Envoy Medical Achieves Clinical Trial Milestone and is Optimistic About Expansion into Final Stage of Trial

About this update from Envoy Medical, Inc.

[{"type":"text","content":"White Bear Lake, Minnesota--(Newsfile Corp. - May 13, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices that leverage the ear's natural anatomy, today announces achieving the important milestone of successful activation of all 10 study participants' fully implanted Acclaim® cochlear implants in the first stage of the Company's pivotal clinical trial.","length":469,"tagName":"p"},{"type":"text","content":"Brent Lucas, CEO of Envoy Medical commented: "We are excited to report the positive and meaningful progress of our pivotal clinical trial, which is currently on track and moving along as anticipated. We are optimistic we will be able to expand the study into the second and final stage during the fourth quarter of this year. We are also encouraged by the reported interest from people suffering from significant hearing loss who want to wait until a fully implanted cochlear implant is an option. We believe there is significant pent-up demand for fully implanted cochlear implants, and we are thrilled to be closer to meeting this unmet need."","length":655,"tagName":"p"},{"type":"text","content":"About the Fully Implanted Acclaim® Cochlear Implant","length":51,"tagName":"p"},{"type":"text","content":"We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. 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.","length":278,"tagName":"p"},{"type":"text","content":"The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.","length":254,"tagName":"p"},{"type":"text","content":"The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.","length":131,"tagName":"p"},{"type":"text","content":"CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.","length":148,"tagName":"p"},{"type":"text","con...

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