Envoy Medical wins FDA IDE for Acclaim cochlear implant

Envoy Medical wins FDA IDE for Acclaim cochlear implant

Envoy Medical

Envoy Medical introduced in the present day that it acquired FDA investigational machine exemption (IDE) for its Acclaim cochlear implant.

White Bear Lake, Minnesota–based mostly Envoy Medical will start a single-center IDE early feasibility research with the absolutely implanted Acclaim cochlear implant at Mayo Clinic in Rochester, Minnesota.

The corporate mentioned in a information launch that its Acclaim implant represents a brand new choice in contrast to present commercially obtainable cochlear implants as a result of lack of any externally worn parts. It acquired FDA breakthrough machine designation in 2019.

If authorized by the FDA, Acclaim can be the primary of its sort as a cochlear implant designed to be absolutely implanted utilizing the ear, somewhat than a microphone, to select up sound, Envoy mentioned. The design leverages the pure anatomy of the ear to seize sound in an effort to deal with the restrictions of present microphone-based listening to gadgets.

Dr. Colin Driscoll — a Mayo Clinic practising neurologist and professor of otolaryngology for head and neck surgical procedure — will function the principal investigator for the research. Aniket Saoji — an affiliate professor of otolaryngology for head and neck surgical procedure — might be a co-investigator. Each investigators serve on Envoy Medical’s Cochlear Implant Advisory Board.

“We imagine {that a} absolutely implanted cochlear implant could enhance their use amongst hundreds of thousands of adults with important listening to loss,” Envoy Medical CEO Brent Lucas mentioned within the information launch. “This research is step one in evaluating the security and effectiveness of the absolutely implanted Acclaim cochlear implant, placing us nearer in direction of doubtlessly filling a big unmet want in listening to loss expertise.”

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