System and method to track conditioning status of implanted electrodes

Abstract

A method includes receiving a user input first signal configured to trigger a device to perform a measurement procedure utilizing at least one electrode implanted within a recipient's body. The method further includes, in response to said receiving the user input first signal, performing an evaluation of whether performing a conditioning procedure of the at least one electrode is potentially warranted prior to performing the measurement procedure. The method further includes generating and communicating a user output signal indicative of a result of the evaluation to the user. The method further includes receiving a user input second signal configured to trigger the device either to perform the conditioning procedure prior to performing the measurement procedure or to perform the measurement procedure without performing the conditioning procedure prior to performing the measurement procedure.

Description

SYSTEM AND METHOD TO TRACK CONDITIONING STATUS OF IMPLANTEDELECTRODESBACKGROUNDField

[0001] The present application relates generally to systems and methods for detecting attributes of electrodes implanted on or within a recipient’s body.Description of the Related Art

[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components / de vices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and / or lifestyle enhancement functions and / or recipient monitoring for a number of years.

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

[0004] In one aspect disclosed herein, a method comprises receiving a user input first signal configured to trigger a device to perform a measurement procedure utilizing at least one electrode implanted within a recipient’s body. The method further comprises, in response to said receiving the user input first signal, performing an evaluation of whether performing aconditioning procedure of the at least one electrode is potentially warranted prior to performing the measurement procedure. The method further comprises generating and communicating a user output signal indicative of a result of the evaluation to the user. The method further comprises receiving a user input second signal configured to trigger the device either to perform the conditioning procedure prior to performing the measurement procedure or to perform the measurement procedure without performing the conditioning procedure prior to performing the measurement procedure.

[0005] In another aspect disclosed herein, an apparatus comprises at least one electrode configured to be implanted within a recipient’s body and configured to, via at least one electrode -body interface, transmit electrical signals to the recipient’s body and / or to receive electrical signals from the recipient’s body. The apparatus further comprises control circuitry in electrical communication with the at least one electrode. The control circuitry is configured to, in response to a measurement trigger signal from a user, generate a determination of an attribute of the at least one electrode -body interface and / or a time period since a previous conditioning procedure was last performed. The control circuitry is further configured to, in response to the determination, generate an estimated efficacy of a conditioning procedure to improve the at least one electrode -body interface, transmit an output signal indicative of the estimated efficacy to the user, and await a conditioning trigger signal from the user. The control circuitry is further configured to, in response to a first value of the conditioning trigger signal, perform the conditioning procedure and then perform a measurement procedure. The control circuitry is further configured to, in response to a second value of the conditioning trigger signal, perform the measurement procedure without performing the conditioning procedure.

[0006] In another aspect disclosed herein, a method comprises, in response to a measurement trigger signal from a user of a medical implant system having at least one electrode in contact with a recipient’s body, generating a determination of an electrical impedance of the at least one interface between the at least one electrode and the recipient’s body and / or a time period since the at least one electrode was last conditioned. The method further comprises, in response to the determination, estimating an efficacy of further conditioning the at least one electrode to improve the at least one interface, transmitting an output signal indicative of the efficacy to the user, and awaiting a conditioning trigger signalfrom the user. The method further comprises responding to a first value of the conditioning trigger signal by further conditioning the at least one electrode and then performing a measurement procedure or responding to a second value of the conditioning trigger signal by performing the measurement procedure without further conditioning the at least one electrode.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Implementations are described herein in conjunction with the accompanying drawings, in which:

[0008] FIG. 1 is a perspective view of an example cochlear implant auditory prosthesis implanted in a recipient in accordance with certain implementations described herein;

[0009] FIG. 2 schematically illustrates a simplified side view of an example internal component;

[0010] FIG. 3 schematically illustrate an example apparatus in accordance with certain embodiments described herein;

[0011] FIG. 4 is a flow diagram of an example method in accordance with certain implementations described herein; and

[0012] FIGs. 5 A-5D are flow diagrams of other examples of a method for providing the user with an option regarding whether to perform a conditioning procedure or not in accordance with certain implementations described herein.DETAILED DESCRIPTION

[0013] Certain implementations described herein provide a system and method for monitoring the conditioning status of implanted electrodes to provide a user (e.g., surgeon; clinician) seeking to perform neural response telemetry (NRT), impedance, complex impedance, transimpedance (TIM), cortical (e.g., auditory steady-state response), or transtympanic electrocochleaography (ECochG) measurements as part of a fitting procedure the option to not perform additional conditioning procedures. An evaluation of the efficacy of a new conditioning procedure can be made (e.g., by monitoring the electrical impedances of the implanted electrodes and / or the elapsed time since a previous successful conditioning procedure), and depending on the result of the evaluation, the user can be given the option whether to perform a new conditioning procedure before the measurements are performed. By reducing the number of conditioning procedures, certain implementations can facilitateimproved comfort of the recipient during the fitting procedure, simplification of the fitting procedure, and / or shortening the time for conducting the fitting procedure.

[0014] The teachings detailed herein are applicable, in at least some implementations, to any type of implantable or non-implantable stimulation and / or measurement system or device (e.g., implantable or non-implantable auditory prosthesis device or system). Implementations can include any type of medical device that can utilize the teachings detailed herein and / or variations thereof. Furthermore, while certain implementations are described herein in the context of auditory prosthesis devices, certain other implementations are compatible in the context of other types of devices or systems comprising electrodes implanted on or within a recipient’s body.

[0015] Merely for ease of description, apparatus and methods disclosed herein are primarily described with reference to an illustrative medical device, namely an implantable transducer assembly including but not limited to: electro-acoustic electrical / acoustic systems, cochlear implant devices, implantable hearing aid devices, auditory brainstem implant devices, middle ear transducer (MET), electro-acoustic implant devices, other types of auditory prosthesis devices that terminate with at least one electrical contact to the recipient’s body, and / or combinations or variations thereof, or any other suitable hearing prosthesis system with one or more externally- worn components. Implementations can include any type of auditory prosthesis that can utilize the teachings detailed herein and / or variations thereof. In some implementations, the teachings detailed herein and / or variations thereof can be utilized in other types of prostheses beyond auditory prostheses.

[0016] For example, certain other implementations are compatible in the context of other types of sensory prosthesis systems that are configured to evoke other types of neural or sensory (e.g., sight, tactile, smell, taste) percepts are compatible with certain implementations described herein, including but are not limited to: vestibular devices (e.g., vestibular implants), tinnitus implant devices; visual devices (e.g., bionic eyes), visual prostheses (e.g., retinal implants), somatosensory implants, and chemosensory implants. Certain other implementations are compatible with other types of medical devices that can utilize the teachings detailed herein and / or variations thereof to provide a wide range of therapeutic benefits to recipients, patients, or other users (e.g., epilepsy monitoring systems; pain control systems; bladder control systems; implantable functional electrical muscle / limbstimulation systems; sleep apnea control systems; neurostimulators; deep brain stimulators; neuromodulators; cardiac pacemakers or defibrillation systems; other medical implants) or to perform monitoring or measuring functionalities (e.g., electroencephalogram monitoring of brain function; electrocardiogram monitoring of heart function).

[0017] FIG. 1 is a perspective view of an example cochlear implant auditory prosthesis 100 implanted in a recipient in accordance with certain implementations described herein. The example auditory prosthesis 100 is shown in FIG. 1 as comprising an implanted stimulator unit 120 and a microphone assembly 124 that is external to the recipient (e.g., a partially implantable cochlear implant). An example auditory prosthesis 100 (e.g., a mostly implantable cochlear implant) in accordance with certain implementations described herein can replace the external microphone assembly 124 shown in FIG. 1 with a subcutaneously implantable microphone assembly, as described more fully herein.

