or variations thereof. The method further includes operating the tinnitus management device at switch-on to manage tinnitus of a human. This exemplary method embraces the utilitarian concepts detailed herein, with or without the testing data or screening data and the use thereof to develop the operating parameters such as the map for the device, the implantable device would not be utilized to manage tinnitus at switch on. Instead, for example, at switch on, there could be a fitting procedure that is implemented, where subsequent to this fitting procedure, the device would be utilized to manage tinnitus. In an exemplary embodiment, the device provides stimulation, to manage tinnitus, for at least 15, 20, 25, 30, 45, 60, 90, 120, 200, 250, 300, 350, or 400 minutes, or any value or range of values therebetween in one minute increments. In an exemplary embodiment, the device provides stimulation at a current level that is at least 50, 55, 60, 65, 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, or 99%, or any value or range of values therebetween in 0.1% increments of the threshold value that would evoke a hearing percept. The aforementioned stimulation provided at switch on can be any of these values. In an exemplary embodiment, the stimulation is provided for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 minutes, or any value or range ofvalues therebetween in 0.1 minute increments or any of the just noted temporal periods.

[0090] In an exemplary embodiment, the device treats the tinnitus effectively at switch on. In an exemplary embodiment, the device reduces the percept of tinnitus by at least at 50, 55, 60, 65, 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100%, or any value or range of values therebetween in 0.1% increments, and this occurs for any of the aforementioned temporal periods. In an exemplary embodiment, the device reduces the percept of tinnitus by any of these percentages after stimulation is ceased owing to residual inhibition. In this regard, the reduction can be according to any of the aforementioned percentages for any of the temporal periods detailed herein. In all of this occurs at switch on in at least some exemplary embodiments.

[0091] In an exemplary embodiment, adjustable settings of the device are set based on screening data and / or pre-implantation test data particular to the human. In an embodiment, the operation of the device at switch-on relies on the set adjustable settings. Set adjustableAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1settings can be map data or other parameters that are utilized to control the device during operation to treat tinnitus. And note that this does not require that all the adjustable settings of the device are set based on the test or screening data. It is sufficient that some of the adjustable settings are set based on the data, although in some embodiments, all of the adjustable settings are set based on the test data. Concomitant with the above, the operation of the device relies on a map of the device that is partially, and in some embodiments, totally developed based on screening data and / or test data particular to the human obtained with a non-invasive and / or minimally invasive electrical stimulation device prior to a surgery implanting the device in the human. This can be in accordance with any of the temporal periods detailed herein.

[0092] In an embodiment, there is a method 900 as represented by the flowchart of FIG. 9, which includes action 910, which entails executing method 800. Method 900 further includes method action 920, which includes, at least after Z hours after switch-on, operating the device to manage tinnitus of the human during normal use. Normal use means that it is not a test period or the like, but instead, is utilized to manage tinnitus in the normal course of business. In an embodiment, Z is equal to 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 150, 200, 250, 300, 400, 500, 600, 700, 800, 900, 1000, 1500, 2000, 2500, 3000, 4000, or 5000, or any value or range of values therebetween in 1 hour increments or longer, including one or two or three or four or five or six or seven or eight or nine or 10 or more years or any value or range of values therebetween in one month increments.

[0093] Method 900 further includes method action 930, which includes adjusting the device within limits set in the device, the limits based on screening data and / or test data particular to the human. This can correspond to the teachings above related to providing guardrails with respect to what the recipient can and cannot adjust on his or her own. In this regard, the action of adjusting device can be executed by the recipient / human who receives the implant and is otherwise suffering from tinnitus. This could be a caregiver / parent of the person. Conversely, in an embodiment, this can be executed by a clinician or healthcare professional, which could be done remotely. In an exemplary embodiment, this can allow the recipient or caregiver of the recipient to adjust the current level within the boundaries / limitations. This could be adjustment of the frequencies, etc. Any of the adjustments detailed above or otherwise any of the parameters detailed above can be adjusted in an exemplary embodiment.

[0094] In an exemplary embodiment, all of the settings adjustable by the recipient or a caregiver or guardian of the recipient and / or are adjustable only by a healthcare professional for an audiologist for example, or an entity that specializes or otherwise his expertise inAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1working with a device that is utilized to treat tinnitus, have guardrails that are based on the screening and / or the testing detailed herein that occurs pretty switch on. In an embodiment, these guardrails are totally based on such testing and / or screening before switching. In an embodiment, there is at least and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 or 18 or any value or range of values therebetween in one increment distinct settings that are adjustable. In an embodiment, any of those numbers or range of numbers are provided with guardrails that were developed based on the testing and / or screening data.

[0095] In an embodiment, in addition to executing one or more of the method actions above, the method(s) further include at least 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, or 100, or any value or range of values therebetween in 0.25 day increments after switch-on, operating the device to manage tinnitus, wherein the action of operating includes automatically activating the device after a period of deactivation, wherein the time of activation is based on residual inhibition of tinnitus due to activation of the device prior to the period of deactivation. In an embodiment, this method action can be repeated at least 5, 10, 15 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, or 100, or any value or range of values therebetween in 1 increment times after any one or more of the noted time periods after switch-on. In an embodiment of these methods, the human experiences no noticeable tinnitus during a majority of the periods of deactivation. In an embodiment, the human experiences no noticeable tinnitus during at least 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%, or any value or range of values therebetween in 1% increments of the periods of deactivation. In an embodiment, if the human experiences noticeable tinnitus, it is at a level that is no more than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60%, or any value or range of values therebetween in 1% increments of that which the recipient normally perceives without treatment. Note that the values need not be the same in the various periods of deactivation. To be clear, any values or range of values provided herein are not required to be the same at different times and / or for different applications, but are instead presented by way of textual economy.

