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.