[0018] As shown in FIG. 1, the recipient has an outer ear 101, a middle ear 105, and an inner ear 107. In a fully functional ear, the outer ear 101 comprises an auricle 110 and an ear canal 102. An acoustic pressure or sound wave 103 is collected by the auricle 110 and is channeled into and through the ear canal 102. Disposed across the distal end of the ear canal 102 is a tympanic membrane 104 which vibrates in response to the sound wave 103. This vibration is coupled to oval window or fenestra ovalis 112 through three bones of middle ear 105, collectively referred to as the ossicles 106 and comprising the malleus 108, the incus 109, and the stapes 111. The bones 108, 109, and 111 of the middle ear 105 serve to filter and amplify the sound wave 103, causing the oval window 112 to articulate, or vibrate in response to vibration of the tympanic membrane 104. This vibration sets up waves of fluid motion of the perilymph within cochlea 140. Such fluid motion, in turn, activates tiny hair cells (not shown) inside the cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and auditory nerve 114 to the brain (also not shown) where they are perceived as sound.

[0019] As shown in FIG. 1, the example auditory prosthesis 100 comprises one or more components which are temporarily or permanently implanted in the recipient. The example auditory prosthesis 100 is shown in FIG. 1 with an external component 142 which is directly or indirectly attached to the recipient’s body, and an internal component 144 which is temporarily or permanently implanted in the recipient (e.g., positioned in a recess of thetemporal bone adjacent auricle 110 of the recipient). The external component 142 typically comprises one or more sound input elements (e.g., an external microphone assembly 124) for detecting sound, a sound processing unit 126 (e.g., disposed in a Behind-The-Ear unit), a power source (not shown), and an external transmitter unit 128. In the illustrative implementations of FIG. 1, the external transmitter unit 128 comprises an external coil 130 (e.g., a wire antenna coil comprising multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire) and, preferably, a magnet (not shown) secured directly or indirectly to the external coil 130. The external coil 130 of the external transmitter unit 128 is part of an inductive radio frequency (RF) communication link with the internal component 144. The sound processing unit 126 processes the output of the microphone assembly 124 that is positioned externally to the recipient’s body, in the depicted implementation, by the recipient’s auricle 110. The sound processing unit 126 processes the output of the microphone assembly 124 and generates encoded signals, sometimes referred to herein as encoded data signals, which are provided to the external transmitter unit 128 (e.g., via a cable). As will be appreciated, the sound processing unit 126 can utilize digital processing techniques to provide frequency shaping, amplification, compression, and other signal conditioning, including conditioning based on recipient-specific fitting parameters.

[0020] The power source of the external component 142 is configured to provide power to the auditory prosthesis 100, where the auditory prosthesis 100 includes a battery (e.g., located in the internal component 144, or disposed in a separate implanted location) that is recharged by the power provided from the external component 142 (e.g., via a transcutaneous energy transfer link). The transcutaneous energy transfer link is used to transfer power and / or data to the internal component 144 of the auditory prosthesis 100. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer the power and / or data from the external component 142 to the internal component 144. During operation of the auditory prosthesis 100, the power stored by the rechargeable battery is distributed to the various other implanted components as needed.

[0021] The internal component 144 comprises an internal receiver unit 132, a stimulator unit 120, and an electrode assembly 118. In some implementations, the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing. The internal receiver unit 132 comprises an internal coil 136 (e.g., a wire antennacoil comprising multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire), and preferably, a magnet (also not shown) fixed relative to the internal coil 136. The internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing, sometimes collectively referred to as a stimulator / receiver unit. The internal coil 136 receives power and / or data signals from the external coil 130 via a transcutaneous energy transfer link (e.g., an inductive RF link). The stimulator unit 120 generates stimulation signals (e.g., electrical stimulation signals; optical stimulation signals) based on the data signals, and the stimulation signals are delivered to the recipient via the electrode assembly 118.

[0022] The electrode assembly 118 has a proximal end connected to the stimulator unit 120, and a distal end implanted in the cochlea 140. The electrode assembly 118 extends from the stimulator unit 120 to the cochlea 140 through the mastoid bone 119. In some implementations, the electrode assembly 118 may be implanted at least in the basal region 116, and sometimes further. For example, the electrode assembly 118 may extend towards apical end of cochlea 140, referred to as cochlea apex 134. In certain circumstances, the electrode assembly 118 may be inserted into the cochlea 140 via a cochleostomy 122. In other circumstances, a cochleostomy may be formed through the round window 121 or an extension of the round window 121, the oval window 112, the promontory 123, or through an apical turn 147 of the cochlea 140.

[0023] The electrode assembly 118 comprises a longitudinally aligned and distally extending array 146 (e.g., electrode array; contact array) of stimulation elements 148 (e.g., electrical electrodes; electrical contacts; optical emitters; optical contacts). The stimulation elements 148 are longitudinally spaced from one another along a length of the body of the stimulation assembly 118. For example, the stimulation assembly 118 can comprise an array 146 comprising twenty-two (22) stimulation elements 148 that are configured to deliver stimulation to the cochlea 140. Although the stimulation elements 148 of the array 146 can be disposed on the stimulation assembly 118, in most practical applications, the array 146 is integrated into the stimulation assembly 118 (e.g., the stimulation elements 148 of the array 146 are disposed in the stimulation assembly 118). As noted, the stimulator unit 120 generates stimulation signals (e.g., electrical signals; optical signals) which are applied by the stimulation elements 148 to the cochlea 140, thereby stimulating the auditory nerve 114.

[0024] While FIG. 1 schematically illustrates an auditory prosthesis 100 utilizing an external component 142 comprising an external microphone assembly 124, an external sound processing unit 126, and an external power source, in certain other implementations, one or more of the microphone assembly 124, sound processing unit 126, and power source are implantable on or within the recipient (e.g., within the internal component 144). For example, the auditory prosthesis 100 can have each of the microphone assembly 124, sound processing unit 126, and power source encapsulated within a biocompatible assembly located subcutaneously), and can be referred to as a totally implantable cochlear implant (“TICI”). For another example, the auditory prosthesis 100 can have most components of the cochlear implant (e.g., excluding the microphone, which can be an in-the-ear-canal microphone) implantable on or within the recipient, and can be referred to as a mostly implantable cochlear implant (“MICI”).

[0025] FIG. 2 schematically illustrates a simplified side view of an example internal component 144 comprising an internal receiver unit 132 which receives encoded signals from an external component 142 of the auditory prosthesis 100 (e.g., cochlear implant system). The internal component 144 terminates in the stimulation assembly 118 that comprises an extra-cochlear region 210 and an intra-cochlear region 212. The intra-cochlear region 212 is configured to be implanted in the recipient’s cochlea 140 and has disposed thereon the longitudinally aligned and distally extending array 146 (e.g., electrode array; contact array) comprising a plurality of stimulation elements 148. In the example schematically illustrated in FIG. 2, the plurality of stimulation elements 148 comprises electrical contacts (e.g., electrodes) configured to apply electrical stimulation and / or optical contacts (e.g., emitters) configured to apply optical stimulation, either alone or in conjunction with electrical or other stimulation mechanisms.

