Company Believes It Is the First to Reach This Milestone in a U.S. Pivotal Trial of a Fully Implanted Cochlear Implant
Remains on Track to Reach 12-Month Visit Milestone by Early Q2 2027 and Submit Final Clinical PMA Module by End of Q2 2027
White Bear Lake, Minnesota--(Newsfile Corp. - October 20, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health and neuroprosthetics company pioneering fully implanted hearing solutions, today announced that it has surpassed the six-month follow-up visit milestone for the Company's pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant. This milestone signifies the halfway point in the trial's final stage of data collection as each participant is followed for a total of 12 months. To the Company's knowledge, Envoy Medical is the first company to achieve this milestone in a U.S. pivotal clinical trial of a fully implanted cochlear implant and remains the only company pursuing fully implanted cochlear implants ("FCIs") with its differentiated device design.
The Company remains on track to complete 12-month visits by early Q2 2027. Envoy Medical has submitted two of the four planned modules of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") and expects to submit the final module, containing final clinical trial data, by the end of Q2 2027.
"We continue to make tangible progress in our pivotal trial and remain on track to complete data collection early next year, allowing for the potential of an FDA decision by the end of 2027 or first part of 2028," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Cochlear implant candidates have wanted a fully implanted cochlear implant option for decades, and they are now within a short year or two of that being a realistic possibility here in the United States. It is an extremely exciting time for those with significant hearing loss."
The design of the Company's investigational Acclaim® device is significantly differentiated from other FCIs being pursued:
The fully implanted 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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It is important to note that approval of an Investigational Device Exemption ("IDE") application, the expansion of an IDE pivotal clinical trial, or the completion of any follow-up visit milestone does not ensure that the results of the investigation will ultimately provide a reasonable assurance of the safety and effectiveness of the device or assure a determination of approval of a premarket submission.
About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health and neuroprosthetics 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.
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.