Envoy Medical®, Inc. (NASDAQ: COCH), a leader in hearing health innovation, has announced a significant achievement in its pivotal clinical trial for the fully implanted Acclaim® cochlear implant. The first three patients, who were implanted at the start of 2025, have successfully completed their 12-month follow-up evaluations. This milestone marks a critical step forward in the study and keeps the company on schedule for its Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA).
Brent Lucas, CEO of Envoy Medical, expressed his excitement about the progress, stating, “We are thrilled to see the first wave of trial participants reach and complete their 12-month endpoint. Our breakthrough technology has the potential to redefine how severe to profound hearing loss is treated and could significantly increase adoption rates. With the trial fully enrolled and 12-month data now being collected, the future of hearing implants is closer than ever.”
The Acclaim® cochlear implant is a groundbreaking, fully implanted device designed to address severe to profound sensorineural hearing loss. Unlike traditional cochlear implants, the Acclaim® eliminates the need for externally worn components. Instead, it uses Envoy Medical’s proprietary sensor technology to leverage the ear’s natural anatomy for sound capture, offering a seamless and discreet hearing experience.
Aiming to Address a Substantial Unmet Need
Envoy Medical believes its fully implanted hearing technology could dramatically expand adoption among patients who are unwilling or unable to use traditional hearing devices. According to the National Institutes of Health (NIH), only six percent of eligible individuals currently receive cochlear implants, highlighting a significant gap in the market.
The company’s leadership in fully implanted hearing solutions is well-established. Its Esteem® fully implanted active middle ear implant has been FDA-approved and commercially available in the United States since 2010. Building on this success, the Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is now undergoing investigation in a U.S.-based pivotal clinical trial.
Next Steps Toward Commercialization
Once all trial participants complete their 12-month evaluations, Envoy Medical plans to submit its PMA application to the FDA. This submission will bring the company one step closer to making the Acclaim® cochlear implant available to patients.
For more information about the Acclaim® pivotal trial, visit Envoy Medical’s website.
About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is dedicated to advancing hearing technology beyond the status quo. The company has pioneered fully implanted devices for hearing loss, including the Esteem® active middle ear implant and the investigational Acclaim® cochlear implant. By focusing on innovation, Envoy Medical aims to improve access, usability, and quality of life for individuals with hearing loss.
About the Acclaim® Cochlear Implant
The Acclaim® cochlear implant is designed to address severe to profound sensorineural hearing loss in adults. Unlike traditional devices, it uses a sensor to capture sound through the ear’s natural anatomy, eliminating the need for external microphones. The Acclaim® is currently limited to investigational use under federal law.
About the Esteem® Fully Implanted Active Middle Ear Implant
The Esteem® is the only FDA-approved, fully implanted hearing device for adults with moderate to severe sensorineural hearing loss. It provides 24/7 hearing capability without any externally worn components or devices placed in the ear canal. Users benefit from an invisible, maintenance-free solution that doesn’t require daily handling.
Envoy Medical continues to push the boundaries of hearing technology, bringing innovative solutions to those who need them most.
For more investor relations information about Envoy Medical, Inc. please visit www.ir.envoymedical.com .
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