The Company expects to complete full enrollment by early 2026 and is moving its timelines up three to six months, cutting its anticipated capital needs by $10-$15 million
White Bear Lake, Minnesota--(Newsfile Corp. - October 7, 2025) - Envoy Medical, Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to expand the Company's pivotal clinical trial for the fully implanted Acclaim® cochlear implant to the final stage based on promising three-month data from the first 10 patients.
The FDA's approval of the expansion request removes a previously uncertain timing variable and allows the Company to solidify its path toward regulatory approval. As a result, the Company has shortened its estimated timeline by three to six months. The updated timeline to commercialization and other improved efficiencies has allowed management to cut its anticipated capital needs by $10-$15 million.
"The FDA's granting of our expansion request is a significant and game-changing milestone for Envoy Medical and our fully implanted Acclaim® cochlear implant," said Brent Lucas, Chief Executive Officer of Envoy Medical. "We believe it is a great sign that we were able to demonstrate to the FDA that our trial data is trending in the right direction and that approving the expansion of the trial to full enrollment was warranted. With the timing of expansion now clear and earlier than originally expected, along with the anticipated rapid enrollment of the remaining participants, we are able to shorten our estimated timeline by at least one full quarter, potentially two. This means we will need less capital as we march toward our goal of changing the hearing industry by redefining the standard of care in cochlear implants."
The first stage consisted of 10 participants at five clinical trial sites in the United States. All 10 patients successfully completed their three-month milestone with no serious adverse events (SAEs) or unanticipated device effects (UADEs) reported. In addition, the preliminary clinical data effectively characterized that the investigational Acclaim® cochlear implant can achieve effectiveness for its proposed intended use, which was a required condition of expanded trial enrollment being approved by the FDA. The fully implanted Acclaim cochlear implant was tested in these participants at the three-month visit in the "cochlear implant only" condition and without the use of a hearing aid.
The second and final stage of the clinical trial will consist of an additional 46 participants at seven clinical trial sites within the United States. The clinical trial sites have noted a high level of interest from patients interested in an investigational fully implanted cochlear implant. As a result, the Company believes enrollment will proceed rapidly within the next few months.
Envoy Medical believes its investigational fully implanted cochlear implant has the potential to address a massive, underpenetrated market opportunity. Of the estimated 2.8 million U.S. adults eligible for cochlear implants, it has been estimated that fewer than 5% currently receive them. In other words, this data indicates that approximately 95% of the adults in the United States who could benefit from a cochlear implant have not received one. Envoy Medical believes one of the primary reasons for this is that most people would prefer not to have a bulky medical device attached to their head telegraphing their hearing disability, which is the case with current partially-implanted cochlear implants. By eliminating external wearable hardware, the Acclaim is designed to overcome practical adoption barriers that have long plagued market penetration in the cochlear implant industry.
"Prior to joining Envoy Medical, I spent 19 years in a clinic as a cochlear implant audiologist," said Caroline Arnedt, Director of Audiology of Envoy Medical. "During my prior employment at the clinic, we often saw candidates pass on getting a cochlear implant because they did not want the bulky external hardware on the side of their head. It is a practical reality that some portion of candidates avoid cochlear implants because of the external wearable component. I firmly believe more candidates will get a cochlear implant once there is a fully implanted option, and that will mean we are helping more people hear by designing a device that patients want."
For more information about Envoy Medical's innovation pipeline and intellectual property portfolio, visit www.envoymedical.com.
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It is important to note that approval of an IDE application or the expansion of an IDE pivotal clinical trial 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 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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