Envoy Medical Early Feasibility Study of Breakthrough Fully Implanted Cochlear Implant Now Underway
WHITE BEAR LAKE, Minnesota – Nov. 1, 2022 – Envoy Medical® Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, today announced the first patient has been enrolled and implanted in the Acclaim® Cochlear Implant early feasibility study at Mayo Clinic in Rochester, Minn. This surgery marks a key milestone for Envoy Medical on the road toward bringing the Acclaim Cochlear Implant to market. If approved by the FDA, the Acclaim would be the first-of-its-kind cochlear implant designed to be fully implanted and use the ear, rather than a microphone, to pick up sound.
Envoy Medical Welcomes Phil Segel as VP of Implant Technology & Training
Most recently Phill was VP of Technology, Research, Quality, and Regulatory at Oticon Medical where he developed all clinical and surgical training for cochlear implant and bone anchored devices, drove sponsored and investigator-initiated research activities in the US and Canada, developed the technical capability for an on-call technical support program and ensured compliance through a quality and regulatory team.
According to Phil, the reason he joined Envoy Medical was, "A fully-implantable cochlear implant not only changes treatment for patients but it brings scalability to the CI industry."
His knowledge of the cochlear implant medical device arena is superior, and we are pleased to have him join our team!
Envoy Medical Receives FDA IDE Approval to Begin Early Feasibility Study of Acclaim® Cochlear Implant
WHITE BEAR LAKE, Minnesota – June 21, 2022 – Envoy Medical® Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, today announced the U.S. Food and Drug Administration (FDA) approved its Investigational Device Exemption (IDE) application to begin a clinical trial with its fully implanted Acclaim® cochlear implant. Envoy Medical’s single-center Early Feasibility Study for the Acclaim will take place at Mayo Clinic in Rochester, Minn.
Gene Berghoff Drops Lawsuit Against Envoy Medical
WHITE BEAR LAKE, Minn. – September 15, 2021 – Envoy Medical® Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, today announced that a lawsuit filed against the Company by Gene Berghoff has been voluntarily dismissed with prejudice. Nothing was paid by the Company to Mr. Berghoff, and the parties will pay their own fees and costs.
“We are pleased that, after investigating his claims, Mr. Berghoff decided to drop his lawsuit," said Brent Lucas, CEO of Envoy Medical.
Independent Study Shows Esteem® Provides Significant Improvements in Hearing for Patients.
Results Published in The Journal of Laryngology & Otology Support Use of Active Middle Ear Implants in Patients with Moderate-to-Severe Sensorineural Hearing Loss Who Have Struggled with Hearing Aids
WHITE BEAR LAKE, Minn. – March 23, 2021 – Envoy Medical® Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, today announced that an independent study published online in The Journal of Laryngology & Otology found that the fully implanted Esteem® osseointegrated active middle ear implant (AMEI) showed statistically significant improvements in post-operative hearing results. The study also reinforced the safety and efficacy of the Esteem® for patients with moderate-to-severe sensorineural hearing loss who have failed to benefit from traditional amplification like hearing aids.