Enrollment Complete in Study Evaluating Fully Implanted Cochlear Implant

Envoy Medical Inc. has completed clinical trial enrollment for the investigational fully implanted Acclaim cochlear implant. With the 56th and final patient having received the device, the company reports that it has become the first cochlear implant manufacturer to complete full U.S. clinical trial enrollment for evaluating a fully implanted cochlear implant system.

“Completing enrollment of a pivotal clinical trial that is evaluating a breakthrough-designated medical device that has the potential to bring about generational change to an entire industry is a very big deal,” Envoy Medical CEO Brent Lucas said. “We strongly believe in our device design and look forward to gathering additional data throughout the trial as we substantially differentiate ourselves from the competition. We believe today brings us significantly closer to redefining the standard of care for adults with severe to profound hearing loss and potentially growing the overall cochlear implant user base to include those patients who could benefit from a cochlear implant but have sat on the sidelines waiting for a fully implanted solution.”

The final two study participants were both implanted yesterday (March 10) by Dr. Patrick Antonelli at the University of Florida. With these procedures, Dr. Antonelli became the second leading enroller in the trial, having implanted 11 of the 56 participants.

“Participating in the Acclaim Cochlear Implant Pivotal Trial has been an eye opener for me,” Dr. Antonelli shared. “I’ve been placing traditional cochlear implants for so long—over 30 years—and these devices evolved so little over that time that I didn’t give much thought to how dramatically they could be improved. The Acclaim changed that. People with profound hearing loss desperately want to be able to hear 24/7 without having to wear an external processor. Others have been reluctant to get a cochlear implant because of the stigma they feel with an external processor. I think just about every Acclaim recipient that we’ve enrolled in this study said, often tearfully, ‘You’ve really made my day,’ when I told them they were cleared to get the Acclaim. Tears of joy followed activation as well. It’s been a real privilege to be able to offer the Acclaim cochlear implant to our patients in this clinical trial. I am delighted that completion of study enrollment brings us a step closer to FDA approval and hopefully being able to offer the Acclaim to all of our properly qualified patients.”

With enrollment completed, the study will now progress through scheduled follow-up visits and data collection in accordance with trial protocol. Once 12-month follow-up data have been collected for all patients, the information will then be analyzed and submitted to the U.S. Food and Drug Administration (FDA) as part of a Pre-Market Approval application. Subject to FDA review and approval, commercialization in the United States would follow.

The Acclaim cochlear implant received FDA Breakthrough Device Designation in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. The product is an investigational device and is limited by U.S. law to investigational use.

The fully implanted Acclaim cochlear implant (Acclaim CI) is considered a first-of-its-kind hearing device featuring a sensor designed to leverage the ear’s natural anatomy instead of a microphone to capture sound. The product addresses severe to profound sensorineural hearing loss that is not adequately addressed by current hearing aid solutions.

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 and requires no externally worn components, and nothing is placed in the ear canal for it to function. Unlike hearing aids, it is never put on or taken off.

* Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.

Envoy Medical is a hearing health company providing innovative technologies across the hearing loss spectrum. The company has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim cochlear implant, an investigational device.