Vestibular implant surgical diagnostics

Abstract

Presented herein are techniques to a monitor a position of a stimulating assembly during surgical implantation. A method includes inserting a stimulating assembly having one or more electrodes into an inner ear of a recipient, and monitoring, during the inserting, a proximity of at least one of the one or more electrodes to a saccule or an utricle of the inner ear.

Description

Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1VESTIBULAR IMPLANT SURGICAL DIAGNOSTICS BACKGROUNDField of the Invention

[0001] The present invention relates generally to implantation techniques for a vestibular implant.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 / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully- implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc. pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and / or lifestyle enhancement functions and / or recipient monitoring for a number of years.

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

[0004] In one aspect, a method is provided. The method includes inserting a stimulating assembly comprising one or more electrodes into an inner ear of a recipient, and monitoring, during the inserting, a proximity of at least one of the one or more electrodes to a saccule or an utricle of the inner ear. In an embodiment, monitoring can be performed by monitoring an impedance, a potential, or other electrical characteristic, associated with the at least one of the one or moreAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1electrodes. The impedance, potential, and or other electrical characteristic, can change as the at least one of the one or more electrodes approaches or contacts tissue, fluid or anatomical structures of the recipient.

[0005] In another aspect, another method is provided. The method includes determining a distance between a location of a surgical opening and a saccule in an inner ear of a recipient, and inserting a stimulating assembly into the inner ear via the surgical opening until an insertion depth of the stimulating assembly is substantially equal to the distance. In an embodiment, medical imaging can be used to measure the distance between the location of the surgical opening and the saccule based on the image. Further, during the inserting, the method can include monitoring a depth to which the stimulating assembly has been inserted. This can be accomplished by monitoring an impedance, a potential, or other electrical characteristic, associated with at least one or more electrodes on the stimulating assembly.

[0006] In another aspect, a system is provided. The system comprises: a display screen, a memory, at least one processor operable coupled to the display screen and the memory, wherein the at least one processor is configured to: generate an image of an inner ear of a recipient of a stimulating assembly, determine an insertion distance between an expected surgical opening into a cavity of the inner ear of the recipient and an otolith organ of the recipient, and generate one or more indications that the stimulating assembly is advancing in the cavity of the inner ear and / or that the stimulating assembly has reached the insertion distance.

[0007] In another aspect, one or more non-transitory computer readable storage media are provided. The one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, are configured to: obtain a plurality of electrical measurements during insertion of a stimulating assembly into an inner ear of a recipient, wherein the plurality of electrical measurements are obtained via one or more electrodes of the stimulating assembly; and monitor, during the insertion of a stimulating assembly, a proximity of at least one of the one or more electrodes to a saccule or an utricle of the inner ear.Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1BRIEF DESCRIPTION OF THE DRAWINGS

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

[0009] FIG. 1 A is a schematic diagram illustrating portions of an ear and portions of a vestibular stimulation device with which aspects of the techniques presented herein can be implemented;

[0010] FIG. IB is a block diagram of a vestibular stimulation device, in accordance with certain embodiments presented herein;

[0011] FIG. 1 C is a schematic, partial cross-sectional view illustrating anatomical structures of the human inner ear and showing the placement therein of a stimulating assembly of vestibular implant, in accordance with certain embodiments presented herein;

[0012] FIG. ID is a perspective view illustrating further details of a portion of the human inner ear of FIG. 1 C and showing the placement of a stimulating assembly, in accordance with certain embodiments presented herein;

[0013] FIG. IE is a schematic diagram illustrating a computing device with which aspects of the techniques presented herein can be implemented;

[0014] FIGs. 2A, 2B, 2C and 2D are schematic diagrams of stimulating assemblies, in accordance with certain embodiments presented herein;

[0015] FIGs. 3A, 3B, 3C, 3D, 3E, and 3F are images of an inner ear showing possible implant trajectories for a stimulating assembly and interaction between an advancing stimulating assembly and surrounding tissue, in accordance with certain embodiments presented herein;

[0016] FIG. 4 is a graph showing how impedance changes with respect to at least one electrode on a stimulating assembly as the stimulating assembly is inserted into the inner ear of a recipient, in accordance with certain embodiments presented herein;

[0017] FIG. 5 is a schematic diagram of stimulating assembly including a pressure or deformation sensor at a tip or distal end, in accordance with certain embodiments presented herein;

[0018] FIG. 6 is a medical image used to determine a distance or depth to which a stimulating assembly should be inserted into the inner ear of a recipient, in accordance with certain embodiments presented herein;Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1

[0019] FIG. 7 shows a stimulating assembly including multiple equidistantly spaced electrodes that correlate to insertion depth, in accordance with certain embodiments presented herein;

[0020] FIG. 8 is a graph showing how the impedance for each electrode is separately monitored to determine a depth to which a stimulating assembly has been inserted, in accordance with certain embodiments presented herein;

[0021] FIG. 9 is a flowchart showing a series of steps for performing a stimulating assembly insertion technique, in accordance with certain embodiments presented herein.

[0022] FIG. 10 is a flowchart showing another series of steps for performing a stimulating assembly insertion technique, in accordance with certain embodiments presented herein.DETAILED DESCRIPTION

[0023] A growing number of implantable medical devices include one or more electrodes that are configured to be implanted within a recipient. For example, cochlear implants and vestibular stimulation devices can include one or more electrodes configured to be implanted in the inner ear of the recipient. In the case of cochlear implants, a plurality of electrodes is configured to be implanted within the cochlea (e.g., scala tympani) of a recipient, while vestibular stimulation devices include one or more electrodes configured to be implanted in, or close to, the vestibular system of the recipient. In certain cases, implantation of the electrodes can impede or damage residual function, such as residual hearing abilities, of the inner ear.

