WHITE BEAR LAKE, MINNESOTA — Envoy Medical Inc. (NASDAQ: COCH) announced that all 56 patients enrolled in its pivotal clinical trial of the investigational Acclaim® cochlear implant have completed their three-month follow-up visits.
The milestone follows the company’s recent announcement that all 56 study participants had been successfully activated with the Acclaim device, marking another step forward in the pivotal clinical trial. Envoy Medical said it continues to collect safety data and other study measures that are expected to support a planned Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).
“Envoy Medical continues to demonstrate its ability to execute. Each milestone achieved brings us one big step closer to our next major goal – submission of our PMA application to the FDA. We are steadily advancing toward our ultimate objective of bringing fully implanted cochlear implants to market in the United States.”
–Brent Lucas, Chief Executive Officer of Envoy Medical
The company anticipates that all participants will complete their six-month visits by late 2026. The 12-month visit milestone for the full study is expected to be reached by April 2027.
The Acclaim cochlear implant remains an investigational device and is not currently approved for commercial use.
For additional information on the study, visit: 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
