Envoy Medical Receives FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data

The Company expects to complete full enrollment by early 2026 and is moving its timelines up three to six months, cutting its anticipated capital needs by $10-$15 million

White Bear Lake, Minnesota--(Newsfile Corp. - October 7, 2025) - Envoy Medical, Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to expand the Company's pivotal clinical trial for the fully implanted Acclaim® cochlear implant to the final stage based on promising three-month data from the first 10 patients.

The FDA's approval of the expansion request removes a previously uncertain timing variable and allows the Company to solidify its path toward regulatory approval. As a result, the Company has shortened its estimated timeline by three to six months. The updated timeline to commercialization and other improved efficiencies has allowed management to cut its anticipated capital needs by $10-$15 million.

"The FDA's granting of our expansion request is a significant and game changing milestone for Envoy Medical and our fully implanted Acclaim® cochlear implant," said Brent Lucas, Chief Executive Officer of Envoy Medical. "We believe it is a great sign that we were able to demonstrate to the FDA that our trial data is trending in the right direction and that approving the expansion of the trial to full enrollment was warranted. With the timing of expansion now clear and earlier than originally expected, along with the anticipated rapid enrollment of the remaining participants, we are able to shorten our estimated timeline by at least one full quarter, potentially two. This means we will need less capital as we march toward our goal of changing the hearing industry by redefining the standard of care in cochlear implants."

The first stage consisted of 10 participants at five clinical trial sites in the United States. All 10 patients successfully completed their three-month milestone with no serious adverse events (SAEs) or unanticipated device effects (UADEs) reported. In addition, the preliminary clinical data effectively characterized that the investigational Acclaim® cochlear implant can achieve effectiveness for its proposed intended use, which was a required condition of expanded trial enrollment being approved by the FDA. The fully implanted Acclaim cochlear implant was tested in these participants at the three-month visit in the "cochlear implant only" condition and without the use of a hearing aid.