[0026] In certain implementations, the stimulation assembly 118 comprises a lead region 220 coupling the internal receiver unit 132 to the array 146. In certain implementations, electrical and / or optical stimulation signals generated by the internal receiver unit 132 are delivered to the array 146 via the lead region 220. The lead region 220 comprises a first portion 222 configured to accommodate movement (e.g., is flexible) and a second portion 224 configured to connect the first portion 222 to the array 146. The first portion 222 of certain implementations is configured to prevent the stimulation assembly 118, the lead region 220and its connection to the internal receiver unit 132, and the array 146 from being damaged due to movement of the internal component 144 (or part of the internal component 144) which may occur, for example, during mastication. In certain implementations, the second portion 224 comprises a distinct connection to the first portion 222 and / or the array 146, while in certain other implementations, the second portion 224 is blended into the first portion 222 and / or the array 146. The relative lengths of the stimulation assembly 118, the lead region 220, the first portion 222, the second portion 224, the extra-cochlear region 210, the intra-cochlear region 212, and the array 146 are not shown to scale in FIG. 2.

[0027] In certain implementations, the lead region 220 comprises a body 226 and a plurality of signal conduits (e.g., electrical wire leads; optical waveguides)(not shown) within the body 226. For example, the body 226 can comprise silicone or other biocompatible material in which the signal conduits are embedded (e.g., the body 226 is molded around the signal conduits) or the body 226 can comprise a tube in which the signal conduits are contained (e.g., the tube backfilled with silicone). The signal conduits of certain implementations comprise wires (e.g., platinum; platinum-iridium alloys) having outer diameters that are wavy or helixed around an axis substantially parallel to the longitudinal direction 221 of the lead region 220 (e.g., within the first portion 222) and / or are substantially straight and substantially parallel to the longitudinal direction 221 (e.g., within the second portion 224). In certain implementations, each of the signal conduits is connected to a corresponding one of the plurality of stimulation elements 148 of the array 146.

[0028] In certain implementations, the extra-cochlear region 210 is located in the middle ear cavity of the recipient after implantation of the intra-cochlear region 212 into the cochlea 140. Thus, the extra-cochlear region 210 corresponds to a middle ear cavity subsection of the array 146. In certain implementations, an outer surface of the extra-cochlear region 210 comprises nubs 214 configured to aid in the manipulation of the stimulation assembly 118 during insertion of the intra-cochlear region 212 into the cochlea 140.

[0029] Various types of stimulation assemblies 118 are compatible with certain implementations described herein, including extracochlear, short, straight, and peri-modiolar. In certain implementations, the stimulation assembly 118 is a peri-modiolar stimulation assembly 118 having an intra-cochlear region 212 that is configured to adopt a curved configuration during and or after implantation into the recipient’s cochlea 140. For example,the intra-cochlear region 212 of the stimulation assembly 118 can be pre-curved to the same general curvature of a cochlea 140. Such peri-modiolar stimulation assemblies 118 are typically held straight by, for example, a stiffening stylet (not shown) or sheath which is removed during implantation, or alternatively by varying material combinations or the use of shape memory materials, so that the stimulation assembly 118 can adopt its curved configuration when in the cochlea 140. Other methods of implantation, as well as other stimulation assemblies 118 which adopt a curved configuration, can also be used.

[0030] In certain implementations, the stimulation assembly 118 is a non- perimodiolar (e.g., straight) stimulation assembly 118 or a mid-scala assembly which assumes a mid-scala position during or following implantation. Alternatively, the stimulation assembly of certain implementations comprises a short electrode implanted into at least the basal region. The stimulation assembly 118 can extend towards the apical end of the cochlea 140, referred to as the cochlea apex. In certain implementations, the stimulation assembly 118 is configured to be inserted into the cochlea 140 via a cochleostomy. In certain other implementations, a cochleostomy is formed through the oval window 112, the round window 121, the promontory 123, or through an apical turn of the cochlea 140.

[0031] FIG. 3 schematically illustrates an example apparatus 300 in accordance with certain embodiments described herein. The apparatus 300 comprises at least one electrode 310 (e.g., electrodes 148 of an electrode array 146 of an electrode assembly 118) configured to be implanted within a recipient’s body 305 (e.g., tissue; bodily fluid) and configured to, via at least one electrode -body interface 312, transmit electrical signals to the recipient’s body 305 and / or to receive electrical signals from the recipient’s body 305. The apparatus 300 further comprises control circuitry 320 in electrical communication with the at least one electrode 310. For example, the apparatus 300 can further comprise at least one signal conduit 330 (e.g., wires of the internal component 144 of FIG. 2; wireless communication link) configured to transmit electrical signals from the control circuitry 320 to the at least one electrode 310 and / or from the at least one electrode 310 to the control circuitry 320. The control circuitry 320 is configured to perform a method in accordance with certain implementations described herein. In certain implementations, the control circuitry 320 is part of an implanted portion of the apparatus 300 on or within the recipient’s body, an external portion of the apparatus 300 outside the recipient’s body, or a portion of a separate devicespaced from the recipient’s body (e.g., smart phone, smart tablet, smart watch; other computing device).

[0032] In certain implementations, the apparatus 300 is an implanted portion (e.g., cochlear implant) of an auditory prosthesis 100. For example, the auditory prosthesis 100 can comprise sound processing circuitry and at least one microphone (e.g., an acoustic transducer; at least one external microphone assembly 124; at least one subcutaneously implantable microphone assembly) configured to generate data signals (e.g., electrical data signals) indicative of sounds received by the at least one microphone. In certain implementations, the sound processing circuitry is a portion of the control circuitry 320, while in certain other implementations, the sound processing circuitry is separate from the control circuitry 320 but in operational communication with the control circuitry 320. The sound processing circuitry can be configured to process the data signals received from the at least one microphone, generate stimulation signals indicative of the sounds, and transmit the stimulation signals via the at least one electrical conduit 330, the at least one electrode 310, and the at least one electrode-body interface 312 to an auditory system of the recipient (e.g., to evoke a hearing percept by the recipient).

[0033] As used herein, the terms “electrode-body interface” and “interface between an electrode and the recipient’s body” refer to a region which includes an electrode surface and a portion of tissue and / or bodily fluid of the recipient’s body that has a surface in contact with the electrode surface. For example, an electrode-body interface can include an interface comprising the electrode surface and protein molecules adsorbed on the electrode surface and / or fibrotic tissue at the electrode surface or in sufficient proximity to the electrode surface to affect the impedance. For another example, an electrode-body interface can include an interface comprising the electrode surface and a volume of bodily fluid (e.g., a surface of an electrode within the cochlea and in contact with perilymph).

[0034] The sound processing circuitry can comprise at least one processor (e.g., digital signal processor; microelectronic circuitry; at least one integrated circuit; a sound processor) and a stimulator unit 120 configured to respond to the processed signals from the at least one processor and to generate and transmit the stimulation signals to a portion of the recipient’s auditory system (e.g., the cochlea 140) via the at least one signal conduit 330, the at least one electrode 310 (e.g., electrodes 148 of the electrode array 146), and the at least oneelectrode-body interface 312, thereby stimulating the recipient’s body 305 (e.g., auditory nerve 114). To generate the stimulation signals, the sound processing circuitry can receive and process the data signals (e.g., applying one or more of digitization, shifting, shaping, amplification, compression, filtering, and / or other signal conditioning to the data signals). Portions of the sound processing circuitry can be located within a device external to the recipient’s body and / or implanted within or on the recipient’s body.

