The short version
- Envoy Medical’s Acclaim is a cochlear implant with no outside parts that picks up sound through a sensor using the ear’s own anatomy instead of a microphone.
- All 56 people in its single-arm US pivotal trial have passed six months, and the first 10 scored 53.2% on a word test at 12 months, up from 15.2% before surgery.
- Those numbers are the company’s and unpublished, the trial has no comparison group, and the full 12-month results are due in early 2027.
Envoy Medical, a Minnesota company, said on November 5 that all 56 people in its US pivotal trial of the Acclaim implant have now passed their six-month visits. The Acclaim is a cochlear implant with nothing worn outside the head. Instead of a microphone, it uses what the company calls “a sensor designed to leverage the natural anatomy of the ear” to pick up sound. It is meant for adults with severe to profound hearing loss that hearing aids do not help enough. The FDA gave it Breakthrough Device designation in 2019.
The first 10 participants have reached 12 months. Their average score on a standard word-recognition test went from 15.2% before surgery to 53.2%, a gain of 38 points (24 points at six months). The trial, registered as NCT06699797 at seven sites, has a single arm with no control group. Its main tests are device and surgery complications through 12 months and each person’s 12-month word score against their own aided score before surgery. The release gives no safety data. Envoy expects the last 12-month visits by early in the second quarter of 2027 and has filed the second of four parts of its FDA application.
Europe already has one fully implanted device, MED-EL’s TICI UNICO. The Acclaim numbers come from the company and have not been published or peer-reviewed.
