Abstract: A device for use in the repair of an ear drum in a subject in need of such treatment, said device: having a tensile strength Youngs Modulus between approximately 12.5 and 40 MPa; comprising one or more membrane layers, wherein at least one membrane layer comprises a plurality of pores; and wherein the device can support proliferation, migration and/or adhesion of cells selected from the group comprising at least any one or more of: keratinocytes, fibroblasts, vascular cells, mucosal epithelial cells, and stem cells.

Abstract: A middle ear implant may include a first interface portion configured to interface with a first structure of a middle ear of a patient, a second interface portion configured to interface with a second structure of the middle ear of the patient, a shaft configured to connect the first interface portion and the second interface portion, and a sensor disposed at one end of the shaft, between the shaft and one of the first interface portion or the second interface portion. The sensor may be configured to provide a DC signal output indicative of static pressure on the sensor based on placement of the sensor between the first and second structures. The sensor may also be configured to provide an AC signal output indicative of a frequency response of the implant in response to the sensor being coupled to an output device.

Abstract: A malleable implantable medical device for implanting in a recipient comprising a flexible region of the medical device, one or more structures proximate to the flexible region, wherein the one or more structures is configured to provide a bending force to the flexible region, and one or more hermetically sealed medical components coupled to the flexible region, wherein the one or more medical components is configured to provide a therapeutic effect on the recipient.

Abstract: A medical implant device includes a prosthesis adapted to replace at least a portion of a bone. The prosthesis includes a drug-eluting polymer adapted to deliver a drug to at least a portion of an area surrounding the prosthesis.

Abstract: The present invention relates to a cochlear implant apparatus, and more particularly, to a cochlear implant apparatus capable of controlling the sensitivity or selectivity of sound through actuators. In accordance with an exemplary embodiment of the present invention, a cochlear implant apparatus for active feedback control which is inserted into the human body and configured to detect a sound in each frequency band includes a sensor unit configured to detect vibration according to a sound and generate an electrical signal corresponding to a magnitude of the vibration and actuators disposed in the sensor unit and each configured to react to the electrical signal and to control sensitivity according to the magnitude of the sound or the selectivity of a sound detected in each frequency band.

Abstract: Embodiments of the invention described herein thus provide systems and methods for ear restoration surgery. Certain embodiments provide an improved framework that provides enhanced cooperation between an ear base and a rim.

Abstract: Disclosed herein is an auricular implant, comprising an auricular base and a supporting member. The auricular base has a first side and a second side opposite to the first side, wherein the first side thereof is disposed with a position unit. The supporting member having a thickness and a recess, wherein the position unit of the auricular base is disposed in the recess of the supporting member to adhere the supporting member to the first side of the auricular base for forming a stereoscopic disk-like structure.

Abstract: An active ossicular replacement device is configured to couple the malleus to the stapes, and conduct sound through the vibratory structures of the ear in response to the transmitted electromagnetic energy. The electromagnetic energy may comprise light so as to decrease interference from sources of noise external to the user. The prosthetic device may comprise an assembly that can be implanted in the middle ear in a manner that simplifies surgery. The assembly may comprise a narrow cross-sectional profile such that the assembly can be positioned in the middle ear through an incision in the eardrum, for example without cutting bone that defines the shape of the ear canal or the shape of the middle ear. The prosthetic device can be sized to the user based on a measurement of the ear.

Abstract: A tympanic construct fabricated from at least one amniotic membrane, at least one chorionic membrane, or at least one amniotic membrane and at least one chorionic membrane obtained from human birth tissue is provided. Methods of preparing a tympanic construct, methods of repairing tympanic membrane defects and surgical sites, as well as kits for the same are also provided.

Abstract: Implants for promoting bone growth and methods of using same, the implants including a perforated placental membrane sheet wrapped around an osteoconductive material composed of bone chips, bone granules, bone powders or combinations thereof, the osteoconductive material being configured for providing a scaffold upon which bone growth can occur. The placental membrane sheet acts to maintain the osteoconductive material in a cohesive, organized configuration within a site of a patient where bone growth is to be induced. The perforations in the placental membrane sheet create passageways in the exterior of the implant through which the osteoconductive material can communicate with adjacent bone surfaces which are to be fused.

Abstract: A prosthetic element enables the stapes footplate to be connected to the foot of a middle ear ossicular prosthesis. The prosthetic connection element is of biocompatible material and forms part of the foot or is connected or connectable to this latter, and includes a body provided with a flat surface intended to rest on the footplate and having an area sufficient to prevent reabsorption of the footplate osseous tissue as a result of the pressure which the ossicular prosthesis exerts on the footplate. The prosthetic element includes at least two pointed projections projecting from the flat surface and to penetrate the footplate.

