White Bear Lake, MN – October 29, 2025 – Envoy Medical, Inc. (NASDAQ: COCH) (“Envoy Medical” or the “Company”), a hearing health company pioneering fully implanted hearing solutions, today announced the three-year anniversary of the first patient receiving its breakthrough first fully implanted cochlear implant. On October 24, 2022, Craig Eggert became the first patient in the world to be implanted with Envoy Medical’s new investigational fully implanted cochlear implant. The implant was done by Dr. Colin Driscoll at Mayo Clinic (Rochester, MN) and programmed by Dr. Aniket Saoji as part of an Early Feasibility Study (EFS).
“This implant has truly changed my life,” Craig Eggert shared. “I was suffering with not being able to hear enough with my hearing aids before getting this device. Being able to hear my wife and daughters’ voices again and fully engage with people around me has been an incredible gift. I’m deeply grateful to the people who made this possible. The entire experience has been overwhelmingly positive, and I can’t wait for the opportunity to have my other ear done once it becomes commercially available.”*
Three patients in total were implanted in the Early Feasibility Study, which was the precursor study to the currently enrolling Pivotal Clinical Trial. All three EFS patients will surpass their three-year anniversary this fall. All three have reported a net positive impact and have expressed interest in getting their other ear implanted in the future.
“It is an incredible boost of confidence to be three years beyond the very first implants and listen to the patients report positive impact on their lives,” said Brent Lucas, Chief Executive Officer of Envoy Medical. “Each one of them has said they would not only do it again but also shared their desire to have their other ear implanted in the future. For me, it doesn’t get much better than that. We are now enrolling our final stage of the pivotal clinical study, and the interest being reported by the sites is overwhelming. We are grateful to have received the Breakthrough Device Designation by the FDA, because, clearly, patients and professionals want to see a device like ours on the market as soon as possible.”
Envoy Medical is distinctly positioned within the hearing device market. Unlike most competitors in the hearing industry, Envoy Medical is an American company with both its headquarters and its manufacturing operations fully within the United States. As American policymakers increasingly prioritize domestic medical device production, Envoy Medical is already aligned with this strategic shift, strengthening its future with a long-term competitive advantage and enhancing shareholder value through operational efficiency, supply chain independence, and long-term competitive advantage.
The pivotal clinical trial for the fully implanted Acclaim cochlear implant is currently enrolling at multiple clinical sites nationwide. More information can be found at https://www.clinicaltrials.gov/study/NCT06699797.
*The information presented or discussed is investigational and for general educational purposes only and may not be representative of all or typical outcomes. It is not intended to be a substitute for professional medical advice and should not be interpreted to contain diagnostic or treatment recommendations. Each person’s situation is unique, and risks, precautions, warnings, outcomes, and results may vary. Mr. Eggert received reimbursement from Envoy Medical for travel costs and received the device at no cost through participation in an early feasibility clinical study. He was not paid for sharing his experience.
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 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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