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No Serious Adverse Events or Unanticipated Device Effects Reported; Company Confirms Program Remains On Track
White Bear Lake, Minnesota--(Newsfile Corp. - September 3, 2025) - Envoy Medical® Inc. (NASDAQ:COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted technologies, today announced that the patients in the first stage of its pivotal clinical trial for the investigational Acclaim® fully implanted cochlear implant have successfully reached their three-month follow-up milestone. During this timeframe, no serious adverse events (SAEs) or unanticipated device effects (UADEs) were reported.
Envoy Medical's pivotal trial is designed to evaluate the safety and effectiveness of its Acclaim® fully implanted cochlear implant, an investigational first-of-its-kind device that aims to overcome adoption barriers associated with wearable external hardware in traditional hearing devices. With the pivotal trial progressing as planned, the Company believes it remains on track to achieve subsequent milestones and is targeting a submission for FDA approval in 2027. Successfully reaching this clinical trial milestone adds crucial data to the risk-benefit profile of Envoy Medical's breakthrough device and underscores the Company's progress toward its goal of redefining the standard of care for adults with significant hearing loss with hearing solutions that are fully implanted.
Posted In: COCH
