Abstract: A method of alerting a user to the existence of an artificially induced neuromuscular response in a subject includes: generating a series of electrical stimuli at a predetermined period with an electrode disposed at a distal end portion of an elongate medical device; detecting a series of mechanomyographic (MMG) responses of the subject using a mechanical sensor, each MMG response indicative of a contraction of a muscle of the subject; determining a degree of statistical confidence that the detected series of MMG responses was artificially induced by the series of electrical stimuli; and outputting, to the user, both an alert that a series of MMG responses has been detected, and the determined degree of statistical confidence that the detected series of MMG responses was artificially induced by the series of electrical stimuli.

Abstract: Robotic devices and methods for performing minimally invasive procedures on the vascular system, particularly cerebrovascular and endovascular neurosurgical procedures, where a submillimeter-scale continuum robotic device is configured and adapted for active steering and navigation based on external magnetic actuation. The submillimeter-scale continuum robotic device includes an elongate body having an inner core and an outer shell, where the outer shell is fabricated of an elastomeric material having a plurality of ferromagnetic particles dispersed therein.

Abstract: A cochlear implant exomagnet that includes a magnet apparatus and a magnet mount configured to secure the magnet apparatus to a cochlear implant in such a manner that the magnet apparatus is not located within the internal magnet pocket of the cochlear implant.

Abstract: Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a therapeutic agent, for example, to the round window niche adjacent to the cochlea under direct visualization. The systems and methods can also be used to improve accessibility and visualization for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

Abstract: A tip member for inserting into the cochlea, a device comprising: an elongate member including at least one electrode mounted thereon; and a tip member extending distally from a distal end of the elongate member, the tip member comprising a tapered portion tapering distally and a blunt end portion at a distal end of the tapered portion, wherein the tip member is resiliently flexible, and a method for making such a device.

Abstract: An implantable medical device comprising a sealed flat housing enclosing an electronic circuitry; a plurality of feedthrough conductors, each feedthrough conductor comprising a proximal end part connected to the enclosed electronic circuitry and a distal end part extending from a side surface of the housing and cumulated on said side surface; a tubing that houses a plurality of wires connected to said feedthrough conductors and that is arranged on the housing; and a longitudinal slit through the wall of the tubing through which the wires extend out of the tubing.

Abstract: An exemplary stiffening member facilitates insertion of an electrode lead into a cochlea of a patient. The stiffening member includes an elongate body configured to integrate with the electrode lead so as to maintain the electrode lead in a substantially linear configuration in an absence of a flexure force on the body. The stiffening member further includes compression slots distributed along a first side of the body closer to the electrodes than a second side while the body is integrated with the electrode lead. The compression slots are configured to compress, in a presence of the flexure force, so as to bias the body to flex in an inward direction. Additionally, the stiffening member includes strain relief slots distributed along the second side of the body and configured to expand so as to complement the compression slots in biasing the body to flex in the inward direction.

Abstract: A system is provided for driving an implantable neurostimulator lead, the lead having an associated plurality of electrodes disposed in at least one array on the lead. The system comprises an implantable pulse generator (IPG), the IPG including an electrode driver, a load system for determining load requirements, an IPG power coupler, and an IPG communication system. The system also includes an external unit, which includes an external variable power generator, an external power coupler, an external communication system, and a controller for varying the power level of the variable power generator.

Abstract: An exemplary cochlear implant assembly includes a cochlear implant configured to apply electrical stimulation to the recipient by way of an electrode array, a cochlear implant antenna communicatively coupled to the cochlear implant, and an encapsulant that covers the cochlear implant and the cochlear implant antenna, the encapsulant impregnated with a dielectric material that is configured to confine an electric field around the cochlear implant antenna. Corresponding methods for manufacturing cochlear implant assemblies are also described.

