WHITE BEAR LAKE, MINNESOTA — Envoy Medical® Inc. (NASDAQ: COCH) announced that the first 10 participants in the initial stage of its pivotal clinical trial for the investigational Acclaim® fully implanted cochlear implant have completed their six-month follow-up visits. According to the company, no serious adverse events have been reported to date.
The six-month milestone marks continued progress in evaluating the Acclaim device’s safety and supports the company’s timeline for advancing the trial, preparing future regulatory submissions, and planning for potential commercialization.
Brent Lucas, Chief Executive Officer of Envoy Medical, noted that the early results have strengthened confidence among clinical investigators in the technology’s potential.
“This marks another important step forward on our mission to redefine hearing health with fully implanted technology solutions. All 10 patients from the initial cohort have now successfully completed their six-month follow-up visits with encouraging results, strengthening confidence among our clinical teams and investigators in the potential of this technology. 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.”
–Brent Lucas, CEO of Envoy Medical
This update follows Envoy Medical’s announcement earlier this fall regarding expansion of the clinical trial and aligns with other recent company developments, including additional patent issuances and continued enrollment momentum.
The Acclaim cochlear implant, which received FDA Breakthrough Device Designation in 2019, is currently being evaluated in a U.S.-based pivotal clinical study.
More information on the trial is available at 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
