Envoy Medical Submits Second Module of Modular Premarket Approval Application to FDA for Breakthrough Designated Acclaim(R) Cochlear Implant
Newsfile Corp•12/10/2026•08:30 ET
0
Key Highlights
- ➤Envoy Medical (COCH) submits second of four planned FDA PMA modules for Acclaim cochlear implant
- ➤Two PMA modules now submitted, enabling FDA review while clinical data collection continues
- ➤Final clinical module submission targeted for end of Q2 2027
- ➤Acclaim cochlear implant remains investigational in a U.S.-based pivotal clinical trial
Expert Statements
Brent Lucas, Chief Executive Officer of Envoy Medical
“The submission of our second module is an important milestone that demonstrates measurable progress. With two of the four modules submitted, we continue to steadily march along our defined regulatory pathway.”
Second of Four Planned Modules Moves Rolling FDA Review Forward
Advances Toward Targeted Completion of the Final Clinical Module Submission in Q2 2027
Get started
Create a free account to read the full story.