Foldable implantable medical device

Abstract

A collapsible medical device configured to be implanted in the tympanic chamber of a recipient is presented herein. More specifically, the medical device has a folded configuration having a physical size (physical footprint occupied by the device) / first form factor that enables insertion of the device through the recipient's ear canal (e.g., through an opening formed at the recipient's tympanic membrane). After the device is inserted into the tympanic chamber, the medical device is deployed from a folded configuration to an expanded configuration. In the expanded configuration, the medical device has a physical dimension (physical footprint occupied by the device) / second form factor greater than the physical dimension in the folded configuration. In some examples, the medical device is configured to be positioned against a projia of a recipient's ear adjacent to a tympanic chamber.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to implantable medical devices. BACKGROUND

[0002] Medical devices have provided a wide range of therapeutic benefits to recipients in recent decades. A medical device can include internal or implantable components / devices, external or wearable components / devices, or a combination thereof (e.g., a device having external components that communicate with implantable components). Medical devices, such as traditional hearing aids, partially or fully implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful for many years in performing life-saving and / or lifestyle improvement functions and / or recipient monitoring.

[0003] The types of medical devices, and the range of functions performed by them, 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 implanted in a recipient, either permanently or temporarily. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or study, replace, or modify an anatomical structure or a physiological process. Many of these functional devices utilize power and / or data received from an external device that is part of, or operates in conjunction with, the implantable components. SUMMARY

[0004] In one aspect, a medical device is provided. The medical device includes a base member configured to be implanted in a recipient’s ear via an opening in or around a recipient’s tympanic membrane into a recipient’s tympanic cavity of the ear, and at least one electrode disposed on the base member. The base member is configured to be secured to a recipient’s bony ridge of the ear within the recipient’s tympanic cavity, and the at least one electrode is configured to deliver a stimulation signal to the recipient. The medical device has a collapsed configuration for implantation into the tympanic cavity via the opening in or around the tympanic membrane, and an expanded configuration for securing to the bony ridge.

[0005] In another aspect, a method is provided. The method includes forming an opening in or around a recipient’s tympanic membrane of the recipient’s ear, inserting a medical device into a tympanic cavity of the ear via the opening, the medical device having a collapsed configuration during insertion through the opening, releasing the medical device into an expanded configuration after the medical device is inserted into the tympanic cavity, and securing the medical device against a bony ridge of the ear in the expanded configuration.

[0006] In another aspect, a medical device is provided. The medical device includes a flexible coil having a first configuration with a first shape factor for insertion into the middle ear cavity of a recipient and a second configuration with a second shape factor for deployment within the middle ear cavity. The medical device also includes at least one stimulating electrode and a stimulator unit electrically connected to the flexible coil and the at least one stimulating electrode. The stimulator unit is configured to generate an electrical stimulation signal for delivery to the recipient via the at least one stimulating electrode. Attached Figure Description

[0007] Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which:

[0008] Figure 1 This is a schematic diagram illustrating an implantable medical device system, which can realize various aspects of the technology presented herein;

[0009] Figure 2 yes Figure 1 A block diagram of an implantable medical device system;

[0010] Figure 3A , 3B 3C are perspective views of implantable components of implantable medical device systems in different configurations according to certain embodiments presented herein;

[0011] Figure 4 This is a front view of another implantable component of an implantable medical device system according to certain embodiments presented herein;

[0012] Figure 5 This is a front view of another implantable component of an implantable medical device system according to certain embodiments presented herein;

[0013] Figure 6 This is a flowchart of a method for implanting an implantable medical device according to certain embodiments presented herein; and

[0014] Figure 7 This is a schematic diagram illustrating an exemplary method for implanting an implantable medical device according to certain embodiments presented herein. Detailed Implementation

[0015] This article presents a foldable medical device configured for implantation in the tympanic cavity (middle ear cavity) of a recipient. More specifically, the medical device has a folding configuration with a physical dimension (physical footprint occupied by the device) / first shape factor that allows the device to be inserted through the recipient's ear canal (e.g., through an opening formed in or around the recipient's tympanic membrane). After insertion into the tympanic cavity, the medical device is deployed from the folding configuration to an expanded configuration. In the expanded configuration, the medical device has a physical dimension (physical footprint occupied by the device) / second shape factor that is larger than the physical dimension in the folding configuration. In some examples, the medical device is configured to be positioned against the promontory of the recipient's ear adjacent to the tympanic cavity.

[0016] In some embodiments, the medical device is at least partially formed of a flexible, elastic material that allows the device to deform to fold into a folded configuration via an applied force (e.g., a manually applied force). The flexible, elastic material has spring-like properties that shift towards an expanded configuration biasing the device even without an applied force. For this reason, the device can be readily arranged in a folded configuration for insertion into a recipient, and then accept an expanded configuration for deployment in the tympanic cavity. The foldability of the device facilitates easier implantation into the recipient (e.g., via the ear canal with a relatively small opening), eliminating the need to create a larger opening within the recipient (e.g., through the recipient's skull) to allow insertion into the tympanic cavity.

[0017] Many different types of devices exist in which / using said devices can implement embodiments of the invention. For ease of description only, the techniques presented herein are described primarily with reference to specific devices configured to alleviate tinnitus symptoms in a recipient. However, it should be understood that the techniques presented herein can also be implemented, in part or entirely, by any of many different types of devices, including consumer electronics devices (e.g., mobile phones), wearable devices (e.g., smartwatches), hearing devices, implantable medical devices, wearable devices, and so on. As used herein, the term “hearing device” will be broadly interpreted as any “device” that acts on an individual’s actual or potential auditory perception, including improving the perception of sound signals, reducing the perception of sound signals, etc. In particular, hearing devices can deliver sound signals to a user in any form (including in the form of acoustic stimulation, mechanical stimulation, electrical stimulation, etc.) and / or can be operated to suppress all or some sound signals. Therefore, hearing devices can be devices for people with hearing impairments (e.g., hearing aids, middle ear prostheses, bone conduction devices, direct acoustic stimulators, electroacoustic hearing prostheses, auditory brainstem stimulators, bimodal hearing prostheses, bilateral hearing prostheses, dedicated tinnitus treatment devices, tinnitus treatment device systems, combinations or variations thereof), devices for people with normal hearing (e.g., consumer devices providing audio streaming, consumer headphones, headphones and other listening devices), hearing protection devices, etc. In other examples, the techniques presented herein can be implemented by or in combination with various implantable medical devices, such as vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and / or treating epileptic events), sleep apnea devices, electroporation devices, etc. In fact, although this disclosure primarily discusses implementations related to tinnitus, the techniques discussed herein (including foldable implantable devices) can be used in any suitable implementation, such as delivering ear-related stimulation (e.g., vestibular stimulation for maintaining balance).