[0024] Presented herein are techniques for surgically implanting a stimulating assembly comprising one or more electrodes into an inner ear of a recipient, and during the insertion, monitoring, a proximity of at least one of the one or more electrodes to the otolith organs (e.g., the saccule or the utricle) of the inner ear. Once the stimulating assembly is positioned, and secured with the inner ear of the recipient, e.g., within the perilymphatic space of the recipient, the stimulating assembly can be configured to deliver stimulation signals (current signals) to the recipient to achieve a therapeutic effect. For example, the stimulation signals can be delivered to the recipient to treat a variety of conditions / disorders, such as hearing disorders, balance disorders or other disorders affecting the vestibular system (e.g., Meniere's disease, other bilateral vestibular disorders, or inflammation of vestibular anatomy), vertigo, motor disorders (e.g., Parkinson’s disease, ataxia, essential tremor, etc.), tinnitus, etc.Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1

[0025] It is important to ensure that surgical insertions / implantations into the inner ear are performed with the utmost care to avoid damage to, or otherwise impeding the function of, the inner ear of the recipient. For example, if the stimulating assembly is inserted too far or too deep, the stimulating assembly could abut, press on, or even penetrate a membrane of the saccule or of the utricle of the inner ear which could result in temporary or permanent hearing loss, or other, damage to the recipient. On the other hand, if the surgeon is too tentative or cautious, and fails to insert the stimulating assembly to a predetermined minimum depth, the utility of the stimulating assembly and electrical stimulation provided thereby can have limited effectiveness.

[0026] In operation, a stimulating assembly implanted into the inner ear delivers electrical stimulation signals (current signals) to a recipient. However, electrical stimulation signals can be delivered in a number of different manners using a number of different medical devices and to treat a number of different conditions. As such, there are a number of different types of device in / with which the techniques presented herein can be implemented. Merely for ease of description, the techniques presented herein are primarily described with reference to a specific device. However, it is to be appreciated that the techniques presented herein can also be partially or fully implemented by any of a number of different types of devices or systems, including consumer electronic devices (e.g., consumer hearing devices, consumer computing devices such as mobile phones and tablets, audio equipment such as home theatre and car audio systems, etc.), computing systems (e.g., servers in data centers, Internet-of- Things (loT) devices), various types of software systems, such as databases, machine learning and artificial intelligence systems, other medical devices, such as diagnostic equipment or life sustaining equipment, etc. For example, the techniques presented herein could be used in or with sensory protheses, including hearing aids and cochlear implants, and various medical devices, such as pacemakers, drug delivery systems, implantable defibrillators, functional electrical stimulation devices, sleep disorder devices (e.g., sleep apnea devices), seizure devices (e.g., devices for monitoring and / or treating epileptic events), balance or movement disorder devices (e.g., vestibular stimulation devices), tinnitus management devices, visual implants (e.g., bionic eyes), and other neuromodulation devices (e.g., braincomputer interfaces.

[0027] FIGS. 1A-1B illustrate diagrams of an example vestibular stimulation device 165 with which aspects of the techniques presented herein can be implemented. The vestibular stimulation device 165 comprises a stimulator unit 150, a lead 140, and a stimulating assembly 156 configuredAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1to be implanted in the perilymphatic space 154 of the recipient. FIGS. 1A-1B also illustrate portions of an ear of a recipient including the ear canal 138, the tympanic membrane 136, the middle ear 133, and the inner ear 135, with adjacent bone 152. The middle ear 133 includes the ossicular chain 134, with the incus 172, the stapes 174, and the malleus 170, while the inner ear 135 includes the cochlea 106, the semicircular (or vestibular) canals 104, the oval window 178, the otolith organs 111 (utricle 112 and saccule 114), and the perilymphatic space 154. As will be described more fully below, stimulating assembly 156 can be inserted through, or adjacent, a footplate of the stapes 174 and through the oval window 178 to reach the perilymphatic space 154. Inserting the stimulating assembly 156 to the appropriate depth is a focus of the techniques described herein.

[0028] FIG. IB depicts an embodiment of the present technology in which the stimulating assembly 156 is at least partially inserted (potentially fully inserted) into the perilymphatic space 154 of the recipient (e.g., suspended within the perilymphatic space 154). The stimulating assembly 156 includes one or more electrodes 158 that collectively form an electrode array 160, where the electrode array 160 can be used to stimulate portions of the recipient. More specifically, the stimulating assembly 156 is connected to the stimulator unit 150 via a lead 140, and the stimulator unit 150 is configured to generate and deliver stimulation signals (current signals) to the recipient via the one or more electrodes 158. In accordance with example embodiments, the stimulator unit 150 can also receive signals from the electrode array 160. In particular, the stimulator unit 150 includes measurement circuitry (e.g., one or more amplifiers, etc.) configure to capture / obtain electrical measurements from the one or more electrodes 158.

[0029] In accordance with certain aspects presented, the presented techniques are used to ensure that the stimulating assembly is inserted to an appropriate depth (D) into the perilymphatic space 154 without causing inadvertent damage to the recipient’s inner ear organs such as the otolith organs 111. In this regard, some of the electrodes 158 can be dedicated to assisting with capturing / obtaining positioning information whereas other electrodes 158 can be dedicated to providing electrical stimulation. Alternatively, selected electrodes 158 can have dual purposes such that they can both deliver electrical stimulation and also operate to obtain positioning information.Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1

[0030] In one example, the stimulator unit 150 can be connected to the lead 140 via a connector 159, which can be used to disconnect and reconnect the lead 140 to / from the stimulator unit 150. The connector 159 can be employed to change or swap the stimulator unit 150 with a different stimulator unit while leaving the lead 140 and the stimulating assembly 156 implanted in the recipient. The stimulator unit 150 could be changed or swapped, for example, due to a malfunction of the stimulator unit 150, upgrade of the stimulator unit 150, and / or to swap out functionality configured to assist in surgical insertion and positioning versus functionality for delivering electrical stimulation signals for a therapeutic purpose / effect.

[0031] As noted elsewhere herein, a stimulating assembly in accordance with embodiments presented herein, such as stimulating assembly 156, is at least partially inserted (potentially fully inserted) into the perilymphatic space 154. In one embodiment, the stimulating assembly 156 is a stiff elongate assembly (e.g., includes one still components) that is prone to little, or no, bending during and / or after insertion.

[0032] Before describing details of the techniques presented herein, relevant aspects of an example human inner ear are first described below with reference to FIGs. 1 C and ID. In particular, shown in FIG. 1C is the bony labyrinth 101, which is the bony outer wall of an inner ear 100. The bony labyrinth 101 includes three sections / parts, referred to as the vestibule 102, which includes the Otolith organs 111, the semicircular canals 104, and the cochlea 106. The vestibule 102, the semicircular canals 104, and the cochlea 106 are cavities that are internally lined with periosteum and that contain a fluid known as perilymph. For ease of illustration, a portion of the bony labyrinth 101 forming the vestibule 102 has been omitted from FIG. 1C, while the entire bony labyrinth 101 has been omitted from FIG. ID.

