Magnetic means assembly for bone conducting hearing aid

According to an embodiment, a magnetic unit assembly for a bone conducting hearing aid is disclosed. The magnetic unit assembly is implantable and comprises one or more magnetic unit and unit for attaching the one or more magnetic unit to the tissue surrounding the magnetic unit assembly when the magnetic unit assembly is implanted in the body of a hearing aid user. The magnetic unit assembly comprises unit for positioning at least a portion of the one or more magnetic unit in the soft tissue between dermis and the subcutaneous fat or the muscle/fat layer.

FIELD

The present disclosure generally relates to a magnetic unit assembly for a bone conducting hearing aid. The present disclosure more particularly relates to a subdermal magnetic unit assembly implant for a bone conducting hearing aid.

PRIOR ART

Implantation of magnetic unit is widely used technique for fixing hearing aids to the skin of a hearing aid user. A bone conduction hearing aid system comprises a vibrator that is adapted to provide a structure-borne acoustic signal transcutaneously or percutaneously transferred to the bony cochlea via bone conduction via the skull bone.

Some bone conduction hearing aid systems have an external hearing aid unit with a sound processor and vibrator. These hearing aid systems are connected to a skin contact pressure plate that is magnetically attached to an implanted unit under the skin. The vibrator transforms an electrical signal into mechanical vibrations and the skin contact pressure plate allows for transmission of the vibrations from the vibrator to the implanted unit when the external hearing aid unit is magnetically fixed to the implanted unit.

It is widely used to apply semi-implantable hearing aid components that comprise an implanted portion as well as external components that are attached to the skin of the user by means of pairs of internal (implanted) and external magnetic unit, respectively. The implanted and external magnetic unit are mutually attracted to one another and thereby fix the external retaining element to the skin of the user.

The magnetic attraction between opposing magnetic unit, on the other hand, cause a pressure load on the “soft tissue” disposed between the implanted and external magnetic unit. The “soft tissue” includes the skin (epidermis and dermis), the subcutaneous fat tissue, and musculature.

A large retention force is required in order to maintain the hearing aid device attached to the skin of the user; however, the load on the “soft tissue” may be crucial. The load on the “soft tissue” may cause short or long term problems such as ischemia or stress concentrations. Too high pressure or unfavourable pressure distribution causing local pressure concentrations may lead to skin problems such as ulcer or necrosis and headache.

In conventional semi implantable hearing aid system the implantable magnetic unit system is typically anchored to the temporal bone, e.g. with bone screws, or placed unanchored on the bone surface below the innermost soft tissue layer (musculature). Some product requires reduction, i.e. skin thinning, of the soft tissue above the implantable magnetic unit to ensure proper attraction of the outer magnetic unit. Skin thinning is associated with a risk of wound complications.

The total force provided to maintain the skin contact pressure plate and the hearing aid unit attached thereto depends on the thickness and geometry of the soft tissue and the elasticity (compression) of the soft tissue between the magnetic unit. These parameters vary between patients and vary in an individual patient over time. It has been reported that the total thickness of the soft tissue lining on the temporal bone range between 2 and 11 mm.

Therefore, in conventional prior art semi implantable hearing aid systems the approximate pressing force needs to be adjusted e.g. by changing the external magnetic unit or change the distance between the magnetic unit in the skin contact pressure plate and the implanted magnetic unit. This complex nature of the prior art hearing aid systems causes an increasing risk for adverse skin reactions due to adjustment errors made by the patient.

For bone conducting hearing aid systems where the sound processor and the vibrator are placed extracorporeal, the problems caused by high pressure on the soft tissue are more significant. As a consequence of the increased weight of the hearing aid a greater retention force is required. The retention force is increased by applying larger magnetic unit or stronger magnetic unit in the skin contact pressure plate. Hereby the total weight of the extracorporeal hearing aid device is increased and the risk for adverse skin reactions is further increased.

Thus, there is a need for a magnetic unit assembly for a bone conducting hearing aid, in which the skin contact pressure can be controlled, for all patients, in a manner that reduces or even eliminates the risk for adverse skin reactions.

