Bone-conduction internal hearing implant having a dual-transduction mode and a system for automatically managing faults, and associated system

Abstract

The invention relates to a bone-conduction hearing implant (100) comprising a subcutaneous implantable module (110) comprising a permanent magnet (111), a first near-field electromagnetic induction antenna (112), and a first transducer (113). In one particular embodiment, the module has a magnetized one-piece body. The permanent magnet (111) and the first transducer (113) define, respectively, a first surface SDC1 of contact and a second surface SDC2 of contact with the temporal bone OT. The module is positioned in a subperiosteal space ESP, the natural tension of the periosteum maintaining the elements without invasive anchoring. The implant interacts with a sound processor (200) and a microphone, both of which are configurable externally or internally. There are two modes of operation: internal transduction via the first transducer (113) using bone-conduction ultrasound technology and SDC2, and external transduction via the permanent magnet (111) and SDC1. A detection system (114) monitors the first transducer and ensures automatic switching. This non-invasive approach provides a scalable solution for different types of hearing loss.

Description

Internal bone conduction hearing implant with dual-mode transmission, automatic failure management system, and associated system

[0001] The invention relates to the field of auditory implants, and more particularly to bone conduction auditory implants (“Bone Conduction Implant”, BCI).

[0002] These medical devices are configured to improve hearing in individuals suffering from certain types of deafness, including conductive hearing loss, mixed hearing loss, or profound unilateral hearing loss (Single Sided Deafness, SSD) in which the contralateral ear is stimulated.

[0003] Bone conduction hearing implants work by transmitting audible vibrations to the cochlea (i.e., inner ear) via the bones of the skull by bone conduction, also called osteophony, thus bypassing the dysfunctional parts of the outer, middle, and inner ear.

[0004] This principle allows for direct stimulation of the ipsilateral or contralateral cochlea (SSD), the sensory organ of hearing, using the body's natural bone conduction capacity. Therefore, the contact surface should be optimized as much as possible to improve transmission efficiency, and the presence of non-osseous material (mastoid air cells, large blood vessels, and cerebral fluid) should be avoided, as this material reduces bone conduction and causes energy dissipation.

[0005] The percutaneous technique involves inserting a screw and an abutment percutaneously and anchoring them in the temporal bone, creating a direct connection between the bone implant and an external processor containing a microphone that is mechanically clipped onto the percutaneous screw. The percutaneous screw keeps the processor in contact with the bone but must be osseointegrated (i.e., integrated into the bone tissue through direct bone growth at the interface with the implant) to withstand manipulation and therefore has a relatively small surface area.

[0006] This approach has certain drawbacks related to the systematic side effects caused by the destruction of the tissue layers traversed, including skin, muscle, periosteum, and bone. These include risks of infection, wound healing problems, and the need for continuous hygienic maintenance of the implantation site. Furthermore, these techniques require a prolonged healing period based on the principle of osseointegration of the screw, ensuring its stability and long-term retention in the bone. This period can last up to three months before the sound processor can be implanted in the patient.

[0007] Furthermore, these percutaneous techniques are not suitable for individuals with poor bone quality or for young children, generally under the age of seven, due to the limitations of insufficient bone thickness in these individuals. Indeed, a minimum bone thickness of 5 mm is required to insert a 3-4 mm screw. In very young children, this insufficient temporal bone thickness and the increased risk of meningeal complications limit the use of these anchored intracranial implants (ICIs). Therefore, it is not possible to place this type of percutaneous implant in young children due to the thinness of the cortical bone. Moreover, the continued growth of the skull in children may necessitate repeated surgical interventions to adjust or replace the implant.

[0008] Furthermore, there is a risk of contact with the meninges. This risk is particularly concerning in young children whose temporal bone is not thick enough to allow for secure fixation, which can lead to weakening of the skull, or even hemorrhage or an abscess.

[0009] Furthermore, the percutaneous technique presents significant aesthetic drawbacks due to the visible presence of the percutaneous abutment protruding from the skin, creating a permanent protrusion on the skull. This appearance is often perceived as unsightly or unsettling and leads to difficulty in acceptance by patients or parents, particularly young children for whom aesthetics and social integration are major concerns. The permanent visibility of the implant can have psychological and social repercussions, limiting the acceptance of this therapeutic solution despite its functional efficacy.

[0010] In addition, this anchored approach involves additional material constraints, such as the use of specific motors and milling cutters, the installation of screws directly above (perpendicular to) the anchor, a relatively long operating time and often technical assistance from the manufacturer, generating additional costs for anchoring, milling, installation and removal equipment.

[0011] Finally, the intervention usually takes more than an hour, which is considerably longer than less invasive techniques.

[0012] Although newer transcutaneous systems have been developed to eliminate skin penetration, traditional manufacturers still maintain that they require invasive bone anchoring or the creation of a bone bed in the mastoid process. These systems implant a permanent magnet under the skin, secured to the temporal bone with a screw or equivalent device. This internal magnet exerts a magnetic attraction through the skin on a magnetized sound processor positioned above the implantation site, thus holding it in place. This configuration allows the transmission of sound vibrations from the sound processor to the internal implant via transcutaneous magnetic coupling.However, they retain the limitations associated with invasive bone anchoring, particularly the limited adaptability of the system: the area of ​​bone used for implantation is permanently altered (it is said to be medically "consigned"), meaning that it cannot be reused, or only with great difficulty, for a new implant or similar procedure in the future. This limits the possibility of easily adapting or replacing the device if the individual's hearing needs change, which will frequently occur in a patient's life (e.g., device malfunctions or upgrades), as it will then be necessary to find another available bone area, which is not always easy or requires relocating the sound processor.

[0013] In practice, due to the consistently two-part design of current transcutaneous devices, the positioning of the sound processor is often suboptimal, placed far back and / or high on the skull. This is particularly problematic in young children and detrimental to optimal capture of the auditory signal (e.g., speech, ambient noise, music). This is also related to the requirement to place the transducer near the anterior incision for the necessary perpendicular anchoring.

[0014] Some techniques described to facilitate anchoring rely on an incision of all layers of the skin down to the bone on the external face directly above the implant and should be avoided: it should always be recommended that no incision or scar be in direct relation to the implant and that the most spared and healthy tissues possible (i.e., well vascularized) be in direct contact with the implant which is by definition a foreign body.

[0015] Furthermore, postoperative complications can be serious, even leading to meningitis. These complications include possible infections at the anchoring site and risks of extrusion due to large wounds and healing complications related to the horizontal nature of traditional surgical incisions.

[0016]

[0017] Therefore, there is a need for a bone conduction hearing implant that offers several simultaneous improvements: optimal positioning of the sound processor 200 near the ear for efficient capture of the auditory signal, suitability for young children and individuals with poor bone quality, and continued operation even in the event of a transducer failure. This system should also significantly reduce the duration of the procedure and its associated costs.

[0018] The invention aims to solve, at least partially, this need by proposing a non-invasive, dual-mode, unanchored bone conduction hearing implant that releases the aforementioned constraints while improving efficiency.

[0019] More specifically, the invention relates to a bone conduction hearing implant comprising a subcutaneous implantable module including a permanent magnet and a first near-field electromagnetic induction antenna.

[0020] The permanent magnet is configured to provide magnetic coupling with a sound processor that also includes a second near-field electromagnetic induction antenna, according to two possible configurations: direct magnetic coupling when the sound processor is placed subcutaneously, or transcutaneous magnetic coupling when the sound processor is external to the human body and in contact with the skin. It has an external face configured to establish direct or near-direct contact with an individual's temporal bone and define a first contact surface with the temporal bone. This contact surface has an area substantially equivalent to the area of ​​the external face for distributed transmission of audible vibrations to the temporal bone in transduction mode.

[0021] The bone conduction hearing implant is configured to cooperate with the sound processor and to operate selectively in two distinct modes.

[0022] In internal transduction mode, the first near-field electromagnetic induction antenna receives electromagnetic signals representative of the sounds processed by the second near-field electromagnetic induction antenna of the sound processor. A first transducer included in the subcutaneous implantable module converts the electromagnetic signals into audible vibrations and transmits them directly to the temporal bone via a second contact surface.

