Envoy Medical has enrolled the first three patients in the final stage of its pivotal clinical trial for the Acclaim cochlear implant, a fully implanted device that eliminates the need for an external microphone.
The final stage will enroll 46 participants in total, with 43 spots remaining. The trial began on November 19 2024, and the company received FDA approval to advance to this stage on October 7 2025, following promising data from the first 10 patients.
The Acclaim implant received FDA Breakthrough Device Designation in 2019 and is positioned to address a significant unmet need in the U.S. cochlear implant market, where fewer than 5% of eligible adults receive implants due to aesthetic and practical barriers.
Envoy anticipates submitting a pre‑market approval application to the FDA in 2027, contingent on successful completion of the pivotal trial. The company’s Esteem® implant has been commercially available in the U.S. since 2010, underscoring its experience in fully implanted hearing solutions.
The enrollment milestone positions Envoy to accelerate its regulatory pathway and potentially reduce capital requirements by $10–15 million, as the FDA approval to advance the trial shortened the expected commercialization timeline by three to six months.
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