WO 2004030572 A2 discloses a retention apparatus for a semi-implantable hearing aid. The retention apparatus includes a first surface and a second surface. One of the first and second surfaces includes a first portion and a second portion having a rounded transition there between for interfacing with a patient's skin. The rounded transition of the interfacing surface of the retention apparatus functions to distribute pressure resulting from the mutual magnetic attraction between an externally located magnetic means and an implanted magnetic means to permit increased magnetic forces there between and maintenance of a desired separation between an external coil and an implanted coil. Since the implanted magnetic means is integrated in the bone tissue of a patient the skin contact pressure depends heavily on skin thickness, and this may vary much from patient to patient, and may also vary over time for the individual patient.

An embodiment of the disclosure provides a magnetic unit assembly for a bone conducting hearing aid, in which the skin contact pressure can be determined and controlled in advance and possibly reduced.

An embodiment of the disclosure to provide a magnetic unit assembly that makes it possible to provide a short distance between external magnetic unit and the internal magnetic unit also in patients with thick skin.

An embodiment of the disclosure to provide a magnetic unit assembly that works properly even if patient gain or lose weight (subcutaneous fat increase or decrease).

SUMMARY

The object of the present disclosure can be achieved by a magnetic unit assembly as defined in claim1and by a hearing aid system as defined in claim13. Preferred embodiments are defined in the dependent claims and explained in the following description and illustrated in the accompanying drawings.

The magnetic unit assembly according to an embodiment of the disclosure is a magnetic unit assembly for a bone conducting hearing aid, which magnetic unit assembly is implantable and comprises one or more magnetic unit and unit for attaching the one or more magnetic unit to the tissue surrounding the magnetic unit assembly when the magnetic unit assembly is implanted in the body of a hearing aid user. The magnetic unit assembly comprises unit for positioning at least a portion of the one or more magnetic unit in the soft tissue between dermis and the subcutaneous fat or the muscle/fat layer.

Hereby a short distance between external magnetic unit of a bone conducting hearing aid and the internal magnetic unit within the magnetic unit assembly according to an embodiment of the disclosure can be achieved.

Moreover the implanted magnetic unit assembly can be kept in the same distance from the outer skin surface even if patient gain or lose weight.

Due to the short distance between the external magnetic unit of a bone conducting hearing aid and the internal magnetic unit within the magnetic unit assembly, the size of the magnetic unit can be reduced compared to the magnetic unit in the prior art devices.

It is not necessary to provide recesses in the bone for anchoring the magnetic unit assembly.

Only a rather simple surgical procedure is required to provide a patient with a magnetic unit assembly according to an embodiment of the disclosure.

If the subcutaneous tissue grows, the implanted magnetic unit assembly will maintain its distance to the outer skin surface.

The magnetic unit assembly is intended for retaining a bone conducting hearing aid to the skin of the user of the hearing aid.

The magnetic unit assembly is implantable which means that the magnetic unit assembly is suitable for and configured to be implanted in the human body.

The magnetic unit may be of any suitable type and geometry. The magnetic unit may be neodymium magnetic unit made from an alloy of neodymium, iron and boron (Nd2Fe14B) or samarium cobalt magnetic unit (SmCo) by way of example. A magnetic unit in this connection is adapted to cooperate with a further magnetic unit to provide attraction forces between the two. One of the magnetic unit may comprise magnetically soft iron, and may not as such be a magnet, but become magnetically active by the presence of a further magnetic unit, such as a permanent magnet close by. Further, magnetic unit may comprise more exotic magnetically active elements such as ferromagnetic fluids, which comprise powdered ferromagnetic iron or iron alloy suspended in a fluid such as oil. Also mixtures of powders of permanent or soft magnetic materials may be utilised either in free floating form or suspended in a fluid, and enclosed in a bag or similar enclosure. Such elements may be especially well suited for implantation, or for working with implanted magnetically active unit due to their ability to distribute pressure evenly over an area.

The unit for attaching the one or more magnetic unit to the tissue surrounding the magnetic unit assembly when the magnetic unit assembly is implanted in the body of a hearing aid user may be any suitable type of means. The unit for attaching the one or more magnetic unit to the tissue surrounding the magnetic unit assembly may have any suitable size and geometry. However, it may be preferred that a short distance can be kept between the external magnetic unit of the bone conducting hearing aid and the internal magnetic unit within the magnetic unit assembly.