[0023] In external transduction mode, a second transducer of the external sound processor generates audible vibrations representative of the processed sounds. The permanent magnet receives the audible vibrations from the second transducer via transcutaneous transmission and transmits the audible vibrations directly to the temporal bone through the first contact surface.

[0024] The subcutaneous implantable module is configured to be positioned in a subperiosteal space of the temporal bone, created by localized periosteal dissection, in order to preserve, as much as possible, the continuity and vascularization of the supraperiosteal tissue in the implantation area. In practice, endoscopy allows verification that the device remains in the correct plane and that there are no residual interposed tissues or, worse, intact periosteum. The natural tension of the periosteal sling and the pressure of the underlying soft tissues exert pressure on the permanent magnet and the first transducer. This configuration allows the external surfaces of the permanent magnet and the first transducer to distribute the contact pressure across their respective contact surfaces, without invasive bone anchorage.

[0025] In specific embodiments, the first transducer can optionally use Bone Conduction Ultrasound (BCU) technology. This feature can be selectively activated or deactivated by an instruction from the sound processor, allowing the exploitation of the specific therapeutic effects of ultrasound stimulation, including the acoustic masking of tinnitus and the direct stimulation of inner hair cells to restore hearing.

[0026] The subcutaneous implantable module includes a first transducer failure detection system configured to monitor critical parameters and ensure a switch to external transduction mode in case of failure. The subcutaneous implantable module is equipped with radiopaque markers and / or reference elements to facilitate implant positioning and tracking with its two distinct contact surfaces.

[0027] Other features and advantages of the invention will be better understood from the description that follows and with reference to the attached drawings, given for illustrative purposes only and not for limitation.

[0028] The diagram schematically represents a bone conduction hearing implant according to the invention.

[0029] The diagram schematically represents a lateral view of the right side of the head of an individual wearing an early implementation of the bone conduction hearing implant, with the front of the head facing to the right of the figure.

[0030] The diagram schematically represents a lateral view of the right side of the head of an individual wearing a second implementation of the bone conduction hearing implant, with the front of the head facing to the right of the figure.

[0031] Lare represents a frontal front-to-back (AV-AR) section of the, showing the bone conduction auditory implant of Lamis in place.

[0032] Lare represents a particular embodiment of the invention which is partly integrated into a cap.

[0033] The figures do not necessarily respect scales, particularly in thickness, for illustrative purposes.

[0034] Preliminary remarks

[0035] To avoid obscuring the description, our explanations are limited to what is necessary for a person skilled in the art to understand the concepts of the invention. The illustrated embodiments are, for the most part, composed of elements widely known to those skilled in the art in the fields of bone conduction hearing implants, electromagnetic and piezoelectric transducers, and transcutaneous magnetic coupling systems.

[0036] 1. General presentation of the invention: a bone conduction hearing implant

[0037] As illustrated in Figures 1 to 4, the bone conduction hearing implant 100 according to the invention comprises a subcutaneous implantable module 110 with a permanent magnet 111 and a first near-field electromagnetic induction antenna 112. The subcutaneous implantable module 110 is configured to be positioned in a subperiosteal space (ESP) of the temporal bone (OT) of an individual with IDVD. It establishes direct or near-direct contact with the temporal bone (OT) via two distinct surfaces SDC1 and SDC2, without requiring invasive fixation.

[0038] In practice, the permanent magnet 111 has an external face configured to define a first contact surface SDC1 with the temporal bone OT. The area of ​​this surface is substantially equivalent to the area of ​​the external face, allowing a distributed transmission of audible vibrations to the temporal bone OT in external transduction mode.

[0039] Furthermore, the bone conduction hearing implant 100 is configured to cooperate with a sound processor 200 and to operate selectively in two modes.

[0040] In internal transduction mode, a first transducer 113 included in the subcutaneous implantable module 110 and connected to the first near-field electromagnetic induction antenna 112 converts electromagnetic signals, received by the first near-field electromagnetic induction antenna 112, into audible vibrations and transmits them directly to the temporal bone OT via a second contact surface SDC2.

[0041] In external transduction mode, a second transducer of the sound processor 200 generates audible vibrations representative of the processed sounds and transmits them via the permanent magnet 111 and its first contact surface SDC1

[0042] This approach aims to enable less invasive and less debilitating surgery, reducing postoperative complications and allowing for faster recovery. It also offers greater flexibility for future replacements of the subcutaneous implantable module 100 or upgrades to the sound processor 200 when at least part of it is located in the subperiosteal space (ESP) of the temporal bone (OT). It maintains or improves the efficiency of sound transmission.

[0043] Furthermore, it allows for the optimal placement of the permanent magnet 111 and the first transducer 113, and therefore of the sound processor 200 and the microphone(s), in the desired optimal, anatomically natural position near the ear. For example, in internal transduction mode, the subcutaneous implantable module 110 is configured so that the permanent magnet 111 is positioned closer to the PVL ear of the individual IDVD than the first transducer 113, allowing for optimal positioning of the sound processor 200.

[0044] Indeed, the classic technique often places the processor in a position very far back or even almost at the vertex on small skulls, which compromises the optimal position of the processor and the capture of incident waves by the microphones.

[0045] This positioning near the ear and ear canal is particularly important for reproducing a natural listening experience, especially in terms of capturing the auditory signal and the ability to localize sound. By placing the microphones close to the outer ear, the device can better utilize the natural acoustic cues provided by the ear. These cues include Interaural Intensity Differences (IIDs) and Interaural Time Differences (ITDs), which are essential for accurate spatial perception of sounds and improved understanding in complex sound environments.

[0046] 2. Detailed presentation of the bone conduction hearing implant

[0047] The bone conduction auditory implant 100 according to the invention, comprises an innovative structure which is distinguished from existing devices by its design and its method of positioning.

[0048] 2.1 Subcutaneous implantable module

[0049] The subcutaneous implantable module 110 forms the core of the bone conduction hearing implant 100 and comprises three essential elements: a permanent magnet 111, a first near-field electromagnetic induction antenna 112, and a first transducer 113.

[0050] In one particular embodiment, the subcutaneous implantable module 110 features a monobloc body integrating all components in a unified configuration. This monobloc architecture provides significant technical advantages in terms of space occupied within the body of the individual with IDVD. The monobloc configuration allows for a substantial reduction in the implantation surface area, decreasing, for example, from an emission area of ​​approximately 21 cm² in traditional two-part configurations to approximately 6 cm² in this embodiment. This reduction in surface area represents a particularly advantageous improvement for pediatric applications, where the available space in the mastoid region is naturally limited.The one-piece integration also optimizes the overall thickness of the subcutaneous implantable module 110, allowing for easier insertion into the subperiosteal space (ESP) while maintaining an anatomical profile compatible with individual morphological variations. This design helps reduce mechanical stress on surrounding tissues and promotes better long-term implant tolerance.

[0051] The bone conduction hearing implant 100 is configured to operate selectively in internal transduction mode using the second contact surface SDC2 of the first transducer 113 and in external transduction mode using the first contact surface SDC1 of the permanent magnet 111.

[0052] In a particular embodiment, the subcutaneous implantable module 110 includes the first transducer 113 which is connected to the first near-field electromagnetic induction antenna 112.

[0053] In the invention, the permanent magnet 111 is configured to provide magnetic coupling with a sound processor 200, the coupling being direct when the sound processor 200 is implanted subcutaneously in the subperiosteal space adjacent to the permanent magnet 111, or transcutaneous when the sound processor 200 is positioned outside the human body in contact with the skin PO of the individual, opposite the bone conduction hearing implant 100.

[0054] In practice, the sound processor 200 includes at least one microphone configured to capture ambient sounds, process them, and transmit the signals to the implant via magnetic coupling. The microphone is preferably external in the preferred embodiments, although configurations with a partially or fully integrated microphone may be considered depending on specific technical and clinical constraints, regardless of the sound processor 200's configuration. When the sound processor 200 is positioned outside the human body, the microphone is an integral part of the sound processor 200. When the sound processor 200 is implanted subcutaneously, the microphone remains external and incorporates a dedicated processor as well as a second near-field electromagnetic induction antenna 212.