[0035] The sound processing circuitry can be configured to access (e.g., retrieve; modify; store) one or more signal processing data sets (e.g., fitting parameters or operational parameter maps) from data storage circuitry (e.g., non-volatile memory; flash memory) that stores the one or more signal processing data sets. The data storage circuitry can be remote from the apparatus 300 (e.g., on a dedicated server available via wireless communication with the internet; “in the cloud”). The sound processing circuitry can use the one or more signal processing data sets to process the data signals received from the at least one microphone. The one or more signal processing data sets can comprise default values (e.g., stored in the data storage circuitry during manufacturing of the apparatus 300) or recipient-specific values that are the result of programming of the sound processing circuitry during a fitting procedure. Such fitting procedures are generally performed to generate signal processing data sets that, when used by the sound processing circuitry, result in proper, safe, and comfortable stimulation signals in response to the received data signals and which are fitted or customized to conform to the specific recipient demands.

[0036] In certain implementations, the control circuitry 320 comprises one or more microprocessors (e.g., application-specific integrated circuits; generalized integrated circuits programmed by software with computer executable instructions; microelectronic circuitry) and at least one storage device (e.g., at least one tangible or non-transitory computer readable storage medium; read only memory; random access memory; flash memory) configured to store information (e.g., data; commands) accessed by the one or more microprocessors during operation. For example, the at least one storage device can be encoded with software (e.g., a computer program downloaded as an application) comprising computer executable instructions for instructing the one or more microprocessors (e.g., executable data access logic, evaluation logic, and / or information outputting logic). In certain implementations, the one or more microprocessors execute the instructions of the software to provide functionality asdescribed herein. The control circuitry 320 can comprise or can be in operative communication with other circuitry of the apparatus 300 (e.g., sound processing circuitry; communication circuitry) and can be configured to, via the communication circuitry, wirelessly receive power, data, and / or control signals from another device (e.g., external to the recipient’s body and / or implanted within or on the recipient’s body) and / or to transmit data and / or control signals to the other device.

[0037] In certain implementations, the control circuitry 320 comprises fitting circuitry 322 configured to perform fitting procedures during or soon after the surgical implantation process (e.g., intraoperatively) to initially establish the one or more signal processing data sets. The fitting circuitry 322 can be further configured to perform fitting procedures (e.g., to update or revise earlier-established signal processing data sets) after the recipient has had time to heal from the surgical process or after the recipient has utilized the apparatus 300 for a substantial amount of time. For example, fitting procedures can be performed during visits by the recipient to a clinician. The fitting procedures can be initiated and performed by the clinician or can be the result of autonomous programming (e.g., performed without clinical intervention beyond merely initiating the fitting procedure).

[0038] Such fitting procedures can utilize neural response telemetry (“NRT”) by making measurements of the response of the recipient’s auditory nerve 114 to electrical stimulation applied using the at least one electrode 310. NRT can include providing stimulation signals to each stimulation channel (e.g., each electrode 148 of the electrode array 146) and measuring the neural response (e.g., electrically-evoked compound action potential) using another electrode 148 of the electrode array 146 (e.g., a neighboring electrode to the stimulating electrode). These measurements can include collection and determination of recipient-specific parameters such as threshold levels and maximum comfort levels for each stimulation channel. During a visit to the clinician, the clinician-performed fitting procedure can also include the clinician initiating a number of beeps or tones and asking the recipient to judge loudness, over a number of stimulation or frequency channels.

[0039] In certain implementations, the control circuitry 320 further comprises conditioning circuitry 324 configured to perform a conditioning procedure during which the conditioning circuitry 324 provides short bursts of electrical current to the at least one electrode 310 (e.g., at least one electrode 148 of the electrode array 146; each electrode 148 of theelectrode array 146). The electrical current bursts are configured to pass through the at least one electrode-body interface 312 and to reduce the electrical impedance of the at least one electrode-body interface 312. For example, the electrical current bursts can reduce an amount of fouling (e.g., passivation by a fouling agent; oxidation) of the electrode surface, an amount of protein adsorption on the electrode surface, and / or an amount of fibrotic tissue at or around the electrode surface (e.g., at the at least one electrode-body interface 312). Without being reduced by such electrical current bursts, the fouling, protein absorption, and / or fibrotic tissue can inhibit the direct contact of an analyte of interest with the electrode surface for electron transfer. Thus, the electrical current bursts can improve the condition of the at least one electrode-body interface 312 for measurements (e.g., NRT measurements) and / or for providing stimulation signals to the recipient’s body 305. While such conditioning procedures can improve the at least one electrode -body interface 312 for subsequent measurements and / or stimulations, the recipient can experience discomfort due to the electrical current bursts. In addition, the conditioning procedure can complicate the surgical implantation process, and can take significant time to perform (e.g., in a range of 5 to 10 minutes over the course of a surgical implantation procedure), thereby extending the time for performing the surgical implantation.

[0040] In certain implementations, the control circuitry 320 comprises at least one input interface 326 configured to receive user input signals (e.g., from a clinician, a surgeon, or the recipient) indicative of user input (e.g., commands such as trigger signals that initiate a corresponding procedure to be performed by the control circuitry 320; operational parameters such as thresholds that are used by the control circuitry 320). For example, as shown in FIG. 3, the user input signals can comprise a measurement trigger signal 342 and / or a conditioning trigger signal 344. Examples of the at least one input interface 326 include but are not limited to: rotatable knobs (e.g., connected to potentiometers); buttons; switches; touchscreen; microphone and voice-responsive circuitry. In certain implementations, the at least one input interface 326 comprises at least one antenna configured to receive wireless input signals (e.g., radio-frequency signals; Bluetooth signals; Bluetooth Low-Energy (BLE) signals; WiFi signals) from an external device separate from the apparatus 300 (e.g., smart phone, smart tablet, smart watch; other computing device). In certain such implementations, the external device is in operable communication with a network (e.g., the internet) and the external device and the at least one input interface 326 are configured to transmit data signals (e.g., operationalparameters; results from previously-performed measurement procedures) and / or command signals (e.g., measurement trigger signals; conditioning trigger signals) from a device on the network to the control circuitry 320.

[0041] In certain implementations, the control circuitry 320 comprises at least one output interface 328 configured to provide output signals (e.g., to a clinician, a surgeon, or the recipient) indicative of an operational state (e.g., status) of the apparatus 300, including prompts to the user to provide user input signals, and / or including advice regarding whether to perform a new conditioning procedure. Examples of the at least one output interface 328 include but are not limited to: an LED or LCD display configured to generate visual signals (e.g., colored lights, images, or alphanumeric characters; speakers configured to generate audio signals (e.g., tones; sounds); a haptic motor configured to generate vibrations or other tactile signals. In certain implementations, the at least one output interface 328 comprises at least one antenna configured to transmit wireless output signals (e.g., radio-frequency signals; Bluetooth signals; BLE signals; WiFi signals) to an external device separate from the apparatus 300 (e.g., smart phone, smart tablet, smart watch; other computing device). In certain such implementations, the external device is in operable communication with a network (e.g., the internet) and the external device and the at least one output interface 328 are configured to transmit data signals (e.g., operational parameters; results from recently-performed measurement procedures) from the control circuitry 320 to a storage device on the network. In certain implementations, the at least one antenna can serve as both the at least one input interface 326 and the at least one output interface 328.

[0042] FIG. 4 is a flow diagram of an example method 400 in accordance with certain implementations described herein. While the method 400 is described by referring to some of the structures of FIG. 3, other apparatus and systems with other configurations of components can also be used to perform the method 400 in accordance with certain implementations described herein. The method 400 can be performed by circuitry of a device that performs the measurement procedure and / or the conditioning procedure (e.g., control circuitry 320 of the apparatus 300) or by circuitry separate from and in operable communication with the device that performs the measurement procedure and / or the conditioning procedure (e.g., circuitry that is a component of a computing device in operablecommunication with the internet). The device performing the method 400 can be external to the recipient’s body or can be implanted on or within the recipient’s body.

