On October 8, 2025, Envoy Medical announced that the U.S. Food and Drug Administration approved the company’s request to expand the pivotal clinical trial of its fully implanted Acclaim® cochlear implant to the final stage. The approval was granted based on promising three‑month data from the first 10 patients enrolled in the first stage of the study.
The FDA review confirmed that all 10 participants completed their three‑month milestone with no serious adverse events or unanticipated device effects. The data demonstrated that the investigational Acclaim device can achieve effectiveness for its intended use, satisfying the FDA’s requirement for expanded enrollment.
The expansion removes a previously uncertain timing variable, allowing Envoy to shorten its estimated commercialization timeline by three to six months. Management also noted that the earlier start of the final stage will reduce the company’s capital needs by $10‑$15 million, improving liquidity and reducing dilution risk for shareholders.
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