Envoy Medical Reaches Critical Milestone in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant

All 56 Enrolled Subjects Have Been Through Their Activation Visit Firming Up Study Timeline

White Bear Lake, Minnesota--(Newsfile Corp. - April 22, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that all 56 patients implanted and enrolled in its pivotal clinical trial evaluating the fully implanted Acclaim® cochlear implant have been through their "Activation Visits," when a patient's device is initially turned on for the first time.

"The conclusion of our trial studying the first-of-its-kind fully implanted Acclaim® cochlear implant is now within sight," said Brent Lucas, Chief Executive Officer of Envoy Medical. "We believe the future of hearing solutions for those with severe to profound hearing loss will be fully implanted devices, and we are excited to be on the leading edge of that revolution."

Now that all 56 patients are through their Activation Visit, the remaining follow-up visits and trial-related events can be scheduled providing increased confidence in timing of upcoming milestones. Upon completion of 12-month follow-up for all patients, the Company expects to analyze the data and submit results to the U.S. Food and Drug Administration (FDA) as part of a Premarket Approval (PMA) application.

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.