[0043] In an operational block 410, the method 400 comprises receiving a user input first signal (e.g., measurement trigger signal 342) configured to trigger (e.g., command) a device (e.g., apparatus 300) to perform a measurement procedure utilizing at least one electrode 310 implanted within a recipient’s body 305. For example, the measurement procedure can comprise at least one NRT measurement, impedance measurement (e.g., to show there is not an open circuit between the electrode 310 and the recipient’s body), complex impedance measurement, transimpedance measurement (e.g., generating at least one transimpedance matrix), cortical (e.g., auditory steady-state response) measurement, or transtympanic electrocochleography (ECochG) measurement. The measurement procedure is not performed immediately after said receiving the user input first signal.

[0044] In an operational block 420, the method 400 further comprises, in response to said receiving the user input first signal, performing an evaluation of whether performing a conditioning procedure of the at least one electrode 310 is potentially warranted prior to performing the measurement procedure. The evaluation is performed before the measurement procedure is performed.

[0045] In an operational block 430, the method 400 further comprises generating and communicating an output first signal 346a indicative of a result of the evaluation to the user. The user output first signal is generated and communicated to the user before the measurement procedure is performed.

[0046] In an operational block 440, the method 400 further comprises receiving a user input second signal (e.g., conditioning trigger signal 344) configured to trigger (e.g., command) the device either to perform the conditioning procedure prior to performing the measurement procedure or to perform the measurement procedure without performing the conditioning procedure prior to performing the measurement procedure. In response to the user input first and second signals, the measurement procedure is performed, either with or without first performing the conditioning procedure.

[0047] For example, the evaluation can comprise, for each electrode 310 of the at least one electrode 310, accessing (e.g., from data storage circuitry) a threshold impedance value for the electrode 310. The threshold impedance value can be indicative of whether aconditioning procedure (e.g., performed by the conditioning circuitry 324) can potentially improve the electrode -body interface 312 (e.g., reduce the electrical impedance between the electrode 310 and the recipient’s body 305). For example, the threshold impedance value can correspond to a minimum electrical impedance value expected to be measured from the electrode-body interface 312 with a measurement-affecting amount of fouling, protein adsorption, and / or fibrotic tissue. The evaluation can further comprise generating a measured impedance value for the electrode 310 (e.g., from an NRT or transimpedance measurement), and comparing the threshold impedance value and the measured impedance value.

[0048] For another example, the evaluation can comprise, for each electrode 310 of the at least one electrode 310, accessing (e.g., from data storage circuitry) a threshold elapsed time value. The threshold elapsed time value can be indicative of whether a conditioning procedure (e.g., performed by the conditioning circuitry 324) can potentially improve the electrode -body interface 312 (e.g., reduce the electrical impedance between the electrode 310 and the recipient’s body 305). For example, the threshold elapsed time value can correspond to a minimum elapsed time value (e.g., from when a previous conditioning procedure was last performed to the present time) that the electrode -body interface 312 can be expected to have degraded (e.g., a measurement-affecting amount of fouling, protein adsorption, and / or fibrotic tissue accumulated at the electrode-body interface 312). Examples of the minimum elapsed time value include, but are not limited to: one minute; 5 minutes; 10 minutes; 15 minutes; 60 minutes; two hours; one day. The evaluation can further comprise generating a measured elapsed time value for the electrode 310 from a previous successfully performed conditioning procedure (e.g., the elapsed time measured since the last conditioning of the electrode 310), and comparing the threshold elapsed time value and the measured elapsed time value. The measured elapsed time value can be generated by accessing a stored time stamp (e.g., from data storage circuitry) of the previous successfully performed conditioning procedure, accessing a current time, and calculating a time difference between the current time and the stored time stamp.

[0049] In both examples, if the measured value is less than the threshold value, then the result of the evaluation can be that the conditioning procedure is not warranted (e.g., the amount of fouling, protein adsorption, and / or fibrotic tissue is too small to substantially affect the measurement; the conditioning procedure has a small estimated efficacy to improve theelectrode-body interface 312). In this circumstance, performing a conditioning procedure would likely be a waste of time since the electrode-body interface 312 is not adversely affected by fouling, protein adsorption, and / or fibrotic tissue, so the measurement procedure can proceed without the conditioning procedure. After receiving the output first signal 346a indicative of the small estimated efficacy, the user can provide the control circuitry 320 with a user input second signal 344 that triggers the control circuitry 320 to proceed with the measurement procedure (e.g., using the measurement circuitry 322) without first performing a conditioning procedure. Alternatively, the control circuitry 320 can be configured to respond to the evaluation result indicative of the small estimated efficacy by automatically (e.g., without receiving the user input second signal 344) proceeding with the measurement procedure without first performing a conditioning procedure.

[0050] In both examples, if the measured value is greater than or equal to the threshold value, then the result of the evaluation can be that the conditioning procedure is warranted (e.g., the amount of fouling, protein adsorption, and / or fibrotic tissue is large enough to substantially affect the measurement; the conditioning procedure has a large estimated efficacy to improve the electrode -body interface 312). In this circumstance, performing a conditioning procedure would likely be beneficial, but the user can still be given the choice to proceed with the measurement procedure without the conditioning procedure or to first perform the conditioning procedure before performing the measurement procedure. After receiving the output first signal 346a indicative of the large estimated efficacy (e.g., a prompt for a command from the user to perform an additional conditioning procedure or not; advice regarding whether to perform the additional conditioning procedure), the user can decide whether to provide the control circuitry 320 with (i) a user input second signal 344 that triggers (e.g., commands) the control circuitry 320 to proceed with the measurement procedure (e.g., using the measurement circuitry 322) without first performing the conditioning procedure or (ii) a user input second signal 344 that triggers (e.g., commands) the control circuitry 320 to first perform a conditioning procedure (e.g., using the conditioning circuitry 324) and then proceeding with the measurement procedure.

[0051] In certain implementations, after performing the conditioning procedure, the control circuitry 320 can perform a second evaluation and can then generate and communicate an output second signal 346b to the user, the output second signal 346b indicativeof a second result of the second evaluation. If the second result of the second evaluation indicates that an additional conditioning procedure is warranted (e.g., the amount of fouling, protein adsorption, and / or fibrotic tissue remaining after the previous conditioning procedure is large enough to substantially affect the measurement; the additional conditioning procedure has a large estimated efficacy to improve the electrode-body interface 312), then the output second signal 346b can comprise a prompt for a command from the user to perform an additional conditioning procedure or not and / or advice regarding whether to perform the additional conditioning procedure. The user can provide a user input third signal configured to trigger (e.g., command) the control circuitry 320 either to perform another conditioning procedure prior to performing the measurement procedure or to perform the measurement procedure without performing another conditioning procedure prior to performing the measurement procedure. If the second result of the second evaluation indicates that an additional conditioning procedure is not warranted (e.g., the amount of fouling, protein adsorption, and / or fibrotic tissue remaining after the previous conditioning procedure is too small to substantially affect the measurement; the additional conditioning procedure has a small estimated efficacy to improve the electrode-body interface 312), then the measurement procedure can proceed without an additional conditioning procedure (e.g., in response to a user input signal or automatically).

[0052] For example, if the first evaluation comprises comparing a threshold impedance value and a measured impedance value, the second evaluation can comprise generating a second measured impedance value and comparing the threshold impedance value and the second measured impedance value. For another example, if the first evaluation comprises comparing a threshold elapsed time value and a measured elapsed time value, the second evaluation can comprise generating a measured impedance value and comparing the measured impedance value and a previously stored measured impedance value (e.g., accessed from data storage circuitry) from a previous measurement procedure that was performed after a successfully performed conditioning procedure.

