Envoy Medical Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, announced the US 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. According to the company’s announcement, 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, PhD, 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 4 million potential people with significant hearing loss in the United States who could benefit from cochlear implants, roughly 5% 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.
Patients interested in learning more about the study should contact Amy Pajula, customer experience manager, at [email protected] for more information.
About the Fully Implanted Acclaim Cochlear Implant
The fully implanted Acclaim cochlear implant is a “first-of-its-kind cochlear implant designed to address the hearing of adults diagnosed with severe-to-profound sensorineural hearing loss.” The Acclaim cochlear implant is designed to leverage sensor technology from the fully implanted Esteem active middle ear implant, according to the company. The Esteem was FDA-approved in 2010.
If approved by the FDA, the Acclaim would be “the first-of-its-kind cochlear implant designed without any externally worn components and to use the ear to pick up sound.”
CAUTION: The fully implanted Acclaim cochlear implant is an investigational device. Limited by United States law to investigational use.
Important safety information for the Esteem can be found at: https://www.envoymedical.com/safety-information.
References
- American Cochlear Implant (ACI) Alliance. Cochlear Implant Candidacy for Adults. https://www.acialliance.org/page/AdultCandidacy.
- Barnett M, Hixon B, Okwiri N, et al. Factors involved in access and utilization of adult hearing healthcare: A systematic review. Laryngoscope. 2017;127(5):1187-1194.
Source: Envoy Medical Corporation, Laryngoscope