[0018] Figure 1This is an exemplary implantable medical device system (e.g., a hearing device system) 100, which enables various aspects of the techniques presented herein to be implemented. The implantable medical device system 100 includes an implantable medical device (implantable component) 106 and an external device (external component) 126. The implantable component 106 is configured to be positioned within the tympanic cavity 108 (e.g., the middle ear cavity) in the middle ear 109 of a recipient. Thus, the tympanic cavity 108 is located distal to the tympanic membrane 110 of the ear 102. The implantable component 106 includes a base member 112 configured to be secured within the tympanic cavity 108 (e.g., in the hypotympanic region, in the medial tympanic region, etc.) to the promontory 114 of the ear 102, and thus secure the implantable component 106 within the tympanic cavity 108.

[0019] In the illustrated embodiment, the implantable component 106 further includes an extension member 116 extending from the base member 112. In this example, each of the base member 112 and the extension member 116 is at least partially formed of an elastic flexible material (such as a metal and / or a polymer (e.g., rubber, silicone)) having sufficient spring-like properties to bias the base member 112 and the extension member 116 away from each other toward an expanded configuration. For example, the implantable component 106 may consist of a stretchable wireframe structure. The biasing of the base member 112 and the extension member 116 away from each other causes the extension member 116 to interact with the surface of the tympanic cavity 108 to bias the base member 112 against the promontory 114.

[0020] In one example, the extension member 116 is configured to abut against the tympanic wall 118 facing the promontory 114 within the tympanic cavity 108 (e.g., in the hypotympanic region of the tympanic cavity 108). For example, the tympanic wall 118 defines a recess or part thereof within the middle ear 109, and the extension member 116 is positioned within the recess and abuts against the tympanic wall 118. The interaction between the surfaces of the extension member 116 and the tympanic wall 118 (e.g., a frictional interface) prevents movement of the extension member 116 relative to the tympanic wall 118. Similarly, the interaction between the base member 112 and the surface of the promontory 114 prevents movement of the base member 112 relative to the promontory 114. In this manner, the implantable member 106 is wedged between the promontory 114 and the tympanic wall 118 to secure the implantable member 106 within the tympanic cavity 108.

[0021] In additional or alternative embodiments, the implantable component 106 is secured to the promontory 114 in another manner. As an example, additional components or features, such as adhesives and / or fasteners, are applied to secure the implantable component 106 to the surface of the promontory 114. As another example, the base member 112 is large enough that the tissue surrounding the recipient 104 within the tympanic cavity 108 captures the base member 112 to prevent movement of the base member 112, thereby securing the base member 112 relative to the promontory 114. In such embodiments, the implantable component 106 may not have an extension member 116.

[0022] The elastic, flexible material of the base member 112 also allows it to capture the contour of the promontory 114. That is, the base member 112 is flexible enough that when pressed against the surface of the promontory 114, it can bend to align with the contour of the promontory 114. In this way, the base member 112 extends along and / or is flush with the surface of the promontory 114. For example, the base member 112 has a convex configuration when placed against the promontory 114 in an expanded configuration to conform to the promontory 114 and avoid intrusion into the vicinity of the tympanic membrane 110. This positioning of the base member 112 against the promontory 114 further facilitates securing / fixing the base member 112 to the promontory 114.

[0023] Additionally, the elastic, flexible material of the implantable component 106 allows it to fold toward a folding configuration in response to an applied force (e.g., a manually applied force). For example, in the folding configuration, the extension member 116 folds onto the base member 112 such that the base member 112 and the extension member 116 abut against each other and / or extend side-by-side. In some embodiments, in the folding configuration, a first portion of the base member 112 also folds onto a second portion of the base member 112. Thus, the implantable component 106 has a reduced size in the folding configuration (relative to the expanded configuration).

[0024] The folded configuration of the implantable component 106 facilitates insertion of the implantable component 106 into the ear 102 of the recipient 104. As an example, in the folded configuration, the implantable component 106 has a shape factor that allows it to be positioned within the ear canal 120 located outside the tympanic membrane 110. For example, the dimensions (e.g., width, thickness) of the implantable component 106 in the folded configuration are smaller than the diameter of the ear canal 120. Therefore, in the folded configuration, the implantable component 106 can be inserted through the ear canal 120 and toward the tympanic cavity 108. To enable access to the tympanic cavity 108 from the ear canal 120, an opening 121 (shown in dashed lines) is formed through or around the tympanic membrane 110, and the opening 121 can be adapted to the shape factor of the implantable component 106 in the folded configuration so that the implantable component 106 can be inserted into the tympanic cavity 108 from the ear canal 120 via the opening 121 of the tympanic membrane 110. As an example, the opening 121 can be formed by making an incision directly in the tympanic membrane 110. As another example, the opening 121 can be formed by making an incision adjacent to the tympanic membrane 110, such as around the outer boundary of the tympanic membrane 110 (e.g., to provide a tympanic flap that can be moved to expose the opening 121).

[0025] The elastic, flexible material of the implantable component 106 allows it to easily transition from a folded configuration to an expanded configuration without the applied force required to hold it in that configuration. In other words, the implantable component 106 can be released from its folded configuration without any force applied to it. In additional or alternative embodiments, additional forces are applied to transition the implantable component 106 to its expanded configuration and / or to hold it in that configuration. In further embodiments, the implantable component 106 transitions from its folded configuration to its expanded configuration in various ways, such as upon exposure to elevated temperatures, upon receiving electrical stimulation, or in response to a chemical reaction. In any of these scenarios, a user (e.g., a surgeon) may insert the implantable component 106 into the tympanic cavity 108 of the recipient 104 when the implantable component 106 is in a folded configuration, change the implantable component 106 from a folded configuration to an expanded configuration after insertion into the tympanic cavity 108, and deploy the implantable component 106 in the tympanic cavity 108 to secure it to the promontory 114 when the implantable component 106 is in an expanded configuration.

[0026] In operation (e.g., when fixed to promontory 114), the implantable component 106 is configured to deliver an electrical stimulation signal (stimulation) to a recipient. The stimulation signal (e.g., electrical current) can take many different forms to provide different benefits to the recipient, such as reducing tinnitus, enabling sound perception, compensating for balance disorders, treating motor disorders (e.g., treating Parkinson's disease or ataxia), etc. For this purpose, the implantable component 106 includes one or more stimulation electrodes 122 (e.g., electrical stimulation contacts) for delivering electrical stimulation to the recipient. The stimulation electrodes 122 are positioned on the base member 112. The base member 112 is positioned within the tympanic cavity 108 such that the stimulation electrodes 122 are properly positioned to provide a stimulation signal. For example, in… Figure 1 In this arrangement, the base member 112 is positioned on the promontory 114 such that one or more stimulating electrodes 122 are adjacent to (positioned against) the promontory 114. This position places the one or more stimulating electrodes 122 within the threshold distance of the inner ear. This position of the one or more stimulating electrodes 122 enables them to effectively deliver stimulation signals to the inner ear.

