WHITE BEAR LAKE, MINNESOTA — Envoy Medical, Inc. (NASDAQ: COCH), a hearing health company pioneering fully implanted hearing solutions, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to expand its pivotal clinical trial for the fully implanted Acclaim® cochlear implant to the final stage.
The decision follows promising three-month data from the first 10 trial participants.
The FDA’s approval removes a key timing uncertainty and allows the company to move forward with a clearer path toward regulatory submission. As a result, Envoy Medical has accelerated its expected commercialization timeline by three to six months. The updated schedule and operational efficiencies have also allowed the company to reduce its anticipated capital requirements by $10–15 million.
“The FDA’s granting of our expansion request is a significant and game-changing milestone for Envoy Medical and our fully implanted Acclaim® cochlear implant. We believe it is a great sign that we were able to demonstrate to the FDA that our trial data is trending in the right direction and that approving the expansion of the trial to full enrollment was warranted. With the timing of expansion now clear and earlier than originally expected, along with the anticipated rapid enrollment of the remaining participants, we are able to shorten our estimated timeline by at least one full quarter, potentially two. This means we will need less capital as we march toward our goal of changing the hearing industry by redefining the standard of care in cochlear implants.”
–Brent Lucas, Chief Executive Officer of Envoy Medical
Promising Early Results
The first stage of the pivotal trial included 10 participants across five U.S. clinical sites. All participants successfully completed the three-month milestone with no serious adverse events (SAEs) or unanticipated device effects (UADEs) reported. Preliminary results showed that the investigational Acclaim cochlear implant achieved effectiveness for its intended use — a key requirement for expanding the study.
At the three-month visit, participants were evaluated in the “cochlear implant only” condition, without the use of a hearing aid.
The second and final stage will include an additional 46 participants across seven U.S. sites. The company reports strong interest from potential participants, suggesting that enrollment could proceed rapidly in the coming months.
Addressing a Large Unmet Need
Envoy Medical believes its investigational fully implanted cochlear implant could address a significant gap in the market. Of the estimated 2.8 million U.S. adults eligible for cochlear implants, fewer than 5% currently receive them. The company attributes much of this underutilization to aesthetic and practical barriers associated with current devices, which require external components worn on the head.
By removing external hardware, the Acclaim is designed to reduce visible stigma and improve adoption rates among potential candidates.
“Prior to joining Envoy Medical, I spent 19 years in a clinic as a cochlear implant audiologist. During my prior employment at the clinic, we often saw candidates pass on getting a cochlear implant because they did not want the bulky external hardware on the side of their head. It is a practical reality that some portion of candidates avoid cochlear implants because of the external wearable component. I firmly believe more candidates will get a cochlear implant once there is a fully implanted option, and that will mean we are helping more people hear by designing a device that patients want.”
–Caroline Arnedt, Director of Audiology at Envoy Medical
For more information about Envoy Medical’s innovation pipeline and intellectual property portfolio, visit www.envoymedical.com.
**Note: Approval to expand an Investigational Device Exemption (IDE) pivotal trial does not ensure that study results will provide reasonable assurance of safety and effectiveness or guarantee future regulatory approval.
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
