Envoy Medical Reports First Patients Reaching 12-Month Endpoint in Pivotal Trial of Fully Implanted Cochlear Implant
Three participants in the Acclaim cochlear implant trial have completed their primary 12-month evaluations, bringing the first fully implanted cochlear implant closer to FDA submission.
Overview
Envoy Medical announced on April 1 that the first three participants in its pivotal clinical trial of the Acclaim cochlear implant have successfully completed their 12-month endpoint evaluations. The milestone marks a critical step toward a Premarket Approval (PMA) application to the U.S. Food and Drug Administration for what the company describes as the first fully implanted cochlear implant to pursue FDA clearance.
Unlike conventional cochlear implants, which require an external sound processor worn behind the ear, the Acclaim uses a proprietary piezoelectric sensor implanted within the ear to capture sound through the ear’s natural anatomy. The design eliminates all externally worn components, offering continuous hearing around the clock.
Trial Progress
The three patients who reached the 12-month mark were implanted at the beginning of 2025, when the pivotal trial began enrolling participants. Envoy Medical completed full enrollment of 56 patients on March 11, 2026, making it the first company to achieve full enrollment of a U.S. pivotal trial evaluating a fully implanted cochlear implant.
The trial’s primary endpoints are tied to 12-month data. As additional participants reach that threshold over the coming months, the company plans to compile and analyze the full dataset before submitting its PMA application to the FDA.
“We are thrilled to highlight the first wave of trial participants successfully reaching and completing their 12-month endpoint,” said Brent Lucas, CEO of Envoy Medical.
How the Acclaim Differs
Traditional cochlear implants consist of two main components: an internal electrode array surgically placed in the cochlea and an external processor that captures sound via a microphone and transmits it wirelessly to the implant. While effective, the external hardware is visible, must be removed for sleeping and water activities, and can carry social stigma.
The Acclaim replaces the external microphone and processor with an implanted piezoelectric sensor that detects vibrations from the eardrum and ossicles — the natural sound-conducting structures of the middle ear. This approach is designed to deliver a more natural listening experience while allowing patients to hear continuously, including during sleep and in wet environments.
The device targets adults with severe to profound sensorineural hearing loss who are not adequately served by hearing aids. The FDA granted the Acclaim Breakthrough Device Designation in 2019, a status that provides more intensive FDA interaction and the potential for expedited review.
A Large Unmet Need
The announcement arrives against a backdrop of significant underutilization of cochlear implants worldwide. According to Envoy Medical, only approximately 6 percent of individuals who could benefit from cochlear implants currently receive them. The National Institute on Deafness and Other Communication Disorders has noted that existing cochlear devices are used by only a small percentage of those who could benefit, citing sound quality limitations and difficulty isolating speech from background noise as key barriers to adoption.
A fully implanted device that eliminates external hardware could address some of the practical and social factors that contribute to low uptake, though its clinical performance relative to conventional implants will not be clear until trial data is published.
What Comes Next
The remaining 53 enrolled participants are progressing through their follow-up periods. Once all patients have completed 12-month evaluations, Envoy Medical will analyze the results and submit them as part of its PMA application. The company has not disclosed a specific timeline for FDA submission, but a Q2 2027 target has been reported in industry publications. If approved, the Acclaim would be the first fully implanted cochlear implant available in the United States.