The magnetic unit assembly comprises unit for positioning at least a portion of the one or more magnetic unit in the soft tissue between dermis and the subcutaneous fat.

These unit may be of any type, size and geometry.

It may be an advantage that the magnetic unit assembly comprises unit for positioning at least a portion of the one or more magnetic unit in the soft tissue between dermis and the subcutaneous tissue.

It may be beneficial that the magnetic unit assembly comprises unit for positioning the one or more magnetic unit completely in the soft tissue between dermis and the subcutaneous fat or the muscle/fat layer.

It may be advantageous that the magnetic unit assembly comprises unit for positioning the one or more magnetic unit completely in the soft tissue between dermis and the subcutaneous fat.

Hereby it is achieved that the distance between the external magnetic unit of a bone conducting hearing aid and the internal magnetic unit within the magnetic unit assembly can be minimized.

It may be beneficial that the magnetic unit assembly comprises unit for facilitating ingrowth of the tissue surrounding the implanted magnetic unit assembly into the magnetic unit assembly and hereby establishing an attachment of the magnetic unit assembly to the surrounding tissue.

Hereby it is possible to achieve a reliable and strong attachment of the implanted magnetic unit assembly to the surrounding tissue. Accordingly, the magnetic unit assembly according to an embodiment of the disclosure ensures that the distance between contact plates of a hearing aid device and the internal magnetic unit of the magnetic unit assembly can be kept constant.

It may be advantageous that unit for ingrowth of the tissue surrounding the implanted magnetic unit assembly into the magnetic unit assembly comprises one or more holding member(s) that are embedded in or comprise an ingrowth structure for fixing the magnetic unit assembly to the tissue that the magnetic unit assembly is implanted into.

Hereby it is achieved that the ingrowth structure of the magnetic unit assembly can be used as unit for attaching the magnetic unit assembly to the tissue surrounding the implanted magnetic unit assembly.

It may be beneficial that that the unit for ingrowth of the tissue surrounding the implanted magnetic unit assembly into the magnetic unit assembly comprises one single ring magnet (circular or non-circular), or two or more, such as four, magnetic unit preferably evenly distributed along the periphery of an ingrowth structure shaped as a thin disc having a mesh structure with a plurality of apertures.

Such unit may be reliable and safe to use.

It may be an advantage that the magnetic unit are to be enclosed in a housing (e.g. made in a bioinert material such as titanium). The housing may be integrated in the ingrowth structure. The ingrowth structure may be a resilient and soft mesh made in polypropylene by way of example. Sharp corners and stress concentrations are hence avoided and the ingrowth structure also adapt to the contour of the skull.

The magnetic unit assembly may include a unit for positioning the magnetic unit assembly under the periosteum, in between the periosteum and the bone. The placement of the housing and magnet under the periosteum allows for a simple procedure and minimal trauma by which this procedure can be performed. A small incision is made with a dissector and the periosteum is separated from the underlying bone, thus creating a pocket. In this pocket, the housing assembly is inserted and the incision is thereafter closed. The housing is held in place by the periosteum. The housing may be equipped with an ingrowth unit described before (resorbable or permanent). Thus, the magnetic unit assembly may be attached by using an implantation technique similar to the one used to implantation of cochlear implants. Accordingly, it is possible to provide a simple surgery and to achieve a beneficial position of the implanted magnetic unit assembly.

Yet another embodiment includes an ingrowth structure made of thin titanium, the structure may be bent and adapted to the contour of the skull comparable to craniofacial retention meshes.

Part or all of the ingrowth structure could be made of a resorbable material (e.g. such as poly (D,L) lactic acid, PDLLA). In general, the potential for foreign body reaction, infection, and extrusion increases with material that is non-absorbable. Hence, initial fixation is achieved by ingrowth in the resorbable ingrowth structure. After some time (weeks to months) the ingrowth structure is absorbed. With a resorbable structure, it may also be easier to remove the housing if it needs to be replaced.

It may be beneficial that the ingrowth structure is made in a polymer material coated with a titanium layer or another suitable material. The ingrowth structure may be made as a thin circular or oval titanium disc penetrated with circumferential tracks and a plurality of small apertures or holes to favour connective tissue ingrowth and anchorage.