[0055] In a first embodiment, the microphone is housed in a body with a known behind-the-ear design, configured to slide and be held behind the PVL ear of the individual IDVD. This body may include an ergonomic shape and a permanent magnet adapted to establish magnetic coupling with the permanent magnet 111 of the subcutaneous implantable module 110, thus ensuring the retention of the bone conduction hearing implant 100.

[0056] In a variant of the first example, as illustrated in Figure 1, the body containing the microphone, which may adopt a geometric configuration not necessarily shaped like an ear hook, for example, semi-circular, is configured to be removably coupled to a cap or headband body designed to be worn on the head of the individual with an IDVD. In this variant, the cap or headband body includes at least one bipolar permanent magnet configured to allow, on its outer face, magnetic coupling with the body containing the microphone, and on its inner face, magnetic coupling with the subcutaneous implantable module 110 via its permanent magnet 111.

[0057] In internal transduction mode, the first near-field electromagnetic induction antenna 112 is configured to receive, by inductive coupling, electromagnetic signals representative of sounds: - either emitted by the second near-field electromagnetic induction antenna of a sound processor 200 located outside the human body, after prior processing of the sounds captured by the microphone, - or emitted by the second near-field electromagnetic induction antenna housed in an external body containing the microphone when the sound processor 200 is implanted subcutaneously, the captured sounds then being processed by the internal sound processor 200. The first transducer 113, included in the subcutaneous implantable module 110 and connected to the first antenna 112, converts the electromagnetic signals thus received into audible vibrations and transmits them directly to the temporal bone OT via its second contact surface SDC2.

[0058] This first transducer 113, often called BC-FMT (Bone Conduction - Floating Mass Transducer) in some systems, or Piezo in other systems, is configured to generate high-frequency vibrations with sufficient power to effectively stimulate the temporal bone OT directly via its second contact surface SDC2.

[0059] Secondly, in external transduction mode, the permanent magnet 111 is configured to receive, via transcutaneous transmission, audible vibrations from a second transducer housed in an external casing that also contains the microphone. In this configuration, the microphone captures ambient sounds, transmits them to the second transducer, which immediately converts them into audible mechanical waves. These waves pass through the skin and are collected by the permanent magnet 111, which relays the vibrations directly to the temporal bone OT via its first contact surface SDC1. This architecture provides an effective backup solution in case of failure of the first internal transducer 113 and thus ensures the continued operation of the bone conduction hearing implant 100.

[0060] The chosen permanent magnet 111 will therefore preferably have a sufficiently large surface area to efficiently transmit audible vibrations directly to the temporal bone (OT) of the individual with DVD. The energy conveyed is proportional to the square of its first contact area (SDC1). Furthermore, the permanent magnet 111 technology will, in all cases, be advantageously compatible with the possibility of performing high-power MRI scans (e.g., 3 Tesla) without having to remove the permanent magnet 111, thus offering increased flexibility for future medical examinations of the individual with DVD.

[0061] In one particular embodiment, the body of the subcutaneous implantable module 110 is configured to have integrated magnetic properties, such that all or part of the body constitutes the permanent magnet 111. This configuration optimizes the first contact surface SDC1 by adapting the body's geometry to specific anatomical constraints. The magnetized body can be circular for uniform magnetic field distribution, parallelepiped-shaped for maximized contact area, or any other geometry suited to the required contact area. This integrated approach achieves the necessary large contact area while maintaining an optimal implantation profile and the MRI compatibility required for future medical examinations.

[0062] In the invention, the first transducer 113, included in the subcutaneous implantable module 110, as well as the permanent magnet 111, is not anchored in the temporal bone (OT). It is configured to be positioned in direct or near-direct contact with the temporal bone (OT) via its second contact surface (SDC2), without requiring invasive fixation. This configuration allows for direct transmission of audible vibrations in internal transduction mode, while avoiding the complications associated with traditional bone anchorage.

[0063] In practice, the first transducer 113 is preferably configured with a second contact surface SDC2 large enough to efficiently transmit audible vibrations directly to the temporal bone (OT) in internal transduction mode. The transmitted energy is proportional to the square of this surface area, thus optimizing auditory stimulation. The materials and design of the transducer are chosen to be compatible with medical imaging examinations, including high-power MRI, without requiring removal of the bone conduction auditory implant 100.

[0064] All of these components are arranged to minimize the overall thickness of the subcutaneous implantable module 110 while ensuring optimal performance with its two distinct contact surfaces SDC1 and SDC2.

[0065] 2.2 Implant positioning

[0066] One of the innovative features of this invention lies in its positioning method.

[0067] Unlike traditional implants that require bone anchorage, the 100 bone conduction hearing implant is designed to be positioned in a subperiosteal space (ESP) of the temporal bone (OT). It utilizes the natural tension of the periosteum (PRST) and the pressure of the underlying soft tissues.

[0068] The subperiosteal space ESP is formed in the periosteum PRST (the membrane that covers the bone) of the temporal bone OT of the individual IDVD.

[0069] The subperiosteal space (ESP) can be considered as creating a bone conduction interface, unlike traditional techniques involving anchoring and osseointegration. This innovative approach allows for greater flexibility in future procedures and reduces complications associated with permanent bone anchors.

[0070] Furthermore, the anchorless ESP subperiosteal space offers the freedom to place the implant in the desired ideal position. In particular, this method allows for optimal positioning of the first transducer 113 and the permanent magnet 111.

[0071] In internal transduction mode, the subcutaneous implantable module 110 is configured so that the permanent magnet 111 is positioned closer to the individual's ear than the first transducer 113. This configuration allows for optimal forward positioning of the sound processor 200 and the microphones while maintaining access to both contact surfaces SDC1 and SDC2. This advantage is particularly significant in young children, whose skull size poses additional constraints for the positioning of traditional implants.

[0072] The subperiosteal ESP space has an opening specifically configured to receive the subcutaneous implantable module 110 during the implantation procedure.

[0073] This design also allows for the subsequent removal or replacement of the subcutaneous implantable module 110, either in its entirety or by modular components depending on the configuration adopted, using the same incision, thus minimizing tissue trauma during future procedures. In the case of replacing only the permanent magnet 111, the privileged accessibility of this component when reopening the previous incision provides a material safety advantage, avoiding manipulation of the rest of the implantable module and reducing the risk of damage from mechanical stress. The subperiosteal space (ESP) thus offers significant flexibility for the long-term maintenance and upgradeability of the bone conduction hearing implant 100, without requiring new invasive incisions.

[0074] This approach significantly minimizes the invasiveness of the surgical procedure. Furthermore, it considerably reduces postoperative complications, particularly those related to skin healing. The scar will be vertical and adapted to the height of the implant to preserve blood flow to the retroauricular region. This method promotes optimal healing while avoiding undesirable horizontal incisions or incisions above the implant. Therefore, this surgical strategy minimizes the risk of skin complications and improves the overall healing process.

[0075] In practice, the dimensions of the subperiosteal space (ESP) are precisely designed to match those of the subcutaneous implantable module 110, ensuring a tight fit that contributes to implant stability. An additional margin (e.g., 1–2 mm) can be provided to facilitate the reception of the subcutaneous implantable module 110.

[0076] The shape of the subperiosteal ESP space is adapted to fit the contours of the subcutaneous implantable module 110 and integrate harmoniously with the anatomy of the mastoid region.

[0077] Contact with the temporal bone (OT) is an important aspect of the invention with its two distinct contact surfaces.

[0078] The permanent magnet 111 is configured to be positioned in direct or near-direct contact with the temporal bone (OT), without any invasive fixation elements, allowing direct transmission without intermediaries. Its external face is configured to define the first contact surface SDC1 with the temporal bone (OT), the area of ​​which is substantially equivalent to the area of ​​the external face for distributed transmission of audible vibrations to the temporal bone (OT) in external transduction mode.

