Envoy Medical Completes Enrollment of Pivotal Clinical Trial Evaluating First-Of-Its-Kind Fully Implanted Cochlear Implant

First Cochlear Implant Company to Announce Completed Enrollment of a U.S. Pivotal Clinical Trial for a Fully Implanted Cochlear Implant seeking FDA Approval

White Bear Lake, Minnesota--(Newsfile Corp. - March 11, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant. With the successful implantation of the 56th and final patient, Envoy Medical is the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial to evaluate a fully implanted cochlear implant seeking FDA approval.

"Completing enrollment of a pivotal clinical trial that is evaluating a breakthrough-designated medical device that has the potential to bring about generational change to an entire industry is a very big deal," said Brent Lucas, Chief Executive Officer of Envoy Medical, "We strongly believe in our device design and look forward to gathering additional data throughout the trial as we substantially differentiate ourselves from the competition. We believe today brings us significantly closer to redefining the standard of care for adults with severe to profound hearing loss and potentially growing the overall cochlear implant user base to include those patients who could benefit from a cochlear implant but have sat on the sidelines waiting for a fully implanted solution."

The final two study participants were both implanted yesterday by Dr. Patrick Antonelli at the University of Florida. With these procedures, Dr. Antonelli became the second leading enroller in the trial, having implanted 11 of the 56 participants.

"Participating in the Acclaim Cochlear Implant Pivotal Trial has been an eye opener for me," Dr. Antonelli shared, "I've been placing traditional cochlear implants for so long-over 30 years-and these devices evolved so little over that time that I didn't give much thought to how dramatically they could be improved. The Acclaim changed that."

Dr. Antonelli continued, "People with profound hearing loss desperately want to be able to hear 24 x 7 without having to wear an external processor. Others have been reluctant to get a cochlear implant because of the stigma they feel with an external processor. I think just about every Acclaim recipient that we've enrolled in this study said, often tearfully, 'you've really made my day,' when I told them they were cleared to get the Acclaim. Tears of joy followed activation as well. It's been a real privilege to be able to offer the Acclaim cochlear implant to our patients in this clinical trial. I am delighted that completion of study enrollment brings us a step closer to FDA approval and hopefully being able to offer the Acclaim to all of our properly qualified patients."

With enrollment completed, the study will now progress through scheduled follow-up visits and data collection in accordance with the trial protocol. Once 12-month follow up data has been collected for all patients, the data will then be analyzed and submitted to the FDA as part of a PMA application seeking FDA approval. Subject to FDA review and approval, commercialization in the United States would follow.

Envoy Medical believes it is the first cochlear implant manufacturer to complete enrollment in a U.S. pivotal trial for a fully implanted cochlear implant, positioning the Company at the forefront of this next generation of hearing technology.

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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