Envoy Medical Corporation, which focuses on providing innovative technologies across the hearing loss spectrum, has announced that it received approval from the U.S. Food and Drug Administration (FDA) to begin clinical trials with the fully implanted Acclaim Cochlear Implant.
According to the company, the Acclaim differs from existing cochlear implants in that it has no external component on the head, and it was granted the FDA's "Breakthrough Device" designation in 2019. If approved by the FDA, the Acclaim would be "the first-of-its-kind cochlear implant designed to be fully implanted and to use the ear rather than a microphone to capture sound."
It is noted that of the estimated 1.4 to 4 million people in the United States with severe hearing loss who could benefit from a cochlear implant, only 5% use one — and that the reason for non-use is often the components worn on the head. Fully implanted cochlear implants are expected to increase the adoption rate for millions of adults. Envoy Medical's technology includes a unique sensor that leverages the ear's natural anatomy to capture sound rather than a microphone.
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