[0079] Similarly, the first transducer 113 is configured to be positioned in direct or near-direct contact with the temporal bone OT, its external face defining the second contact surface SDC2 with the temporal bone OT for distributed transmission of audible vibrations in internal transduction mode.

[0080] This dual-interface configuration allows efficient transmission of audible vibrations to the temporal bone OT according to the selected mode, while avoiding complications associated with traditional bone anchors.

[0081] Indeed, this approach represents the best way to remain atraumatic beneath the PRST periosteal layer and therefore beneath the blood vessels, thus maintaining good vascularization of the muscular and superficial transcutaneous layers at the implant. Furthermore, it ensures direct or near-direct contact with the temporal bone (OT) without the interposition of any material (PRST periosteum, muscle, fibrosis), thereby optimizing the transmission of audible vibrations via the two contact surfaces, SDC1 and SDC2.

[0082] The subcutaneous implantable module 110 is held in place solely by the pressure exerted by the combination of the natural tension of the periosteum PRST, the pressure of the underlying soft tissues and the substantially flat or concave shapes of the external faces of the permanent magnet 111 and the first transducer 113. This configuration allows the external faces of the permanent magnet 111 and the first transducer 113 to ensure an optimal distribution of the contact pressure on their respective contact surfaces SDC1 and SDC2 of the temporal bone OT.

[0083] This non-invasive fixation method relies on the natural tension of the surrounding tissues, particularly the muscular and cutaneous sling, to hold the subcutaneous implantable module 110 in place. Once closed, the subperiosteal space (ESP) exerts constant and virtually uniform pressure on the subcutaneous implantable module 110, firmly securing both components against the temporal bone (OT) without invasive bone anchorage.

[0084] This non-invasive approach represents a significant advance in the field of bone conduction hearing implants.

[0085] The absence of invasive fixation elements (screws, anchors) on the surface of the subcutaneous implantable module 110 in contact with the temporal bone (OT) is a distinctive feature of this system. The system takes advantage of the natural elasticity of the underlying soft tissues and the pressure exerted by the surrounding anatomical structures to ensure stable retention, while allowing efficient transmission of audible vibrations.

[0086] This design without bone anchorage also presents a significant advantage in terms of the contact surfaces of SDC1 and SDC2 with the temporal bone OT.

[0087] Indeed, unlike traditional systems using an anchoring screw that offers a limited contact area (typically on the order of 0.5 cm²), the subcutaneous implantable module 110 of the invention can have a significantly larger total contact area (SDC1 + SDC2), up to approximately 3 cm². The area of ​​each contact surface is substantially equivalent to the area of ​​the outer face of the corresponding element, allowing for optimal distributed transmission of audible vibrations. This substantial increase in the active contact area, depending on the mode used, has important implications for the transmission of audible vibrations. According to the principles of wave mechanics, the power of the transmitted signal is proportional to the square of the active contact area, potentially offering significantly more effective auditory stimulation.

[0088] 3. Operating Modes

[0089] The bone conduction auditory implant 100 according to the invention is configured to operate in two distinct modes: an internal transduction mode and an external transduction mode.

[0090] This dual functionality offers increased flexibility and adaptability, allowing the implant to respond to various hearing situations and potential technical failures.

[0091] 3.1 Internal transduction mode

[0092] In internal transduction mode, two configurations are possible depending on the position of the sound processor 200.

[0093] First configuration with external sound processor: the first near-field electromagnetic induction antenna 112 of the subcutaneous implantable module 110 is configured to receive, by electromagnetic induction, electromagnetic signals representative of the sounds processed by the sound processor 200 positioned outside the human body.

[0094] Second configuration with internal sound processor: when the sound processor 200 is implanted subcutaneously in the implantable module 110, the electromagnetic signals representing the sounds captured by the external microphone are received by the first near-field electromagnetic induction antenna 112 integrated into the sound processor 200, processed internally, and then transmitted directly to the first transducer 113.

[0095] In both configurations, the first transducer 113 converts the received signals into audible vibrations and transmits them to the temporal bone OT via its second contact surface SDC2, while the permanent magnet 111 maintains the transcutaneous magnetic coupling.

[0096] The first 113 transducer is generally based on electromagnetic or piezoelectric technologies, chosen for their efficiency and long-term reliability.

[0097] In one particular embodiment, the first transducer 113 utilizes Bone Conduction Ultrasound (BCU) technology. BCU, although known, exhibits an increased capacity for vibrational transmission, making it potentially more effective in restoring hearing in patients with profound deafness.

[0098] This USCO transducer generates ultrasonic vibrations of a different nature than those produced by traditional bone conduction implants. The USCO uses ultrasonic waves, which are audible vibrations at very high frequencies, typically at least 120 kHz. These vibrations are considered mechanical because they involve the movement of particles within a medium, in this case, the bones of the skull. This characteristic distinguishes them from traditional bone conduction implants, which generate audible vibrations generally between 20 Hz and 20 kHz.

[0099] The method of sound transmission in USCO and traditional implants is similar in that vibrations are transmitted through the bones of the skull. However, the way these vibrations are then interpreted by the inner ear differs. In the case of traditional implants, the audible vibrations directly stimulate the cochlea. In contrast, for USCO, the ultrasonic vibrations must be "demodulated" in the bone of the otic capsule (comparable to the diffraction of light in a prism) or converted into audible signals by the inner ear.

[0100] The use of higher frequencies in USCO can offer potential advantages. The increased vibrational transmission resulting from these higher frequencies generates greater audiological gain. This can allow for better frequency resolution and more efficient sound transmission through bone. This is because ultrasound waves have shorter wavelengths, which can potentially offer greater precision in stimulating the inner ear.

[0101] In practice, USCO allows for the effective masking of acute tinnitus, particularly subjective tinnitus, an important category for the audiology expert, as it is the majority in tinnitus patients, thus offering an innovative solution for tinnitus reduction.

[0102] Furthermore, high-frequency ultrasound can potentially directly stimulate residual inner hair cells, allowing patients with profound deafness to hear sounds again and opening new perspectives for auditory rehabilitation in some cases of severe to profound deafness.

[0103] Integrating USCO technology into the implant creates a truly multifunctional bone conduction interface. This system combines traditional bone conduction auditory stimulation with tinnitus treatment capabilities and direct hair cell stimulation.

[0104] This innovative approach can offer better sound quality and a wider frequency range, making the 100 bone conduction hearing implant more discreet and comfortable for the user.

[0105] The permanent magnet 111 of the subcutaneous implantable module 110 is configured to provide transcutaneous magnetic coupling with the sound processor 200, thus ensuring a stable and efficient connection.

[0106] The audible vibrations generated by the first transducer 113 are transmitted directly to the temporal bone OT of the individual IDVD via its second contact surface SDC2 in internal transduction mode, thus bypassing the damaged parts of the external or middle ear.

[0107] This operating mode allows direct and precise stimulation of the temporal bone OT via the second contact surface SDC2 of the first transducer 113, offering optimal sound quality and increased energy efficiency.

[0108] 3.2 External transduction mode

[0109] The external transduction mode works differently.

[0110] The permanent magnet 111 of the subcutaneous implantable module 110 plays a dual role: it serves both as a coupling means with the sound processor 200 and as a direct transmitter of audible vibrations to the temporal bone OT via its first contact surface SDC1 in external transduction mode.

[0111] As previously described, the permanent magnet 111 can be configured according to a particular embodiment where all or part of the body of the subcutaneous implantable module 110 has integrated magnetic properties, thus optimizing the first contact surface SDC1.

[0112] A second transducer of the sound processor 200 is configured to generate audible vibrations representative of the sounds processed by the sound processor 200. The second transducer is generally based on electromagnetic or piezoelectric technologies, chosen for their efficiency and long-term reliability.

[0113] The permanent magnet 111 is configured to receive audible vibrations from the second transducer by transcutaneous transmission, and to transmit audible vibrations directly to the temporal bone OT via its first contact surface SDC1.