[0027] It should be noted that the implantable component 106 delivers electrical stimulation to the recipient from within the tympanic cavity 108, rather than from within the recipient's inner ear. Therefore, the implantable component 106 can be easily implanted into and / or removed from the recipient 104. Furthermore, the implantable component 106 can be manufactured separately and independently from other components that can be implanted within the recipient 104. In this manner, the manufacturing cost of the implantable component 106 can be reduced compared to embodiments where the implantable component is part of or integrated with another component implanted within the recipient 104.

[0028] The implantable component 106 includes circuitry 124 (e.g., electrical components, processing circuitry). Circuitry 124 is configured to output a control signal to cause stimulation signals to be delivered by stimulation electrodes 122(one or more). Circuitry 124 may be at least partially enclosed by a base member 112 and an extension member 116. When the implantable component 106 is deployed in the tympanic cavity 108, circuitry 124 additionally or alternatively extends at least partially to the exterior of the base member 112 and / or the extension member 116, such as extending toward the tympanic membrane 110. In some embodiments, circuitry 124 is disposed on or within a flexible material to facilitate transitions between a folded configuration and an expanded configuration of the implantable component 106. Additionally or alternatively, circuitry 124 is enclosed within one of the base member 112 or the extension member 116. Thus, circuitry 124 may not fold when the extension member 116 moves relative to the base member 112. In some embodiments, the implantable component 106 is configured to output control signals without communicating with another component or device separate from the implantable component 106 via circuitry 124. That is, the implantable component 106 can operate independently to deliver stimulation signals, at least for a period of time.

[0029] In additional or alternative embodiments, the implantable component 106 may communicate with an external component 126 of the implantable medical device system 100 to deliver stimulation signals based on communication with the external component 126. For example, the external component 126 transmits data to the implantable component 106, and one or more stimulation electrodes 122 deliver stimulation signals based on data received from the external component 126. In the illustrated embodiment, the external component 126 is positioned within the ear canal 120 of the recipient 104. For example, the external component 126 is sized such that tissue of the recipient 104 within the ear canal 120 (e.g., the periphery of the ear canal 120) captures the external component 126 to maintain its position within the ear canal 120 (e.g., adjacent to the tympanic membrane 110 and the implantable component 106).

[0030] In some examples, one or more additional features may be used to secure the external component 126 within the ear canal 120. As an example, each of the implantable component 106 and the external component 126 includes a magnetic feature that enables the implantable component 106 and the external component 126 to magnetically engage with each other. As another example, a temporary adhesive or fastener is used to secure the external component 126 within the ear canal 120. A link (e.g., a radio frequency (RF) link) for communication is established between the external component 126 and the implantable component 106 at a location within the ear canal 120 and near the implantable component 106.

[0031] External component 126 transmits data and / or electrical signals percutaneously across tympanic membrane 110 to implantable component 106. For example, a link established between external component 126 and implantable component 106 enables external component 126 to wirelessly transmit data to implantable component 106 for delivering stimulation signals. For this purpose, external component 126 includes external coil 128 configured to transmit data to implantable component 106. For example, implantable component 106 includes a corresponding implantable coil (e.g., integrated in a body, coil, or housing) configured to receive data transmitted by external coil 128, and the implantable coil transmits data to circuitry 124 to enable stimulation electrodes 122 to deliver stimulation signals.

[0032] External component 126 may additionally or alternatively deliver power to implantable component 106. That is, implantable component 106 receives power via a link established between external component 126 and implantable component 106, and implantable component 106 uses the received power to operate. For example, circuit 124 uses power to operate one or more stimulation electrodes 122 to deliver stimulation signals.

[0033] In the illustrated embodiment, the implantable medical device system 100 is also capable of communicating with a computing device 130, such as a personal computer (e.g., a laptop computer, desktop computer, tablet computer), a mobile phone (e.g., a smartphone), a handheld device (e.g., a tablet computer), a surgical system, a remote control unit, a hearing aid, or other implantable devices. The computing device 130 and the implantable medical device system 100 communicate wirelessly via a bidirectional communication link 132. The bidirectional communication link 132 may include, for example, short-range communication, such as a Bluetooth link, a Bluetooth Low Energy (BLE) link, a proprietary link, etc. As an example, the computing device 130 may transmit signals (e.g., control signals, data signals, power signals) via the bidirectional communication link 132 to operate the implantable component 106 and / or the external component 126. As another example, the implantable component 106 and / or the external component 126 may transmit signals to the computing device 130 to provide operational information to the computing device 130, which may then provide notifications (e.g., displays) to the user to indicate the operational information. Therefore, the computing device 130 can further enhance the operation of the implantable medical device system 100.

[0034] Figure 2This is a block diagram of an implantable medical device system 100 including an implantable component 106 and an external component 126. In the illustrated embodiment, the implantable component 106 includes a medium 150 to which various portions of the circuitry 124 of the implantable component 106 are coupled. In some embodiments, the medium 150 includes a printed circuit board (PCB) electrically connecting at least some portions of the circuitry 124 to each other. In additional or alternative embodiments, the medium 150 includes a housing or enclosure in which the component is disposed, and the medium 150 shields the component from external elements (e.g., dust, debris). The medium 150 may extend along at least a portion of the base member 112 and / or the extension member 116.

[0035] As described elsewhere herein, the implantable component 106 can operate independently of the external component 126 for at least a period of time to stimulate the recipient 104. As an example, the implantable component 106 includes an implantable processing module 152 configured to provide a control signal 151 to the stimulator unit 154 of the implantable component 106, without the implantable component 106 needing to receive an initial signal (e.g., a data signal) from the external component 126. The stimulator unit 154 is then configured to utilize the control signal 151 to generate a stimulation signal 156 for delivery to the recipient 104 via one or more stimulation electrodes 122. In some embodiments, the implantable component 106 includes one or more sensors 158 configured to provide sensor data 160 to the implantable processing module 152, and the implantable processing module 152 is configured to generate and transmit the control signal 151 based on the sensor data 160. As an example, sensor data 160 includes received sound signals (e.g., sounds provided by the nearby or surrounding environment), time periods, parameters associated with receiver 104 (e.g., biometric data, motion data), and / or any other suitable data indicating whether stimulus signal 156 should be delivered to receiver 104.