[0096] In an embodiment, after switch-on, during normal use, the treatment device is used (provides stimulation) for less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750 or 2000 or more minutes or 30, 35, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300 or more hours or any value or range of values therebetween in one second increments (e.g., 10 minutes and 3 seconds, 33 minutes, 305 to 555 minutes and 17 seconds, etc.). In an exemplary embodiment, the stimulation is provided continuously for anyAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1one or more of those just detailed values as would be enabled by the art, in the interests of textual economy. In an exemplary embodiment, the stimulation is provided discontinuously over one or more of those values (i.e., for a period of 33 minutes, the first and / or second stimulation would be provided discontinuously, so there would be stimulation for less than 33 minutes). In an embodiment, the total time of actual stimulation for any one or more of the just detailed periods can be less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% or any value or range of values therebetween in 0.1% increments of the total time period (e.g., for a period of 33 minutes with stimulation at 50% of the total time period, that would be stimulation provided for 16.5 minutes) just detailed as enabled by the art. In an embodiment, the discontinuous stimulation is divided up into 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2500, 3000, 3500, 4000, 5000, 6000, 7000, 8000, 9000, 10000, 12500, 15000 or 20000 or more blocks or any value or range of values therebetween in 1 block increments, and the blocks may or may not be the same and / or the time between a given block of stimulation may or may not be the same. The continuous stimulation is located between those blocks. This can have utilitarian value with respect to avoiding constant and / or ongoing delivery of stimulation, which can be undesirable for various reasons. Indeed, the equipment can be physically incompatible with sleeping or showering as noted above. The external device may also simply be something that is desired to not be seen in public or under certain circumstances for cosmetic reasons.

[0097] Embodiments thus include a system that is trained for example to create a personalized stimulation protocol for tinnitus and / or other conditions. The protocol can be arranged to titrate stimulation levels, while balancing between stimulation on (continuous stimulation, even if there are spaces between stimulation pulses) and stimulation off states (stimulation discontinued). Implementations of use of the device for stimulation and the non-stimulation and simulation on / stimulation off can be implemented based on data developed regarding residual inhibition of tinnitus of the given person in accordance with the teachings detailed herein. This can be developed utilizing the pre-switch on data that is collected and / or post switch on data that is a collected in accordance with the teachings detailed herein. Embodiments include balancing the concept or otherwise the requirements of constant stimulation / on-state simulation against periodic stimulation and utilizing interleaved on and off periods relying on residual inhibition. Put another way, there is a price to pay for constantAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1on stimulation over long periods, such as an entire day or an entire waking period. This price is balanced against the results of periodic stimulation interleaved by periodic non-stimulation. These results can be based on the pre-switch on testing and / or the post switch on testing.

[0098] Embodiments can include a trainable system for example, and this system can include default habitual usage of the device and / or user adjustments and / or user responses to adjustments and / or other preferences, such as the subjective tolerability of non-stimulated state. All of which can be balanced against the price of one-state stimulation.

[0099] Embodiments also include post switch on data collection and refinement to maps and / or treatment profiles based on usage of the device by the recipient. Embodiments include tracking the “volume” and / or current adjustments that might be made by the recipient or other caregiver during usage of the device, including normal usage of the device, to treat tinnitus. In an exemplary embodiment, it could be that the recipient adjusts the threshold level to be higher in a noisy environment. Interestingly, this is counterintuitive with respect to the utilization of cochlear implants, where in noisy environments, users typically do not increase volume. The switch on and switch off times and / or periods thereof can be charted or otherwise logged. And any one or more of the settings or otherwise operating parameters that are associated therewith (frequency, current level, pulse width, rate of the electrical pulses, etc., any of the parameters detailed above that have applicability to such) are logged including in some embodiments, with timestamps or the like. This log data can be later analyzed or can be analyzed in real time for that matter.[ooioo] Embodiments can also include analyzing the on and off times, or other operational data to identify periods of residual inhibition. With respect to other operational data, it could be that an adjustment that results in the current level being lower or higher for example - it could be that the recipient does not one to deactivate the device or otherwise turn off the device or stop stimulation, but instead you simply once the device to have reduced stimulation for whatever reason for example and then the recipient increases the stimulation when the residual inhibition wears off or otherwise lapses. The rate of electrical pulses that is delivered by the device could be adjusted and this also could be indicative of the presence or absence of residual inhibition.[ooioi] Tracking recipient usage and otherwise usage data can entail collecting usage data following switch-on. In an exemplary embodiment, the data is collected over a period that can last Z hours or Z days after switch-on or longer, including one or two or three or four or fiveAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1or six or seven or eight or nine or 10 or more years or any value or range of values therebetween in one month increments. Note that the period(s) of tracking during this period can be any of the values of Z in hours or Z days, and there can be less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, or 100, or more data collection periods, which periods are separated by periods of non-data collection however long or short they may be.

[0102] Stimulation metrics can be captured or otherwise logged after switch on, which can include parameter level (maximum, minimum, mean, median and / or mode) and / or parameter level variance from a baseline parameter value or some other baseline or from an average for example or any other data point for points that can of utilitarian value, parameter trends (increasing and / or decreasing and / or periodic variation and / or the rate of increase or decrease and / or the frequency increase or decrease, etc.). Parameters can include any of those detailed herein, such as current level, frequency, pulse width, pulse rate and impedance, by way of example. Impedance values can be logged over the various periods of time, and this can be based on data that is obtained by the implant, which has the ability to perform impedance data collection.