It may be an advantage that unit for ingrowth of the tissue surrounding the implanted magnetic unit assembly into the magnetic unit assembly comprises a disc having a concave shape to mimic the contour of the skull and prevent stress concentrations.

Hereby it is possible to fit the implanted magnetic unit assembly to the contour of the skull in order to minimise the stress of the tissues caused by the magnetic attraction.

It may be advantageous that the implantable disc is made in a soft plastic material.

It may be advantageous that the disc has a basically elliptical cross-section.

Hereby it is possible to prevent stress concentrations.

It may be an advantage that the magnetic unit assembly is not brought into mechanical contact with the bone. Hereby it is possible to maintain a fixed distance from the outer skin surface to the implemented magnetic unit even if patient gains weight or loses weight.

It may be an advantage that the one or more magnetic unit are hermetically sealed.

Hereby it is possible to avoid corrosion of the magnetic unit.

It may be beneficial that the one or more magnetic unit have an arched profile/surface.

Hereby it is possible to reduce the risk of introducing too high pressure or unfavourable pressure distribution causing local pressure concentrations that may lead to skin problems such as ulcer or necrosis and headache.

It may be advantageous that the arched profile/surface is concave.

By applying a concave surface the magnetic unit mimics the anatomy of the head and thus unfavourable pressure distribution can be avoided since reduced magnetic unit attraction can be applied.

It may be beneficial that the magnetic unit assembly comprises one or more, preferably two or more magnetic unit embedded in a disc made in a flexible material.

It is possible to implant such magnetic unit assembly in the soft tissue underneath the skin and the subcutaneous fat. Thus, the magnetic unit of the magnetic unit assembly can be kept positioned close to the skin. Accordingly, the size and strength of the magnetic unit may be reduced.

The magnetic unit assembly may be implemented within the muscle/fat layer in a significant distance from the bone. Accordingly, the magnetic unit assembly may be implemented by unit of a simple surgical procedure.

It may be beneficial that the disc has an elliptic cross-section.

The object of the disclosure can be achieved by a hearing aid system comprising a magnetic unit assembly according to one of the claims1-12.

It may be advantageous that the hearing aid system comprises at least one contact plate that is magnetically attached to an implanted magnetic unit assembly according to one of the claims1-12, where the at least one contact plate comprises at least one magnetic unit, where the hearing aid system comprises one or more skin wafer arranged between the skin of the hearing aid user and the at least one contact plate.

Hereby it is possible to distribute the pressure from the contact plate evenly to the skin of the user of the hearing aid. Moreover it is possible to adjust the distance between the implanted magnetic unit(s) and the at least one magnetic unit of the at least one contact plate.

It may be an advantage that a skin wafer is arranged between each of the contact plate(s) and the skin of the hearing aid user, where the skin wafer(s) provided between the contact plate(s) and the skin are configured to regulate the pressure provided by the contact plate(s) towards the skin by changing the thickness of the skin wafer(s).

In the present context, a “hearing device” refers to a device, such as e.g. a hearing aid, a listening device or an active ear-protection device, which is adapted to improve, augment and/or protect the hearing capability of a user by receiving acoustic signals from the user's surroundings, generating corresponding audio signals, possibly modifying the audio signals and providing the possibly modified audio signals as signals to at least one of the user's ears.

A “hearing device” further refers to a device such as an earphone or a headset adapted to receive audio signals electronically, possibly modifying the audio signals and providing the possibly modified audio signals as audible signals to at least one of the user's ears. Such audible signals may e.g. be provided in the form of acoustic signals radiated into the user's outer ears, acoustic signals transferred as mechanical vibrations to the user's inner ears through the bone structure of the user's head.

A hearing device may be configured to be worn in any known way, e.g. as a unit arranged behind the ear, as a unit attached to a fixture implanted into the skull bone, as a partly implanted unit. A hearing device may comprise a single unit or several units communicating electronically with each other.

More generally, a hearing device comprises an input transducer for receiving an acoustic signal from a user's surroundings and providing a corresponding input audio signal and/or a receiver for electronically receiving an input audio signal, a signal processing circuit for processing the input audio signal and an output unit for providing an audible signal to the user in dependence on the processed audio signal. Some hearing devices may comprise multiple input transducers, e.g. for providing direction-dependent audio signal processing. In some hearing devices, the receiver may be a wireless receiver. In some hearing devices, the receiver may be e.g. an input amplifier for receiving a wired signal. In some hearing devices, an amplifier may constitute the signal processing circuit.