[0033] Within the bony labyrinth 101 is the membranous labyrinth 103, which consists of the semicircular ducts 105, the otolith organs 111 (i.e., the utricle 112 and the saccule 114), and the cochlear duct 116. The membranous labyrinth 103 is filled with a fluid known as endolymph, and is surrounded by the perilymph of the bony labyrinth 101. The membranous labyrinth 103 is also suspended from the bony labyrinth 101 by fine connective tissue strands.

[0034] As shown, the bony labyrinth 101 includes three (3) semicircular canals 104, referred to as the superior or anterior semicircular canal 104(A), the posterior semicircular canal 104(B), and the horizontal or lateral semicircular canal 104(C). Within the superior semicircular canal 104(A) isAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1the superior semicircular duct 105(A), within the posterior semicircular canal 104(B) is the posterior semicircular duct 105(B), and within the horizontal semicircular canal 104(C) is the horizontal semicircular duct 105(C). The semicircular ducts 105 are situated superoposterior to the vestibule 102 and each has a swelling at one end, known as an ampulla 110 (i. e. , three ampullae 110 are shown in FIGs. 1C and ID, one for each semicircular duct 105). The semicircular ducts 105, the utricle 112, and the saccule 114 are sometimes collectively referred to as the “peripheral vestibular apparatus” or the “peripheral vestibular system” 125.

[0035] The semicircular ducts 105(A), 105(B), and 105(C) are half-circular, interconnected tubes that are aligned approximately orthogonally to one another (i.e., at right angles to each other) so that they measure motions in all three planes. Specifically, the lateral duct 105(C) is aligned roughly horizontally in the head, while the superior 105(A) and posterior ducts 105(B) are aligned roughly at a 45 degree angle to a vertical through the center of the individual’s head. The semicircular ducts 105(A), 105(B), and 105(C) are each maximally sensitive to angular accelerations (head rotations) that lie in the plane of the duct. The result of this arrangement is that three semicircular ducts 105(A), 105(B), and 105(C) can uniquely specify the direction and amplitude of any arbitrary head rotation. That is, upon movement of the head, the flow of endolymph within the ducts 105 changes speed and / or direction. Sensory receptors in the ampullae 110 detect these changes and send signals to the brain via the vestibular nerve 118 (FIG. ID), allowing for the processing of balance.

[0036] As noted, the membranous labyrinth 103 also includes the utricle 112 and the saccule 114, which are collectively referred to as the otolith organs 111. The utricle 112 and the saccule 114 are two membranous sacs located in the vestibule 102, which detect movement or acceleration of the head in the horizontal and vertical planes, respectively (i.e., linear accelerations). The utricle 112 is the larger of the two, receiving the three semi-circular ducts 105. The saccule 114 is globular in shape and receives the cochlear duct 116.

[0037] The utricle 112 and the saccule 114 each contain a macula, which is an organ consisting of a patch of hair cells covered by a gelatinous membrane containing particles of calcium carbonate, called otoliths. Motions of the head cause the otoliths organs 111 to pull on these hair cells, stimulating the vestibular nerve 118, which allow the individual to perceive linear acceleration, both horizontally and vertically, and gravity control (i.e., gravitoinertial information).Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1

[0038] The vestibular nerve 118 is one of the two branches of the vestibulocochlear nerve (the other being the auditory nerve 119), which functions to relay / transmit sensory information transmitted by the vestibular hair cells located in the two otolith organs (i.e., the utricle 112 and the saccule 114) and the three semicircular ducts 105 via the vestibular (Scarpa’s) ganglion 121. Again, as noted, information from the otolith organs 111 reflects gravity and linear accelerations of the head, while information from the semicircular ducts 105 reflects rotational movement of the head.

[0039] The peripheral vestibular nerve fibers are generally divided into three branches. First, the superior vestibular nerve branch 126 passes through the foramina in the area vestibularis superior and ends in the utricle 112 and in the ampullae 110 of the superior and horizontal semicircular ducts 105(A) and 105(C), respectively. Second, the inferior vestibular nerve branch 128 traverses the foramina in the area vestibularis inferior and ends in the saccule 114. Third, the posterior vestibular nerve branch 131 runs through the foramen singulare and supplies the ampulla 110 of the posterior semicircular duct 105(B).

[0040] Also shown in FIG. 1C is the round window 120 and the oval window 122. The round window 120 and oval window 122 are the two openings from the middle ear into the inner ear 100. The round window 120 is situated inferior to (below) and posterior to (behind) the oval window 122, from which it is separated by the promontory (rounded elevation). The oval window 122 is sealed by a membrane (oval window membrane) and leads from the middle ear to the vestibule of the inner ear 100. Vibrations that contact the tympanic membrane (ear drum) in the outer ear (not shown) travel through the three ossicles (i.e., malleus, incus, and stapes) of the middle ear and into the inner ear 100 via the oval window 122. That is, the oval window 122 is the intersection of the middle ear with the inner ear 100 and is directly contacted by the stapes 174. The round window 120 is also sealed by a membrane (round window membrane), which vibrates with opposite phase to vibrations entering the inner ear 100 through the oval window 122. The round window 120 allows fluid in the cochlea 106 to move.

[0041] Also shown in FIGs. 1C-1D is stimulating assembly 156 that has been inserted through the oval window 122 and suspended within the perilymphatic space with a distal, or tip end, of the stimulating assembly 156 approaching the otolith organs 111 (e.g., the saccule 114 and / or the utricle 112). As noted previously, it can be preferable that the stimulating assembly 156 not abut,Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1touch, or penetrate the membrane of either of the saccule 114 or utricle 112. In this regard, embodiments described herein provide techniques for monitoring a position of a tip or distal end of the stimulating assembly 156 with respect to such membranes and / or dynamically monitoring the insertion depth of the stimulating assembly 156 during the surgical insertion process to avoid contacting or penetrating those membranes.

