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

The trials expansion highlights the Company's clinical momentum and growing confidence in the device's adoption and Company's commercial strategy

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.

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.

"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."

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.

The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S.-based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.

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About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.

About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.

The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.

The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.

CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.

About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.

*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.

Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.

Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.

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