[0114] This mode offers a backup solution in case of failure of the first transducer 113, thus ensuring the continuity of the hearing function.

[0115] 3.3 Switching between modes

[0116] The bone conduction hearing implant 100 is equipped with switching means allowing switching from internal transduction mode to external transduction mode, and vice versa.

[0117] In one technical embodiment, the switching means include an electronic switching circuit integrated into the subcutaneous implantable module 110, comprising at least one analog or digital multiplexer configured to selectively route audio signals either to the first transducer 113 in internal transduction mode or to the permanent magnet 111 in external transduction mode. This switching circuit can be implemented using semiconductor components such as MOSFET transistors or miniaturized electronic relays, ensuring fast and reliable switching between the two transduction paths.

[0118] This switching can be performed automatically, in response to the detection of a failure in the first transducer 113 by the integrated detection system 114. For example, the detection system 114 can monitor the electrical impedance of the first transducer 113 or analyze the return signals to identify a failure, automatically triggering the switch to the external transduction mode by activating the switching circuit.

[0119] It can also be performed manually by the user or a healthcare professional, via a control interface on the sound processor 200. In a particular embodiment, this control interface may include, externally, a push button, a magnetic switch activated by the approach of an external magnet, or a capacitive touch interface integrated into the housing of the external sound processor 200 or the body integrating the microphone, transmitting the switching commands to the switching circuit by inductive coupling link.

[0120] The ability to switch between these two modes ensures optimal flexibility and continuity of operation, even in the event of a component failure. This feature enhances the overall reliability of the 100 bone conduction hearing implant, providing an immediate backup solution in case of a technical problem and allowing for fine-tuning to the user's specific hearing needs in various acoustic environments.

[0121] 4. Specific characteristics

[0122] The bone conduction hearing implant 100 according to the invention has several specific characteristics that distinguish it from existing devices and improve its effectiveness and safety.

[0123] 4.1 Fault detection system

[0124] The subcutaneous implantable module 110 includes a system for detecting failure of the first transducer 113 114.

[0125] This 114 detection system is configured to continuously monitor several critical parameters.

[0126] The detection system 114 can detect an abnormal variation in the impedance of the first near-field electromagnetic induction antenna 112, which allows for the rapid identification of any electrical malfunction of the transducer.

[0127] In addition, an accelerometer 115 integrated into the subcutaneous implantable module 110 allows for the detection of a predetermined intensity of audible vibrations or the absence of audible vibration, thus ensuring that the transducer effectively generates the vibrations necessary for sound transmission.

[0128] The detection system 114 is also capable of detecting any change in the frequency response of the first transducer 113, which makes it possible to identify any alteration in the acoustic performance of the transducer.

[0129] This multi-parametric approach to fault detection significantly improves the reliability of the bone conduction hearing implant 100 and allows for rapid intervention in case of malfunction.

[0130] 4.2 Radiopaque markers and reference elements for implant positioning and monitoring

[0131] The subcutaneous implantable module 110 is provided with a plurality of radio-opaque markers positioned on the external faces of the permanent magnet 111 and the first transducer 113 in contact with the temporal bone and visible by imaging and / or reference elements.

[0132] The radiopaque markers are specifically configured to allow, during medical imaging procedures, the precise verification of the positioning of the contact surfaces SDC1 and SDC2 between the external faces of the permanent magnet 111 and the first transducer 113 and the temporal bone OT. Made of tantalum, platinum-iridium, platinum alloys or any highly radiopaque material (i.e., visible on radiographs, CT scans and / or fluoroscopies) they are arranged in an asymmetrical geometric configuration comprising three markers forming a scalene triangle, allowing unambiguous identification of the three-dimensional orientation of the subcutaneous implantable module 110.

[0133] The geometric asymmetry of the scalene triangle creates a unique signature on the radiographic image. The absolute distances between markers remain constant, but their relative spatial configuration changes predictably depending on the orientation of the bone conduction hearing implant. This method eliminates the orientation ambiguities present with symmetrical configurations (equilateral or isosceles triangles) where several spatial positions produce similar images.

[0134] The scalene triangle establishes an intrinsic coordinate system: the longer side serves as the primary reference axis, and the shorter side indicates the anteroposterior direction. In one example, the three markers have distinct geometric shapes depending on their anatomical position: circular (anterior), square (posterior), and triangular (lateral). This standardization allows practitioners to instantly assess the position and orientation of the implant.

[0135] This configuration offers a measurable technical advantage: evaluation in less than 30 seconds compared to 2-5 minutes with conventional markers, and automatic detection of angular deviations greater than 5 degrees. The markers create characteristic distance ratios that are easily identifiable on standard radiographic images.

[0136] In one example, the reference elements are visual markers integrated into the external surface of the implant in the form of colored marks, engraved patterns, or raised structures specifically configured for easy identification during an endoscopic procedure. They allow the surgeon to visually verify the positioning and orientation of the implant during the procedure, without resorting to radiological imaging.

[0137] These features greatly facilitate the implantation procedure by allowing the surgeon to ensure optimal placement of the implant.

[0138] Furthermore, these markers and reference points allow for precise post-operative monitoring, ensuring optimal positioning of the implant with its two contact surfaces, SDC1 and SDC2, for efficient transmission of audible vibrations over the long term. They also facilitate any subsequent interventions by providing clear reference points for locating and assessing the implant's condition without requiring invasive procedures.

[0139] 4.3 Permanent Magnet Surface

[0140] The outer face of the implant's permanent magnet 111 is specifically configured to optimize contact with the temporal bone OT via its first contact surface SDC1. Similarly, the outer face of the first transducer 113 is configured to optimize contact with the temporal bone OT via its second contact surface SDC2.

[0141] Two configurations are proposed to accommodate different bone morphologies for each of the two elements in contact with the temporal bone.

[0142] The first configuration features a substantially concave and smooth surface, ensuring intimate contact and an extensive initial contact area SDC1 between the permanent magnet 111 and the temporal bone OT. This shape allows for optimal adaptation to the bone surface, thus maximizing vibration transmission in external transduction mode.

[0143] The second configuration offers a substantially flat and smooth surface, which also provides intimate contact and an extended initial contact area (SDC1) between the permanent magnet 111 and the temporal bone (OT) in external transduction mode. This option may be preferred in certain specific anatomical cases.

[0144] These two surface options allow for increased adaptability to different bone morphologies, thus ensuring optimal efficiency of the 100 bone conduction hearing implant for a wide range of IDVD individuals with its two distinct contact surfaces SDC1 and SDC2.

[0145] 4.4 Biocompatible sheath

[0146] An innovative feature of the implant is the use of a sheath 116 made of a biocompatible material.

[0147] This sheath 116 encapsulates and protects the internal components of the subcutaneous implantable module 110, while allowing optimal transmission of audible vibrations. It ensures an optimal interface between the subcutaneous implantable module 110 and the surrounding tissues.

[0148] Furthermore, the sheath 116 contributes to the sealing of the subcutaneous implantable module 110, protecting the electronic components from bodily fluids. Its flexibility allows movement of the internal components while protecting them.

[0149] This biocompatible sheath 116 is configured to be positioned in the subperiosteal ESP space and to receive the subcutaneous implantable module 110.

[0150] It features an opening specifically configured to allow the insertion of the subcutaneous implantable module 110 during the implantation of the bone conduction hearing implant 100.

[0151] This design also allows for the subsequent removal or replacement of the subcutaneous implantable module 110 using the same incision that leads to the opening. This approach minimizes tissue trauma during future procedures.

[0152] The sheath 116 is capable of holding the subcutaneous implantable module 110 in place against the temporal bone OT only by pressure, without requiring invasive fixation.

[0153] This pressure is exerted by the combination of the natural tension of the PRST periosteum, the pressure of the underlying soft tissues and the substantially flat or concave shapes of the external faces of the permanent magnet 111 and the first transducer 113.