Abstract: A prosthesis for insertion in an ear to reduce pain resulting from TMJ disorders. The ear insert has a predefined shape conforming to the shape of the ear canal when the jaw is in an open position. The ear insert supports the TMJ and associated secondary musculature to reduce strain in the TMJ area, including the muscles, ligaments, nerves, and the temporo-mandibular joint itself. The insert is hollow in the inside to permit hearing and is made of a rigid material which retains the shape of the ear canal. A scalloped indenture extends across a surface of the ear insert positioned behind the tragus.

Abstract: A middle ear ossicle prosthesis in which the component for ossicular attachment comprises a surface bearing a plurality of discrete projections facing the ossicle to which it is attached which minimize total contact between the prosthesis and the ossicle. The prosthesis may comprise a loop forming a partial circle for encircling an ossicle, a piston for transmitting vibrations from the loop to the inner ear, and a rod solidly connecting the loop to the piston. The loop may have an upwardly turned end to facilitate placement of the loop over the ossicle. The projections may be provided in one row, two rows, or may be otherwise arrayed, and may be dissimilar from one another in configuration and dimensions.

Abstract: An apparatus including: at least one processor; and at least one memory including computer program code, the at least one memory and the computer program code configured to, with the at least one processor, allow the apparatus to perform at least the following: receiving a background audio signal from an earpiece microphone, the earpiece microphone configured to convert sound from a surrounding environment into the background audio signal; and allow a user of the apparatus to control the generation and characteristics of a noise cancellation signal, the noise cancellation signal configured to interfere destructively with the background audio signal to alter the amplitude of the background audio signal.

Abstract: An ossicular prosthesis formed as a sound-conducting, elongated prosthesis body has a first coupling element designed as a tympanic membrane top plate or a clip or a connecting piece to an actuator end piece of an active hearing implant and a second coupling element provided with an access opening into a receiving space designed as a bell or a clip for a mechanical connection of the prosthesis to the head of the stapes. The second coupling element has a backing section on an inner surface of the receiving space as an axial extension of the prosthesis body. The backing section protrudes from the prosthesis body into the receiving space. In an implanted state, the backing section bears against a head of the stapes and prevents a formation of a hollow space between the stapes and an inner surface of the receiving space in an axial extension of the elongated prosthesis body.

Abstract: A total prosthesis for the middle ear, with a prosthesis body, with a first coupling element for connection of the prosthesis to the tympanic membrane or for coupling to the manubrium, and with a second coupling element for connection to the footplate of the stirrup, which second coupling element has a receiving part, connected rigidly to the prosthesis body, and has an insert part with a plug element that can be inserted coaxially, and with a shoe that is connected rigidly to the plug element and that bears on the footplate of the stirrup, is characterized in that the receiving part has an elongate cavity as a receiving opening with a cylindrical bore which extends axially and encloses the full circumference of the plug element and whose inside diameter is greater than the maximum transverse extent of the plug element, which elongate cavity is closed at the end away from the insert part and acts as an end abutment for the plug element, and in that the second coupling element extends axially by at most a thir

Abstract: A method of fabricating an anisotropic porous scaffold includes heating a previously-formed porous metal scaffold to permit deformation of a material of the previously-formed porous metal scaffold, and deforming, while heated, the previously-formed porous metal scaffold in at least a first direction.

Abstract: Internal nasal valve involves injecting a biomaterial filler into the internal nasal valve of the patient. The injected biomaterial filler in the internal nasal valve increases an internal nasal valve angle.

Abstract: An implantable medical device, comprising a first implantable component having a first interface surface and a second implantable component. The second implantable component has a second interface surface comprising one or more integrated protrusions extending therefrom configured to mate with the first interface surface and to provide a desired spacing between the first and second implantable components.

Abstract: An implantable receptacle for receiving a hearing aid component includes a body having a proximal portion, a distal cylindrical portion and a joining portion joining the proximal portion to the distal cylindrical portion. First flexible tines extending from an outer wall of the distal cylindrical portion in the general direction of the proximal portion are configured to engage with and lock the distal cylindrical portion to a wall of a fenestration in a bone of the patient in a permanent fashion in response to pressing the sleeve into the fenestration. Second flexible tines extending from an outer wall of the distal cylindrical portion in a direction generally tangential to the circumference of the distal cylindrical portion are configured to engage with and prevent rotation of the distal cylindrical portion within the wall of the fenestration.

