About Envoy Medical
Envoy Medical Corporation is a privately held hearing health company focused on providing innovative technologies across the hearing loss spectrum. We have pioneered one-of-a-kind, fully implanted devices for hearing loss, including the fully implanted Esteem® active middle ear implant, available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Our novel sensor technology is designed to leverage the natural anatomy of the ear rather than a microphone to capture sound entering the ear.
Envoy developed the Acclaim to address the limitations of current microphone-based cochlear implants in adults diagnosed with severe to profound sensorineural hearing loss. If approved by the U.S. Food and Drug Administration (FDA), the Acclaim would be the first fully implanted cochlear implant designed without any externally worn components and to use the ear rather than a microphone to pick up sound. Unlike current commercially available cochlear implants which are partially implanted, the Acclaim is designed to remain active all day and night.
The Acclaim received the Breakthrough Device Designation from the FDA. Envoy Medical received FDA investigational device exemption (IDE) approval to begin the first clinical trial with the Acclaim cochlear implant. The Early Feasibility Study for the Acclaim is taking place at Mayo Clinic in Rochester, Minnesota.
Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance and ultimately quality of life.
CAUTION The fully implanted Acclaim cochlear implant is an investigational device. Limited by United States law to investigational use.