[0103] Therapy metrics can be logged. Any of the parameter concepts of the stimulation metrics noted above (parameter level or parameter level variance, etc.) can be applicable to therapy metrics. This could be average duration (mean, median and / or mode), maximum and / or minimum duration, time of day, correlation to sleep / non-sleep, variance from a baseline (duration and / or time, etc.) Again, trends (increasing, decreasing, periodic variation, etc.) can be logged / captured.

[0104] Some of the usage data that can be captured can be classified as “follow-up events.” By way of example only and not by way of limitation, a sudden change in usage can be logged or otherwise would be something that would be logged, and would be indicative of an event to which attention should be paid. Trends of the data can be logged or otherwise would be present in the log data, and problematic trends can be identified. By way of example only and not by way of limitation, a decreasing adherence to a treatment plan could be identified based on temporal usage of the device. A decreasing adherence to treatment plan could be identified based on stimulation current level of the device or other parameters that would be indicative of such. In the rate of decrease of adherence could be evaluated and one or more of the actions detailed herein can be executed based thereon.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1

[0105] Embodiments also include executing momentary ecological assessment. This can be real-time recipient sampling, which could be subjective feedback from the recipient. This can be initiated automatically or could be initiated by the recipient or a third party provider. Indeed, some sophisticated examples could include the ability of the external device or even the implant device for that matter to recognize words spoken by the recipient as indicative of there being a problem or indicative of there being goodness. Recall that some embodiments utilize an external device of a cochlear implant, which can have a microphone and a sound processor. This device can be adapted to record or even analyze spoken words, such as with a voice to text system. This could be present in the handheld computer for example, in signal communication with the external device of the implant. Indeed, the data can be logged by simply recording the recipient’s voice with respect to commentary about the performance of the treatment. Corollary to this is that the device could automatically log the data. The log data can be streamed or downloaded to a remote device, such as a handheld computer or a smart phone in batch or in real time. There could be correlation between the recipient’s comments and the underlying data that is logged automatically.

[0106] Any one or more or all of the data or otherwise data from these sources can be evaluated and utilized as the basis to adjust the map or otherwise adjust a treatment regime or otherwise change something related to the device, whether that be how the devices used how much the device is used or as setting on the device.

[0107] Embodiments include automatically and / or manually adapting a personalized profile, whether that be a treatment regime or settings of the device or how the device is used, to take into account recipient usage / to adjust such based on recipient usage. In an embodiment, there can be incremental increase in the current level (maximum, minimum, average, etc.). For example, if recipient usage is regularly at and / or near a maximum current level setting and / or at or near a maximum therapy duration (recommended therapy duration, it could be that there is utilitarian value with respect to increasing the maximum current level. The opposite would be the case in some embodiments where opposite scenarios exist. In embodiments, the threshold current levels and otherwise estimates therefore serve as current level ceilings. This is the opposite of a cochlear implant, where threshold level is a current level floor. This threshold could be raised or lowered depending on the performance or the usage. In some embodiments, consistent or otherwise statistically significant usage of the device of the maximum current level indicates that there could be efficacy for going higher, and such may or may not result in a hearing percept. In an exemplary embodiment, it could be that after aAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1determination is made that there could be utilitarian value with respect to increasing the current level or there could be utilitarian value with respect to decreasing the current level (maximum allowable current level) the current level is gradually increased or decreased respectively, such as, by way of example only and not by way of limitation, by predetermined units of current level and / or by predetermined percentages. These percentages and / or current levels could be adopted based on an analysis of the usage data, where more aggressive or less aggressive increases or decreases per temporal increase or decrease could be applied. In an exemplary embodiment, there could be an increase or decrease followed by additional data logging followed by an evaluation and then followed by an additional increase or decrease or a decision to hold the current level at that newly changed value. In an exemplary embodiment, there could be an increase or decrease followed by another increase or decrease after a temporal period has elapsed, followed by additional data logging, etc. In an exemplary embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or more, or any value or range of values therebetween in one increments discrete increases or decreases in current level followed by any of the just noted numbers discrete data collections and associated data analysis followed by an increase or decrease or a holding steady / maintaining the current level at a given value as previously changed based on the data analysis.

[0108] Stimulation characteristics can be adjusted based on the usage data or otherwise the analysis of the uses data. By way of example, in a scenario where the recipient regularly exceeds the maximum therapy duration that is recommended by prescription or the like, or otherwise presented in the therapy regime, any given current level or a lower current level could be an indication of super threshold stimulation potentially where the recipient is purposely lowering the current level to avoid the super threshold stimulation, such as, for example, a hearing percept being evoked by the stimulation or some other sensation. That is, the recipient could be purposely lowering the current level and then utilizing a longer stimulation period to compensate therefore. In an exemplary embodiment, an adjustment to the stimulation characteristics can entail reducing pulse amplitude could be reduced and pulse width could be respectively increased. Note that in other scenarios, it could be that there is utilitarian value with respect to reducing the pulse amplitude and increasing the pulse width or increasing the pulse amplitude and decreasing the pulse width, or changing one and holding the other constant.

