WHITE BEAR LAKE, MINNESOTA — Envoy Medical, Inc. (NASDAQ: COCH) announced that all 56 participants enrolled in its pivotal clinical trial evaluating the fully implanted Acclaim® cochlear implant have completed their activation visits, marking a key milestone in the study timeline.
The activation visit represents the point at which each participant’s device is turned on for the first time.
“With all patients now activated, the conclusion of our trial studying the first-of-its-kind fully implanted Acclaim® cochlear implant is within sight. We believe the future of hearing solutions for those with severe to profound hearing loss will be fully implanted devices, and we are excited to be on the leading edge of that evolution.”
–Brent Lucas, Chief Executive Officer of Envoy Medical
According to the company, completion of activation visits for all participants allows for more predictable scheduling of remaining follow-up visits and other trial-related milestones.
Following completion of 12-month follow-up for all subjects, Envoy Medical plans to analyze the data and submit the results to the U.S. Food and Drug Administration (FDA) as part of a Premarket Approval (PMA) application.
The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently being evaluated in a U.S.-based pivotal clinical trial.
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
