Envoy Medical Reports FDA Approves Clinical Trial of First Fully Implanted Cochlear Implant

The First-of-Its-Kind Fully Implanted Acclaim Cochlear Implant Received Breakthrough Device Designation

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. The Acclaim is unlike current commercially available cochlear implants due to the lack of any externally worn components and it was granted Breakthrough Device Designation in 2019 by the FDA.

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.

Colin Driscoll, MD, practicing neurotologist, professor of otolaryngology – head and neck surgery at Mayo Clinic, is principal investigator for this study and Aniket Saoji, Ph.D., associate professor of otolaryngology – head and neck surgery at Mayo Clinic is co-investigator. Both investigators serve on Envoy Medical’s Cochlear Implant Advisory Board.

Of the estimated 1.4 to four million potential people with significant hearing loss in the United States who could benefit from cochlear implants, roughly five percent of eligible candidates use cochlear implants.[1] Potential adult recipients often wait longer than they should to get existing partially implanted cochlear implants, and a reason often cited is the amount of external hardware.[2]

“We believe that a fully implanted cochlear implant may increase their use among millions of adults with significant hearing loss,” said Brent Lucas, CEO of Envoy Medical. “This study is the first step in evaluating the safety and effectiveness of the fully implanted Acclaim cochlear implant, putting us closer towards potentially filling a large unmet need in hearing loss technology.”
Designed to address the limitations of current microphone-based hearing devices, Envoy Medical’s fully implanted technology includes a completely unique sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.

References

[1] Cochlear Implant Candidacy for Adults. https://www.acialliance.org/page/AdultCandidacy
[2] Barnett, M. et al. Factors involved in access and utilization of adult hearing healthcare: A systematic review. Laryngoscope (2017). doi:10.1002/lary.26234

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

“It’s exciting to be one of the first two hospitals in Europe to use Stryker’s Mixed Reality Guidance System,” said Professor Berhouet. “I am also pleased to be leading a pilot study to investigate the safety and effectiveness of this new technology, alongside three other centres in France.”
The KnowU incorporates the sensor that the Company plans to submit to the FDA for clearance. This proprietary sensor has been tested and proven stable and accurate in the lab setting. It was included in the Company’s prototype to validate stability outside of the lab, and is now miniaturized and wearable.
The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.

By using this website you agree to accept Medical Device News Magazine Privacy Policy