Abstract: The present embodiment is an implantable device capable of controlling cochlear implant electrode insertion and positioning. The embodiment uses an implanted mechanical positioning unit to advance position and monitor an electrode array. The device can be controlled via an external controller to reposition or advance an electrode array at any point after implantation with no surgical re-intervention. A cochlear implant electrode array whose position can be advanced and modified over time to best fit a patient's evolving hearing pattern would improve functional outcomes and significantly expand the candidacy range for cochlear implantation to include patients with substantial residual hearing.

Abstract: A cochlear implant, for use with a micro camera, including a stimulation assembly, a cochlear lead with an electrode array, a lens associated with the distal region of the electrode array, an optical fiber bundle that extends proximally from the lens and outwardly from the proximal region of the cochlear lead, a camera interface in which the proximal end of the optical fiber bundle is located and that is configured to receive the micro camera, and at least one illumination guide that extends from the camera interface to the cochlear lead.

Abstract: A navigation system or combination of navigation systems can be used to provide one or more navigation modalities to track a position and navigate a single instrument in a volume. For example, both an Electromagnetic (EM) and Electropotential (EP) navigation system can be used to navigate an instrument within the volume. The two navigation systems may be used separately to selectively individually navigate the single instrument in the volume. Disclosed are also systems and processes to determine a shape of the single instrument either alone or in combination with the position of the instrument. The instrument may be navigated with the addition of tracking devices or with native or inherent portions of the instrument.

Abstract: An exemplary self-curling cochlear electrode lead includes a flexible body formed of a flexible insulating material, a shape memory polymer element that is embedded within the flexible body and that is configured to cause the self-curling cochlear electrode lead to transition to a curved spiral shape so as to conform with a curvature of a human cochlea when a temperature of the shape memory polymer element reaches a transition temperature, a plurality of electrode contacts arranged along a side of the flexible body, and a plurality of wires embedded within the flexible body and configured to electrically connect the plurality of electrode contacts to at least one signal source. Corresponding methods of manufacturing a self-curling cochlear electrode lead are also described.

Abstract: Presented herein are dual-function surgical tools for insertion of implantable stimulating assemblies, such as intra-cochlear stimulating assemblies. In addition to facilitating intra-operative positioning of a stimulating assembly within a recipient (e.g., operating to guide the stimulating assembly of an implantable medical device into position), the surgical tool also includes a plurality of electrodes configured to apply an electroporation electrical field to a recipient's nerve cells to enable introduction of treatment substance into the nerve cells.

Abstract: A cochlear including a housing, an antenna, a stimulation processor operably connected to the antenna, and an electrode array, operably connected to the stimulation processor, including a flexible body defining a longitudinal axis, a proximal region and a distal region, a plurality of electrically conductive contacts on the flexible body, and at least one stiffener within the flexible body.

Abstract: A method of forming an electrode array is disclosed, the method comprising: forming an elongate comb structure comprising a plurality of longitudinally-spaced electrode contacts extending from and supported by a spine; electrically connecting each of a plurality of electrically conductive pathways to a respective one of the plurality of electrode contacts; placing the conductive pathways adjacent the contacts; placing silicone over the conductive pathways and contacts; curing the silicone so as to substantially retain the longitudinal spacing between neighboring contacts; and severing the spine from the plurality of electrode contacts.

Abstract: A transcutaneous nerve stimulation system includes a multifunctional earphone assembly that receives a sound signal from a sound source or other sources (such as a signal generator). An amplifier receiving the sound signal from the sound source or independent signal generator amplifies the sound signal to generate an amplified electrical signal. A stimulator, which includes multiple conductive electrode contacts, is coupled to the amplifier to receive the amplified electrical signal. The electrode contacts may protrude from an earbud/headphone or extend from an adjustable probe arm. The amplified electrical signal is used to apply electrical stimulation while the earphone assembly emits audible sounds according to the sound signal. The combined functionality enhances compliance with treatment regimens involving electrical stimulation of vagus nerves and other regions of a subject.

Abstract: Provided is a method of transfecting cells of the cochlea with an agent by electroporation, and in certain embodiments using a cochlear implant to provide at least one electroporation electrode.