[0036] The implantable processing module 152 can then generate a control signal 151 to cause the stimulator unit 154 to generate a stimulation signal 156 (e.g., a stimulation signal 156 with certain characteristics) for delivery to the recipient 104. In additional or alternative embodiments, the implantable processing module 152 can cause one or more stimulating electrodes 122 to deliver the stimulation signal 156 without using one or more sensors 158. For example, the implantable processing module 152 can cause one or more stimulating electrodes 122 to deliver the stimulation signal 156 in a predetermined manner, such as providing a stimulation signal with predetermined characteristics (e.g., causing the recipient 104 to perceive a predetermined sound), regardless of the signals in the surrounding environment.

[0037] As described elsewhere herein, external component 126 is configured to deliver signals to implantable component 106, such as percutaneously across tympanic membrane 110. The illustrated external component 126 includes an external processing module 162 configured to transmit a control signal 164 directed to implantable component 106 for delivering stimulation signal 156. For example, external processing module 162 outputs control signal 164 to RF transceiver 166 of external component 126, and RF transceiver 166 percutaneously transmits control signal 164 (e.g., in an encoded manner) to implantable component 106 via external coil 128. Implantable component 106 includes implantable coil 168 (e.g., induction coil) disposed in medium 150 and communicatively coupled to external coil 128 via a wireless link 170 (e.g., RF link, infrared link, electromagnetic link, capacitive link, inductive link) formed between external coil 128 and implantable coil 168.

[0038] The implantable coil 168 receives a control signal 164 from an external component 126 via a wireless link 170. The implantable component 106 also includes an RF interface circuit 172 configured to receive the control signal 164 via the implantable coil 168. The RF interface circuit 172 is configured to transmit the control signal 164 to an implantable processing module 152, which then processes the control signal 164 to transmit a control signal 151 to the stimulator unit 154 to deliver a stimulation signal 156. For example, the control signal 164 includes less processed information, and the implantable processing module 152 can perform processing operations to convert the control signal 164 into a control signal 151 usable by the stimulator unit 154. Alternatively or additionally, the RF interface circuit 172 is configured to deliver the control signal 164 directly to the stimulator unit 154, bypassing the implantable processing module 152, and the stimulator unit 154 is configured to generate and transmit the stimulation signal 156 based on the control signal 164 received from the RF interface circuit 172.

[0039] Each of the implantable processing module 152 and the external processing module 162 may include, for example, one or more processors and a memory device (memory) including sound processing logic. The memory device is one or more software- or hardware-based computer-readable storage media operable to store information accessible by one or more processors, and the memory device may include one or more of the following: non-volatile memory (NVM), ferroelectric random access memory (FRAM), read-only memory (ROM), random access memory (RAM), electrically erasable programmable read-only memory (EEPROM), disk storage media devices, optical storage media devices, flash memory devices, electrical, optical, magnetic, solid-state, or other physical / tangible memory storage devices. The memory device may include transient or non-transitory memory. As an example, the memory device may include wired media (such as wired networks or direct wired connections) and / or wireless media (such as acoustic, RF, infrared, other wireless media, or combinations thereof). One or more processors (e.g., microprocessors, microcontrollers) are, for example, hardware or software processors (e.g., central processing units) capable of receiving and executing instructions stored on the memory device. One or more processors may also communicate with and control the operation of other parts of the implantable medical device system 100. For example, one or more processors in the implantable processing module 152 (e.g., one or more processing elements implementing firmware, software, etc.) execute instructions in the memory device of the implantable processing module 152 to generate and output control signals 151, and one or more processors in the external processing module 162 execute instructions stored in the memory device of the external processing module 162 to generate and output control signals 164.

[0040] In some embodiments, external component 126 includes one or more audio input devices 174 (e.g., one or more external microphones, audio input ports, data ports, pickup coils, etc.) configured to receive an input audio signal 176 and transmit it to an external processing module 162. The external processing module 162 then processes the input audio signal 176 to generate and output a control signal 164 based on the input audio signal 176. For example, the external processing module 162 generates a control signal 164 that induces the generation of a stimulus signal 156, which enables the receiver 104 to perceive the input audio captured by the audio input device(s) 174. Therefore, the input audio signal 176 received by the audio input device(s) 174 serves as the basis for delivering the stimulus signal 156.

[0041] Implantable component 106 includes an implantable power source 178 (e.g., one or more batteries, one or more capacitors, etc.) that provides power to enable implantable component 106 (e.g., implantable processing module 152, stimulator unit 154, implantable sound processing module 158, RF interface circuitry 172) to operate. External component 126 is additionally or alternatively configured to provide power for operating implantable component 106. For example, implantable power source 178 is rechargeable, and power provided by external component 126 is delivered to implantable power source 178. For this purpose, external component 126 includes external power source 180. RF transceiver 166 receives power from external power source 180 and transmits power via external coil 128 to implantable coil 168 of implantable component 106. Power source 178 receives power from implantable coil 168, and the power is available for the operation of the remainder of circuitry 124.

[0042] External component 126 also includes a wireless transceiver 182 communicatively coupled to computing device 130 via bidirectional communication link 132. For example, computing device 130 may transmit data to wireless transceiver 182 via bidirectional communication link 132, and / or wireless transceiver 182 may transmit data to computing device 130 via bidirectional communication link 132. Data communication between external component 126 and computing device 130 enables certain operations of external component 126, computing device 130, and / or implantable component 106. Although Figure 2 The external processing module 162, RF transceiver 166, one or more voice input devices 174, and external power supply 180 are shown as being implemented at external component 126, but it should be understood that these elements (e.g., functional operation) may also be implemented as part of computing device 130.

[0043] In some embodiments, the implantable component 106 does not include an implantable magnet and / or ferromagnetic material. The absence of an implantable magnet reduces the complexity associated with retaining the implantable component 106 within the recipient. As an example, during magnetic resonance imaging (MRI) procedures or in other cases where a magnetic field is provided to the recipient, the entire implantable component 106 may remain within the recipient, and the provided magnetic field (which would otherwise cause undesirable movement and / or undesirable modulation of the implantable magnet) will not affect the positioning of the implantable component 106.

[0044] As described above, the implantable component 106 can be folded between a folded configuration and an expanded configuration, and vice versa. For this purpose, different portions of the medium 150 and the implantable component 106 (such as the implantable processing module 152, the stimulator unit 154, one or more sensors 158, the implantable coil 168, the RF interface circuit 172, and / or the implantable power supply 178) are configured (e.g., positioned or spatially arranged) to enable the folding of the implantable component 106. In this way, the different portions of the implantable component 106 can be folded so that the implantable component 106 can be folded in a desired manner for insertion and deployment in the tympanic cavity 108.