[0154] The 116 sleeve is manufactured from biocompatible materials that comply with ISO 10993 standards. While medical-grade silicone is commonly used due to its proven biocompatibility, other materials can be considered. These materials include ultra-high molecular weight polyethylene (UHMWPE) or other materials that comply with ISO 10993 standards, including polyurethane or thermoplastic elastomers (TPE).

[0155] The choice of material depends on the specific requirements of the implant in terms of acoustic performance, biocompatibility and long-term durability.

[0156] This approach offers an elegant solution for implant positioning and retention. It reduces the risks associated with more invasive fixation methods while ensuring optimal stability of the bone conduction hearing implant.

[0157] The sheath 116 allows near-direct contact between the permanent magnet 111 and the first transducer 113 and the temporal bone OT, providing significant flexibility for long-term maintenance and scalability of the bone conduction hearing implant 100.

[0158] 5. External Components

[0159] The bone conduction hearing implant 100 according to the invention cooperates with external components that are essential to its operation.

[0160] These elements are configured to work in synergy with the subcutaneous implantable module 110, thus ensuring efficient sound transmission and an optimal listening experience for the user.

[0161] The main external components are the sound processor 200 and the magnetic coupling system, each playing an important role in the overall operation of the bone conduction hearing implant 100.

[0162] 5.1 Sound Processor

[0163] The 200 sound processor is an essential component of a 100 bone conduction hearing aid system. It can be configured in two implantation modes: external or internal.

[0164] In external configuration, the sound processor 200 is configured to ensure transcutaneous magnetic coupling with the permanent magnet 111 of the bone conduction hearing implant 100, capture surrounding sounds, process them and transmit them to the subcutaneous implantable module 110 by,- transmission of electromagnetic signals representative of the processed sounds in internal transduction mode for activation of the first transducer 113 and transmission via SDC2, and- generation of audible vibrations representative of the processed sounds in external transduction mode for transmission via the permanent magnet 111 and its surface SDC1.

[0165] In its internal configuration, the sound processor 200 is integrated into the subcutaneous implantable module 110 and receives audio signals via a wireless communication antenna from an external microphone. In this configuration, the sound processor 200 directly processes the received signals and transmits them to the first transducer 113 without requiring transcutaneous magnetic coupling.

[0166] In external configuration, the 200 sound processor includes one or more highly sensitive microphones capable of capturing a wide range of sound frequencies, typically between 20 Hz and 20 kHz. In internal configuration, the 200 sound processor receives audio signals from a remote external microphone via a wireless connection.

[0167] In both configurations, it incorporates an advanced digital signal processing system that analyzes and optimizes captured sounds in real time. This process involves several steps. First, the analog signal is converted into a digital signal. Then, noise is filtered and certain frequencies are selectively amplified. Finally, sound processing algorithms are applied to improve the clarity and intelligibility of the audio signal.

[0168] In external configuration, the 200 sound processor is equipped with a rechargeable battery offering extended operating time, as well as controls allowing the user to adjust the volume and select different listening programs adapted to various acoustic situations. In internal configuration, power is supplied by a battery integrated into the 110 subcutaneous implantable module, and the control functions are located on the external device containing the microphone.

[0169] In external configuration, its ergonomic design allows for comfortable behind-the-ear wear, while its water- and dust-resistant casing provides protection against the elements. In internal configuration, the Sound Processor 200 benefits from the biocompatible encapsulation of the subcutaneous implantable module 110, ensuring optimal protection against biological fluids and mechanical stress.

[0170] 5.2 Magnetic Coupling

[0171] The magnetic coupling system ensures efficient transmission of signals between the external components and the subcutaneous implantable module 110, according to two distinct configurations depending on the position of the sound processor 200.

[0172] In the configuration with external sound processor, the magnetic coupling system consists of an external permanent magnet integrated into the sound processor and the internal permanent magnet 111 which is part of the subcutaneous implantable module 110.

[0173] In the configuration with internal sound processor, the magnetic coupling system consists of an external permanent magnet integrated into the body containing the microphone and the internal permanent magnet 111 of the subcutaneous implantable module 110.

[0174] In both configurations, these permanent magnets are configured to create a stable and secure connection through the individual's PO skin, without requiring skin penetration.

[0175] The magnetic force is carefully calibrated to hold the processor in place while avoiding excessive pressure on the tissues. In configurations with an external sound processor, this force holds the 200 sound processor in position. In configurations with an internal sound processor, this force holds the body containing the microphone in the optimal position for sound capture.

[0176] When configured with an external sound processor, the magnetic coupling system also ensures optimal transmission of audible vibrations, thus minimizing energy loss between external and internal components. When configured with an internal sound processor, the magnetic coupling only maintains the positioning of the external microphone; audio signal transmission occurs wirelessly.

[0177] In both configurations, the system offers the flexibility to easily detach the external component for cleaning, charging, or replacement, while ensuring precise and consistent repositioning. In the configuration with an external sound processor, this flexibility directly applies to the 200 sound processor. In the configuration with an internal sound processor, this flexibility applies to the body containing the microphone, allowing for replacement or maintenance of this component without affecting the implanted 200 sound processor.

[0178] 6. Complete Bone Conduction Hearing Aid System

[0179] The bone conduction hearing aid system according to the invention constitutes an integrated and innovative solution for the treatment of various types of hearing loss, including conductive hearing loss, mixed hearing loss and unilateral hearing loss.

[0180] This complete system combines the advantages of a 100% bone conduction hearing implant with a sophisticated 200% sound processor, thus offering an optimized and customizable hearing experience for the user.

[0181] The following sections detail the important interactions between system components, fault management mechanisms, and automatic features that ensure consistent and reliable performance.

[0182] 6.1 Interaction between the implant and the sound processor 200

[0183] The interaction between the bone conduction hearing implant 100 and the sound processor 200 is at the heart of the system's operation.

[0184] This interaction relies on sophisticated magnetic coupling which allows efficient transmission of sound signals through the individual's PO skin, according to two distinct modes of operation.

[0185] In internal transduction mode, the Sound Processor 200 captures ambient sounds using its directional microphones, digitally processes them to optimize sound quality, and then transmits them to the implant as electromagnetic signals. In external transduction mode, the Sound Processor 200 activates its second transducer, which generates audible vibrations representative of the processed sounds. These vibrations are transmitted transcutaneously to the permanent magnet 111.

[0186] In internal transduction mode, the implant converts electromagnetic signals into audible vibrations that directly stimulate the temporal bone (TO) via the second contact surface (SDC2) of the first transducer (113). In external transduction mode, the permanent magnet (111) plays a dual role: it provides magnetic coupling with the sound processor (200) and receives the audible vibrations from the second transducer via transcutaneous transmission, then transmits them directly to the temporal bone (TO) via the first contact surface (SDC1) of the permanent magnet (111). This external transduction mode serves as a backup in case of failure of the first transducer (113), thus ensuring continuity of hearing function. Both modes bypass damaged parts of the outer or middle ear.

[0187] This interaction allows for fine-tuning to the user's specific hearing needs, with possibilities for personalized parameter adjustment.

[0188] 6.2 Failure Management

[0189] The system incorporates advanced failure management mechanisms to ensure optimal reliability and performance.

[0190] A fault detection system 114 continuously monitors the operation of the first transducer 113, analyzing parameters such as the impedance of the first near-field electromagnetic induction antenna 112, the presence of audible vibrations, and the frequency response of the first transducer 113.

[0191] If an anomaly is detected, the system can automatically switch to external transduction mode or alert the user via the sound processor 200.

[0192] Furthermore, the system is configured to facilitate maintenance or replacement, with modular components that can be upgraded or replaced without requiring invasive surgery. When the bone conduction hearing implant 100 includes the first transducer failure detection system 114, the sound processor 200 is configured to receive information from the detection system 114 and send a signal to an external computer system to report the failure of the first transducer 113. The external computer system is selected from a group including a smartwatch, a phone, a computer, and a tablet.

[0193] This approach extends the lifespan of the bone conduction hearing implant 100 and ensures its scalability in the face of future technological advances.