Abstract: An implantable electrode arrangement for a cochlear implant system is described. A retraction limiter fits around and securely engages a portion of the distal end of an electrode lead. The retraction limiter includes flexible retraction limiting projections longitudinally distributed along its outer surface. An insertion tube fits around the electrode array and the retraction limiter and engages against the outer surface of the patient cochlea at a cochlear opening. An insertion plunger fits within the insertion tube and engages against the proximal end of the retraction limiter. The insertion plunger slides within the insertion tube to push against the proximal end of the retraction limiter to push the electrode array through the cochlear opening into the patient cochlea.

Abstract: An apparatus and method for implanting and securing an implanted medical device in a recipient. The implantable medical device of the generally includes an electrode assembly that comprises an elongate carrier member having at least one stimulating electrode positioned thereon. The carrier member further has a fixation structure positioned thereon configured to interact with a portion of the rigid structure to longitudinally secure the carrier member in the recipient.

Abstract: A device and method for the continuous monitoring of otoacoustic emissions (OAE) levels on an individual worker uses as a pair of earpieces each featuring an external microphone, an internal microphone and a pair of miniature receivers. An adaptive filtering noise rejection processing of the measured distortion product OAE (DPOAE) is used to further improve the Signal-to-Noise ratio in frequencies where passive isolation remains insufficient. The adaptive filtering noise rejection technique relies on a Normalized Least-Mean-Square (NLMS) algorithm that uses the ipsilateral external microphone and the contralateral internal microphone to reject the noise from the measured DPOAE signals for each in-ear OAE probe. A DPOAE signal extraction algorithm provides for an increase in results reliability on a greater dynamic range in DPOAE magnitudes than known methods of DPOAE signal extraction.

Abstract: A method for operating a hearing prosthesis including operating the hearing prosthesis in a first mode, and monitoring an operating characteristic of the hearing prosthesis. The operating characteristic may relate to one or more of a power supply configured to provide power to the hearing prosthesis, or a temperature characteristic of the hearing prosthesis. The method also includes determining that the operating characteristic is at a threshold level, and responsive to determining that the operating characteristic is at the threshold level, operating the hearing prosthesis in a second mode. In this example, operating the hearing prosthesis in the second mode at least one of uses less power or generates less heat than operating the hearing prosthesis in the first mode.

Abstract: Distant support is provided to a personal hearing system user by a support provider over a network. Support provider and user communicate with each other by speech transmitted over the network. The user depends in regard to understanding speech on his or her hearing aids. During the support session the hearing aids may have to be removed, may have to be switched off or may be programmed in an unfavorable way. In this case, the user may not be able to understand the speech of the support provider any more. The system enables the support provider to select a message from a list of available messages which is then presented as a visual image to the user. The obstructed acoustical channel is bypassed by relying on visual communication.

Abstract: Presented herein are intra-operative techniques for setting the angular insertion depth of a stimulating assembly during implantation into a recipient's cochlea. In certain embodiments, the angular insertion depth is monitored in real-time and advancement of the stimulating assembly is terminated when a selected angular insertion depth is achieved. In further embodiments, a linear insertion depth that corresponds to a selected angular insertion depth is intra-operatively calculated and advancement of the stimulating assembly is terminated when the calculated linear insertion depth is achieved.

Abstract: Systems and methods are disclosed herein that can allow for wirelessly powering and/or communicating with a sterile-packed electronic device without removing the electronic device from its sterile packaging and while maintaining the sterility of the electronic device. In some embodiments, a base station with a power transmitter wirelessly transfers power to a power receiver of the electronic device, for example using inductive, capacitive, or ultrasonic coupling. The base station or another external device can also be used to wirelessly program or interrogate the electronic device. Battery charging circuits and switching circuits for use with said systems and methods are also disclosed.

