Envoy Medical Reaches Key Milestone in Cochlear Implant Trial

First Patients Complete 12-Month Endpoint, Paving Way for FDA Submission

Apr. 1, 2026 at 12:10pm

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Envoy Medical, a hearing health company, announced that the first three patients implanted in its pivotal clinical trial for the fully implanted Acclaim® cochlear implant have successfully completed their 12-month endpoint visit, marking a key milestone in the study's progress. The company plans to submit its Premarket Approval (PMA) application to the FDA after all trial participants complete their 12-month evaluations.

Why it matters

Envoy Medical's fully implanted Acclaim cochlear implant is designed to address severe to profound sensorineural hearing loss without the need for externally worn components. The company believes this technology has the potential to significantly expand adoption among patients who are unwilling or unable to use traditional hearing devices.

The details

The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. The first three pivotal trial patients implanted at the start of 2025 are now the first to reach the 12-month follow-up evaluation point, a critical milestone as the company works towards commercialization.

  • The first three pivotal trial patients were implanted at the start of 2025.
  • The first three patients have now successfully completed their 12-month endpoint visit.

The players

Envoy Medical, Inc.

A hearing health company focused on providing innovative technologies across the hearing loss spectrum, including the fully implanted Esteem® active middle ear implant and the investigational Acclaim® cochlear implant.

Brent Lucas

CEO of Envoy Medical.

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What they’re saying

“We are thrilled to highlight the first wave of trial participants successfully reaching and completing their 12-month endpoint. We believe our first-of-its-kind breakthrough technology has the potential to change the perception around how severe to profound hearing loss is treated and potentially increase adoption rates.”

— Brent Lucas, CEO of Envoy Medical

What’s next

After all trial participants complete their 12-month evaluations, Envoy Medical plans to submit its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).

The takeaway

Envoy Medical's progress with the Acclaim cochlear implant trial represents a significant milestone in the development of fully implanted hearing solutions, which could potentially expand access and improve quality of life for those with severe to profound hearing loss.