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Envoy Medical Completes Enrollment of Pivotal Clinical Trial Evaluating First-Of-Its-Kind Fully Implanted Cochlear Implant
First Cochlear Implant Company to Announce Completed Enrollment of a U.S. Pivotal Clinical Trial for a Fully Implanted Cochlear Implant seeking FDA Approval
About this update from Envoy Medical, Inc.
[{"type":"text","content":"First Cochlear Implant Company to Announce Completed Enrollment of a U.S. Pivotal Clinical Trial for a Fully Implanted Cochlear Implant seeking FDA Approval\nWhite Bear Lake, Minnesota--(Newsfile Corp. - March 11, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) (\"Envoy Medical\" or the \"Company\"), a hearing health company pioneering fully implanted hearing solutions, today announced completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant. With the successful implantation of the 56th and final patient, Envoy Medical is the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial to evaluate a fully implanted cochlear implant seeking FDA approval.\n\"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,\" said Brent Lucas, Chief Executive Officer of Envoy Medical, \"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.\"\nThe final two study participants were both implanted yesterday 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.\n\"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.\"\nDr. Antonelli continued, \"People with profound hearing loss desperately want to be able to hear 24 x 7 without having to wear an external processor. Others have been reluctant to get a cochlear implant because of the stigma they feel with...