Envoy Medical announced today that it received FDA investigational device exemption (IDE) for its Acclaim cochlear implant.
White Bear Lake, Minnesota-based Envoy Medical will begin a single-center IDE early feasibility study with the fully implanted Acclaim cochlear implant at Mayo Clinic in Rochester, Minnesota.
The company said in a news release that its Acclaim implant represents a new option unlike current commercially available cochlear implants due to the lack of any externally worn components. It received FDA breakthrough device designation in 2019.
If approved by the FDA, Acclaim would be the first of its kind as a cochlear implant designed to be fully implanted using the ear, rather than a microphone, to pick up sound, Envoy said. The design leverages the natural anatomy of the ear to capture sound in an effort to address the limitations of current microphone-based hearing devices.
Mayo Clinic practicing neurologist and professor of otolaryngology — head and neck surgery, Dr. Colin Driscoll, will serve as the principal investigator for the study. Associate professor of otolaryngology – head and neck surgery Aniket Saoji will be a co-investigator. Both investigators serve on Envoy Medical’s Cochlear Implant Advisory Board.
“We believe that a fully implanted cochlear implant may increase their use among millions of adults with significant hearing loss,” Envoy Medical CEO Brent Lucas said in the news release. “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.”