Abstract: A system and method for wireless streaming link break-in is disclosed. A first device transmits digital packets to a second device over a wireless streaming link. A third device synchronizes itself with the second device. Once the third device is synchronized with the second device, the third device transmits command request packets to the second device during a data receive window. The wireless streaming link is inactive during the data receive window. The second device responds to the request during a next data receive window.

Abstract: An exemplary method includes a sound processor 1) mapping an analysis channel associated with a frequency band to a stimulation channel that comprises at least three electrodes communicatively coupled to an auditory prosthesis associated with a patient, 2) identifying a spectral peak included in an audio signal presented to the patient, the spectral peak having a peak frequency included in the frequency band, and 3) directing the auditory prosthesis to apply electrical stimulation representative of the spectral peak to a stimulation site associated with the peak frequency by simultaneously stimulating at least two of the at least three electrodes at substantially fifty percent or less of their respective most comfortable current levels (M levels) in accordance with a multi-monopolar current steering strategy. Corresponding methods and systems are also disclosed.

Abstract: Methods and devices for providing a gas pathway between the nasopharynx and the Eustachian tube are provided. One device may include a lumen with a valve. A portion of the valve may be tethered to adjacent muscle. Another portion of the valve may be tethered to adjacent cartilage. When the muscle contracts the valve may open through movement of the tethers, and provide a gas pathway between the nasopharynx and the Eustachian tube.

Abstract: In one embodiment, a method of treating hearing loss in a patient, comprises: creating a first channel in osseous tissue at or immediately adjacent to the promontory of the patient; creating a second channel through the first channel to the scala tympani or the scala vestibuli; and implanting a hearing device in the first channel, the hearing device being in fluid communication with cochlear fluid through the second channel, the hearing device being adapted to drive cochlear fluid to activate auditory receptor cells in the cochlea of the patient.

Abstract: Purifying human derived collagen from human tissue includes treating harvested human tissue with an enzyme to form a collagen product, deactivating the enzyme with a non-alkaline enzyme deactivation solution, and collecting the collagen product resulting from the enzyme treatment, where the collected collagen product includes a preserved amount of its natural collagen constituents. Various medical implants can be formed using the isolated, enzymatically-treated human derived collagen having an amount of its natural collagen constituents preserved, and may include implantable sponges, patches, tubes, structural supports and coatings, and which may be used for repair, barrier, support and/or stabilization purposes.

Abstract: Present example embodiments relate generally to nasal implants comprising a body portion, the body portion forming a central axis and having opposing inner body and outer body surfaces. The inner body surface may comprise a ventral groove portion disposed substantially parallel to the central axis, and the outer body surface may comprise a ridge portion. The ventral groove portion may comprise a deepest portion in proximate correspondence to a highest portion of the ridge portion with respect to the central axis. The nasal implant may comprise an elongated tail portion. A lower portion of the tail portion may be in communication with at least an upper portion of the body portion. An angle formable between an axis definable by the tail portion and the central axis may be between 0 to 90 degrees. The nasal implant may comprise a first wing portion, head portion, second wing portion, and leg portion.

Abstract: A system and method for correcting misshaped ears using a molding device having one or more braces supporting a scaphal mold. The one or more braces and the scaphal mold are adapted to retain the helix and the helical rim of a misshaped ear within a space defined between the one or more braces and the scaphal mold, and to maintain a substantially correct anatomical shape of the helix and the helical rim.

Abstract: The invention is a tympanic membrane pressure equalization tube. The tube has a distal end and a proximal end and a tube lumen. A medial flange is located at the distal end of the tube and has 2 or more retention elements and a space between each retention element. A lateral flange is located at the proximal end of the tube. The outside diameter of the medial flange is greater than the outside diameter of the lateral flange and the diameter of the medial flange is between about 2.0 and 5.0 mm and the diameter of the lateral flange is between about 1.75 mm and 4.0 mm.

Abstract: A method of dilating an infundibular space within the human head includes directing at least a distal portion of an elongate member of a medical device into a nasal cavity of the human head, the distal portion including a piercing tip and an expandable portion. The piercing tip is directed through tissue of an uncinate process or tissue near an uncinate process and into an ethmoid infundibulum and the expandable portion of the distal end is expanded within the ethmoid infundibulum.

Abstract: The specification discloses compositions and methods for treating a soft tissue defect of an individual.

Abstract: A nasal valve retention stent assembly is positionable within a person's nasal cavity to enlarge the nasal cavity and promote easier breathing through the person's nose. The assembly includes a frame having a pair of ends and a plurality of rib elements extending between and being attached to each of the ends. The rib elements are arched between the ends to form a cage like structure having a hollow interior. The rib elements are spaced from each other such that air freely flows through the frame. The frame is positionable within an inner nasal valve of the nose.