[0109] In an exemplary embodiment, implant settings can be adjusted based on the usage data or otherwise based on usage trends, etc. For example, it can be determined based on the usageAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1data that there is utilitarian value with respect to increasing power that is provided to the nerve. This can be accomplished by increasing the current and / or increasing the pulse width. It could be determined that the opposite is the case.[oono] Note that a given stimulation curve might be adjusted or otherwise modified based on the usage data. In this regard, the stimulation provided to the recipient can be charted out over time or as a function of one or more parameters. This curve will have a specific shape as one would expect. The shape of this curve could be adjusted by adjusting various parameters etc., and the new shape would be a control factor for otherwise the new shape could be compared to the old shape utilizing statistical analysis or the like to find deviations between the two so as to quantify and / or qualify a change that is made.[oom] Note that in at least some exemplary embodiments, any actions are evaluated for safety purposes. For example, if adjustments are made to pulse amplitude for safety, charge balance considerations could be taken into account to ensure that there is not a buildup of current or charge in the tissue. Of course, stimulation rate could be adjusted based on the usage data. The rate could be changed by one or two or three or four or five or six or seven or eight or more hertz for example. And as with current level, the changes could be incremental or analog.

[0112] And it is briefly noted that in the interest of textual economy, any of the changes detailed herein presented with respect to current level for example, can correspond to any of the other parameters that can be adjusted based on usage data providing that the art enables such unless otherwise noted.

[0113] And stimulation characteristics can also be adjusted to reflect momentary ecological assessments and / or adherence to a treatment plan or otherwise deviations from the treatment plan. For example, in an exemplary embodiment, there can be an increase in current level and / or pulse characteristics to deliver more charges treatment duration is constrained. In this regard, for example, it could be that the recipient only has a limited amount of time to operate the device for treatment purposes, where, thereafter, he will rely on residual inhibition. Alternatively, it could be that the recipient simply needs to have a period of maximum efficacy for tonight’s suppression or inhibition or otherwise reduction of the sensation of tinnitus, for whatever important reason. Thus, the recipient or a third-party remotely could control the device to provide different stimulation characteristics to achieve a given requirement where there is a time constraint.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1

[0114] It could be that the recipient simply believes that certain stimulation characteristics are better than others, and the recipient changes the stimulation characteristics accordingly. This can be part of an interactive arrangement that is presented on the cell phone or the smart phone for example, where the recipient can log his or her opinions about certain stimulation characteristics or otherwise performance resulting from certain characteristics, or otherwise indicate in a go no go fashion that one is better than the other followed by the next one being better than the other or not better, etc., and adjust the stimulation characteristics based on the one that is deemed to be the best through process of elimination or a taboo algorithm for example.

[0115] In view of the above, it can be seen that there is an exemplary method 1000, as represented by way of example only and not by way of limitation, the flowchart of figure 10, which includes method action 1010, which includes the action of obtaining data based on data pertaining to use of a tinnitus management device used by a human suffering from tinnitus. The action of obtaining the data can be executed directly or indirectly in accordance with the teachings above. The action of obtaining the data can be executed by the implants or by the device in signal communication with the implant, such as, for example, the smart phone or the portable handheld electronics device. In an embodiment, the action of obtaining data is executed by receiving a data file that has the data. Method 1000 also includes method action 1020, which entails evaluating the obtained data. This can be done automatically or manually. Method 1000 further includes method action 1030, which includes the action of, based on the evaluation, adjusting and / or developing a new a new control regime of / for the device. By control regime, it is meant anything that is utilized as a basis to control use of the device, such as, for example, a map that is used by the device or settings of the device or a tinnitus treatment therapy that is utilized as a basis for utilization of a device (where this can be programmed into the device or could require the user to utilize the device accordingly based on his or her own volition), etc. Consistent with the teachings above, in an embodiment, the adjustment reflects (is based on) trends of use of the device by the human.

[0116] In an exemplary embodiment, the obtained data is indicative of the human increasing an output of the device in a noisy environment, and the map adjustment increases a magnitude of stimulation by the device in a noisy environment. In an embodiment, the use indicates a time period between an affirmative activation of the device by the recipient and a beginning of a prior period of inactivation immediately prior to the affirmative activation. This could be indicative of the lapsing of residual inhibition, where the recipient activates the device to obtainAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1inhibition of tinnitus. In an exemplary embodiment, the adjustment of the control regime and / or the new control regime reduces a time that elapses between automatic activation and an end of an immediate prior activation. This could be because, for example, the previous time period between automatic activation and an end of an immediate prior activation is too long. The residual inhibition could wear off before the automatic activation. In an exemplary embodiment, the opposite can be the case.

[0117] In an embodiment, the action of evaluating the data includes analyzing the data to identify a statistically significantly reliable temporal value for residual inhibition and the action of adjusting the control regime and / or developing the new control regime sets an automatic activation time of the device after an end of a prior activation. The statistically significant reliable temporal value would be something that is based on a statistical analysis of the usage data. Various statistical approaches can be implemented providing that such is utilitarian value providing that the art enables such. In an exemplary embodiment, a 90thpercentile or 95thpercentile confidence level could be the goal and / or is achieved.

[0118] In some embodiments, the method actions 1010, 1020, and / or 1030 are executed automatically by the tinnitus treatment device or a device in signal communication there with that is geographically colocated with the device or geographically remotely located.

[0119] As noted above, there are method actions that can be practiced in combination with various other method actions. Accordingly, FIG. 11 provides another exemplary flowchart for an exemplary method, method 1100, that includes method action 1110, which includes executing method 800. Method 1100 also includes method 1120, which includes automatically analyzing adjustments to the device made by the human and method action 1130 includes automatically adjusting a stimulation regime of the device based on the automatic analysis.

