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Envoy Medical claims that the first 10 people in its Acclaim cochlear implant trial have completed their three-month checkups with no serious safety problems or unexpected device issues. The company says the study is on track and it still plans to file for FDA approval in 2027 if results support it.
They allege that Acclaim is designed to be fully implanted inside the body. It is supposed to work without any external hardware by using an implanted sensor that picks up sound through the ear’s natural structures, rather than a microphone worn on the head. The goal is all-day hearing without visible parts.
Read Envoy’s claims here.
