Envoy Medical Submits Second Module of Modular Premarket Approval Application to FDA for Breakthrough Designated Acclaim(R) Cochlear Implant
Envoy Medical announced submission of the second of four planned modules of a Modular Premarket Approval (PMA) application to the U.S. Food and Drug Administration for the Acclaim cochlear implant, a device holding FDA Breakthrough Device Designation. The company says the second module focused on engineering information and that the final clinical module is expected by the end of Q2 2027.