[0120] Embodiments also include “sanity check” concepts applied to the developed parameters and / or even the underlying data that is obtained from the screening and / or testing or other sources. In this regard, a confidence score for example, could be developed that can be utilized for clinicians or otherwise for healthcare professionals. It could be that the healthcare professional evaluates the patient and identifies his or her opinion as to whether or not the utilization of the data that is obtained can be utilized for the parameter development and implementations for use at switch on, etc. It could be that the clinician or otherwise the healthcare professional has low confidence with respect to whether or not the test data were screening data is useful. It could be that this is a go no go situation, and, in an alternative, itAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1could be that waiting is applied to the ultimately developed parameters. For example, it could be that the test data intuitively indicates that the resulting current level would be super threshold even though the test data would indicate otherwise. It also could be that for example the resulting frequency identified as having utilitarian value with respect to treating the tinnitus would be potentially two higher too low in his or her expert opinion.

[0121] Thus, in some embodiments, the coherence of the data can be evaluated. The data can be reviewed for evidence of inconsistencies or otherwise aberrant results that might indicate that the data is not totally suitable for implementing development parameters, at least some of the development parameters. In this regard, the confidence of the data could include waiting different parameters with respect to what should and / or should not be based on the test data, more accurately, at least partially based on the test data. Other objective measures can also be utilized, such as for example, changes in impedance measured perioperatively vs. at switch-on. Any objective measure that can have utilitarian value with respect to evaluating the data obtained from the testing for the purposes of assessing the suitability of the data for use in accordance with the teachings detailed herein can be utilized in at least some exemplary embodiments, providing that the art enables such, unless otherwise noted.

[0122] And note that in some instances, the data available for implementing the development of the parameters may not be based on a complete data set or otherwise may not include a data set that is as thorough as otherwise might be totally utilitarian. In this regard, it could be that the data available for developing the fitting parameters for example, are based on only partial screening data. It could be that the professional determines based on the data available that additional screening data is required or otherwise can be utilitarian, and thus recommends and otherwise acquires extended screening data. That said, it could be the full screening data is available to the healthcare professional when making the assessment about the utility of the data with respect to developing the parameters.

[0123] An embodiment includes a computer system having utility associated with the teachings herein. Embodiments include systems that implement at least some of the methods / functions disclosed herein. In an embodiment, there is a computer system that includes an input subsystem (e.g., including the input component(s) of the devices detailed above, a touch screen, a keyboard, a microphone (where the computer can use voice to text), a mouse and the accompanying computer screen, a USB port or an internet connection or a Bluetooth connection and the associated hardware and software configured to receive input regarding information related to a tinnitus suffering person. The input subsystem need not directlyAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1interface with a human (USB port vs. a keyboard and mouse and / or a touch screen), but in some embodiments the input subsystem does so directly interface with a human. The system also has an output subsystem (e.g., including the output component(s) of the devices detailed above, a touch screen, a keyboard, a microphone, a mouse and the accompanying computer screen, a USB port or an internet connection or a Bluetooth connection and the associated hardware and software). In embodiments, there are electronics interposed between the input subsystem and the output subsystem, wherein the system is configured to automatically develop and / or adjust, with the use of the electronics, a product corresponding to a prescription and / or a tinnitus treatment device map, based on the received input, and output the developed product. In an embodiment, this can correspond to the system presented in FIG. 1 that is in signal communication with the implant (which can be representative of a tinnitus treatment implant).

[0124] In an embodiment, the information used by the system / received by the input subsystem is related to a regular usage of the tinnitus treatment device for the person and the developed product has a map feature different from a current map feature of the device. In an exemplary embodiment, the product can be any of the products detailed herein, such as a prescription for the use of the device or control settings or parameters for the device. Any of the parameters detailed herein can be developed by the system based on the input and then such can be outputted by the output system providing that the art enable such, unless otherwise noted. In an embodiment, the information utilized by the system relates to an instantaneous usage of the device by the person. For example, if the recipient makes a sudden change to the device and such is correlated to a changing environment for example, or such as correlated to a temporal period that has elapsed since the device was switched off (so for example here, the sudden change is activation) where this can be extrapolated from log data that is input into the subsystem, which log data can be developed in accordance with the teachings herein, the product could be a control setting or a set of control parameters for the device that automatically activates and / or deactivates the tinnitus treatment device. In this regard, the activation can be considered a latent variable indicative of the residual inhibition wearing off, at least to a level where the tinnitus becomes noticeable or otherwise sufficiently irritable to the person so that he or she activates the device again.

[0125] And briefly, it is noted that we variously will refer to switched on and switched off. This corresponds as well to not just the recipient turning a switch or activating or depressing a switch, but also the more simple concept where the recipient removes the external coil fromAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1interfacing with his or her skin, which can effectively shut the implant down from stimulating in at least some scenarios. This is so-called “coil off’ time. And note that “switch-on” is a distinct concept that happened only once for a device after implantation.

[0126] In an embodiment, the electronics implements machine learning and / or is a product of machine learning to execute the automatic development. In an embodiment, the electronics has access to big data or statistical analysis of big data and is configured to use the big data or the analysis to develop the product. In this regard, in an exemplary embodiment, big data techniques that are applicable to predicting or evaluating data in the oncology arts can be utilized in an analogous manner to develop a product.

