Envoy Medical Inc. (NASDAQ: COCH) announced that the first three patients in its pivotal clinical trial for the Acclaim cochlear implant have completed their 12-month endpoint evaluations. The patients were implanted at the start of 2025.

The company stated that the primary endpoints for the trial are tied to 12-month data collection. Envoy Medical plans to submit its Premarket Approval application to the U.S. Food and Drug Administration after all trial participants complete their 12-month evaluations.

"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. "Now that the trial has been fully enrolled and we are beginning to collect 12-month data, the future of hearing implants may be closer than you realize."

The Acclaim cochlear implant is designed as a fully implanted device for severe to profound sensorineural hearing loss without external components. The device uses proprietary sensor technology that leverages natural ear anatomy to capture sound.

According to the National Institutes of Health, only six percent of eligible individuals receive cochlear implants. Envoy Medical believes fully implanted technology could expand adoption among patients who cannot or will not use traditional hearing devices requiring external hardware.

The Acclaim device received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation in a U.S.-based pivotal clinical trial. The device remains investigational and is limited by federal law to investigational use.

Envoy Medical also markets the FDA-approved Esteem fully implanted active middle ear implant, which has been commercially available in the United States since 2010.