A middle-ear microphone, designed to pick up vibrations from the tiny bones inside the ear, will be tested in six human volunteers for the first time. Current cochlear implants require a user to wear an external processor—a box behind the ear—that contains the microphone, battery, and electronics. This external hardware is visible, can be knocked off, and cannot be worn while sleeping or swimming. Many users and surgeons find these limitations frustrating. A fully implantable system, with the microphone hidden inside the middle ear, could restore hearing around the clock without visible parts or cables. If the microphone works as intended, it would eliminate the need for external equipment, allowing users to hear continuously—even while asleep or in the shower. The device also benefits from the ear’s natural sound amplification and directional sensitivity, which could improve speech understanding in noisy environments. This feasibility study will test whether the microphone can be safely implanted, whether it picks up body noise, and whether patients can use it effectively with their existing cochlear implant. Success would pave the way toward a totally invisible, always-on hearing solution.
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Cochlear implants have been shown over the decades to provide a highly effective and safe treatment for people with severe to profound hearing impairment. Conventional cochlear implant (CI) systems are partially implantable devices utilizing an external speech processor, worn behind the user s ear, containing the battery and microphone. The processor is used to transmit information and power to the cochlear implant via a transcutaneous coil system. A TICI (Totally Implantable Cochlear Implant) system is fully implantable and invisible i.e. the speech processor, rechargeable battery and microphone components are integrated into or connected to the implant. Extensive market studies with patients, surgeons and audiologists show that there is dissatisfaction that cannot be addressed with a conventional CI system. A totally implantable system will deliver significant safety benefits associated with 24/7 hearing and overall improved quality of life, without the limitations imposed by external parts and cables. Cochlear™ has commenced development of a middle-ear microphone which measures the vibrations of the ossicles and benefits from the natural amplification and directionality of the pinna and ear canal. Prototypes of this microphone have been verified on the bench and in human cadaver heads with promising results. To further assess the benefits of a TICI with a middle-ear microphone, this project will assess the clinical feasibility/efficacy of this technology and recruit 6 patients to assess this implant. To do this, we will: Develop a human grade middle-ear microphone - The middle-ear microphone is an experimental device not yet suitable for a clinical trial. A detailed risk analysis will be made, including a hazard analysis and a Failure Mode and Effects Analysis. This will result in a middle-ear microphone design that is regarded as safe for implantation in the human body. Develop an investigational system to be used in a clinical trial - The investigational system involves the human grade middle-ear microphone device connected via a lead to a percutaneous connector that is used to connect the implanted device through the skin to the external sound processor. The implantable microphone signal needs to be matched to the sound processor and subjects might need to use a dedicated fitting map. The complete set up described above will be developed and verified on the bench prior to the start of the study. Develop and optimize the surgical implantation method - The performance of the middle-ear microphone is related to its placement and connection to the ossicular chain. Different coupling methods will be assessed and compared in cadaver heads. Develop and optimize an intraoperative test method - To ensure the middle-ear microphone is properly implanted and to verify the functionality during surgery, an intraoperative test is mandatory. This test will be developed and verified in cadaver heads prior to use during the clinical trial. Compare different preoperative screening methods to guarantee proper patient selection - Only patients with normal middle-ear function are eligible candidates for a middle-ear microphone as performance depends on the mobility of the ossicular chain. Different non-invasive repeatable screening methods will be compared, the most suitable one selected and used during the clinical trial. A short term clinical trial will assess the clinical efficacy of the middle-ear microphone in combination with a cochlear implant. - Eligible subjects are adults that have already had a CI for more than a year with stable audiological results. They will receive the percutaneous plug middle ear microphone implant on the contra-lateral side. During the study the subject will be able to listen, via the implanted microphone, using the investigational system described above. Subjects will be assessed on the presence of body and contact noise.
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