Envoy Medical files first PMA module with FDA for cochlear implant

Envoy Medical Inc. (NASDAQ: COCH) announced it has submitted the first module of a Modular Premarket Approval application to the U.S. Food and Drug Administration for its Acclaim cochlear implant, which holds FDA Breakthrough Device Designation.

The company plans to submit a total of four modules under the modular PMA pathway, with the final module — containing clinical trial data — targeted for submission in the second quarter of 2027. Unlike a traditional PMA, the modular pathway allows completed sections to be submitted for FDA review as they become available, enabling the agency to begin reviewing nonclinical data and manufacturing information while the clinical trial remains ongoing.

"This submission represents the first of several milestones that we expect to achieve over the coming quarters," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Rather than concentrating regulatory risk into a single binary event at the end of a multi-year process, this approach gives us a roadmap with meaningful accomplishments along the way."

The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation in a U.S.-based pivotal clinical trial. The device is described as fully implanted and is designed to address severe to profound sensorineural hearing loss in adults. It remains an investigational device and has not received FDA approval.

Envoy Medical said the modular approach is intended to allow for iterative FDA feedback on individual sections, which the company believes may reduce the likelihood of unanticipated issues arising at the time of final submission.

You May Also Be Interested In

• Badger Meter (BMI) PT Lowered to $165 at Stifel on In-Line Q2 Revenue
• Popular, Inc. CEO to retire in 2026, CFO named successor
• StandardAero chosen to build and service engines for UK military helicopters