[0042] FIG. IE is a block diagram illustrating one example arrangement for an external computing device 180 configured to perform one or more operations in accordance with certain embodiments presented herein. As shown in FIG. IE, in its most basic configuration, the external computing device 180 includes at least one processing unit 183 and a memory 184. The processing unit 183 includes one or more hardware or software processors (e.g., Central Processing Units) that can obtain and execute instructions. The processing unit 183 can communicate with and control the performance of other components of the external computing device 180. The memory 184 is one or more software or hardware-based computer-readable storage media operable to store information accessible by the processing unit 183. The memory 184 can store, among other things, instructions executable by the processing unit 183 to implement applications or cause performance of operations described herein, as well as other data. The memory 184 can be volatile memory (e.g., RAM), non-volatile memory (e.g., ROM), or combinations thereof. The memory 184 can include transitory memory or non-transitory memory. The memory 184 can also include one or more removable or non-removable storage devices. In examples, the memory 184 can include RAM, ROM) EEPROM (Electronically-Erasable Programmable Read-Only Memory), flash memory, optical disc storage, magnetic storage, solid state storage, or any other memory media usable to store information for later access. By way of example, and not limitation, the memory 184 can include wired media, such as a wired network or direct-wired connection, and wireless media, such as acoustic, RF, infrared, other wireless media, or combinations thereof. In certain embodiments, the memory 184 comprises logic 195 that, when executed, enables the processing unit 183 to perform aspects of the techniques presented. Logic 195 can, for example, when executed, operate to monitor a position of a tip or distal end of the stimulating assembly 156 with respect to the saccule or utricle and / or dynamically monitor the insertion depth of the stimulating assembly 156.

[0043] In the illustrated example of FIG. IE, the external computing device 180 further includes a network adapter 186, one or more input devices 187, and one or more output devices 188. TheAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1external computing device 180 can include other components, such as a system bus, component interfaces, a graphics system, a power source (e.g., a battery), among other components. The network adapter 186 is a component of the external computing device 180 that provides network access (e.g., access to at least one network 189). The network adapter 186 can provide wired or wireless network access and can support one or more of a variety of communication technologies and protocols, such as Ethernet, cellular, Bluetooth, near-field communication, and RF, among others. The network adapter 186 can include one or more antennas and associated components configured for wireless communication according to one or more wireless communication technologies and protocols. The one or more input devices 187 are devices over which the external computing device 180 receives input from a user. The one or more input devices 187 can include physically-actuatable user-interface elements (e.g., buttons, switches, or dials), a keypad, keyboard, mouse, touchscreen, and voice input devices, among other input devices that can accept user input. The one or more output devices 188 are devices by which the external computing device 180 is able to provide output to a user. The output devices 188 can include a display 190 (e.g., a liquid crystal display (LCD)) and one or more speakers 191, among other output devices for presentation of visual or audible information to the recipient, a clinician, an audiologist, or other user.

[0044] It is to be appreciated that the arrangement for the external computing device 180 shown in FIG. IE is merely illustrative and that aspects of the techniques presented herein can be implemented at a number of different types of systems / devices including any combination of hardware, software, and / or firmware configured to perform the functions described herein. For example, the external computing device 180 can be a personal computer (e.g., a desktop or laptop computer), a hand-held device (e.g., a tablet computer), a mobile device (e.g., a smartphone), a surgical system, and / or any other electronic device having the capabilities to perform the associated operations described elsewhere herein.

[0045] As shown in FIG. IE, a user device 192, such as, e.g., a medical imaging system, can be in communication with external computing device 180. Likewise, stimulator unit 150 can also be in communication with external computing device 180.

[0046] As noted above, in accordance with embodiments presented herein, a stimulating assembly, such as stimulating assembly 156 shown in FIG. ID, is inserted such that a distal end of theAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1stimulating assembly approaches the otolith organs 111 (e.g., the saccule 114 and / or the utricle 112). Also as noted above, it can be preferable that the distal end of the stimulating assembly 156 does not abut, touch, or penetrate the membrane of either of the saccule 114 or utricle 112. In this regard, in accordance with certain embodiments, the techniques described herein use impedance / potential (or, more generally, “electrical characteristic”) monitoring of electrodes on the stimulating assembly 156 during insertion of the stimulating assembly 156 into the inner ear of the recipient. FIGs. 2A, 2B, 2C and 2D illustrate possible configurations for a stimulating assembly with electrodes incorporated therewith for use with embodiments presented herein. In general, impedance / potential with respect to at least one of the electrodes can be measured during a surgical insertion procedure to monitor a position of the stimulating assembly within the inner ear of the recipient (e.g., using the connected stimulator unit / measurement circuitry to capture / obtain electrical measurements from the one or more electrodes).

[0047] Referring first to FIG. 2A, shown is a stimulating assembly 251 comprising an elongate body 253 having two electrodes disposed thereon, namely relatively smaller tip electrode 255 and a relatively larger body electrode 258 that is set back from (e.g., positioned proximal to) the tip 210 of the stimulating assembly 251. An optional stopper 259, in the form of, e.g., a collar, flange or other form, can be provided and is positioned toward a proximal end 215 of the stimulating assembly 251. The stopper 259 can be configured to abut a surgical opening of the oval window or stapes footplate or of a vestibuleostomy. Connecting wires (not shown) electrically connect electrodes 255, 258 to, e.g., stimulating unit 150 (not shown in the figure).

[0048] FIG. 2B shows another stimulating assembly 261 comprising an elongate body 263 having two electrodes disposed thereon, namely a relatively smaller tip electrode 265 and a relatively larger body electrode 268 that is set back from the tip 210. An optional stopper 269, in the form of, e.g., a collar, flange, or other form, can be provided and is positioned toward a proximal end 215 of the stimulating assembly 261. Connecting wires (not shown) electrically connect electrodes 265, 268 to, e.g., stimulating unit 150 (not shown in the figure).

[0049] The difference between the configurations of FIGs. 2A and 2B is that, in FIG. 2A, the electrodes 255, 258 extend circumferentially around the body 253 of the stimulating assembly 251. In contrast, in the embodiment of FIG. 2B, the electrodes 265, 268 do not extend circumferentiallyAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1around the body 263. Instead, the electrodes 265, 268 in FIG. 2B are disposed, for example, on only a portion or side of the body 263 of the stimulating assembly 261.

[0050] FIG. 2C shows still another possible configuration for a stimulating assembly in accordance with an embodiment. Here, stimulating assembly 271 includes two electrodes at the tip 210 of a body 273 of the stimulating assembly 271, namely a first tip electrode 274 and a second tip electrode 275. A stopper 279, similar to stopper 259 or 269, can also be provided towards a proximal end 215 of stimulating assembly 271. Connecting wires (not shown) electrically connect electrodes 265, 268 to, e.g., stimulating unit 150 (not shown in the figure).