In the hearing devices, the output unit may comprise an output transducer, such as vibrator for providing a structure-borne or liquid-borne acoustic signal.

In the hearing device, the vibrator may be adapted to provide a structure-borne acoustic signal transcutaneously or percutaneously to the skull bone. In some hearing devices, the vibrator may be adapted to provide a structure-borne acoustic signal to a middle-ear bone and/or to the cochlea.

A “hearing aid system” refers to a system comprising one or two hearing devices, and a “binaural hearing system” refers to a system comprising one or two hearing devices and being adapted to cooperatively provide audible signals to both of the user's ears. Hearing systems or binaural hearing systems may further comprise “auxiliary devices”, which communicate with the hearing devices and affect and/or benefit from the function of the hearing devices. Auxiliary devices may be e.g. remote controls, remote microphones, audio gateway devices, mobile phones, public-address systems, car audio systems or music players. Hearing devices, hearing systems or binaural hearing systems may e.g. be used for compensating for a hearing-impaired person's loss of hearing capability, augmenting or protecting a normal-hearing person's hearing capability and/or conveying electronic audio signals to a person.

DETAILED DESCRIPTION

Referring now in detail to the drawings for the purpose of illustrating preferred embodiments of the present disclosure, different views of magnetic unit assembly according to embodiments of the disclosure are illustrated inFIG. 2-7.

FIG. 1a) is a schematic cross-sectional close-up view of a section of the head of a hearing aid user. The section comprises an outer layer of skin10arranged outside a layer of subcutaneous fat20. A layer of muscle and fat12is arranged under the layer of subcutaneous fat20, while the layer of muscle and fat12surrounds a bone layer14.

FIG. 1b) shows a schematic view of a prior art bone conducting hearing aid system8. The bone conducting hearing aid system8is attached on the head of a user2. The bone conducting hearing aid system8comprises an external hearing aid unit comprising a sound processor4and a vibrator. The sound processor4is connected to a skin contact pressure plate6that is magnetically attached to an implanted unit16under the skin. A part of the bone conducting hearing aid system8is arranged behind the ear18of the hearing aid user2.

The vibrator transforms an electrical signal into mechanical vibrations and the skin contact pressure plate6transmits the vibrations from the vibrator to the implanted unit16when the external hearing aid device8is magnetically fixed to the implanted unit16. The sound is transmitted by bone conduction via the skull to the bony cochlea.

A significant retention force is required to maintain the hearing aid device8magnetically fixed to the implanted unit16. The load on the soft tissue10,20,12should be minimised in order to prevent short or long term problems such as ischemia or stress concentrations. Too high pressure or unfavourable pressure distribution causing local pressure concentrations may cause skin problems such as ulcer or necrosis and headache.

The implantable magnetic unit system16is anchored to the temporal bone. This may be established by means of bone screws, or by placing the magnetic unit system16unanchored on the bone surface below the innermost soft tissue layer (musculature)12.

Depending on the total thickness of the soft tissue lining10,20,12on the temporal bone14, skin thinning of the soft tissue10,20,12above the implantable magnetic unit16may be required in order to ensure proper attraction of the outer magnetic unit within the contact pressure plate6. Skin thinning introduces risk of wound.

FIG. 2shows a schematic view of a bone conducting hearing aid system8attached to the head of the user2by means of a magnetic unit assembly58according to an embodiment of the disclosure. The bone conducting hearing aid system8comprises a sound processor4arranged behind and above the ear18of the user2.

The bone conducting hearing aid system8comprises two contact plates30,30′ that are mechanically connected to the vibrator28by means of connection members36,36′. Each of the contact plates30,30′ comprise a magnetic unit34,34′ integrated in the contact plate30,30′.

The contact plates30,30′ are attached to the skin10of the user by means of magnetic attraction to the magnetic unit assembly58.