[0053] FIGs. 5A-5D are flow diagrams of other examples of a method 500 for providing the user with an option regarding whether to perform a conditioning procedure or not in accordance with certain implementations described herein. While the examples of the method 500 are described by referring to some of the structures of FIG. 3, other apparatus andsystems with other configurations of components can also be used to perform the method 500 in accordance with certain implementations described herein. The method 500 can be performed by circuitry of a device that performs the measurement procedure and / or the conditioning procedure (e.g., control circuitry 320 of the apparatus 300) or by circuitry separate from and in operable communication with the device that performs the measurement procedure and / or the conditioning procedure (e.g., circuitry that is a component of a computing device in operable communication with the internet). The device performing the method 500 can be external to the recipient’s body or can be implanted on or within the recipient’s body.

[0054] As shown in FIG. 5A, in an operational block 510, the method 500 comprises, in response to a measurement trigger signal (e.g., user input first signal 342) from a user, generating a determination of an attribute of the at least one electrode-body interface 312 and / or a time period since a conditioning procedure was last performed. In an operational block 520, the method 500 further comprises, in response to the determination, generating an estimated efficacy of a new conditioning procedure to improve the at least one electrode-body interface 312 in an operational block 522, transmitting an output signal (e.g., output first signal 346a) indicative of the estimated efficacy to the user in an operational block 524, and awaiting a conditioning trigger signal (e.g., user input second signal 344) from the user in an operational block 526. In an operational block 530, the method 500 comprises, in response to a first value of the conditioning trigger signal, performing the new conditioning procedure and then performing a measurement procedure. In an operational block 540, the method 500 comprises, in response to a second value of the conditioning trigger signal, performing the measurement procedure without performing (e.g., skipping) the new conditioning procedure.

[0055] FIG. 5B is a flow diagram of an example method 500 in which the attribute comprises an electrical impedance of the at least one electrode-body interface 312 in accordance with certain implementations described herein. As shown in FIG. 5B, the method 500 can comprise, in an operational block 502, performing an initial conditioning procedure on the at least one electrode 310 of the at least one electrode 310 (e.g., in response to a conditioning trigger signal 503; in response to a “coil on” or “start up” command signal). Generating the determination of the electrical impedance in the operational block 510 can be performed (e.g., in response to a measurement trigger signal 342) by accessing at least one threshold electrical impedance value (Zthreshoid) for the at least one electrode -body interface 312in an operational block 512 (e.g., from data storage circuitry) and generating at least one measured electrical impedance value Zmeasured) in an operational block 514 (e.g., by performing NRT of the at least one electrode -body interface 312). Generating the estimated efficacy of a new conditioning procedure can be performed by comparing Zmeasured and Zthreshoid in the operational block 522. Zthreshoid can correspond to a minimum value expected to be measured from the at least one electrode 310 with a measurement-affecting amount of fouling, protein adsorption, and / or fibrotic tissue. If Zmeasured is greater than or equal to Zthreshoid, the new conditioning procedure can be deemed to have a first estimated efficacy value (e.g., indicative of the new conditioning procedure having the potential to improve the electrodebody interface 312) and if Zmeasured is less than Zthreshoid, the new conditioning procedure can be deemed to have a second estimated efficacy value less than the first estimated efficacy value (e.g., indicative of the new conditioning procedure not having the potential to improve the electrode-body interface 312).

[0056] As shown in FIG. 5B, if Zmeasured is less than Zthreshoid, then the measurement procedure is performed without performing (e.g., skipping) the new conditioning procedure (e.g., without having transmitted an output signal 346 to the user). If Zmeasured is greater than or equal to Zthreshoid, then the output signal 346 is transmitted to the user and if the user input second signal (e.g., conditioning trigger signal 344) indicates that the new conditioning procedure is to be performed, then the new conditioning procedure is performed prior to performing the measurement procedure. In certain implementations, as shown in FIG. 5B, the output signal 346 (e.g., a prompt for a command from the user to perform an additional conditioning procedure or not; advice regarding whether to perform the additional conditioning procedure) indicative of the estimated efficacy is transmitted to the user only in response to the first estimated efficacy value (e.g., Zmeasured is greater than or equal to Zthreshoid). In certain other implementations, an output signal 346 (e.g., a confirmation that the new conditioning procedure is not warranted) can be transmitted to the user in response to the second estimated efficacy value (e.g., Zmeasured is less than Zthreshoid .

[0057] FIG. 5C is a flow diagram of an example method 500 in which an elapsed time period since a conditioning procedure was last performed is used to generate an estimated efficacy of a new conditioning procedure in accordance with certain implementations described herein. FIG. 5D is a flow diagram of an example method 500 in which both theelapsed time period and the electrical impedance of the at least one electrode-body interface 312 are used in accordance with certain implementations described herein.

[0058] As shown in FIGs. 5C and 5D, in an operational block 502, the method 500 can comprise, in response to a conditioning trigger signal 503, performing an initial conditioning procedure on the at least one electrode 310 of the at least one electrode 310. In an operational block 504, the method 500 can further comprise, after performing the initial conditioning procedure, performing an initial measurement procedure to generate and store at least one initial impedance value (Zn) and an initial time stamp (7y) indicative of the time that the at least one initial impedance value Zn is measured. In certain implementations, performing the initial measurement procedure can comprise performing multiple measurements of the at least one initial impedance value and comparing at least two of the measurements to one another to ensure a sufficient stability of the at least one initial impedance value ZTI. For example, the operational block 504 can comprise performing a first initial measurement procedure to generate and store a first impedance value (ZTO) and a first time stamp (Ta) indicative of the time that the first impedance value Zrawas measured, performing another initial conditioning procedure, and performing a second initial measurement procedure to generate and store a second impedance value (Z ) and a second time stamp (Tb) indicative of the time that the second impedance value Zn was measured. The operational block 504 can further comprise comparing an absolute difference (Aa,b = \Z - Zn\) between the two impedance values Zia, Zn to a predetermined stability threshold value (e.g., accessed from data storage circuitry of the control circuitry 320), the stability threshold value (e.g., 0.2 kOhm) indicative of stability between the two impedance values Zia, Zn.

[0059] If the absolute difference Aa,b is less than the stability threshold value (e.g., indicative of a sufficient stability level), then either of the two impedance values Zia, Zn and the two time stamps Ta, Tb can be used as the initial impedance value ZTI and corresponding initial time stamp Ti, respectively. In addition, a user output signal can be provided to the user indicating that an initial conditioning procedure has been successfully completed.

[0060] If the absolute difference Aa,b is greater than or equal to the stability threshold value (e.g., indicative of an insufficient stability level), then still another initial conditioning procedure can be performed, a third initial measurement procedure can be performed to generate and store a third impedance value Z and a third time stamp (Tc)indicative of the time that the third impedance value Zrcwas measured, and another absolute difference (Ab.c = I n, - Zrd) between the two impedance values Zn, ZTCcan be compared to the predetermined stability threshold value. This process can be repeated until an absolute difference between subsequently measured impedance values is less than the stability threshold value, and one of the two latest impedance values and the two corresponding time stamps can be used as the initial impedance value ZTI and corresponding initial time stamp Ti, respectively. In addition, a user output signal can be provided to the user indicating that an initial conditioning procedure has been successfully completed.