[0045] Figure 3A , 3B The images shown are perspective views of implantable component 106 with different configurations than 3C. More specifically, Figure 3A An expanded configuration 200 (e.g., an unfolded configuration) of the implantable component is shown, wherein an extension member 116 extends away from a base member 112. In this arrangement, the base member 112 has a circular shape with an annular body 202 defining a central opening 204 (e.g., a coil, a housing enclosing a coil), and the extension member 116 has an elongated shape extending from the annular body 202 and away from the central opening 204 in the expanded configuration 200. In additional or alternative embodiments, the base member 112 has any other suitable shape (e.g., a triangular shape, a rectangular shape, an irregular shape) and / or the base member 112 does not define a central opening 204 (e.g., the base member 112 includes a continuous or solid shape) to accommodate other portions of the implantable component 106 (e.g., circuitry 124, dielectric 150) and / or to provide sufficient flexibility for the base member 112.

[0046] The base member 112 also includes a central member 206 having an elongated shape extending from the annular body 202 and into a central opening 204. As an example, the extension member 116 and the central member 206 are circumferentially aligned with each other around the annular body 202. In additional or alternative embodiments, the extension member 116 and the central member 206 are circumferentially offset from each other.

[0047] Circuit 124 extends from the central member 206 to the extension member 116. Thus, in the expanded configuration 200, circuit 124 is generally deployed and extends across at least a portion of the annular body 202. Additionally, one or more stimulation electrodes 122 are positioned at the distal end 210 of the central member 206 within the central opening 204. Therefore, the central member 206 may be exposed and / or uninsulated to facilitate the delivery of electrical stimulation via the one or more stimulation electrodes 122. Moreover, in this specific example, the implantable component 106 includes one or more return electrodes 208 positioned in the expanded configuration 200 at the distal end 210 of the extension member 116 outside the central opening 204. Circuit 124 extends along each of the central member 106 and the extension member 116 to be electrically connected to the one or more stimulation electrodes 122 and the one or more return electrodes 208. Therefore, circuit 124 can operate electrodes 122, 208 (e.g., deliver current to electrodes 122, 208) so that (one or more) stimulating electrodes 122 can deliver stimulation to recipient 104.

[0048] The elastic, flexible material of the implantable component 106 allows the extension member 116 and the annular body 202 to fold around each other, such that the extension member 116 extends side-by-side with and / or abuts against the central member 206. For example, the extension member 116 and the annular body 202 can be folded relative to each other around a first axis 212 extending along the joint 214 (in... Figure 3A (As shown in the diagram) Rotation, the extension member 116 extends from the annular body 202 at the joint. (As shown in the diagram) Figure 3B As shown, the folding of the extension member 116 and the annular body 202 relative to each other around the first axis 212 transforms the implantable member 106 from an expanded configuration 200 to a first folded configuration 216 (e.g., a partially folded configuration), in which the extension member 116 extends into or radially overlaps with the central opening 204.

[0049] The implantable component 106 is relatively smaller in the first folded configuration 216 than in the expanded configuration 200. That is, the implantable component 106 has a first shape factor in the expanded configuration 200, a second shape factor in the first folded configuration 216, and occupies a smaller physical footprint compared to the first shape factor. As an example, the outer boundary of the implantable component 106 in the first folded configuration 216 includes the periphery (e.g., circumference) of the annular body 202, while the outer boundary of the implantable component 106 in the expanded configuration 200 includes the periphery of the annular body 202 plus the periphery of the extension member 116.

[0050] exist Figures 3A-3CIn the example, the elastic flexible material of the implantable component 106 also allows different portions of the annular body 202 to fold relative to each other. As an example, the first portion 218 of the annular body 202 (e.g., the first half, the first semicircular portion) and the second portion 220 of the annular body 202 (e.g., the second half, the second semicircular portion) can be folded around a second axis 222 (in... Figure 3B (As shown in the diagram) Relative to each other, the second axis rotates along the central member 206 and extends at the joint 224 where the first portion 218 and the second portion 220 join. Figure 3C As shown, the folding of the first portion 218 and the second portion 220 of the annular body 202 relative to each other around the second axis 222 transforms the implantable component 106 from a first folding configuration 216 to a second folding configuration 226 (e.g., a fully folded configuration), in which the first portion 218 and the second portion 220 of the annular body 202 extend side by side and / or are adjacent to each other.

[0051] The implantable component 106 is even smaller in size in the second folding configuration 226 than in the first folding configuration 216. For example, the implantable component 106 has a third shape factor in the second folding configuration 226, and the third shape factor occupies a smaller physical footprint than each of the first shape factor associated with the expanded configuration 200 and the second shape factor associated with the first folding configuration 216. For example, the outer boundary of the implantable component 106 in the second folding configuration 226 includes the periphery of either the first portion 218 or the second portion 220 of the annular body 202, rather than the periphery of the entire annular body 202.

[0052] A third shape factor of the implantable component 106 facilitates insertion of the implantable component 106 into the tympanic cavity 108. For example, the size and / or shape of the third shape factor allows the implantable component 106 to move through the ear canal 120 (e.g., the size of the third shape factor is smaller than the diameter of the ear canal 120), into the opening 121 formed through or around the tympanic membrane 110, and into the tympanic cavity 108. After insertion of the implantable component 106 into the tympanic cavity 108, the implantable component 106 can be released to transform into an expanded configuration 200. As an example, a force is applied to transform the implantable component 106 into a second folded configuration 226 and to hold the implantable component 106 in the second folded configuration. The force can be removed after insertion of the implantable component 106 into the tympanic cavity 108. When the force is removed, the elastic flexible material of the implantable component 106 pushes / biases the implantable component 106 toward the expanded configuration 200. As another example, the implantable component 106 is formed of a shape memory alloy, wherein the implantable component 106 is deformable when exposed to temperatures below a threshold, and returns to a pre-deformed configuration when exposed to temperatures above a threshold. For example, an expanded configuration 200 is a pre-deformed configuration of the implantable component 106, and the implantable component 106 deforms and remains in a second folded configuration 226 before insertion into a recipient. Upon insertion into a recipient, the implantable component 106 is exposed to a higher temperature (e.g., the recipient's body temperature, or the temperature emitted from a separate heating device) to cause the implantable component 106 to transform from the second folded configuration 226 into the pre-deformed expanded configuration 200. Thus, the implantable component 106 can remain in the second folded configuration 226 without the need for applied force, and the implantable component 106 readily transforms from the second folded configuration 226 into the expanded configuration 200 upon insertion. In either case, the first portion 218 of the annular body 202 rotates about the second axis 222 away from the second portion 220 of the annular body 202 to change the implantable member 106 toward the first folded configuration 216, and the extension member 116 rotates about the first axis 212 away from the central member 206 to change the implantable member 106 toward the expansion configuration 200. Thus, the implantable member 106 is in the expansion configuration 200 in the tympanic cavity 108.