[0127] Irrespective of whether or not big data is utilized or a form of artificial intelligence is utilized, or even if limited data analysis is utilized implemented utilizing parameters that have been shown to have statistical correlation in the past sufficient to at least establish a first map or first product that can be utilized at switch-on, in an embodiment, the system includes a database of data based on data pertaining to trans-tympanic electrical stimulation of the tinnitus suffering person, which data in the database was received via the input subsystem. This can correspond to the screening and / or testing data. Note also that this database can include data based on data pertaining to post switch-on use of the device in accordance with the teachings herein. In an embodiment, the system is configured to automatically analyze the data based on data pertaining to the trans-tympanic electrical stimulation to automatically develop and / or adjust the product.

[0128] Consistent with the embodiment of figure 1, the system can be in signal communication with the tinnitus treatment device. Here, the system could develop the map for example, and then load the map by the signal communication link into the device. This could be a remote connection as well.

[0129] In an embodiment, the electronics of the system is or includes an artificial intelligence subsystem that is used to implement the development. This could instead be conventional logic circuitry. In an embodiment, the electronics implements machine learning and / or is a product of machine learning.

[0130] In an embodiment, the artificial intelligence system is a neural network that is at least a partially taught neural network (which means that it can be a fully taught neural network). It can be a deep neural network or can include such. In an embodiment, the artificial intelligence system is a neural network that is a partially taught neural network that is trainable withAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1feedback provided through the input subsystem or another subsystem of the system. In an embodiment, the electronics includes or is a product of machine learning. The electronics can be configured to implement machine learning.

[0131] In an embodiment, the electronics and / or software used by the electronics (herein, reference is made to electronics - however, this is done in the interest of textual economy, and any reference to electronics corresponds to a corollary disclosure of and / or firmware that is utilized with the electronic) are configured to analyze data received via the input subsystem, and this can be or include a product of machine learning to develop output. In an exemplary embodiment, this can correspond to analyzing the raw data that is inputted to the system and / or analyze modified data or filtered data or transformed data (hence analyzing data based on the obtained data - this can be the data or data that has been transformed provided into the input subsystem. In an exemplary embodiment, the electronics can be or can include a chip that is fabricated based on the results of machine learning. In an exemplary embodiment, the electronics and / or software and / or firmware is a neural network, such as a deep neural network (DNN). The electronics and / or software and / or firmware can be based on or be from a neural network. In an exemplary embodiment, the system includes code to implement one or more of the teachings detailed herein. In an exemplary embodiment, the electronics includes a logic circuit that is fabricated based on the results of machine learning. The electronics can be an ASIC (e.g., an artificial intelligence ASIC). The electronics can be implemented directly on a silicon structure or the like. Any device, system, and / or method that can enable the results of artificial intelligence to be utilized in accordance with the teachings detailed herein, can be utilized in at least some exemplary embodiments. The electronics and / or software can be a trained neural network or a trained deep neural network and / or can be a product based on or from the neural network whatever that may be.

[0132] It is noted that any method action disclosed herein corresponds to a disclosure of a non-transitory computer readable medium that has program there on a code for executing such method action providing that the art enables such. Still further, any method action disclosed herein where the art enables such corresponds to a disclosure of a code from a machine learning algorithm and / or a code of a machine learning algorithm for execution of such. In some embodiments, the code results from traditional programming. Still, in this regard, the code can correspond to a trained neural network. That is, as will be detailed below, a neural network can be “fed” significant amounts (e.g., statistically significant amounts) of data corresponding to the input of a system and the output of the system (linked to the input), and trained, such thatAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1the system can be used with only input, to develop output (after the system is trained). This neural network used to accomplish this later task is a “trained neural network.” That said, in an alternate embodiment, the trained neural network can be utilized to provide (or extract therefrom) an algorithm that can be utilized separately from the trainable neural network.

[0133] It is noted that any method detailed herein also corresponds to a disclosure of a device and / or system configured to execute one or more or all of the method actions associated therewith detailed herein. In an exemplary embodiment, this device and / or system is configured to execute one or more or all of the method actions in an automated fashion. That said, in an alternate embodiment, the device and / or system is configured to execute one or more or all of the method actions after being prompted by a human being. It is further noted that any disclosure of a device and / or system detailed herein corresponds to a method of making and / or using that the device and / or system, including a method of using that device according to the functionality.

[0134] It is also noted that any disclosure herein of any process of manufacturing other providing a device corresponds to a device and / or system that results there from. It is also noted that any disclosure herein of any device and / or system corresponds to a disclosure of a method of producing or otherwise providing or otherwise making such.

[0135] Any method action disclosed herein can be executed in an automated or manual manner, providing that the art enables such.

[0136] Any embodiment or any feature disclosed herein can be combined with any one or more or other embodiments and / or other features disclosed herein, unless explicitly indicated and / or unless the art does not enable such. Any embodiment or any feature disclosed herein can be explicitly excluded from use with any one or more other embodiments and / or other features disclosed herein, unless explicitly indicated that such is combined and / or unless the art does not enable such exclusion.

[0137] While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention.

Claims

1. Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1CLAIMSWhat is claimed is:

1. A method, comprising:obtaining data indicative of a response to electrical stimulation to tissue of a human; evaluating the obtained data; andbased on the evaluation, determining fitting settings for a tinnitus treatment device.

2. The method of claim 1, wherein:the obtained data is a response to extra-cochlea electrical stimulation implemented by a temporary device temporarily placed into electrical communication with the human.

3. The method of claims 1 or 2, further comprising:based at least on part of the obtained data, determining a suitability of the human for the tinnitus treatment device.

4. The method of claims 1, 2 or 3, wherein:the tinnitus treatment device has not been previously switched on to treat the human at the time of determining the fitting settings; andthe method further comprises applying the fitting settings to the tinnitus treatment device prior to switch on, wherein those settings are used by the device at switch-on of the device.