Abstract: An implantable electrode arrangement for a cochlear implant system is described. The arrangement includes a flexible intracochlear electrode array having an outer surface with electrode contacts for applying cochlear stimulation signals to target neural tissue within the implanted cochlea. A flexible extracochlear electrode lead is coupled at a lead proximal end to an implanted signal processor that provides the cochlear stimulation signals, and connected at a lead distal end to a proximal end of the electrode array. A lead holder is connected to the lead distal end and has an initial shape. The lead holder is malleable and adapted to be intra-surgically deformed into and retain a new desired shape so as to secure the lead distal end at the electrode opening into the implanted cochlea and decouple post-surgical mechanical strain at the lead distal end from the electrode array.

Abstract: An implantable electrode is described for a cochlear implant patient with a cochlea having a single internal cavity defined by an outer cavity wall. The electrode includes an extra-cochlear electrode lead with signal wires for conducting electrical stimulation signals. An intra-cochlear electrode array is configured to be inserted into the cochlea through a single cochleostomy opening and is made of a resilient carrier material having an outer surface with one or more stimulation contacts for delivering the electrical stimulation signals to adjacent neural tissue. An insertion line is attached to the outer surface of the electrode array at a distal end and is made of a line material different from the electrode carrier material. The insertion line is configured to have an extra-cochlear end extending outside the cochleostomy opening during surgical insertion of the electrode array into the cochlea.

Abstract: An implantable electric lead arrangement for a medical implant system includes an implantable electric lead with parallel lead wires wound in an elongated helix about a central longitudinal axis. A conical shape lead core is fixed and enclosed within the wire helix for providing impact strain relief to the electric lead by resisting radial and/or axial deformation from external impact force. The conical shape of the lead core is configured for a smooth transition between a lead core portion of the electric lead that is protected against external impact force and a non-lead core portion of the electric lead that is unprotected from external impact force.

Abstract: A tip member for inserting into the cochlea, a device comprising: an elongate member including at least one electrode mounted thereon; and a tip member extending distally from a distal end of the elongate member, the tip member comprising a tapered portion tapering distally and a blunt end portion at a distal end of the tapered portion, wherein the tip member is resiliently flexible, and a method for making such a device.

Abstract: A device, system and method for inserting a pre-curved electrode array (100) held in a substantially straight configuration by a straightening member (101) into a cochlea of a subject. As the electrode array (100) is inserted into the cochlea by the device, the straightening member (101) is held by the device such that the electrode array (100) advances off the straightening member (101) such that it is free to take on its pre-curved configuration in the cochlea of the subject.

Abstract: A microcircuit integrated cochlear electrode array and a process for the manufacture thereof, the electrode array comprising a multiconductor tail portion with longitudinally spaced outwardly exposed electrode receiving pads and a flat multiconductor head portion connected to the tail portion and having spaced outwardly exposed circuit attachment pads, the tail and head portions being laminated between a nonconductive film substrate and an insulating cover and the tail portion being helically wrapped into a helix with the electrode receiving circuit attachment pads exposed and carrying ring electrodes overmolded with a suitable polymeric material.

Abstract: Embodiments presented herein are generally directed to a stimulating assembly of a cochlear implant. The stimulating assembly comprises one or more fixation features configured to be inserted into a recipient's cochlea via an opening in the cochlea. Following insertion, the one or more fixation features are configured to engage an inner surface of the cochlea adjacent to the opening to prevent movement of the stimulating assembly out of the cochlea through the opening.

Abstract: An implantable device for stimulating body tissue that includes an electrode lead body and at least one stimulating electrode contact disposed on the electrode lead body. The electrode lead body may be a percutaneous electrode lead or an electrode paddle that is configured and arranged to be substantially stiff outside the patient's body and during insertion into the patient's body and then becomes non-stiff within the patient's body. The stiffness may be modified using, for example, resorbable materials, temperature sensitive materials, or a lumen within the lead body for introducing a pressurized gas or liquid to modify a stiffness of the lead body. In one embodiment, the lead body may have different acute and/or chronic shapes.

