Envoy Medical gets FDA nod to expand pivotal Acclaim cochlear implant trial to final stage

Envoy Medical, Inc.

FDA approved expansion based on 3-month data from first 10 patients; no SAEs or UADEs reported.
Final stage will add 46 participants across 7 U.S. sites; full enrollment expected by early 2026.
Timeline shortened by 3–6 months, reducing anticipated capital need by $10–$15 million.
Preliminary data showed Acclaim can achieve effectiveness for proposed intended use in cochlear-implant-only condition.
Company believes fully implanted design addresses 95% of eligible adults who have not received a cochlear implant.

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