White Bear Lake, Minnesota — November 18, 2025 — Leads & Copy — Envoy Medical Inc. (NASDAQ: COCH) announced that all 10 patients in the first stage of its pivotal clinical trial for the investigational Acclaim® fully implanted cochlear implant have successfully completed their six-month follow-up visits.
The company also noted that there have been no serious adverse events reported, reinforcing the trial’s positive progress and the device’s promising safety profile. This milestone reinforces Envoy Medical’s strategy and timeline for continued trial advancement, FDA submission, and future commercialization.
Brent Lucas, Chief Executive Officer of Envoy Medical, said this marks another important step forward on the company’s mission to redefine hearing health with fully implanted technology solutions. He added that the encouraging results strengthen confidence among clinical teams and investigators in the potential of this technology.
According to Lucas, patients are eager for a solution that delivers discreet, full-time hearing without external wearable hardware, and the Acclaim fully implanted cochlear implant continues to show promise toward meeting that need in an impactful way.
The company recently expanded the trial earlier this fall and has achieved other corporate milestones, including new patent issuances and accelerating momentum in enrollment in the clinical trial for this device.
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. More information on the trial can be found at www.envoymedical.com/acclaim-pivotal.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. The company has pioneered 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 quality of life.
Envoy Medical believes 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 and is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.
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.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.com
Source: Envoy Medical
