Envoy Medical submits second PMA module to FDA for Acclaim cochlear implant
COCH•Envoy Medical submitted the second module of its rolling premarket approval application to the FDA for its breakthrough-designated Acclaim cochlear implant. The company targets Q2 2027 for submission of the final clinical module.
1. FDA review advances
Envoy Medical said it submitted the engineering-focused second module of its rolling PMA to the FDA for the Acclaim cochlear implant. The company targets Q2 2027 to submit the final clinical module.