Abstract: Paranasal sinus apparatus is provided, including a hole-forming member configured to form a hole through a bone wall of a paranasal sinus of a subject. An implant is provided, having a proximal end and a distal end, and which is shaped to define a lumen. The implant is couplable to the hole-forming member, and is securable to the wall and extendable through the hole, such that the proximal end is disposed external to the paranasal sinus and the distal end is disposed within the paranasal sinus. The implant includes a biodegradable material. Other applications are also described.

Abstract: Described here are self-expanding devices and methods of using and making them. The devices may be useful in a variety of locations within the body, for a number of different uses. In some variations, the devices have a first compressed configuration enabling low profile delivery through a delivery device, a second expanded configuration for apposition against tissue, and comprise either a single continuous filament or at least two non-intersecting filaments. In some variations, the device is formed into a shape having a series of peaks and valleys. At least one of the peaks and valleys may have a loop at then end thereof. At least a portion of these devices may be capable of biodegrading over a predetermined period of time, and the devices may be configured for drug delivery. Methods of treating one or more sinus cavities are also described here.

Abstract: Methods and systems for medializing a turbinate. Exemplary embodiments comprise methods and systems for repositioning a turbinate proximal to a septum. Certain embodiments comprise an implant and a flexible member coupled to the implant. Embodiments may also comprise an insertion device to install the implant in a desired location.

Abstract: A suction activated instrumentation system for use in implanting an ossicular prosthesis into the middle ear includes a suction handpiece and a vacuum source. A removable suction tip is coupled to the handpiece for engaging an ossicular prosthesis. The suction tip includes a distal portion with an elongate slot opening at an end face, and two arms defined at the end face. When suction is applied through the suction tip, the prosthesis is drawn against the end face and retained between the arms. In the event the prosthesis is inadvertently contacted during implantation, the suction tip provides for self-correction, causing a prosthesis to re-orient into the prior intended configuration.

Abstract: A middle ear prosthesis comprises an ossicular attachment component contiguous with a vibration transmission element, the attachment component comprising a loop or other structure to surround and attach the prosthesis to an ossicle. The prosthesis has a plurality of recesses designed to be securely engaged by the jaws of an applicator or forceps into the recesses. This engagement can allow the attachment element to be opened or closed via an expanding or compressing force from the applicator. The recesses may be squared off in appearance or rounded and may have a complex shape to more precisely accommodate the jaws of the applicator. The applicator can also be angled, configured, and dimensioned to provide an optimum engagement with the prosthesis.

Abstract: An ossicular prosthesis includes a sound-conducting prosthesis body with a first coupling element designed for the mechanical connection to the limb of incus (A) at one end and a second coupling element for the mechanical connection to parts of a component of the ossicular chain or directly to the inner ear, The first coupling element has a receiving part rigidly connected to the prosthesis body to accommodate the free end section of the limb of incus, including a U-shaped cliplock rotatably supported in the receiving part and swivellable over the free end section of the limb of incus in order to secure the limb of incus. The cliplock has at least one bulge directed toward the receiving part that protrudes from the cliplock so far that said bulge touches an outer surface of the receiving part when swivelled.

Abstract: An in-ear device with one or more proprioceptive features for providing an indication to a subject to help manage or reduce pain, discomfort, or other symptoms associated with TMJ disorder. Also disclosed are methods of using optical scanning to create a three dimensional replication of the ear canal that is used to design a customized in-ear device. In some embodiments, the in-ear device is customized based on the configuration of the subject's ear canal when the subject's jaw is in the therapeutic or optimal position.

Abstract: A middle ear prosthesis (40) is provided for mounting in the middle ear (4). The middle ear prosthesis comprises a shaft (42) having a distal end configured for the introduction into the inner ear (8) through an aperture (30) formed in a footplate (23) of a stapes bone and in a membrane of an oval window of the inner ear, by moving the shaft in an introduction direction, the shaft being configured for transmitting sound wave vibrations to the inner ear. The prosthesis further comprises a coupling portion (46), for coupling, the shaft to at least one of the ossicles (17) so as to allow transmitting thereby sound wave vibrations from the ossicles to the shaft; and a stop member (48) spaced from the distal end of the shaft and configured for bearing against the remaining portions thereby limiting the movement of the shaft in the introduction direction.

Abstract: An in-ear orthotic with one or more features to help manage or reduce pain, discomfort, or other symptoms associated with temporomandibular joint disorder. Also disclosed are methods of using optical scanning to create a three dimensional replication of the ear canal that is used to design a customized in-ear orthotic to help manage one or more symptoms of temporomandibular joint disorder.