[0061] As shown in FIGs. 5C and 5D, in response to a measurement trigger signal 342, an elapsed time period since a conditioning procedure was last performed can be determined, the elapsed time period corresponding to an estimated efficacy of a new conditioning procedure to improve the at least one electrode -body interface 312. For example, in response to the measurement trigger signal 342, a current time stamp T2 and the previous time stamp Ti can be accessed in an operational block 552. The previous time stamp Ti can be used as the time that the last conditioning procedure was performed, and the elapsed time from Ti to T2 can be compared to a predetermined time threshold difference value (e.g., accessed from data storage circuitry). The time threshold difference value can correspond to a minimum estimated amount of time (e.g., one minute; 5 minutes; 10 minutes; 15 minutes; 60 minutes; two hours; one day) for a newly conditioned electrode -body interface 312 to have degraded (e.g., accumulated sufficient fouling, protein adsorption, and / or fibrotic tissue) such that a new conditioning procedure would have a large expected efficacy to improve the electrode-body interface 312. For an elapsed time period less than the time threshold difference would be too short for the electrode -body interface 312 to have degraded. In this way, the elapsed time period can be indicative of the estimated efficacy of a new conditioning procedure.

[0062] As shown in FIGs. 5C and 5D, if the elapsed time period is less than or equal to the time threshold difference value (e.g., indicative of a short amount of time since the last conditioning procedure), then, in the operational block 540, the measurement procedure can be performed without performing (e.g., skipping) a new conditioning procedure.

[0063] As shown in FIG. 5C, if the elapsed time period is greater than the time threshold difference value (e.g., indicative of a larger estimated efficacy of a new conditioningprocedure), then, in the operational blocks 524,526, an output signal (e.g., output first signal 346a) indicative of the estimated efficacy can be transmitted to the user and a conditioning trigger signal (e.g., user input second signal 344) from the user can be awaited. Depending on the value of the conditioning trigger signal that is received from the user, the new conditioning procedure can be performed and then a measurement procedure can be performed (e.g., operational block 530), or the measurement procedure can be performed without performing (e.g., skipping) the new conditioning procedure.

[0064] As shown in FIG. 5D, if the elapsed time period is greater than the time threshold difference value, then, in an operational block 562, the stored at least one initial impedance value Z77 can be accessed (e.g., from digital storage circuitry) and, in an operational block 564, at least one measured impedance value Z7 can be generated. In an operational block 566, a difference (2 / 7,2 = Z72 - Z77) between the two impedance values Zn, ZT2 can be compared to a predetermined impedance threshold difference value (Dzthreshoid) (e.g., accessed from data storage circuitry), the impedance threshold difference value Dzthreshoid (e.g., 1 kOhm) corresponding to a substantial degradation of the electrode -body interface 312 at time T2 as compared to the initial condition of the electrode-body interface 312 at initial time Ti.

[0065] As shown in FIG. 5D, if 2 / 7,2 is less than Dzthreshoid (e.g., corresponding to the second estimated efficacy value indicative of the new conditioning procedure not having the potential to improve the electrode -body interface 312), then the measurement procedure is performed without performing (e.g., skipping) the new conditioning procedure (e.g., without having transmitted an output signal 346 to the user). If A 7,2 is greater than or equal to Dzthreshoid (e.g., corresponding to the first estimated efficacy value indicative of the new conditioning procedure having the potential to improve the electrode-body interface 312), then the output signal 346 is transmitted to the user and if the user input second signal (e.g., conditioning trigger signal 344) indicates that the new conditioning procedure is to be performed, then the new conditioning procedure is performed prior to performing the measurement procedure. In certain implementations, as shown in FIG. 5D, the output signal 346 (e.g., a prompt for a command from the user to perform an additional conditioning procedure or not; advice regarding whether to perform the additional conditioning procedure) indicative of the estimated efficacy is transmitted to the user only in response to the first efficacy value (e.g., 2 / 7,2 is greater than or equal to Dzthreshoid). In certain other implementations, an output signal346 (e.g., a confirmation that the new conditioning procedure is not warranted) can be transmitted to the user in response to the second estimated efficacy value (e.g., A 1,2 is less than / threshold) -

[0066] Although commonly used terms are used to describe the systems and methods of certain implementations for ease of understanding, these terms are used herein to have their broadest reasonable interpretations. Although various aspects of the disclosure are described with regard to illustrative examples and implementations, the disclosed examples and implementations should not be construed as limiting. Conditional language, such as, among others, "can," "could," "might," or "may," unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain implementations include, while other implementations do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more implementations or that one or more implementations necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular implementation. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a nonexclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0067] It is to be appreciated that the implementations disclosed herein are not mutually exclusive and may be combined with one another in various arrangements. In addition, although the disclosed methods and apparatuses have largely been described in the context of various devices, various implementations described herein can be incorporated in a variety of other suitable devices, methods, and contexts. More generally, as can be appreciated, certain implementations described herein can be used in a variety of implantable medical device contexts that can benefit from certain attributes described herein.

[0068] Language of degree, as used herein, such as the terms “approximately,” “about,” “generally,” and “substantially,” represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” “generally,” and“substantially” may refer to an amount that is within ± 10% of, within ± 5% of, within ± 2% of, within ± 1 % of, or within ± 0.1% of the stated amount. As another example, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by ± 10 degrees, by ± 5 degrees, by ± 2 degrees, by ± 1 degree, or by ± 0.1 degree, and the terms “generally perpendicular” and “substantially perpendicular” refer to a value, amount, or characteristic that departs from exactly perpendicular by ± 10 degrees, by ± 5 degrees, by ± 2 degrees, by ± 1 degree, or by ± 0.1 degree. The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” less than,” “between,” and the like includes the number recited. As used herein, the meaning of “a,” “an,” and “said” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “into” and “on,” unless the context clearly dictates otherwise.

[0069] While the methods and systems are discussed herein in terms of elements labeled by ordinal adjectives (e.g., first, second, etc.), the ordinal adjective are used merely as labels to distinguish one element from another (e.g., one signal from another or one circuit from one another), and the ordinal adjective is not used to denote an order of these elements or of their use.

[0070] The invention described and claimed herein is not to be limited in scope by the specific example implementations herein disclosed, since these implementations are intended as illustrations, and not limitations, of several aspects of the invention. Any equivalent implementations are intended to be within the scope of this invention. Indeed, various modifications of the invention in form and detail, in addition to those shown and described herein, will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the claims. The breadth and scope of the invention should not be limited by any of the example implementations disclosed herein but should be defined only in accordance with the claims and their equivalents.

Claims

WHAT IS CLAIMED IS:

1. A method comprising: receiving a user input first signal configured to trigger a device to perform a measurement procedure utilizing at least one electrode implanted within a recipient’s body; in response to said receiving the user input first signal, performing an evaluation of whether performing a conditioning procedure of the at least one electrode is potentially warranted prior to performing the measurement procedure; generating and communicating a user output signal indicative of a result of the evaluation to the user; and receiving a user input second signal configured to trigger the device either to perform the conditioning procedure prior to performing the measurement procedure or to perform the measurement procedure without performing the conditioning procedure prior to performing the measurement procedure.

2. The method of claim 1, wherein the measurement procedure comprises at least one neural response telemetry measurement, impedance measurement, complex impedance measurement, transimpedance measurement, cortical measurement, auditory steady-state response measurement, or transtympanic electrocochleography (ECochG) measurement.

3. The method of claim 1 or claim 2, wherein the evaluation comprises, for each electrode of the at least one electrode: accessing a threshold impedance value; generating a measured impedance value; and comparing the threshold impedance value and the measured impedance value, wherein the conditioning procedure is not warranted upon the measured impedance value being less than the threshold impedance value and the conditioning procedure is warranted upon the measured impedance value being greater than or equal to the threshold impedance value.