5. The method of claims 1, 2, 3 or 4, wherein the obtained data includes minimum maximum current levels, etc.

6. The method of claims 1, 2, 3, 4 or 5, wherein the tinnitus treatment device is an implantable prosthesis; andthe obtained data was obtained with a non-implantable device and / or minimally invasive device.

7. The method of claims 1, 2, 3, 4, 5 or 6, further comprising determining non-fitting data.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC18. The method of claim 1, further comprising determining which electrodes of the device to act as a primary electrode.

9. The method of claims 1, 2, 3, 4, 5, 6, 7 or 8, wherein:the obtained data includes objective measures related to phenomenon inside the human.

10. The method of claim 11, wherein:the control regime sets a pulse width of electrical stimulation provided by the device to the human.

11. A method, comprising:obtaining data based on data pertaining to use of a tinnitus management device used by a human suffering from tinnitus;evaluating the obtained data; andbased on the evaluation, adjusting and / or developing a new a control regime of / for the device.

12. The method of claim 11, wherein:the control regime is a map of the device.

13. The method of claims 11-12, wherein:the adjustment reflects trends of use of the device by the human.

14. The method of claims 11, 12 or 13, wherein:the obtaining data is indicative of the human increasing an output of the device in a noisy environment, and the map adjustment increases a magnitude of stimulation by the device in a noisy environment.

15. The method of claims 11, 12, 13 or 14, wherein:the use indicates a time period between an affirmative activation of the device by the recipient and a beginning of a prior period of inactivation immediately prior to the affirmative activation; andAtty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1the adjustment of the control regime and / or the new control regime reduces a time that elapses between automatic activation and an end of an immediate prior activation.

16. The method of claims 11, 12, 13, 14 or 15, wherein the affirmative activation of the device by the recipient after a period of inactivation is due to residual inhibition from the prior activation ceasing.

17. The method of claims 11, 12, 13, 14, 15 or 16, wherein:the action of evaluating the data includes analyzing the data to identify a statistically significantly reliable temporal value for residual inhibition and the action of adjusting the control regime and / or developing the new control regime sets an automatic activation time of the device after an end of a prior activation.

18. The method of claims 11, 12, 13, 14, 15 or 16, wherein:actions of obtaining data, evaluating the data and / or adjusting a control regime are developing a new control regime are executed automatically by the device or a remote device in signal communication with the device that is geographically colocated with the device19. The method of clams 11, 12, 13, 14, 15, 16, 17 or 18, wherein:the data includes device stimulation metrics, therapy metrics, momentary ecological assessment data and sudden event data.

20. The method of clams 11, 12, 13, 14, 15, 16, 17, 18 or 19, wherein:the control regime sets a pulse frequency of electrical stimulation provided by the device to the human.

21. A method, compri sing :obtaining data indicative of a response to electrical stimulation to tissue of a human; evaluating the data; andbased on the evaluation, developing a tinnitus therapy prescription for the human.

22. The method of claim 21, wherein:the response is an immediate response to the stimulation.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC123. The method of claims 21 or 22, wherein: the response is a latent response to the stimulation.

24. The method of claims 21, 22 or 23, wherein: the prescription includes duration of electrical stimulation for the human.

25. The method of claims 21, 22, 23 or 24, wherein: the prescription is for use of a tinnitus treatment device, and provides for residual inhibition implementation using the device.

26. The method of claims 21, 22, 23, 24 or 25, wherein: the electrical stimulation is minimally invasive stimulation, and the prescription is for use of an invasive stimulation device.

27. The method of claims 21, 22, 23, 24, 25 or 26, wherein:the obtained data is screening data.

28. A computer system, comprising:an input subsystem configured to receive input regarding information related to a tinnitus suffering person;an output subsystem; andelectronics interposed between the input subsystem and the output subsystem, wherein the system is configured to automatically develop and / or adjust, with the use of the electronics, a product corresponding to a prescription and / or a tinnitus treatment device map, based on the received input, and output the developed product.

29. The computer system of claim 28, wherein:the information is related to a regular usage of the tinnitus treatment device for the person and the developed product has a map feature different from a current map feature of the device.

30. The computer system of claims 28 or 29, wherein:Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1the information is related to an instantaneous usage of the device by the person, and the developed product has a map feature different from a current map.

31. The computer system of claims 28, 29 or 30, wherein:the electronics implements machine learning and / or is a product of machine learning to execute the automatic development.

32. The computer system of claims 28, 29, 30 or 31, wherein:the electronics has access to big data or statistical analysis of big data and is configured to use the big data or the analysis to develop the product.

33. The computer system of claims 28, 29, 30, 31 or 32, wherein:the system is in signal communication with a tinnitus treatment device.

34. The computer system of claims 28, 29, 30, 31, 32 or 33, wherein:the system includes a database of data based on data pertaining to trans-tympanic electrical stimulation of the tinnitus suffering person, which data in the database was received via the input subsystem; andthe system is configured to analyze the data based on data pertaining to the trans-tympanic electrical stimulation to automatically develop and / or adjust the product.

35. The computer system of claims 28, 29, 30, 31, 32 or 33, wherein:the system includes a database of data based on data pertaining to extracochlear stimulation of the tinnitus suffering person, which data in the database was received via the input subsystem; andthe system is configured to analyze the data based on data pertaining to the extracochlear stimulation to automatically develop and / or adjust the product.

36. A method, comprising:obtaining an implantable tinnitus management device; andoperating the tinnitus management device at switch-on to manage tinnitus of a human.