Abstract: A system for fitting a hearing prosthesis to a recipient. The system comprises a stimulation arrangement configured to at least one of mechanically and acoustically stimulate the recipient's inner ear based on an input signal; a neural response detection arrangement configured to detect the recipient's neural responses to the stimulation; and a processor configured to assess the recipient's neural responses, and to adjust operation of the hearing prosthesis based on the assessment of the neural responses.

Abstract: A passive ossicular prosthesis includes a first and second fastening element for connection to the tympanic membrane. A connecting element connects the fastening elements in a sound-conducting manner. The connecting element includes a receiving part and an insertion part. The insertion part is inserted into a receiving opening of the receiving part. The receiving part encloses an end section of the insertion part in the manner of a clamp by way of two opposing, parallel legs disposed parallel to a shank axis of the connecting element. The legs have catch devices that fix the enclosed end section discrete spatial positions relative to the shank axis.

Abstract: A method for non-surgically treating an internal nasal valve of a patient comprising, injecting a working device into the internal nasal valve of the patient, wherein the injected working device in the nasal tissue causes an alteration of an internal or external nasal valve. A device introduced by injection into the nose, allowing for structural support or filling of defects in the nose, and causing a change in external shape of the nose. The device and inserts and implants described also have use in cosmetic applications relating to the facial tissue.

Abstract: The specification discloses compositions and methods for treating a soft tissue defect of an individual.

Abstract: An ossicular replacement prosthesis (ORP) (10) for coupling a first point to a second point in the middle ear of a patient, to replace all or part of the ossicular chain. The ORP includes a coupling having a variable configuration for accounting for pressure differentials. The coupling includes a fluid filled chamber (28, 14) having two relatively moveable portions (12, 22) for varying the configuration of the coupling. The coupling further includes unsealed portion constituting leak portion and flowpath portion for permitting displacement of the fluid (30). The relative movement of the relatively moveable portions is controlled by the movement of the fluid in said chamber. The chamber is configured to restrict the movement of the fluid such that relative movement of the moveable portions is permitted in response to quasi-static changes in pressure, and is substantially prevented in response to vibrational changes corresponding to sound frequencies.

Abstract: Disclosed herein is an auricular implant, comprising an auricular base and a supporting member. The auricular base has a first side and a second side opposite to the first side. The supporting member having a thickness is adhered to the first side of the auricular base for forming a stereoscopic disk-like structure.

Abstract: A middle ear ossicle prosthesis in which the component for ossicular attachment comprises a surface bearing a plurality of discrete projections facing the ossicle to which it is attached which minimize total contact between the prosthesis and the ossicle. The prosthesis may comprise a loop forming a partial circle for encircling an ossicle, a piston for transmitting vibrations from the loop to the inner ear, and a rod solidly connecting the loop to the piston. The loop may have an upwardly turned end to facilitate placement of the loop over the ossicle. The projections may be provided in one row, two rows, or may be otherwise arrayed, and may be dissimilar from one another in configuration and dimensions.

Abstract: An auditory ossicle prosthesis, which at one end has a first securing element for mechanical connection to a member of the ossicular chain, which securing element is designed in the form of a loop that encloses the member, is partially open to the outside via a slit-like aperture and engages with a force fit around the member, the slit-like aperture being considerably smaller than the diameter of the member engaged by the loop, wherein, after attachment, the loop bears with a force fit on the engaged member via at least three areas, and that, in the circumferential direction around the engaged member, at least three areas of the loop do not touch the engaged member but instead each extend at a distance from the surface of the latter.

Abstract: The invention relates to compositions comprising a silk fibroin material, adipose tissue and a compound of the structure where X1 and X5 are independently CH or N; X7 is NH, O or S; X8 and X9 are independently CH or N; R13 is an optionally substituted aryl or optionally substituted heteroaryl and R14 is C1-6 alkyl, optionally substituted aryl or optionally substituted heteroaryl. The composition is administered to a site of a soft tissue condition including those of breast tissue. The silk fibroin material can be in the form of a silk hydrogel, a silk film, a silk scaffold, a silk sheet, a silk porous material or a silk fiber. The silk fibroin material can be substantially sericin free.

Abstract: The invention relates to compositions comprising adipose tissue, a silk fibroin material and a compound of the structure The composition is administered to a site of a soft tissue condition including those of breast tissue. The silk fibroin material can be in the form of a silk hydrogel, a silk film, a silk scaffold, a silk sheet, a silk porous material, a silk fiber or a combination of those materials. The silk material may be substantially sericin free.