4. The method of claim 3, further comprising, after performing the conditioning procedure:performing a second evaluation comprising generating a second measured impedance value and comparing the threshold impedance value and the second measured impedance value; generating and communicating a second user output signal indicative of a second result of the second evaluation to the user; and receiving a user input third signal configured to trigger the device either to perform another conditioning procedure prior to performing the measurement procedure or to perform the measurement procedure without performing another conditioning procedure prior to performing the measurement procedure.

5. The method of claim 3 or claim 4, wherein the threshold impedance value is indicative of the conditioning procedure potentially reducing an electrical impedance between the electrode and the recipient’s body.

6. The method of claim 1 or claim 2, wherein the evaluation comprises, for each electrode of the at least one electrode: accessing a threshold elapsed time value; generating a measured elapsed time from a previous successfully performed conditioning procedure; and comparing the threshold elapsed time value and the measured elapsed time value, wherein the conditioning procedure is not warranted upon the measured elapsed time value being less than the threshold elapsed time value and the conditioning procedure is warranted upon the measured elapsed time value being greater than the threshold elapsed time value.

7. The method of claim 6, further comprising, after performing the conditioning procedure: performing a second evaluation comprising generating a measured impedance value and comparing the measured impedance value and a previously stored measured impedance value from a previous measurement procedure that was performed after a successfully performed conditioning procedure; generating and communicating a second user output signal indicative of a second result of the second evaluation to the user; andreceiving a user input third signal configured to trigger the device either to perform another conditioning procedure prior to performing the measurement procedure or to perform the measurement procedure without performing another conditioning procedure prior to performing the measurement procedure.

8. The method of claim 6 or claim 7, wherein said generating the measured elapsed time comprises accessing a stored time stamp of the previous successfully performed conditioning procedure, accessing a current time, and calculating a time difference between the current time and the stored time stamp.

9. The method of any of claims 1 to 8, wherein said receiving user input first signals, said performing the evaluation, said generating and communicating the user output signal, and said receiving user input second signals are performed by circuitry of the device.

10. The method of claim 9, wherein the circuitry is external to the recipient’s body.

11. The method of claim 9, wherein the circuitry is implanted within the recipient’s body.

12. The method of any of claims 1 to 8, wherein said receiving user input first signals, said performing the evaluation, said generating and communicating the user output signal, and said receiving user input second signals are performed by circuitry separate from and in operable communication with the device.

13. The method of claim 12, wherein the circuitry is a component of a computing device in operable communication with a network.

14. An apparatus comprising: at least one electrode configured to be implanted within a recipient’ s body and configured to, via at least one electrode-body interface, transmit electrical signals to the recipient’s body and / or to receive electrical signals from the recipient’s body; and control circuitry in electrical communication with the at least one electrode, the control circuitry configured to: in response to a measurement trigger signal from a user, generate a determination of an attribute of the at least one electrode-body interface and / or a time period since a previous conditioning procedure was last performed;in response to the determination, generate an estimated efficacy of a conditioning procedure to improve the at least one electrode-body interface, transmit an output signal indicative of the estimated efficacy to the user, and await a conditioning trigger signal from the user; in response to a first value of the conditioning trigger signal, perform the conditioning procedure and then perform a measurement procedure; and in response to a second value of the conditioning trigger signal, perform the measurement procedure without performing the conditioning procedure.

15. The apparatus of claim 14, wherein the attribute comprises an electrical impedance of the at least one electrode -body interface and the control circuitry is configured to generate the determination of the electrical impedance by: accessing at least one threshold electrical impedance value for the at least one electrode -body interface; generating at least one measured electrical impedance value of the at least one electrode -body interface; and comparing the at least one measured electrical impedance value and the at least one threshold electrical impedance value; and wherein the conditioning procedure has a first estimated efficacy value in response to the at least one measured electrical impedance value being greater than or equal to the at least one threshold electrical impedance value and has a second estimated efficacy value in response to the at least one measured electrical impedance value being less than the at least one threshold electrical impedance value, the second estimated efficacy value less than the first estimated efficacy value.

16. The apparatus of claim 15, wherein the control circuitry transmits the output signal indicative of the estimated efficacy to the user only in response to the first estimated efficacy value.

17. The apparatus of claim 15 or claim 16, wherein the measurement procedure comprises performing a neural response telemetry (NRT) measurement, performing an impedance measurement, performing a complex impedance measurement, generating a transimpedance matrix (TIM), performing a cortical measurement, performing an auditorysteady-state response measurement, or performing a transtympanic electrocochleography (ECochG) measurement.

18. The apparatus of claim 14, wherein the control circuitry is configured to, in response to the measurement trigger signal from the user, generate the determination of the time period since a conditioning procedure was last performed.

19. The apparatus of any of claims 14 to 18, wherein the apparatus is an implanted portion of an auditory prosthesis system, the auditory prosthesis system comprising: at least one microphone configured to generate data signals indicative of sounds received by the at least one microphone; and sound processing circuitry configured to process the data signals received from the at least one microphone, generate stimulation signals indicative of the sounds, and transmit the stimulation signals via the at least one electrode and the at least one electrode -body interface to an auditory system of the recipient.

20. The apparatus of claim 19, wherein the auditory prosthesis system comprises a cochlear implant.

21. The apparatus of any of claims 14 to 20, further comprising at least one input interface configured to provide the measurement trigger signal and the conditioning trigger signal to the control circuitry.

22. The apparatus of claim 21 , wherein the at least one input interface comprises at least one antenna configured to receive wireless input signals from an external device separate from the apparatus.

23. The apparatus of claim 22, wherein the external device is in operable communication with a network and the external device and the at least one input interface are configured to transmit data and / or command signals from a device on the network to the control circuitry.

24. A method comprising: in response to a measurement trigger signal from a user of a medical implant system having at least one electrode in contact with a recipient’s body, generating a determination of an electrical impedance of at least one interface between the at leastone electrode and the recipient’s body and / or a time period since the at least one electrode was last conditioned; in response to the determination: estimating an efficacy of further conditioning the at least one electrode to improve the at least one interface, transmitting an output signal indicative of the efficacy to the user, and awaiting a conditioning trigger signal from the user; responding to a first value of the conditioning trigger signal by further conditioning the at least one electrode and then performing a measurement procedure or responding to a second value of the conditioning trigger signal by performing the measurement procedure without further conditioning the at least one electrode.

25. The method of claim 24, further comprising, in response to an initial conditioning trigger signal received prior to receiving the measurement trigger signal, performing an initial conditioning of the at least one electrode prior to receiving the measurement trigger signal.

26. The method of claim 25, further comprising, after performing the initial conditioning and prior to receiving the measurement trigger signal, performing an initial measurement procedure to generate and store at least one initial impedance value and an initial time stamp indicative of the time that the at least one initial impedance value is measured.

27. The method of claim 26, wherein the initial measurement procedure comprises performing multiple measurements of the at least one initial impedance value and comparing at least two of the measurements to one another to ensure a sufficient stability of the at least one initial impedance value.

28. The method of any of claims 24 to 27, wherein said generating the determination of the time period since the at least one electrode was last conditioned comprises calculating an elapsed time period between a current time stamp and a previously stored time stamp indicative of the time that the at least one electrode was last conditioned, and comparing the elapsed time period to a predetermined time threshold difference value.

29. The method of claim 28, wherein an estimated efficacy corresponding to the time period being less than or equal to the time threshold difference value is less than anestimated efficacy corresponding to the time period being greater than the time threshold difference value.

30. A non-transitory computer readable storage medium having stored thereon a computer program that instructs a computer system to perform the method of any of claims 24 to 29.

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