WHITE BEAR LAKE, MINNESOTA — Envoy Medical® Inc. (NASDAQ: COCH), a hearing health company developing fully implanted hearing solutions, today announced that it has completed the first set of activations in the final stage of its pivotal clinical study for the investigational fully implanted Acclaim® cochlear implant.
The initial activations took place at Shohet Ear Associates in Seal Beach, California, and the Center for Neurosciences Ear and Hearing Center in Tucson, Arizona — two of the seven investigational sites participating in the study. While specific hearing outcomes cannot be released until the study concludes, the company reported no serious adverse events and noted that activation appointments proceeded as expected.
“The steady progress of our pivotal clinical study is exceeding my initial expectations. Despite the holiday season and end-of-year crunch for surgical time, enrollment for the study is moving along nicely. We continue to be encouraged by the high level of interest from potential patients and professionals throughout the hearing industry and look forward to successfully completing the trial and preparing for robust commercial demand.”
–Brent Lucas, Chief Executive Officer of Envoy Medical
The Acclaim® cochlear implant is an investigational, fully implanted device designed to capture sound using the natural ear rather than an external microphone. It leverages Envoy Medical’s proprietary implanted piezoelectric sensor in combination with the body’s natural anatomy.
Unlike traditional, partially implanted cochlear implants, the Acclaim® system does not require an external processor or an implanted magnet to secure external components, as it has no external wearable parts required for hearing.
The design also allows for several days — approximately four to five — between battery recharging, and features a removable battery pack that can be replaced independently without explanting the full system.
Continued Lucas, “I believe our amazing team has designed a cochlear implant for the future by putting the patient first and foremost with our design choices, and we look forward to bringing those with significant hearing loss a true breakthrough.”
Full enrollment of the pivotal trial is expected in early 2026. Additional information about the study and participating investigational sites can be found at: https://www.envoymedical.com/acclaim-pivotal.
About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant will be a first-of-its-kind cochlear implant. 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 is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim 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. We believe the Acclaim was the first hearing-focused device to receive Breakthrough Device Designation and may still be the only hearing focused medical technology to receive the designation.
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by United States law to investigational use.
Important safety information for the Esteem can be found at: https://www.envoymedical.com/safety-information.
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, requires no externally worn components, and nothing is placed in the ear canal for it to function. Unlike hearing aids, it does not need to be put on or taken off, cannot be lost, and does not require cleaning. 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.
About Envoy Medical Corporation
Envoy Medical Corporation is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. The company is dedicated to improving the quality of life for people with hearing loss through the development of implantable hearing devices.
Source: Envoy Medical
