TL;DR
A cochlear implant can give back usable hearing to people with severe hearing loss, but today's versions come with a microphone and processor worn on the outside of the head, which has to come off for the shower, the pool and bed. Envoy Medical is testing an implant built to sit entirely under the skin, so a wearer could hear while swimming, showering and sleeping with nothing on the head. The company says all 56 adults in its U.S. pivotal trial, the large study meant to support an approval decision, have now passed their six-month visits, which it calls a first for a fully implanted cochlear implant in a U.S. pivotal trial. Earlier figures from the first 10 patients showed average word recognition rising from about one word in seven to just over half. The full 12-month results arrive in 2027, and the last piece of the FDA application follows a few months later. To see our odds on when an implant with nothing outside reaches patients, and the timeline of breakthroughs on the way to restored hearing, subscribe.
Below the line, for paid subscribers: The full story: where it stands, how we got here and what's dated next; our labeled speculation on what it adds up to; and every source.