[0194] 6.3 Automatic activation of external transduction mode

[0195] An innovative feature of the system is its ability to automatically activate the external transduction mode in the event of failure of the first transducer 113, when the bone conduction hearing implant 100 is configured with both transduction modes and the external sound processor 200 has the necessary second transducer.

[0196] This feature ensures continuity of the hearing experience for the user, even in the event of a technical problem. In systems equipped with both transduction modes, the bone conduction hearing implant 100 initially operates in internal transduction mode, and the external sound processor 200 is configured to automatically switch from internal to external transduction mode in response to receiving failure information from the first transducer 113. When the failure detection system 114 identifies a malfunction of the first transducer 113, it sends a signal to the sound processor 200.

[0197] The external sound processor 200 then activates its own second transducer, generating audible vibrations that are transmitted directly to the implant's permanent magnet 111 through the individual's skin PO and transmitted to the temporal bone OT via the first contact surface SDC1.

[0198] This transition is seamless for the user, thus minimizing interruptions in their auditory perception.

[0199] Furthermore, the system can notify the user of this change via a dedicated application, allowing them to take the necessary steps for a possible maintenance or follow-up consultation. This automatic switching function is only available with an external 200 sound processor equipped with the second transducer and is not applicable in the configuration with an internal sound processor where only the external microphone remains functional.

[0200] 7. Advantages and applications

[0201] The bone conduction hearing implant system 100 according to the invention offers many advantages over existing devices and presents a wide range of potential applications in the field of audiology.

[0202] One of the main advantages of this system lies in its non-invasive nature.

[0203] Unlike traditional bone-anchored implants which require screwing into the skull bone, the present bone conduction hearing implant 100 uses a permanent magnet 111 and a first transducer 113 positioned in a subperiosteal space ESP.

[0204] This approach significantly reduces the risks associated with invasive surgery, such as post-operative infections and complications related to osseointegration.

[0205] In addition, this implantation method allows for faster recovery and minimizes the waiting time before activation of the bone conduction hearing implant 100.

[0206] The system's flexibility, with its internal and external transduction modes, offers increased adaptability to the specific needs of each individual IDVD.

[0207] This feature also allows for upgrades to the bone conduction hearing implant 100, facilitating future upgrades (processor evolution) without requiring further invasive surgical procedures. This represents a significant advantage in terms of long-term cost and comfort for the individual with hearing loss.

[0208] The integrated 114 fault detection system and the ability to switch between transduction modes ensure superior reliability and continuity of operation.

[0209] These features minimize potential periods of hearing loss due to technical malfunctions, thus improving the quality of life for users.

[0210] In terms of applications, this system is particularly well-suited for individuals with IDVD who suffer from conductive hearing loss, mixed hearing loss, or unilateral hearing loss of the SSD type. It can be used effectively in both adults and children, including in cases where the cortical thickness is still too low and skull growth is ongoing, thanks to its less invasive and more adaptable nature.

[0211] The bone conduction hearing implant according to the invention offers significant theoretical advantages over existing devices in terms of audiometric performance. The innovative architecture of the system theoretically allows for an improvement in the average tonal threshold (ATT) compared to other conventional bone conduction systems. Overclosure, an indicator of the efficiency of direct bone transmission, theoretically benefits from a substantial improvement compared to conventional devices. These theoretical performance improvements result directly from the optimization of the contact surfaces SDC1 and SDC2, whose areas are substantially equivalent to the areas of the external faces of the permanent magnet 111 and the first transducer 113, respectively.This configuration theoretically allows for a more efficient distributed transmission of audible vibrations to the temporal bone, thus optimizing energy transfer according to the principles of wave mechanics where the transmitted power is proportional to the square of the active contact area.

[0212] 8. Conclusion

[0213] We have described and illustrated the invention. However, the invention is not limited to the embodiments we have presented. Indeed, numerous combinations of variants, alternatives, embodiments, and implementations can be envisaged without requiring substantial modifications to the invention. Thus, an expert in the field of bone conduction hearing implants can deduce other variants, alternatives, embodiments, and implementations by reading the description and the accompanying figures, and taking into account the anatomical, biomedical, technological, and economic constraints to be respected.

[0214] Regarding the term "substantially equivalent," used particularly to describe the contact areas of SDC1 and SDC2, it indicates flexibility in the dimensions and proportions mentioned. This term means that the area of ​​the first contact surface, SDC1, may vary slightly from the exact area of ​​the outer face of the permanent magnet 111, and that the area of ​​the second contact surface, SDC2, may vary slightly from the exact area of ​​the outer face of the first transducer 113, while still maintaining the essential functionality of distributed transmission of audible vibrations. The use of "substantially equivalent" thus encompasses manufacturing tolerances, individual anatomical variations, and necessary technical adaptations.

[0215] On the other hand, when an element is "configured" to perform a particular function, it means that this element is designed, adapted or programmed specifically for the purpose of performing that particular function in the context of the bone conduction hearing implant 100.

[0216] However, depending on the needs and resources available, consideration may be given to using an existing element from the field of implantable medical devices, which will be modified or adapted to fulfill this particular function, without requiring substantial modifications to the invention.

[0217] It should be noted that the examples provided throughout this description, particularly those concerning biocompatible materials such as medical-grade silicone or UHMWPE, USCO technology, tantalum radiopaque markers, or concave or flat surface configurations, are presented for illustrative purposes only and are not intended to limit the application of the invention. These examples are designed to facilitate understanding of the invention by a person skilled in the art of hearing implants.

[0218] However, the invention is not limited to these specific examples. Those skilled in the art will understand that these examples can be generalized, adapted or modified according to the specific needs of patients, technological advances in the field of transducers and biocompatible materials, or particular anatomical constraints, without departing from the spirit of the invention.

[0219] The invention is capable of numerous variations and applications other than those described above. In particular, unless otherwise specified, the various structural and functional features of each particular embodiment described above should not be considered as combined and / or closely and / or inextricably linked to one another, but rather as mere juxtapositions. Furthermore, the structural and / or functional features of the various embodiments described above may be juxtaposed or combined, in whole or in part, in any different manner, thus allowing the bone conduction hearing implant 100, with its two distinct contact surfaces SDC1 and SDC2, to be adapted to the specific needs of each medical application.

[0220] In an advanced alternative embodiment, the system can integrate a microphone within the subcutaneous implantable module 110, thus creating a fully implanted configuration. This variant would require specific technical adaptations, particularly in terms of biocompatible microphone encapsulation, optimized power management, and adapted maintenance protocols. Although this configuration presents substantial technical challenges related to sealing, component lifespan, and surgical complexity, it could meet specific clinical needs where aesthetics and complete discretion of the system are major priorities. This approach maintains the fundamental advantages of the invention—subperiosteal positioning without anchoring and dual transduction mode—while offering maximum component integration.