The magnetic unit assembly58consists of two magnetic unit,22,22′. The magnetic unit22,22′,34,34′ may be neodymium magnetic unit made from an alloy of neodymium, iron and boron (Nd2Fe14B) or samarium cobalt magnetic unit (SmCo) by way of example. Each of the two magnetic unit,22,22′ are integrated in a corresponding holding member24,24′ that is anchored to the temporal bone14by means of corresponding abutments26,26′.

A skin wafer32,32′ is arranged between each of the contact plates30,30′ and the skin10. The skin wafer32,32′ provided between the contact plates30,30′ and the skin10can be used to regulate the pressure provided by the contact plates30,30′ towards the skin10. The pressure can be changed by changing the thickness of the skin wafers32,32′.

The thickness of the layer of skin (also referred to as the dermis)10, the layer of subcutaneous fat and the layer of muscle/fat12outside the temporal bone14ranges between 2 and 11 mm between patients. In contrast, the thickness of the epidermis and dermis layer ranges between 1-4 mm between patients.

The magnetic unit assembly58is placed in the soft tissue between skin10and the subcutaneous fat20.

The magnetic unit assembly58comprises two hermetically sealed magnetic unit22,22′. The magnetic unit assembly58may comprise an ingrowth structure for anchoring the magnetic unit assembly58in the soft tissue. The magnetic unit assembly58according to an embodiment of the disclosure ensures that the distance between the contact plates30,30′ and the internal magnetic unit22,22′ of the magnetic unit assembly58is kept constant.

The distances between the epidermal surface and the internal magnetic unit22,22′ are determined at the time of surgery by the position of the magnetic unit22,22′ on the abutment26,26′.

The magnetic unit22,22′ may have a concave shape to prevent high pressure points. The abutments26,26′ are anchored in the bone14and the height of the abutments26,26′ can be individually chosen in order to meet patient specific requirements. The abutments26,26′ protrude through the soft tissue12positioning the magnetic unit22,22′ at a defined distance from the epidermal surface.

The abutments26,26′ may be made in titanium. The abutments may comprise mesh structure (seeFIG. 6bandFIG. 6c) allowing tissue ingrowth through the structure. The amount of titanium (or another material) may be reduced and hence the risk for infection may be reduced, since the mesh structure is enclosed by vascularised soft tissue.

It is possible to provide a mesh structure in a soft material, e.g. plastic like silicone or a thermoplastic elastomer. By choosing a soft and resilient material the risk for high pressure points can be reduced, e.g. when the patient is sleeping with the implant side against a pillow.

The abutments26,26′ could also be supplied in one height whereby the distance to the epidermal surface is controlled by placing the abutments in a recess in temporal bone14. The depths of the recesses would be determined by the patient soft tissue thickness.

The magnetic unit assembly58according to an embodiment of the disclosure provides a number of advantages.

A short distance between external magnetic unit34,34′ and the internal magnetic unit22,22′ can be achieved.

The implanted magnetic unit assembly58will be in the same distance from the outer skin surface even if patient gain or lose weight (subcutaneous fat increase or decrease).

Due to the short distance between the external magnetic unit34,34′ and the internal magnetic unit22,22′, the size of the magnetic unit22,22′,34,34′ can reduced compared with the prior art.

It is not necessary to provide recesses in the bone14for anchoring the magnetic unit assembly58.

Only a simple surgical procedure is required to provide a patient with a magnetic unit assembly58according to an embodiment of the disclosure.

If the subcutaneous tissue12grows, the implanted magnetic unit assembly58will maintain its distance to the outer skin10surface.

FIG. 3shows a schematic cross-sectional view of a magnetic unit assembly58according to an embodiment of the disclosure. The magnetic unit assembly58is shaped as a disc42having a basically elliptical cross-section. The magnetic unit assembly58comprises two magnetic unit22,22′ embedded in a disc42made in a flexible material.

The magnetic unit assembly58is implanted in the soft tissue underneath the skin10and the subcutaneous fat20. Thus, the magnetic unit22,22′ of the magnetic unit assembly58are arranged close to the skin10. Accordingly, the size and strength of the magnetic unit22,22′ may be reduced.

The magnetic unit assembly58is implemented within the muscle/fat12layer in a significant distance from the bone14. Accordingly, the magnetic unit assembly58may be implemented by means of a simple surgical procedure.