[0051] FIG. 2D shows a configuration of a stimulating assembly 281 having two electrodes 284 extending distally from the tip 210 of the stimulating assembly 281. As such, the two electrodes 284, 285 extend from body 283 and are separated by an insulator / insulating material 287. Connecting wires 288, 289 electrically connect electrodes 284, 285 to stimulating unit 150 (not shown in this figure).

[0052] In the example of FIG. 2D, a portion of the body 283 can be inserted into the inner ear. In other embodiments, only the two electrodes 284, 285 (and the separating insulator / insulating material 287) are inserted into the inner ear. That is, in such an example, the tip 210 or a collar (not shown in FIG. 2D) positioned at the tip 210 could be positioned at the opening, and only the two electrodes 284, 285 (and the separating insulator / insulating material 287) are inserted into the inner ear.

[0053] As described elsewhere herein, the stimulating assemblies of FIGs. 2A, 2B, 2C, and 2D can be inserted into the inner ear of a recipient. During insertion, the corresponding electrodes of the stimulating assemblies can be used to perform one or more monitoring functions (e.g., impedance / potential monitoring, ECochG monitoring, or other electrical characteristic monitoring, etc.) to facilitate proper placement of the stimulating assembly relative to the otolith organs. In certain examples, at least one of the electrodes of a given stimulating assembly of FIGs.2A, 2B, 2C, or 2D is driven with a current and at least one other electrode functions as a return for the current. By monitoring applied current and voltage (AC or DC), and knowing the inherent resistance of the conductive components (electrodes, associated wires, etc.) it is possible determine an impedance or potential with respect to a given one of the electrodes, and, in particular, changesAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1to that impedance or potential as one or more of the electrodes is exposed to fluid, anatomical structures, and organs in the inner ear.

[0054] Reference is now made to FIGs. 3 A-3F, which are images of an inner ear showing possible implant trajectories for a stimulating assembly and interaction between the stimulating assembly and surrounding tissue, in accordance with certain embodiments presented herein, and to FIG. 4, which is a graph showing how impedance changes with respect to at least one electrode on a stimulating assembly as the stimulating assembly is inserted into the inner ear of a recipient. Those skilled in the art will appreciate that a similar graph depicting changes in potential, or still other electrical characteristic, could also be presented and relied upon. For ease of explanation, the following description is presented in the context of impedance monitoring.

[0055] Referring first to FIG. 3 A, shown are two possible insertion trajectories 301, 302 for a stimulating assembly 310, with trajectory 301 passing through a footplate of the stapes 374, and trajectory 302 passing near the stapes 374. Those skilled in the art will appreciate that other trajectories are possible depending on the recipient’s anatomy, age, etc. As noted, a goal of the described embodiments is to ensure that the stimulating assembly 310 is inserted to an appropriate depth into the perilymphatic space 354 without causing inadvertent damage to the recipient’s inner ear organs such as saccule 314 (or utricle 312). It is noted that the overall distance between penetrating the oval window and, e.g., a membrane 320 of the saccule can be on the order of only a few millimeters. It is thus important to monitor a position of a tip or distal end of the stimulating assembly 310 with respect to, e.g., the membrane 320 of the saccule 314 and / or dynamically monitor the overall insertion depth of the stimulating assembly 310 during the surgical insertion process. To accomplish the monitoring, and in one embodiment, the impedance with respect to one or more electrodes on the stimulating assembly can be monitored as the stimulating assembly is implanted / inserted into the inner ear of the recipient. That is, electrical current can be supplied, e.g. , via stimulator unit 150, to one or more electrodes while monitoring at least one other electrode to determine the impedance to that electrical current.

[0056] Referring to FIG. 4, before the stimulating assembly 310 is inserted into the inner ear of the recipient, the electrodes thereon are exposed to air and, thus, as shown in region 410 of FIG.4, the impedance between a driven electrode and a sensing electrode (e.g., tip electrode 265 and body electrode 268) is relatively high (and would be the same for potential), as shown in regionAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1410 (e.g., as air acts as an insulator to electric current). It is noted that measure 0 microns on the x-axis in FIG. 4 represents the entry into the vestibular organ of the recipient, or, alternatively, the tissue separating the air from the perilymphatic space 354.

[0057] FIG. 3B shows stimulating assembly 310 advancing into the perilymphatic space 354. Perilymph is a fluid that is more conductive than air, and as such, it can be seen in region 412 (FIG. 4) that the impedance immediately drops. FIG. 3C shows stimulating assembly 310 further advancing into the perilymphatic space 354 and tip electrode 265 touching or coming into contact with membrane 320 of saccule 314. The impedance associated with tip electrode 265 can increase due to contact with membrane 320, as indicated by region 414 in FIG. 4

[0058] FIG. 3D shows still further advancement of stimulating assembly 310 such that, e.g., tip electrode 265 penetrates into, or embeds itself in, membrane 320. Correspondingly, the impedance associated with tip electrode 365 can increase further still, as indicated by region 416 in FIG. 4. Finally, as shown in FIG. 3E, stimulating assembly 310 fully penetrates membrane 320 of saccule 314 and enters the endolymphatic space 360. The endolymph fluid is more conductive than the perilymph fluid and, as such, the impedance associated with tip electrode 365 decreases, as shown in region 418 in FIG. 4.

[0059] Therefore, by monitoring the impedance of at least one electrode disposed on a stimulating assembly during implantation, it is possible to determine the position of the stimulating assembly beyond the oval window, or other entry point into the inner ear of the recipient. As explained further below, this monitoring can be configured to detect puncturing of, a distance from, and / or contact with, the otolith organs (e.g. the saccular membrane 320 in the vestibule) so as to avoid damaging the membrane, which is believed to be a cause of losing residual hearing.

[0060] The impedance (or other electrical characteristic) changing pattern shown in FIG. 4 can be learned, enhanced or fine-tuned, using, for example, pattern recognition algorithms to optimize the diagnostics. Specifically, machine learning algorithms can identify patterns associated with proximity to critical structures, such as the membrane 320. A Neural Network approach might also be implemented for this purpose. Artificial neural networks (ANNs) can be used for pattern recognition, as ANNs learn from data and can adapt to complex relationships. Similarly, deep learning architectures (e.g., convolutional neural networks) excel in image recognition and can beAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1of use to map the inner structures in connection with inserting a stimulating assembly into the inner ear of the recipient.

