Envoy Medical Hits Six-Month Milestone, Marks Halfway Point in Final Stage of Data Collection, and Highlights Differentiated Device Design
Newsfile Corp•20/10/2026•08:30 ET
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Key Highlights
- ➤Six-month follow-up milestone reached in U.S. pivotal Acclaim cochlear implant trial
- ➤12-month participant visits remain on track for completion by early Q2 2027
- ➤Final clinical PMA module submission expected by end of Q2 2027
- ➤Two of four planned Modular PMA application modules submitted to FDA
- ➤Acclaim device requires no external head-worn device or implanted magnet
Expert Statements
Brent Lucas, Chief Executive Officer of Envoy Medical
“We continue to make tangible progress in our pivotal trial and remain on track to complete data collection early next year, allowing for the potential of an FDA decision by the end of 2027 or first part of 2028.”
Brent Lucas, Chief Executive Officer of Envoy Medical
“Cochlear implant candidates have wanted a fully implanted cochlear implant option for decades, and they are now within a short year or two of that being a realistic possibility here in the United States.”
Brent Lucas, Chief Executive Officer of Envoy Medical
“It is an extremely exciting time for those with significant hearing loss.”
Company Believes It Is the First to Reach This Milestone in a U.S. Pivotal Trial of a Fully Implanted Cochlear Implant
Remains on Track to Reach 12-Month Visit Milestone by Early Q2 2027 and Submit Final Clinical PMA Module by End of Q2 2027
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