A fully implanted cochlear implant reaches its first PMA module

Envoy Medical reported on 10 August 2026, alongside its second-quarter results, that it has submitted the first module of a modular Premarket Approval application to the US Food and Drug Administration for the Acclaim cochlear implant. The company expects to file four modules in total, with the last one — carrying the final clinical trial data — targeted for the second quarter of 2027.

It also reported twelve-month hearing data. The first ten Stage 1 participants in the pivotal trial reached a mean Consonant-Nucleus-Consonant word recognition score of 53.2% at their twelve-month visits, against a pre-implantation baseline of 15.2% — an improvement of 38.0 percentage points. The full trial has passed the three-month follow-up mark.

What distinguishes the Acclaim is that nothing is worn. Conventional cochlear implants pair an internal receiver with an external microphone and processor held on the head by a magnet. The Acclaim is fully implanted and uses a sensor that takes sound from the natural anatomy of the ear rather than a microphone, so there is no external component to remove for sleeping, showering or swimming. It received FDA Breakthrough Device Designation in 2019.

The device remains investigational and the twelve-month figure covers ten people.