Envoy Medical Inc. (NASDAQ: COCH) reported initial clinical data from the first 10 patients in its pivotal study of the investigational Acclaim cochlear implant. The data covers six-month follow-up visits for patients using the fully implanted hearing device.

According to presentations at medical conferences, no serious adverse events were reported in the study protocol. Reported adverse events were classified as mild or moderate and resolved with routine care or programming adjustments.

Speech recognition scores improved from a mean of 15.2% before implantation to 39.2% at six months, representing a 24 percentage point increase. Patients reported wearing the device 24 hours daily, compared to a median 15.5 hours daily with previous hearing aids.

Quality of life scores improved as measured by the CI-QOL35 instrument. Four patients with pre-surgery tinnitus showed reduced symptoms, with Tinnitus Handicap Inventory scores decreasing from a mean of 24.5 to 6.25.

Survey data indicated 80% of participants previously declined traditional cochlear implants because they did not want to wear an external processor. All participants cited wanting 24-hour hearing capability and the ability to hear during water activities as motivations for choosing the fully implanted system.

The Acclaim cochlear implant received FDA Breakthrough Device Designation in 2019 and remains under investigation in a U.S.-based pivotal clinical trial. Additional data presentations are scheduled for conferences in May 2026.

The company will host a discussion of the clinical data on April 29, 2026, featuring physicians from the Medical University of South Carolina who presented the findings.