The Company Begins Strategic Preparations To Support Anticipated Demand And Optimization Of The Acclaim® Fully Implanted Cochlear Implant Opportunity
Six-month follow-up visits are now underway and will continue over the next two months
White Bear Lake, Minnesota--(Newsfile Corp. - September 24, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted hearing solutions, today announced it is scaling its commercialization planning for the company's breakthrough investigational Acclaim® fully implanted hearing device, as its pivotal clinical trial continues to build momentum. The Company's proactive approach reflects its conviction that fully implanted cochlear implants have an opportunity to unlock a significant market opportunity. By accelerating efforts to train and engage in a network of clinical centers, Envoy Medical aims to achieve sufficient capacity to meet anticipated demand once the Acclaim device receives regulatory approval.
Envoy Medical's pivotal trial is progressing well, with all patients in the first stage having successfully completed their three-month follow-up milestones with no serious adverse events or unanticipated device effects reported. Six-month follow-up visits have begun with additional follow-up visits being completed over the next two months. The Company is now preparing for the next enrollment phase of the trial, which will be conducted at seven U.S. sites, to commence upon FDA approval of the Company's expansion request.
"We believe our fully implanted Acclaim® cochlear implant, now advancing through pivotal trials, has the potential to unlock a significant, underserved segment of the hearing loss market - individuals who have not pursued or adopted traditional treatment options. The early interest we're seeing is encouraging, and we are now focused on laying the groundwork to meet that anticipated demand," said Brent Lucas, Chief Executive Officer of Envoy Medical.
The Company's commercialization strategy will focus on identifying, training, and solidifying 30-40 sites should FDA regulatory approval be received. Envoy Medical plans to emphasize depth over breadth, prioritizing excellence and building a strong foundation. Assuming typical volumes at similar sites and a healthy price point, the Company believes there would be a relatively quick path to significant top-line growth.
Those interested in becoming potential surgical or audiological sites should contact customerservice@envoymedical.com.
Envoy Medical plans to provide additional updates on its FDA pivotal clinical trial and other topics over the next several months.
The investigational Acclaim® cochlear implant received Breakthrough Device Designation from the U.S. Food and Drug Administration in 2019. Envoy Medical anticipates submitting for premarket approval (PMA) in 2027, pending successful completion of its pivotal trial milestones.
For more information about Envoy Medical's innovation pipeline and intellectual property portfolio, visit www.envoymedical.com.
To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.
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.