FIG. 4a) is a schematic view of a bone conducting hearing aid system8attached to the head of the user by means of a magnetic unit assembly58according to an embodiment of the disclosure.

The bone conducting hearing aid system8comprises a sound processor4arranged behind and above the ear18of the user of the hearing aid system8. The bone conducting hearing aid system8comprises two contact plates30,30′ mechanically connected to a vibrator28by means of connection members36,36′. Each of the contact plates30,30′ comprise a magnetic unit34,34′ integrated in a corresponding contact plate30,30′.

The contact plates30,30′ are retained to the skin10of the user by means of magnetic attraction provided by using the magnetic unit assembly58.

The magnetic unit assembly58consists of a number of magnetic unit,22,22′ (e.g. neodymium magnetic unit). Each of the magnetic unit,22,22′ are integrated in a corresponding holding member24,24′ that is embedded in an ingrowth structure38for fixing the magnetic unit assembly58to the tissue that it is implanted into.

A skin wafer32,32′ is arranged between each of the contact plates30,30′ and the skin10. The pressure provided by the contact plates30,30′ towards the skin10can be regulated by using the skin wafers32,32′ provided between the contact plates30,30′ and the skin10. The pressure can be changed by changing the thickness of the skin wafers32,32′.

The magnetic unit assembly58is arranged in a relative short distance to the outer surface of the skin10. Accordingly, the distance between the external magnetic unit34,34′ and the magnetic unit22,22′ in the magnetic unit assembly58is short. Accordingly, the size of the magnetic unit22,22′ in the magnetic unit assembly58can be reduced compared to a prior art magnetic unit assembly.

Moreover, the magnetic unit assembly58shown inFIG. 4a) can be implemented by means of a simple surgical procedure.

FIG. 4b) is a schematic view of a magnetic unit assembly58according to an embodiment of the disclosure. The magnetic unit assembly58is an implant46configured to be implanted in the soft tissue in the same tissue layer as the magnetic unit assembly58shown inFIG. 4a).

The magnetic unit assembly58comprises four magnetic unit22evenly distributed along the periphery of an ingrowth structure38. The ingrowth structure38is shaped as a thin disc having a mesh structure with a plurality of apertures through which the tissue surrounding an implanted magnetic unit assembly58can grow. Hereby a firm and reliable attachment of the magnetic unit assembly58can be achieved.

A circular vibration faceplate area is provided centrally and concentrically with the ingrowth structure disc38.

The magnetic unit may be enclosed in a housing (e.g. made in titanium in order to prevent corrosion). The housing may be integrated in the ingrowth structure38. The ingrowth structure38may be a resilient and soft mesh made in polypropylene by way of example.

The ingrowth structure38may alternatively be made in another polymer coated with a titanium layer or another suitable material. The ingrowth structure38may be made as a thin circular or oval titanium disc penetrated with circumferential tracks and a plurality of small apertures or holes to favour connective tissue ingrowth and anchorage.

It may be an advantage that the disc (implant)46has a concave shape to mimic the contour of the skull and prevent stress concentrations. The disc (implant)46could also be made of a soft plastic material. It may be an advantage that the disc46has an elliptical cross-section in order to avoid force concentrations.

FIG. 5a) is a schematic cross-sectional view of a magnetic unit assembly58according to an embodiment of the disclosure. The magnetic unit assembly58comprises a disc48having a concave structure. The magnetic unit assembly58constitutes an implant46configured to be implanted in the soft tissue of a hearing aid user.

The magnetic unit assembly58may be made in titanium or another material suitable for being implanted into the soft tissue of a hearing aid user. A plurality of apertures50,50′,50″ are provided in the disc48. These apertures/holes are provided to facilitate tissue ingrowth.

FIG. 5b) is another schematic view of the magnetic unit assembly shown inFIG. 5a). The magnetic unit assembly58is embedded in an implant46comprising a disc48having a concave structure made in e.g. titanium.

A vibrator faceplate area40is provided centrally within the disc48.

The magnetic unit assembly58is implanted during a surgical procedure, in which the dermis is separated from the underlying hypodermis/subcutis with a tool ensuring that a cleavage is created about 3 mm from the epidermis. Hereafter the implant46may be inserted into the cleavage and the incision can be closed. A healing time is required in order to ensure ingrowth of the implant46.