Claims

Bone conduction hearing implant (100) comprising: - a subcutaneous implantable module (110) having a permanent magnet (111) and a first near-field electromagnetic induction antenna (112), the permanent magnet (111) being configured to ensure direct magnetic coupling when a sound processor (200) is implanted subcutaneously in the subperiosteal space adjacent to the permanent magnet (111), or transcutaneously with the sound processor (200) when the latter is positioned outside the human body, and having an external face configured to: - establish direct or near-direct contact with the temporal bone, OT, of an individual with IDVD, and - define a first contact surface, SDC1, with the temporal bone, OT, the area of ​​which is substantially equivalent to the area of ​​the external face for distributed transmission of audible vibrations to the temporal bone, OT, in mode of external transduction, in whichThe bone conduction hearing implant (100) is configured to cooperate with the sound processor (200) configured according to two modes of external or internal implantation, and to operate selectively: - in the internal transduction mode, in which: - when the sound processor (200) is positioned outside the human body, the first near-field electromagnetic induction antenna (112) is configured to receive, by electromagnetic induction, electromagnetic signals representative of the sounds processed by the external sound processor (200); - when the sound processor (200) is implanted subcutaneously in the implantable module (110), the electromagnetic signals representative of the sounds captured by a microphone are received by the first near-field electromagnetic induction antenna (112) integrated into the sound processor (200), processed internally, and then transmitted directly to a first transducer (113); - in both configurations,The first transducer (113), included in the subcutaneous implantable module (110) and connected to the first near-field electromagnetic induction antenna (112) or to the internal sound processor (200) depending on the configuration, is configured to convert electromagnetic signals into audible vibrations and has an external face configured to define a second contact surface, SDC2, with the temporal bone, OT, and to transmit the audible vibrations directly to the temporal bone, OT, via the second contact surface, SDC2, and—in external transduction mode, wherein—a second transducer housed in an external body that also contains a microphone is configured to generate audible vibrations representative of the sounds captured by the microphone and converted by the second transducer,—the permanent magnet (111) is configured to—receive the audible vibrations from the second transducer by transcutaneous transmission,and--- directly transmit audible vibrations to the temporal bone, OT, via the first contact surface, SDC1, wherein the subcutaneous implantable module (110) is configured to be positioned in a subperiosteal space (ESP) of the temporal bone, OT, such that the natural tension of the periosteum (PRST) and the pressure of the underlying soft tissues exert pressure on the permanent magnet (111) and the first transducer (113), allowing the external faces of the permanent magnet (111) and the first transducer (113) to distribute contact pressure on their respective contact surfaces SDC1 and SDC2 of the temporal bone, OT, without invasive bone anchoring. Bone conduction hearing implant (100) according to claim 1, wherein the first transducer (113) uses bone conduction ultrasound technology, USCO. Bone conduction hearing implant (100) according to any one of claims 1 to 2, wherein, in the internal transduction mode, the subcutaneous implantable module (110) is configured so that the permanent magnet (111) is positioned closer to the PVL ear pinna of the individual IDVD than the first transducer (113). Bone conduction hearing implant (100) according to any one of claims 1 to 3, wherein the subcutaneous implantable module (110) has two distinct contact surfaces with the temporal bone, OT, - the first contact surface, SDC1, of the permanent magnet (111) used in external transduction mode, and - the second contact surface, SDC2, of the first transducer (113) used in internal transduction mode, wherein the two surfaces are configured for direct or quasi-direct contact with the temporal bone, OT. Bone conduction hearing implant (100) according to any one of claims 1 to 4, wherein the subcutaneous implantable module (110) includes a system for detecting the failure of the first transducer (113), the detection system (114) being configured to detect one of the following parameters: -- an abnormal variation in the impedance of the first near-field electromagnetic induction antenna (112), -- a predetermined intensity of audible vibrations or an absence of audible vibration detected by an accelerometer (115) integrated into the subcutaneous implantable module (110), and -- a change in the frequency response of the first transducer (113). Bone conduction hearing implant (100) according to any one of claims 1 to 5, wherein the subcutaneous implantable module (110) is provided with a plurality of radio-opaque markers positioned on the external faces of the permanent magnet (111) and the first transducer (113) in contact with the temporal bone and visible by imaging and / or reference elements, the radio-opaque markers being arranged in a predetermined asymmetric geometric configuration comprising three markers forming a scalene triangle, which are configured to allow verification of the positioning of the contact surfaces, SDC1, and SDC2 between the external faces of the permanent magnet (111) and the first transducer (113) and the temporal bone, OT, and identification of the three-dimensional orientation of the subcutaneous implantable module (110). Bone conduction auditory implant (100) according to claim 6, wherein the three radio-opaque markers have distinct geometric shapes according to their anatomical position, the anterior reference marker, the posterior reference marker, and the lateral reference marker each having a different shape. Bone conduction hearing implant (100) according to any one of claims 1 to 7, wherein, - the permanent magnet (111) has an external face with a smooth, substantially concave or substantially flat surface, configured to ensure intimate contact with the temporal bone, OT, at the level of the first contact surface, SDC1, and / or - the first transducer (113) has an external face with a smooth, substantially concave or substantially flat surface, configured to ensure intimate contact with the temporal bone, OT, at the level of the second contact surface, SDC2. Bone conduction hearing implant (100) according to any one of claims 1 to 8, comprising a sheath (116) formed of a biocompatible material, configured to be positioned in the subperiosteal space ESP and to receive the subcutaneous implantable module (110) through an opening, the sheath (116) being configured to allow quasi-direct contact between the permanent magnet (111) and the temporal bone, OT. Bone conduction hearing implant (100) according to any one of claims 1 to 9, wherein the subcutaneous implantable module (110) has a one-piece body integrating the permanent magnet (111), the first near-field electromagnetic induction antenna (112), and the first transducer (113) in a unified configuration. Bone conduction hearing implant (100) according to any one of claims 1 to 10, wherein the body of the subcutaneous implantable module (110) is configured to exhibit integrated magnetic properties, such that all or part of the body constitutes the permanent magnet (111). Bone conduction hearing implant (100) according to any one of claims 1 to 11, comprising switching means integrated into the subcutaneous implantable module (110) and comprising at least one analog or digital multiplexer configured to selectively route audio signals either to the first transducer (113) in internal transduction mode, or to the permanent magnet (111) in external transduction mode. Bone conduction hearing implant (100) according to any one of claims 1 to 12, wherein, when the sound processor (200) is positioned outside the human body, the microphone is an integral part of the external sound processor (200) and is configured to capture surrounding sounds, process them and transmit them to the subcutaneous implantable module (110) by transcutaneous magnetic coupling. Bone conduction hearing implant (100) according to any one of claims 1 to 13, wherein, when the sound processor (200) is implanted subcutaneously in the implantable module (110), the microphone remains external and incorporates a dedicated processor as well as a second near-field electromagnetic induction antenna (212), configured to transmit the signals captured to the internal sound processor (200) by wireless link. Bone conduction hearing implant (100) according to any one of claims 1 to 14, wherein the microphone is integrated into the subcutaneous implantable module (110) jointly with the sound processor (200), thus creating a fully implanted configuration where all active sound capture and processing components are integrated into the subcutaneous implantable module (110). Bone conduction hearing aid system comprising: - a bone conduction hearing implant (100) according to any one of claims 1 to 15; - a sound processor (200) configured according to two modes of external or internal implantation; - in external configuration, the sound processor (200) being configured to ensure transcutaneous magnetic coupling with the permanent magnet (111) of the bone conduction hearing implant (100), capture ambient sounds via an integrated microphone, process them and transmit them to the subcutaneous implantable module (110) by: - ​​transmission of electromagnetic signals representative of the sounds processed in internal transduction mode; and - generation of audible vibrations representative of the sounds processed in external transduction mode; - in internal configuration,The sound processor (200) is integrated into the subcutaneous implantable module (110) and configured to receive audio signals from an external microphone housed in an external body, directly process the received signals and transmit them to the first transducer (113) without requiring transcutaneous magnetic coupling. Bone conduction hearing aid system according to claim 16, in external configuration, where the bone conduction hearing implant (100) depends on claim 5, wherein the sound processor (200) is configured to: - receive information from the failure detection system (114) of the first transducer (113), and - send a signal to an external computer system to report the failure of the first transducer (113), the external computer system being selected from the group including a smartwatch, a phone, a computer and a tablet. Bone conduction hearing aid system according to claim 17, wherein the bone conduction hearing implant (100) initially operates in internal transduction mode, and the external sound processor (200) is configured to automatically switch from internal transduction mode to external transduction mode in response to receiving failure information from the first transducer (113). Bone conduction hearing aid system according to claim 17 in internal configuration, wherein the external microphone is housed in a body having a behind-the-ear type earpiece shape configured to slide and be held behind the ear, PVL, of the individual, IDVD, the body comprising a permanent magnet adapted to establish magnetic coupling with the permanent magnet (111) of the subcutaneous implantable module (110). Bone conduction hearing aid system according to claim 19, wherein the body containing the microphone is configured to be removably coupled with a cap or headband body configured to be worn on the individual's head, IDVD, the cap or headband body comprising at least one bipolar permanent magnet configured to permit, on its outer face, magnetic coupling with the body containing the microphone, and on its inner face, magnetic coupling with the subcutaneous implantable module (110) via its permanent magnet (111).

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