The company has implanted 45 of 56 participants for its investigational fully implanted device, targeting an FDA submission in Q2 2027.
Envoy Medical announced it has nearly completed enrollment for the pivotal clinical trial of its investigational fully implanted Acclaim cochlear implant. To date, 45 of the targeted 56 participants have been implanted and enrolled in the study, completing over 80% of the trial’s goal.
The company expects to achieve full enrollment by the end of March 2026. According to Envoy Medical, the trial remains on track for a potential Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2027.
“We are extremely encouraged by the steady progress we’ve seen since receiving FDA approval to expand our pivotal study,” says Brent Lucas, chief executive officer of Envoy Medical, in a release. “Reaching 45 implanted patients and being approximately one month away from full enrollment is an exciting milestone for our entire organization. The journey to get to this point has been long, but we are now moving quickly and with great confidence.”
Lucas adds that the company plans to provide an update at an industry meeting in May as results are formally analyzed.
The Acclaim cochlear implant is designed to leverage the natural ear to capture sound via a proprietary implanted piezoelectric sensor, differing from traditional cochlear implants that use an external microphone. The device is designed without required externally worn components. The Acclaim implant received Breakthrough Device Designation from the FDA in 2019 and is intended to address severe to profound sensorineural hearing loss in adults.