[0061] FIG. 3F shows a stimulating assembly 380 with two electrodes at a tip / distal end touching membrane 320 of saccule 314. This electrode configuration, similar to the configuration depicted in FIG. 2C, can generate a similar impedance (or other electrical characteristic) profile as shown in FIG. 4 as stimulating assembly 380 is advanced into the inner ear of the recipient. The stimulating assembly 281 (FIG. 2D) would operate similarly. It is noted that the implementation of the impedance monitoring approach described herein need not be limited to the stimulation assembly configurations described and depicted herein. Other electrode configurations for impedance-based position monitoring, as well as other position monitoring approaches are also possible.

[0062] For example, instead of relying on impedance, a pressure and / or force and / or deformation sensor 560 can be disposed on the tip or distal end of a stimulating assembly 551 , as shown in FIG.5, to determine whether the stimulating assembly 551 has come into contact with a membrane of the saccule or utricle. In this embodiment, electrodes 555, for delivering electric stimulation are disposed on body 553.

[0063] In another embodiment, external responses to touching or contacting the membrane of the saccule or utricle can be monitored. For instance, a stimulator unit (e.g., stimulator unit 150) can, as noted, also be configured to receive signals from an implanted stimulator assembly. In this regard, stimulator unit 150 (or other device) can be configured to monitor neural responses evoked in response to electrical stimulation delivered via the at least one of the one or more electrodes of the stimulating assembly. The system can also be configured to monitor Electrocochleography (ECochG) responses evoked in response to acoustic stimulation delivered to the inner ear. The system can also monitor one or more muscular responses of the recipient, including, e.g., eye movement of the recipient as a result of the stimulating assembly touching the membrane of the saccule or utricle. Such eye movement can be referred to as a vestibulo-ocular reflex.

[0064] In any of the embodiments described herein, the recipient can be awake during performance of the implantation, although it can be more likely that the recipient is sedated.

[0065] Another embodiment related to impedance monitoring relies on pre-surgery / implantation imaging along with a surgical planning system. In this embodiment, and again with reference toAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1FIG. IE, user device 192 can be a medical imaging device that can generate an image like that shown in FIG. 6. Imaging can also rely on scanning with dies or other contrast enhancement techniques. Imaging could also be based on ultrasound techniques. User device 192 can also include elements of the surgical planning system. The image of FIG. 6 can be used to measure a distance DI for a given recipient. Distance DI can be, e.g., a measure of distance between a surface of the footplate of the stapes 674 (or the surgical opening in the oval window 622, or an opening via vestibuleostomy) and a surface of membrane 620 of saccule 614 (or a membrane of the utricle). Distance DI can be on the order of 1-4 mm (or 100-400 microns).

[0066] The medical planning system can be used to determine a preferred trajectory and depth (DI) to implant a vestibular stimulating assembly into the inner ear cavity of a recipient. FIG. 7 shows a stimulating assembly 701 including multiple equidistantly (optional) spaced electrodes 758. The distance between electrodes 758 can be on the order of, e.g., 50-100 microns and is known by the system of FIG. IE. As shown, each electrode 758 is marked with a respective indicator El, E2, E3, E4, E5, E6, starting from a tip or distal end 710 of the stimulating assembly 701. In accordance with an embodiment, as stimulating assembly 701 is advanced into the inner ear of the recipient along, for example, the trajectory 601 shown in FIG. 6, successive electrodes 758 will come into contact with perilymph fluid in the inner ear. When a given electrode contacts the perilymph fluid, that electrode’s impedance to electric current will decrease, and that change is monitored.

[0067] FIG. 8 is a graph showing how the impedance for each electrode 758 is separately monitored. In the example of FIG. 8, electrodes E1-E4 are measured (e.g., impedance measurements are captured from the electrodes E1-E4) to have an impedance low enough that suggests those electrodes have contacted the perilymph fluid, whereas electrodes E5 and E6 can still be exposed to the air and thus have a higher impedance. This means that the stimulating assembly has advanced into the inner ear a distance corresponding to the cumulative distance from electrode El to electrode E4. If the distance between electrodes is 50 microns, this means that that stimulating assembly 701 has been advanced 200 microns into the inner ear. Thus, the impedance monitoring approach described with respect to FIGs. 6-8 enables dynamic monitoring of the insertion depth of the stimulating assembly. Once the depth of stimulating assembly reaches the depth DI, then the surgeon will know that the stimulating assembly has been implanted to an intended depth, based on the medical imaging, without harming other tissue or structures withinAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1the inner ear. In accordance with an embodiment, the system can generate one or more indications (visual, sound, haptic) indicative of a decrease of impedance for each successive electrode (i.e., a “tick” for each successive electrode that has contacted perilymph fluid) as the stimulating assembly is advanced into the inner ear and / or that the stimulating assembly has reached the insertion distance.

[0068] It is also noted that by adding an element of timing to the monitoring, the speed of insertion of the stimulating assembly 701 can also be monitored. More specifically, speed equals distance / time. Thus, keeping track of the time that it takes for each of the electrodes El to E4 to come into contact with the perilymphatic fluid, makes it possible to determine distance (i.e., the cumulative distance, or individual distance between each of, electrodes El to E4) over a measured period of time, thus providing a speed (distance / time) of insertion.

[0069] FIG. 9 is a flowchart showing a series of steps for performing a stimulating assembly insertion technique, in accordance with certain embodiments presented herein. At 902, an operation includes inserting a stimulating assembly comprising one or more electrodes into an inner ear of a recipient. And, at 904, an operation includes monitoring, during the inserting, a proximity of at least one of the one or more electrodes to a saccule or an utricle of the inner ear. The monitoring can be performed using impedance monitoring, potential monitoring, or other electrical characteristic monitoring, of at least one electrode disposed on the stimulating assembly.

[0070] FIG. 10 is a flowchart showing a series of steps for performing a stimulating assembly insertion technique, in accordance with certain embodiments presented herein. At 1002, an operation includes determining a distance between a location of a surgical opening and a saccule in an inner ear of a recipient. And, at 1004, an operation includes inserting a stimulating assembly into the inner ear via the surgical opening until an insertion depth of the stimulating assembly is substantially equal to the distance. The distance can be determined, for example, using one or more medical imaging techniques. The speed of insertion can also be derived by knowing the period of time over which the stimulating assembly is inserted.