Abstract: A method is described to implant a cochlear implant electrode into a cochlea having a single internal cavity defined by an outer cavity wall. An implantable electrode array is made of a resilient electrode carrier material and has an outer surface with one or more stimulation contacts for delivering the electrical stimulation signals to adjacent neural tissue. A distal end of the electrode array is attached to an insertion line made of a line material different from the electrode carrier material. The distal end of the electrode array is inserted through a single cochleostomy opening into the cochlea while an extra-cochlear end of the insertion line is held outside the cochleostomy opening. The remainder of the electrode array is inserted through the cochleostomy opening into the cochlea while continuing to hold the extra-cochlear end outside the cochlea to maneuver all of the stimulation contacts against the outer cavity wall.

Abstract: An implantable electrode arrangement for a cochlear implant system is described that prevents post-surgical retraction of the electrode. The arrangement includes at least one retraction limiter having an extracochlear portion located at a distal end of the extracochlear electrode lead and an intracochlear portion located at a proximal end of the intracochlear electrode array and made at least in part of a swellable material that expands in response to fluid contact. The intracochlear portion of the retraction limiter is adapted for deformation away from an outer surface of the array proximal end in response to exposure of the swellable material to perilymph fluid within the cochlea after surgical insertion of the electrode array into the implanted cochlea so as to form an anti-retraction projection preventing post-surgical retraction of the array proximal end back through the electrode opening in the outer surface of the implanted cochlea.

Abstract: A novel implantable electric lead arrangement is described for medical implant systems such as middle ear implants (MEI), cochlear implants (CI) and vestibular implants (VI). An electric lead contains parallel lead wires wound in an elongated helix about a central longitudinal axis. A lead core is fixed and enclosed within the wire helix for providing impact strain relief to the lead wires by resisting radial and/or axial deformation from external impact force.

Abstract: An implantable medical device, comprising an implantable component having a rechargeable power supply and an external wireless charger. The wireless charger has a rechargeable power supply, and an inductive coil configured to transcutaneously transfer power from the charger power supply to the implantable power supply, and configured to detect and receive, via the inductive coil, power from an auxiliary charger for recharging of the charger power supply.

Abstract: An electrode array (30) which is able to be inserted to a desired depth within the cochlea to provide useful percepts for the recipient which will also preferably not cause damage to the sensitive structures of the cochlea. The electrode array (30) is insertable through an opening in the cochlea and into at least the basal region of the cochlea and comprises an elongate carrier (31) having a proximal end, a distal end, and a plurality of electrodes (32) supported by the carrier at respective spaced locations thereon in a region between the proximal end and the distal end. A stabilizing collar (35) extends outwardly from the elongate carrier (31) at or adjacent a proximal end thereof and has an abutment surface adapted to abut a portion of the cochlea surface around the cochleostomy and at least substantially prevent movement of the carrier (31) following completion of insertion of the array (30) into the cochlea.

Abstract: An implantable drug-delivery sleeve for an elongate component of an implantable medical device. The sleeve includes a tubular substrate having a lumen configured to receive the elongate component so as to allow relative displacement of the substrate and the elongate component, wherein the substrate is shaped so as to be retained stationary at a desired position along the elongate component, and a drug releasably carried by the substrate.

Abstract: A method for delivering drugs from an implantable medical device to an implantee, comprising implanting the medical device having a receptacle configured to receive a drug release capsule, the drug release capsule having at least one drug disposed thereon, placing the drug release capsule in the receptacle subsequent to the implanting, and permitting the release of the at least one drug from the drug release capsule to the recipient.

Abstract: A vestibular stimulation array is disclosed having one or more separate electrode arrays each operatively adapted for implantation in a semicircular canal of the vestibular system, wherein each separate electrode array is dimensioned and constructed so that so that residual vestibular function is preserved. In particular, the electrode arrays are dimensioned such that the membranous labyrinth is not substantially compressed. Furthermore, the electrode array has a stop portion to limit insertion of the electrode array into the semi-circular canal and is stiff enough to avoid damage to the anatomical structures.