[0053] The first shape factor of the implantable component 106 in the expansion configuration 200 facilitates deployment of the implantable component 106 in the tympanic cavity 108. For example, in the expansion configuration 200, the base member 112 is shaped (e.g., has a convex configuration) to facilitate fixation to the promontory 114. Moreover, in the expansion configuration 200, the extension member 116 extends obliquely relative to the base member 112 (e.g., away from the annular body 202) to facilitate abutment against the tympanic wall 118. Therefore, the expansion configuration 200 facilitates fixation / securement of the implantable component 106 within the tympanic cavity 108.

[0054] In the illustrated embodiment, the central member 206 is not folded to transform the implantable component 106 into a first folded configuration 216 or a second folded configuration 226. For example, in each of the expanded configuration 200, the first folded configuration 216, and the second folded configuration 226, the central member 206 is included within the outer boundary of the implantable component 106. Therefore, folding the central member 206 may not reduce the size of the implantable component 106. However, in additional or alternative embodiments, the central member 206 may be folded.

[0055] In practice, the implantable component 106 can be folded in any suitable manner to reduce its size. As an example, from the second folding configuration 226, a portion of the first portion 218 of the annular body 202, a portion of the second portion 220 of the annular body 202, and / or a portion of the central member 206 are configured to fold about a third axis 226 that bisects the annular body 202. This folding of the implantable component 106 from the second folding configuration 226 further reduces its size (e.g., by half compared to the second folding configuration 226).

[0056] Figure 4 This is a front view of an implantable component 250 according to some of the presented embodiments. The implantable component 250 shown includes a body 252 having a rectangular shape and an extension member 254 having an elongated shape. The body 252 has a continuous or solid shape and therefore does not define any openings. Thus, the implantable component 250 does not include a member similar to the central member 206 of the implantable component 106. Instead, one or more stimulation electrodes 256 of the implantable component 250 are positioned directly on the surface of the body 252 (e.g., at a central location on the body 252). Additionally, one or more return electrodes 258 of the implantable component 250 are positioned on the extension member 254. The implantable component 250 also includes circuitry 260 extending from the extension member 254 to the body 252 for electrical connection to the electrodes 256, 258.

[0057] The implantable component 250 is made of a flexible, elastic material and is configured to fold (e.g., via an applied force). As an example, the body 252 and the extension member 254 are configured to rotate relative to each other about a first axis 262 extending along a junction 264 from the body 252 at said junction. As another example, different portions of the body 252 are configured to rotate relative to each other about a second axis 266 extending alongside the extension member 254. Rotation of these portions of the implantable component 250 transforms the implantable component 250 into a folded configuration (e.g., a fully folded configuration) to reduce the size of the implantable component 250. This folded configuration of the implantable component 250 facilitates insertion of the implantable component 250 into the tympanic cavity 108 of the recipient 104, such as through the ear canal 120, and through positioning and movement via an opening 121 formed in or around the tympanic membrane 110. Additionally, the elastic flexible material of the implantable component 250 pushes the implantable component 250 into an expanded configuration, such as by pushing the extension member 254 and the body 252 away from each other about a first axis 262 and / or a portion of the body 252 away from each other about a second axis 266. This facilitates the deployment of the implantable component 250 in the tympanic cavity 108 (e.g., securing the body 252 to the promontory 114).

[0058] Figure 5 This is a front view of another implantable component 350 having an annular body 302 with a defined central opening 304. However, the implantable component 350 does not include any members (e.g., extension members) extending from the body 302 (e.g., toward or away from the central opening 304). Alternatively, one or more stimulation electrodes 306 and return electrodes 308 of the implantable component 300 are positioned directly on the surface of the annular body 302. In such an embodiment, circuitry electrically connected to the stimulation electrodes 306 and return electrodes 308 extends around at least a portion of the periphery (e.g., circumference) of the annular body 302. Although the annular body 302 includes a circular shape defining a central opening 304, in additional or alternative embodiments, the implantable component 350 may have a body of any suitable shape (e.g., rectangular, triangular, irregular) that may or may not define a central opening.

[0059] The implantable component 350 is also made of a flexible material and configured to fold (e.g., via an applied force). For example, different portions of the annular body 302 are configured to rotate relative to each other about a first axis 310 to reduce the size of the implantable component 300, thereby facilitating insertion of the implantable component 300 into the tympanic cavity 108 of the recipient 104. In some embodiments, the annular body 302 can be folded multiple times. For example, after folding different portions of the annular body 302 about the first axis 310, additional portions of the annular body 302 can be folded about a second axis 312 to further reduce the size of the implantable component 300. The flexible material of the implantable component 300 also pushes the implantable component 300 into an expanded configuration (e.g., portions of the annular body 302 rotate away from each other about the first axis 310 and / or about the second axis 312), which facilitates deployment of the implantable component 300 in the tympanic cavity 108.

[0060] Figure 6 This is a flowchart of method 650 for implanting any of the implantable components described herein into a recipient. Method 650 may be performed manually (e.g., by a surgeon) and / or automatically (e.g., by a robotic surgical device) and / or by a combination thereof. In some embodiments, method 650 is performed by a single entity. Alternatively, different entities may perform different operations of method 650. It should be noted that method 650 may be performed differently than depicted in different embodiments. For example, the depicted operations may not be performed, additional operations may be performed, and / or any depicted operations may be performed in a different order.

[0061] At 652, the implantable component is transformed into a foldable configuration. As an example, the implantable component includes a base member and an extension member extending from the base member. The base member and the extension member rotate about each other such that the extension member extends within the outer boundary of the base member (e.g., the extension member extends along the base member) to reduce the size of the implantable component. As another example, different portions of the base member of the implantable component rotate about each other such that these portions extend along each other to reduce the size of the implantable component. The implantable component is constructed of an elastic, flexible material to allow forces to be applied to transform the implantable component into a foldable configuration and / or to hold the implantable component in a foldable configuration. As an example, tweezers are used to grip the implantable component to apply a force to hold the implantable component in a foldable configuration. Additionally or alternatively, the implantable component maintains its foldable configuration without being exposed to elevated temperatures.