[0071] As should be appreciated, while particular uses of the technology have been illustrated and discussed above, the disclosed technology can be used with a variety of devices in accordance with many examples of the technology. The above discussion is not meant to suggest that the disclosed technology is only suitable for implementation within systems akin to that illustrated in the figures.Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1In general, additional configurations can be used to practice the processes and systems herein and / or some aspects described can be excluded without departing from the processes and systems disclosed herein.

[0072] This disclosure described some aspects of the present technology with reference to the accompanying drawings, in which only some of the possible aspects were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible aspects to those skilled in the art.

[0073] As should be appreciated, the various aspects (e.g., portions, components, etc.) described with respect to the figures herein are not intended to limit the systems and processes to the particular aspects described. Accordingly, additional configurations can be used to practice the methods and systems herein and / or some aspects described can be excluded without departing from the methods and systems disclosed herein.

[0074] According to certain aspects, systems and non-transitory computer readable storage media are provided. The systems are configured with hardware configured to execute operations analogous to the methods of the present disclosure. The one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.

[0075] Similarly, where steps of a process are disclosed, those steps are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular sequence of steps. For example, the steps can be performed in differing order, two or more steps can be performed concurrently, additional steps can be performed, and disclosed steps can be excluded without departing from the present disclosure. Further, the disclosed processes can be repeated.

[0076] Although specific aspects were described herein, the scope of the technology is not limited to those specific aspects. One skilled in the art will recognize other aspects or improvements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative aspects. The scope of the technology is defined by the following claims and any equivalents therein.Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1

[0077] It is also to be appreciated that the embodiments presented herein are not mutually exclusive and that the various embodiments can be combined with another in any of a number of different manners.

Claims

Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1CLAIMSWhat is claimed is:

1. A method comprising:inserting a stimulating assembly comprising one or more electrodes into an inner ear of a recipient; andmonitoring, during the inserting, a proximity of at least one of the one or more electrodes to a saccule or an utricle of the inner ear.

2. The method of claim 1 , wherein monitoring the proximity of the at least one of the one or more electrodes to the saccule or the utricle comprises:monitoring an impedance associated with the at least one of the one or more electrodes.

3. The method of claim 2, wherein the one or more electrodes comprise a plurality of electrodes, and wherein monitoring an impedance associated with the at least one of the one or more electrodes comprises:monitoring impedances associated with two or more of the plurality of electrodes.

4. The method of claim 2, wherein monitoring the impedance associated with the at least one of the one or more electrodes comprises:monitoring impedance changing patterns using a trained neural network.

5. The method of claim 2, wherein the at least one of the one or more electrodes is one of a pair of electrodes disposed at a tip end of the stimulating assembly.

6. The method of claim 2, wherein the at least one of the one or more electrodes is one of a pair of electrodes disposed successively along a longitudinal axis of the stimulating assembly.

7. The method of claim 2, wherein monitoring an impedance associated with the at least one of the one or more electrodes comprises:monitoring the impedance for a change indicating contact between the stimulating assembly and the saccule or the utricle.Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR18. The method of claim 7, wherein the one or more electrodes comprise a plurality of electrodes, and wherein the method further comprises:determining a change in impedance between at least two electrodes of the plurality of electrodes.

9. The method of claim 7, further comprising:determining a change in impedance caused by a change in properties of a body fluid or body tissue with which the at least one of the one or more electrodes comes into contact.

10. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, further comprising:determining when the at least one of the one or more electrodes is a predetermined distance from the saccule or the utricle.

11. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, further comprising:determining whether the at least one of the one or more electrodes has contacted the saccule or utricle.

12. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, further comprising:determining whether the at least one of the one or more electrodes has penetrated a membrane of the saccule or the utricle.

13. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein monitoring the proximity of the at least one of the one or more electrodes to the saccule or the utricle comprises:monitoring neural responses evoked in response to electrical stimulation delivered via the at least one of the one or more electrodes.

14. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein monitoring the proximity of the at least one of the one or more electrodes to the saccule or the utricle comprises:monitoring Electrocochleography (ECochG) responses evoked in response to acoustic stimulation delivered to the inner ear.

15. The method of claim 1 , 2, 3, 4, 5, 6, 7, 8, or 9, wherein monitoring the proximity of the at least one of the one or more electrodes to the saccule or the utricle comprises:Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1monitoring one or more muscular responses of the recipient.

16. The method of claim 13, wherein monitoring the one or more muscular responses comprises:monitoring eye movement of the recipient.

17. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, further comprising:determining, based on the monitoring, a deformation of a distal tip of the stimulating assembly.

18. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the monitoring comprises:detecting a signal from a pressure sensor disposed at a distal tip of the stimulating assembly.

19. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein inserting the stimulating assembly comprises:inserting the stimulating assembly in a substantially straight trajectory from, or near, a stapes footplate of the recipient into the inner ear.

20. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, further comprising:after placement of the stimulating assembly, delivering stimulation signals to at least one of the saccule or the utricle.

21. The method of claim 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein inserting the stimulating assembly comprises:creating an opening in a stapes footplate at the inner ear or adjacent to the stapes footplate;advancing the stimulating assembly through the opening and towards the saccule; and during the advancing, monitoring the proximity of the at least one of the one or more electrodes to the saccule or the utricle.Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR122. A method, comprising:determining a distance between a location of a surgical opening and a saccule in an inner ear of a recipient; andinserting a stimulating assembly into the inner ear via the surgical opening until an insertion depth of the stimulating assembly is substantially equal to the distance.

23. The method of claim 22, wherein determining the distance between the location of the surgical opening and the saccule comprises:imaging the inner ear of the recipient to obtain an image, and measuring the distance between the location of the surgical opening and the saccule based on the image.

24. The method of claim 22 or 23, further comprising monitoring, while performing the inserting, a depth to which the stimulating assembly has been inserted.

25. The method of claim 24, wherein the stimulating assembly comprises one or more electrodes, and the monitoring comprises monitoring an impedance associated with at least one of the one or more electrodes.

26. The method of claim 25, wherein monitoring the impedance associated with at least one of the one or more electrodes comprises;monitoring impedance changing patterns using a trained neural network.

27. The method of claim 26, wherein the one or more electrodes comprises a plurality of electrodes disposed along an exterior surface of the stimulating assembly and spaced equidistantly from each other.

28. The method of claim 27, wherein each electrode in the plurality of electrodes is correlated with a predetermined insertion depth.