37. The method of claim 36, wherein:Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1adjustable settings of the device are set based on screening data particular to the human; andthe operation of the device at switch-on relies on the set adjustable settings.

38. The method of claims 36 or 37, wherein:the operation of the device relies on a map of the device that is totally developed based on screening data particular to the human obtained with a non-invasive and / or minimally invasive electrical stimulation device prior to a surgery implanting the device in the human.

39. The method of claims 36, 37 or 38, further comprising:at least after 6 hours after switch-on, operating the device to manage tinnitus of the human during normal use; andadjusting the device within limits set in the device, the limits based on screening data particular to the human.

40. The method of claims 36, 37, 38 or 39, further comprising;at least seven days after switch-on, operating the device to manage tinnitus, wherein the action of operating includes automatically activating the device after a period of deactivation, wherein the time of activation is based on residual inhibition of tinnitus due to activation of the device prior to the period of deactivation.

41. The method of claim 40, wherein:at least seven days after switch-on, operating the device to manage tinnitus, wherein the action of operating includes, at least 20 times: respectively automatically activating the device after a respective period of deactivation, wherein respective times of activations are based on residual inhibition of tinnitus due to respective activations of the device prior to the period of deactivation; andthe human experiences no noticeable tinnitus during a majority of the periods of deactivation.

42. The method of claims 36, 37, 38, 39, 40 or 41, further comprising:automatically analyzing adjustments to the device made by the human; and automatically adjusting a stimulation retime of the device based on the automatic analysis.Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC143. The method of claims 36, 37, 38, 39, 40, 41 or 42, further comprising:obtaining data based on data for impedance measurements inside the human associated with one or more electrodes of the tinnitus management device; andthe action of operating the tinnitus management device at switch-on takes into account the obtained data.

44. The method of claim 38, wherein:the screening data includes impedance measurement data indicative of impedance associated with electrode(s) of the device.

45. A computer system, comprising:one or more of an internet connection, a USB port or other serial data port or a microphone or GUI, all configured to receive input regarding information related to a tinnitus suffering person;one or more of the internet connection, USB port or other serial data port, GUI, speaker or computer screen or printer, configured to output data developed by the computer system; andone or more chips and / or one or more processors and / or one or more circuits interposed between the above-noted input / output components, wherein the chips and / or processors and / or circuits are configured to automatically develop and / or adjust, with the use of the chips and / or processors and / or circuits, a product corresponding to a prescription and / or a tinnitus treatment device map, based on input inputted into the system, and output the developed product by the above-noted output components.

46. A device, system and / or method and / or computer readable medium, wherein at least one of:the method includes any one or more of the method actions of any one or more of claims 1-27 and 36-44;the system includes any one or more of the features of any one or more of claims 28-34;the method using a cochlear implant to treat tinnitus;the computer readable medium includes code to execute any one or more of the method actions of claims 1-27 and 36-44;Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1the system is a sleep apnea treatment system;the device is implanted in a human;the method includes and / or the system enables adjustment of:current level settings;frequency of electrical signal applied to electrode(s);frequency of continuous stimulation separated by non-stimulation;the stimulation applied to the human is sub-threshold;increasing a level of stimulation to or above a threshold level; measuring and / or evaluating impedance and / or ECAP data and adjusting a map or control settings based thereon;the method includes using and / or the system includes machine learning algorithms and / or big data statistical analysis algorithms;the method includes programming the device based on the screening and / or test data and using such based solely on that data;the methods include utilizing objective measures;the methods include utilizing subjective measures;the methods include developing duration time periods from the data developed during the tests;the methods include identifying when stimulation should commence and / or should be being applied;the methods include developing guardrails to be used with the device that enable the recipient to make adjustments within certain parameters but not outside those parameters; the device is configured to prevent the recipient from increasing output to or above a threshold level;the device is configured to allow the recipient to increase output to or above a threshold level and / or provide a warning to the recipient that he / she is doing so;the method includes treating tinnitus of the recipient at switch-on based solely on pre implantation testing and / or pre-switch-on testing;the system is a trained machine learning system that is configured to create a personalized stimulation protocol for tinnitus and / or other conditions;the method includes balancing results of continuous stimulation against results of non-continuous stimulation to develop a frequency of stimulation regime;Atty. Docket No. 5441-221PCT Client Ref. No. CID03872WOPC1the method includes and / or the device / system is configured to automatically analyze input from the recipient and adjust a treatment regime based on that input and / or automatically log adjustments to the device and / or the input;automatically adjusting a current level in an incremental manner based on analysis of recipient usage of the device;the device and / or system includes one or more ofa totally implantable tinnitus device;a partially implantable tinnitus device;a converted cochlear implant configured to operate as a tinnitus treatment device;a hardball electrode implanted in a bind hole; oran electrode array outside a cochlea;no part of the device is located in a cochlea;the method includes generating and / or the device / system is configured to generate a personalized map / profile from screening data and / or test data prior to implantation and / or switch-on of the implant;the method includes and / or the device / system is configured to develop a fitting data set based on data based on one or more of minimum and / or maximum current levels to treat tinnitus, electrical impedance, duration of stimulation that suppresses tinnitus, presence and / or duration of residual tinnitus inhibition frequency and / or pulse width and / or pulse amplitude, evoked physiological responses and / or objective measurements; and / orthe method includes refining a personalized profile for the device and / or treatment regime based on logged and / or captured usage data after switch-on of the device that includes current level (maximum, minimum, average, variance and / or trends), impedance, average duration of continuous stimulation and / or times and / or variance from trends.

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