Abstract: A cochlear lead includes a plurality of electrode assemblies partially embedded in a flexible body configured to stimulate an auditory nerve from within a cochlea. Each of the electrode assemblies includes a flexible electrically conductive material forming a plurality of support structures and an electrode pad attached a support structure, the electrode pad having a surface that is configured to be exposed to cochlear tissue and fluids and has a charge transfer to the cochlear tissue and fluids that is higher than the flexible electrically conductive material.

Abstract: An implantable electrode array for a cochlear implant has an array trunk that extends along a center axis from an insertion opening in an outer surface of a patient cochlea into the scala tympani. An apical section extends along the center axis from a distal end of the array trunk and a basal branch is separate from the array trunk and extends back from the distal end of the array trunk towards the insertion opening. The apical section follows along an outer lateral wall of the scala tympani during surgical insertion to attain a final insertion position towards the outer lateral wall in an apical portion of the scala tympani beyond a first basal turn of the cochlea. The basal branch attains a final insertion position towards an inner modiolar wall by the first basal turn of the cochlea with the basal branch stimulation contacts facing the inner modiolar wall.

Abstract: A cochlear lead includes a plurality of electrodes configured to stimulate an auditory nerve from within a cochlea and a flexible body supporting the plurality of electrodes along a length of the flexible body. A stiffening element is slidably encapsulated within the flexible body and positioned such that the stiffening element plastically deforms upon insertion into a curved portion of the cochlea.

Abstract: An implantable apparatus for delivering electrical stimuli to a user, the apparatus including at least a stimulator adapted to generate stimulation signals, an electrode array, said array including a plurality of electrodes for delivering said stimulation signals; and a plurality of release sites for pharmaceutical agents, said release sites being positioned at locations along said array, said release sites being controlled such that said agents can be operatively delivered at selected ones of said locations.

Abstract: Embodiments presented herein are generally directed to a stimulating assembly of a cochlear implant. The stimulating assembly comprises one or more fixation features configured to be inserted into a recipient's cochlea via an opening in the cochlea. Following insertion, the one or more fixation features are configured to engage an inner surface of the cochlea adjacent to the opening to prevent movement of the stimulating assembly out of the cochlea through the opening.

Abstract: A system, including a first prosthetic device configured to evoke a hearing percept based on a first ambient sound and a second non-invasive device configured to stimulate skin based on a second ambient sound generated by a voice.

Abstract: A cochlear implant electrode includes an electrode carrier having an electrode array with a groove disposed in a longitudinal direction along the electrode carrier, and a stopper positioned around the electrode carrier. The stopper has a protrusion on its inner surface that is configured to be positioned within the groove such that the stopper is movable with respect to the electrode carrier and a skirt disposed on a portion of its outer surface. Another configuration includes an electrode carrier having an electrode array with grooves disposed in a transverse direction along the electrode carrier, and a stopper positioned around the electrode carrier and configured to be positioned within each groove and movable with respect to the electrode carrier. The stopper has a skirt disposed on a portion of its outer surface.

Abstract: A novel sensing system and methods for preventing damage to the cochlea during cochlear implant surgery are disclosed, using optical sensing to determine the distance of a stylet or the end of the implant itself from the interior wall of the scalar tympani. A variety of feedback methods are proposed to enable the surgeon to perform the procedure safely without damage to the basilar membrane or other delicate anatomic structures. Although a number of embodiments are disclosed, one preferred embodiment comprises a robotically manipulated end-effector.

Abstract: A cochlear implant arrangement is described for creating sound perception in an implanted patient. An implant electrode contains electrode wires for carrying stimulation signals to corresponding electrode contacts distributed along a length of an outer surface of an apical electrode array section of the implant electrode. An apical portion of the electrode array is characterized by a tendency to fold back against a more basal section of the electrode array when inserted into a cochlea of the patient. An implantable stimulation processor produces the stimulation signals such that each electrode contact, including any in a folded back portion, delivers stimulation signals for a frequency band defined based on a function of spatial spread of stimulation voltage and correctly associated with tonotopic frequency response of the adjacent neural tissue.