29. The method of claim 26, wherein monitoring the impedance comprises:monitoring a change in impedance attributed to a change in properties of a body fluid or body tissue with which the at least one of the one or more electrodes comes into contact.Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR130. The method of claim 22 or 23, further comprising detecting whether the stimulating assembly has penetrated a membrane of the saccule.

31. The method of claim 22 or 23, further comprising:monitoring one or more muscular responses of the recipient in response to inserting the stimulating assembly.

32. The method of claim 31 , wherein monitoring the one or more muscular responses comprises:monitoring eye movement of the recipient.

33. A system comprising:a display screen;a memory;at least one processor operable coupled to the display screen and the memory, wherein the at least one processor is configured to:generate an image of an inner ear of a recipient of a stimulating assembly; determine an insertion distance between an expected surgical opening into a cavity of the inner ear of the recipient and an otolith organ of the recipient; andgenerate one or more indications that the stimulating assembly has reached the insertion distance.

34. The system of claim 33, wherein the stimulating assembly comprises one or more electrodes, and the at least one processor is configured to:monitor an impedance associated with at least one of the one or more electrodes.

35. The system of claim 34, wherein the one or more electrodes comprises a plurality of electrodes disposed along an exterior surface of the stimulating assembly and each electrode in the plurality of electrodes is correlated with a predetermined insertion depth.

36. The system of claim 34, wherein the at least one processor is configured to:Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1monitor a change in impedance attributed to a change in properties of a body fluid or body tissue with which the at least one of the one or more electrodes comes into contact.

37. The system of claim 33, 34, 35, or 36, wherein the at least one processor is configured to:detect whether the stimulating assembly has contacted or penetrated a membrane of a saccule or utricle of the recipient.

38. One or more non-transitory computer readable storage media comprising instructions that, when executed by one or more processors, are configured to:obtain a plurality of electrical measurements during insertion of a stimulating assembly into an inner ear of a recipient, wherein the plurality of electrical measurements are obtained via one or more electrodes of the stimulating assembly; andmonitor, during the insertion of a stimulating assembly, a proximity of at least one of the one or more electrodes to a saccule or an utricle of the inner ear.

39. The one or more non-transitory computer readable storage media of claim 38, wherein the instructions to monitor the proximity of the at least one of the one or more electrodes to the saccule or the utricle comprise instructions that, when executed by the one or more processors, are configured to:monitor an impedance associated with the at least one of the one or more electrodes.

40. The one or more non-transitory computer readable storage media of claim 39, wherein the instructions to monitor the impedance associated with the at least one of the one or more electrodes comprise instructions that, when executed by the one or more processors, are configured to:monitor impedance changing patterns using a trained neural network.

41. The one or more non-transitory computer readable storage media of claim 39, wherein the instructions to monitor the impedance associated with the at least one of the one or more electrodes comprise instructions that, when executed by the one or more processors, are configured to:Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1monitor the impedance for a change indicating contact between the stimulating assembly and the saccule or the utricle.

42. The one or more non-transitory computer readable storage media of claim 39, wherein the one or more electrodes comprise a plurality of electrodes, and wherein the instructions to monitor the impedance associated with the at least one of the one or more electrodes comprise instructions that, when executed by the one or more processors, are configured to:determine a change in impedance between at least two electrodes of the plurality of electrodes.

43. The one or more non-transitory computer readable storage media of claim 38, 39, 40, 41, or 42, further comprising instructions that, when executed by the one or more processors, are configured to:determine when the at least one of the one or more electrodes is a predetermined distance from the saccule or the utricle.

44. The one or more non-transitory computer readable storage media of claim 38, 39, 40, 41, or 42, further comprising instructions that, when executed by the one or more processors, are configured to:determine whether the at least one of the one or more electrodes has contacted the saccule or utricle.

45. The one or more non-transitory computer readable storage media of claim 38, 39, 40, 41, or 42, further comprising instructions that, when executed by the one or more processors, are configured to:determine whether the at least one of the one or more electrodes has penetrated a membrane of the saccule or the utricle.

46. The one or more non-transitory computer readable storage media of claim 38, 39, 40, 41, or 42, wherein the instructions to monitor the proximity of the at least one of the one or more electrodes to the saccule or the utricle comprise instructions that, when executed by the one or more processors, are configured to:Atty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1monitor neural responses evoked in response to electrical stimulation delivered via the at least one of the one or more electrodes.

47. The one or more non-transitory computer readable storage media of claim 38, 39, 40, 41, or 42, wherein the instructions to monitor the proximity of the at least one of the one or more electrodes to the saccule or the utricle comprise instructions that, when executed by the one or more processors, are configured to:monitor Electrocochleography (ECochG) responses evoked in response to acoustic stimulation delivered to the inner ear.

48. A system, comprising:a stimulating assembly comprising one or more electrodes configured to be inserted into an inner ear of a recipient; andone or more processors configured to, while the stimulating assembly is inserted into the inner ear, monitor a proximity of at least one of the one or more electrodes to a saccule or an utricle of the inner ear.

49. The system of claim 48, wherein the stimulating assembly includes a stopper.

50. The system of claim 49, wherein the stopper is a collar.

51. The system of claim 48, where the stimulating assembly is a stiff elongate assembly52. The system of claim 48, wherein the stimulating assembly comprises two elongate electrodes separated by insulating material, and wherein only the two elongate electrodes and the insulating material are inserted into the inner ear.

53. The system of claim 48, further comprising a stimulator unit configured to capture impedance measurements from at least one of the one or more electrodes, and wherein the one or more processors are configured to monitor the proximity of the at least one of the one or moreAtty. Docket No. 3065.0870P Client Ref. No. CID03923USPR1electrodes to the saccule or the utricle based on the impedance measurements captured from the at least one of the one or more electrodes.

54. The system of claim 53, wherein to monitor the impedance associated with the at least one of the one or more electrodes, the wherein the one or more processors are configured to monitor impedance changing patterns using a trained neural network.

55. The system of claim 53, wherein the at least one of the one or more electrodes is one of a pair of electrodes disposed at a tip end of the stimulating assembly.

56. The system of claim 53, wherein the at least one of the one or more electrodes is one of a pair of electrodes disposed successively along a longitudinal axis of the stimulating assembly.

57. The system of claim 53, wherein to monitor the impedance associated with the at least one of the one or more electrodes, the wherein the one or more processors are configured to monitor the impedance for a change indicating contact between the stimulating assembly and the saccule or the utricle.

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