[0062] At point 654, an opening is formed in or around the tympanic membrane of the recipient's ear. For example, an incision is made through the tympanic membrane or near its outer boundary. As a result, the recipient's tympanic cavity is exposed to the recipient's ear canal via the opening at the tympanic membrane. In other words, the tympanic cavity can be accessed from the ear canal via the opening at the tympanic membrane. As an example, the opening is surgically formed to have dimensions that can accommodate an implantable component in a folded configuration.

[0063] At point 656, the implantable component is inserted into the recipient's tympanic cavity via an opening. For example, the dimensions (e.g., diameter, width, thickness) of the implantable component in its folded configuration are smaller than the diameter of the ear canal (e.g., the narrowest part of the ear canal) so that the implantable component can be positioned and moved within the ear canal toward the opening at the tympanic cavity, and enters the tympanic cavity via an opening at the tympanic membrane. In some embodiments, forceps used to hold the implantable component in its folded configuration are also used to insert the implantable component into the tympanic cavity via the ear canal, such as using a speculum or catheter extending toward the tympanic cavity through the ear canal.

[0064] At 658, the implantable component is released from the folded configuration, thereby transforming it into an expanded configuration within the tympanic cavity. For example, the forces previously applied to hold the implantable component in the folded configuration are removed. Additionally or alternatively, the implantable component is exposed to elevated temperatures (e.g., the recipient's body temperature). As a result, the elastic, flexible material of the implantable component pushes it out into the expanded configuration. For example, portions of the base member rotate about each other and / or the base member and the extension member rotate about each other to extend away from each other, thereby increasing the size of the implantable component.

[0065] At 660, the implantable component is secured against the promontory of the ear so that the stimulating electrode attached to the base member can contact the promontory. For example, in an expanded configuration, the base member can be easily secured to the promontory (e.g., the elastic, flexible material of the base member allows the base member to conform to the contour of the promontory). In some embodiments, the implantable component is wedged into the tympanic cavity, wherein the extension member abuts against a surface in the tympanic cavity to bias the base member against the promontory. In additional or alternative embodiments, additional features such as adhesives and / or fasteners (e.g., applied adjacent to the stimulating electrode on the base member) are used to secure the base member to the promontory. In another embodiment, surrounding tissue within the tympanic cavity captures the base member to secure it to the promontory. In yet another embodiment, the implantable component is secured by inserting the stimulating electrode attached to the base member into a hole (e.g., having a diameter of 0.5 mm) formed through the promontory (e.g., surgically formed) via an interference fit. Thus, the promontory captures the electrode, thereby maintaining the position of the electrode and the base member within the tympanic cavity. After the implantable component is secured in the tympanic cavity, the tympanic membrane can be sealed to remove the opening, thereby shielding the recipient's ear from the implantable component placed therein.

[0066] Figure 7 This is a schematic diagram illustrating a technique for implanting an implantable medical device, such as the implantable component 106 described above, according to certain embodiments presented herein. In this example, the implantable component 106 is folded / rolled into a folded configuration configured to be adapted for use via a septum 780 positioned in the recipient's ear canal.

[0067] The implantable component can be secured against the promontory at a target location that positions a stimulating electrode (e.g., one of stimulating electrodes 122) in a desired manner to deliver a stimulating signal to the recipient. For example, the target location of the implantable component positions the stimulating electrode within a threshold distance of the recipient's round window, round window niche, and / or cochlea. Such a target location allows at least a portion of the basal member to which the stimulating electrode is attached to overlap with the round window and / or round window niche. However, in some embodiments, securing the implantable component to the promontory avoids applying direct pressure to the round window to avoid affecting its structure and / or function. The positioning of the implantable component within the tympanic cavity also positions the return electrode of the implantable component (e.g., return electrode 208) in a desired manner, such as in contact with the recipient's tissue and / or bone within the tympanic cavity. The target location of the implantable component may include the hypotympanic region and / or the midtympanic region within the tympanic cavity.

[0068] It should be noted that operations similar to those described with respect to method 650 can be performed to remove the implantable part from the recipient. For example, an opening is formed in or around the tympanic membrane of the ear to allow access to the implantable part positioned within the tympanic cavity. Access to the implantable part via the opening at the tympanic membrane allows the implantable part to separate from the promontory of the ear and change from an expanded configuration to a folded configuration (e.g., via applied force). Then, in the folded configuration, the implantable part moves from the tympanic cavity into the ear canal via the opening at the tympanic membrane, and then moves along the ear canal and exits the recipient's ear.

[0069] The procedures described herein enable the implantation and / or removal of implantable components relative to the recipient without requiring more invasive or intensive procedures. For example, a single opening is formed in the recipient (e.g., in or around the tympanic membrane) for the implantation and / or removal of the implantable component, and the opening is relatively small to accommodate the size of the implantable component in a folded configuration. In effect, the foldability of the implantable component facilitates its implantation and / or removal, eliminating the need to form additional openings (e.g., in the recipient's skull, through additional tissue) and / or to form openings of relatively large size to accommodate movement of the implantable component therethrough. For this reason, the implantation and / or removal of the implantable component is simplified or otherwise improved.

[0070] Furthermore, the foldability and / or flexibility of the implantable component allows it to be easily implanted into any recipient. For example, the size of an implantable component in a folded configuration can be small enough to be inserted into the ear canal of any recipient (e.g., different ear canal sizes of different recipients). Additionally, the adjustability of the implantable component allows it to adapt to different anatomical features of different recipients (e.g., different contours of the promontory). Thus, the same embodiment of the implantable component can be inserted and deployed in different recipients. Therefore, it is possible to avoid manufacturing different embodiments of the implantable component (e.g., specific embodiments designed for recipients with ear canal sizes of a particular size and / or promontory contours). In this way, the cost and / or complexity associated with the manufacture of the implantable component is reduced.

[0071] It should be understood that while the specific uses of this technology have been described and discussed above, the disclosed technology can be used with various devices based on many examples of this technology. The foregoing discussion is not intended to suggest that the disclosed technology is only suitable for implementation in systems similar to those shown in the accompanying drawings. In general, additional configurations can be used to practice the processes and systems described herein and / or some aspects can be excluded without departing from the processes and systems disclosed herein.

[0072] This disclosure describes some aspects of the invention with reference to the accompanying drawings, which illustrate only some possible aspects. However, other aspects may be embodied in many different forms and should not be construed as limited to those set forth herein. Rather, these aspects are provided to make this disclosure exhaustive and complete and to fully convey the scope of possible aspects to those skilled in the art.

[0073] It should be understood that the various aspects described herein with respect to the accompanying drawings (e.g., parts, components, etc.) are not intended to limit the system and process to the specific aspects described. Therefore, the methods and systems described herein can be practiced using additional configurations, and / or some aspects described may be excluded without departing from the methods and systems disclosed herein.

