New Cochlear Implant Gets FDA Clearance, Eyes Mayo Clinic Study

Hearing loss solutions leader Envoy Medical’s cochlear implant, dubbed Acclaim, has received clearance from the FDA in a crucial investigational device exemption (IDE) decision that will allow the company to perform an early feasibility single-center study at the Mayo Clinic. The sensor technology in Acclaim leverages the ear’s natural anatomy, addressing the inherent limitations of microphones, which are the most common means of sound capture found in cochlear implants.

Envoy has designed its device to process sound vibrations entering the ear into unique electronic signals, which are subsequently transmitted to stimulate the cochlea and hearing nerve to receive sounds. Although the implant does away with an external artificial microphone, it does feature a rechargeable battery that can provide power for several days between charges.

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Acclaim had already been given a Breakthrough Device Designation from the FDA in 2019, and the agency also accepted it into its Center for Devices and Radiological Health Early Feasibility Study Program. Envoy was proud to announce that an ultimate FDA approval will make the device the first cochlear implant on the market to use the power of the natural ear rather than a microphone.

“We believe that a fully implanted cochlear implant may increase their use among millions of adults with significant hearing loss,” said Brent Lucas, Envoy Medical’s Chief Executive Officer. “This study is the first step in evaluating the safety and effectiveness of the fully implanted Acclaim cochlear implant, putting us closer towards potentially filling a large unmet need in hearing loss technology.”