Envoy Medical Achieves Six-Month Milestone with First 10 Patients in Acclaim(R) Cochlear Implant Clinical Trial

About this update from Envoy Medical, Inc.

[{"type":"text","content":"The trials expansion highlights the Company's clinical momentum and growing confidence in the device's adoption and Company's commercial strategy","length":157,"tagName":"p","attribs":{"class":"nfSubHeading"},"className":""},{"type":"text","content":"White Bear Lake, Minnesota--(Newsfile Corp. - November 18, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that all 10 patients in the first stage of its pivotal clinical trial for the investigational Acclaim® fully implanted cochlear implant have successfully completed their six-month follow-up visits. Notably, there have been no serious adverse events reported, reinforcing the trial's positive progress and the device's promising safety profile.","length":596,"tagName":"p"},{"type":"text","content":"This important milestone for the investigational Acclaim cochlear implant reinforces Envoy Medical's strategy and timeline for continued trial advancement, FDA submission, and future commercialization.","length":205,"tagName":"p"},{"type":"text","content":""This marks another important step forward on our mission to redefine hearing health with fully implanted technology solutions," said Brent Lucas, Chief Executive Officer of Envoy Medical. "All 10 patients from the initial cohort have now successfully completed their six-month follow up visits with encouraging results, strengthening confidence among our clinical teams and investigators in the potential of this technology. Patients are eager for a solution that delivers discreet, full-time hearing without external wearable hardware and the Acclaim fully implanted cochlear implant continues to show promise toward meeting that need in an impactful way."","length":678,"tagName":"p"},{"type":"text","content":"This update comes on the heels of news of the Company's recent expansion of the trial earlier this fall and complements a series of corporate milestones, including new patent issuances and accelerating momentum in enrollment in the clinical trial for this device.","length":267,"tagName":"p"},{"type":"text","content":"The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part o...

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