[0074] According to some aspects, a system and a non-transitory computer-readable storage medium are provided. The system is configured with hardware configured to perform operations similar to those of the present disclosure. One or more non-transitory computer-readable storage media include instructions that, when executed by one or more processors, cause one or more processors to perform operations similar to those of the present disclosure.

[0075] Similarly, where the steps of a process are disclosed, these steps are described for illustrative purposes of the method and system and are not intended to limit this disclosure to a particular sequence of steps. For example, these steps may be performed in a different order, two or more steps may be performed simultaneously, additional steps may be performed, and the disclosed steps may be excluded without departing from this disclosure. Furthermore, the disclosed process may be repeated.

[0076] Although specific aspects have been described herein, the scope of this technology is not limited to these specific aspects. Those skilled in the art will recognize other aspects or modifications within the scope of this invention. Therefore, specific structures, operations, or media are disclosed only as illustrative aspects. The scope of this technology is defined by the following claims and any of their equivalents.

[0077] It should also be understood that the embodiments presented herein are not mutually exclusive, and various embodiments can be combined with one embodiment in any of a variety of different ways.

Claims

1. A medical device comprising: A base member configured to be implanted into the tympanic cavity of the recipient's ear via an opening in or around the tympanic membrane, wherein the base member is configured to be fixed to the promontory of the ear within the tympanic cavity; as well as At least one electrode disposed on the base member, the at least one electrode being configured to deliver a stimulation signal to the receiver. The medical device described herein has a folded configuration for implantation into the tympanic cavity via the opening in or around the tympanic membrane and an expanded configuration for fixation to the promontory.

2. The medical device according to claim 1, further comprising an elastic flexible induction coil disposed in the base member.

3. The medical device of claim 1, wherein the expansion configuration of the medical device includes a convex configuration to capture the outline of the promontory of the ear.

4. The medical device according to claim 1, 2, or 3, wherein the medical device includes an extension member extending from the base member, and wherein, In the expanded configuration of the base member, the extension member is configured to interact with a surface in the tympanic cavity to offset the base member against the promontory.

5. The medical device according to claim 4, wherein, In the expanded configuration of the base member, the extension member is configured to abut against the drum wall facing the promontory within the tympanic cavity.

6. The medical device of claim 4, further comprising at least one return electrode disposed at the distal end of the extension member.

7. The medical device of claim 4, wherein the extension member is configured to rotate relative to the base member to transform the medical device between the folded configuration and the expanded configuration.

8. The medical device according to claim 1, 2 or 3, wherein the base member comprises an annular body defining a central opening.

9. The medical device of claim 8, wherein the medical device includes a central member extending into the central opening, and wherein the at least one electrode is disposed on the central member.

10. The medical device of claim 8, wherein the at least one electrode is disposed on the surface of the annular body.

11. The medical device according to claim 1, 2 or 3, further comprising: A stimulator unit electrically connected to the at least one electrode, wherein the stimulator unit is configured to generate the stimulation signal for delivery to the recipient via the at least one electrode.

12. The medical device of claim 11, wherein the stimulator unit is configured to generate the stimulation signal for alleviating tinnitus symptoms experienced by the recipient.

13. The medical device of claim 11, wherein the stimulator unit is configured to generate the stimulation signal for treating a movement disorder experienced by the recipient.

14. The medical device of claim 11, wherein the stimulator unit is configured to generate the stimulation signal for treating the balance dysfunction experienced by the recipient.

15. The medical device of claim 11, wherein the stimulator unit is configured to generate the stimulation signal based on data transmitted from an external component.

16. The medical device of claim 11, further comprising an implantable processing module, wherein the implantable processing module is configured to output a control signal to the stimulator unit to cause the stimulator unit to generate the stimulation signal.

17. A method for implanting a medical device into a recipient, comprising: An opening is formed at the eardrum of the recipient; The medical device is inserted into the tympanic cavity of the ear through the opening, wherein the medical device has a folded configuration during insertion through the opening; After inserting the medical device into the tympanic cavity, the medical device is released into an expanded configuration; and The medical device in the expanded configuration is fixed against the promontory of the ear.

18. The method of claim 17, further comprising: The medical device is folded into the folded configuration before being inserted through the opening at the tympanic membrane.

19. The method of claim 18, further comprising: Apply force to fold the medical device into the folded configuration; as well as Remove the force applied to fold the medical device to release the medical device into the expanded configuration.

20. The method of claim 18, further comprising: After the medical device is inserted into the tympanic cavity, the medical device is exposed to elevated temperatures to release the medical device into the expanded configuration.

21. The method of claim 17, wherein securing the medical device against the promontory comprises: At least one of the adhesives or fasteners is applied to the medical device.

22. The method of claim 17, wherein the medical device comprises a base member and an extension member extending from the base member, and wherein securing the medical device against the promontory comprises: The base member is brought into contact with and abuts the promontory of the ear; as well as The extension member is positioned abutted against the drum wall facing the promontory within the tympanic cavity, such that the base member is offset against the promontory.

23. An implantable medical device system, comprising: A flexible coil having a first configuration with a first shape factor for insertion into the middle ear cavity of a recipient and a second configuration with a second shape factor for deployment in the middle ear cavity; At least one stimulating electrode; as well as A stimulator unit electrically connected to the elastic flexible coil and the at least one stimulating electrode, wherein the stimulator unit is configured to generate an electrical stimulation signal for delivery to the recipient via the at least one stimulating electrode.

24. The implantable medical device system of claim 23, comprising an external component configured to be positioned in the ear canal of the recipient, wherein the external component is configured to transmit data and / or power percutaneously to the resilient flexible coil across the tympanic membrane of the recipient.

25. The implantable medical device system of claim 24, wherein the stimulator unit is configured to generate the electrical stimulation signal based on data transmitted from the external component.

26. The implantable medical device system of claim 23, 24 or 25, comprising an implantable processing module, wherein the implantable processing module is configured to output a control signal to the stimulator unit to cause the stimulator unit to generate the electrical stimulation signal.

27. The implantable medical device system of claim 23, 24, or 25, wherein the flexible coil comprises: Part One; as well as A second portion extending from the first portion, wherein the first portion and the second portion are configured to rotate relative to each other to cause the elastic flexible coil to transition between the first configuration and the second configuration.

28. The implantable medical device system of claim 23, 24 or 25, wherein the elastic flexible coil is made of a shape memory alloy configured to transform into and maintain the second configuration during exposure to a first temperature below a threshold, and to transform from the second configuration into the first configuration upon exposure to a second temperature above the threshold.

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