FIG. 6a) is a schematic view of a magnetic unit assembly58according to an embodiment of the disclosure anchored in the temporal bone14of a user of a bone anchored hearing aid device. The magnetic unit assembly58comprises two magnetic unit22arranged in the subcutaneous fat layer20between the skin (dermis)10and the muscle/fat layer12in a distance from the temporal bone14.

The magnetic unit22are anchored to the temporal bone14by means of threaded screw members52,52′ screwed into the temporal bone14. Each magnetic unit22is attached to an abutment26,26′ that is mechanically attached to the corresponding screw member52,52′.

The magnetic unit assembly58hereby makes it possible to provide a short distance between external magnetic unit (not shown) and the internal magnetic unit22,22′.

FIG. 6b) is a schematic cross-sectional view of a magnetic unit assembly58corresponding to one of the two magnetic unit assembly portions shown inFIG. 6a). The magnetic unit22has a concave shape. This shape is applied in order to prevent high pressure points when external magnetic unit are attached to the skin of the user of the hearing aid.

The magnetic unit assembly58comprises an abutment26configured to be anchored in the temporal bone as indicated inFIG. 6a). The height of the abutment26may be individually chosen.

The abutment26may be made in could be a solid titanium post, however, the abutment shown inFIG. 6b) illustrates an abutment having a mesh structure54allowing tissue ingrowth through the apertures50.

Hereby it is possible to reduce the amount of titanium and thus, the risk for infection can be reduced due to the fact that the mesh structure54is enclosed by vascularised soft tissue.

The magnetic unit assembly58comprises a mesh members56provided with apertures50allowing for ingrowth of the tissue surrounding the magnetic unit assembly58.

The abutment26is attached to a threaded screw member52.

FIG. 6c) is a schematic side view of the magnetic unit assembly58shown inFIG. 6b). The magnetic unit assembly58comprises a concave magnetic unit22attached to an abutment26comprising a mesh structure54that comprises a plurality of mesh members56provided with apertures50.

The abutment26is attached to (integrated into) a threaded screw member52.

It would be possible to make the mesh structure54in a soft material, such as a plastic material like silicone or a thermoplastic elastomer. It may be an advantage to make the abutment26in a resilient material in order to reduce the risk for creating high pressure when the patient is sleeping with the implant side against a pillow.

FIG. 7is a schematic view of a bone conducting hearing aid system8attached to the head of the user by means of a magnetic unit assembly58according to an embodiment of the disclosure. The bone conducting hearing aid system8comprises a sound processor4arranged behind and above the ear18of the user.

The bone conducting hearing aid system8comprises a first contact plate30and a second contact plate30′. The contact plates are mechanically connected to a vibrator28by means of connection members36,36′. The first contact plate30comprises a first hermetically sealed magnetic unit34integrated in the first contact plate30, while the second contact plate30′ comprises a second hermetically sealed magnetic unit34′ integrated in the second contact plate30′.

The contact plates30,30′ are retained to the skin10of the user by means of magnetic unit attraction between the first magnetic unit34and a corresponding implanted magnetic unit22and between the second magnetic unit34′ and a corresponding second implanted magnetic unit22′.

The two magnetic unit,22,22′ are integrated in holding members24,24′ anchored to the temporal bone14by means of abutments26,26′.

Skin wafers32,32′ are arranged between the contact plates30,30′ and the skin10. The skin wafers32,32′ are used to regulate the pressure provided by the contact plates30,30′ towards the skin10, by changing the thickness of the skin wafers32,32′.

The magnetic unit assembly58is positioned between the periosteum20and the bone14. The placement of the housing and magnet under the periosteum allows for a simple procedure and minimal trauma by which this procedure can be performed. A small incision is made with a dissector and the periosteum is separated from the underlying bone, thus creating a pocket. In this pocket, the housing assembly is inserted and the incision is thereafter closed. The housing is held in place by the periosteum. The housing may be equipped with an ingrowth unit described before (resorbable or permanent). Thus, the magnetic unit assembly58may be attached by using an implantation technique similar to the one used to implantation of cochlear implants. Accordingly, it is possible to provide a simple surgery and to achieve a beneficial position of the implanted magnetic unit assembly58.

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