The pivotal clinical trial for the investigational device has now enrolled all 56 participants, moving the company closer to a potential FDA submission.
Envoy Medical Inc announced it has completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim cochlear implant. The company reached the milestone with the successful implantation of the 56th and final patient in the study, which is evaluating the device for FDA approval.
“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,” says Brent Lucas, chief executive officer of Envoy Medical, in a release. “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 implanted by Dr Patrick Antonelli at the University of Florida. Dr Antonelli has implanted 11 of the 56 total participants in the trial.
“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,” says Dr Antonelli. He adds that patients desire a 24/7 hearing solution without an external processor, partly due to the stigma they may feel with an external device.
With enrollment complete, the trial will now enter a data collection phase involving scheduled follow-up visits. According to the company, once 12-month follow-up data has been collected for all patients, the results will be analyzed and submitted to the FDA as part of a Premarket Approval (PMA) application. Commercialization in the US would follow a potential FDA approval.
The Acclaim cochlear implant is designed to address severe to profound sensorineural hearing loss in adults. According to Envoy Medical, the device uses a sensor that leverages the natural anatomy of the ear to capture sound rather than an external microphone. The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019.
Photo: Envoy Medical
