Cochlear Implant Study Underway at Mayo Clinic

Envoy Medical Corporation has enrolled and treated the first patient in the Acclaim Cochlear Implant early feasibility study at Mayo Clinic (Rochester, Minn). This surgery marks a key milestone for Envoy Medical in its journey to bring the Acclaim Cochlear Implant to market.

“We at Envoy Medical are extremely proud that our Acclaim early feasibility study is taking place at Mayo Clinic. There is a strong medical device history and culture here in Minnesota, and we are honored to add to that legacy,” Envoy Medical CEO Brent Lucas said. “This study is an important step towards demonstrating whether the fully implanted Acclaim Cochlear Implant works as it was designed, turning the page to a new chapter in cochlear implants. We hope to change the status quo within the hearing industry, and I am so proud of our team for bringing this breakthrough technology to fruition—implantable medical devices are not for the faint of heart.”

If approved by the U.S. Food and Drug Administration (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, according to Envoy Medical.
 
The implantation surgery was conducted by Colin Driscoll, MD, practicing neurotologist, professor of otolaryngology – head and neck surgery at Mayo Clinic, and principal investigator for this study. After a healing period, the Acclaim Cochlear Implant will be activated by Aniket Saoji, Ph.D., associate professor of otolaryngology – head and neck surgery at Mayo Clinic and co-investigator of the study. Both investigators serve on Envoy Medical’s Cochlear Implant Advisory Board. 
 
Based on an Investigational Device Exemption (IDE) granted by the FDA, the early feasibility study for the Acclaim is expected to last 18 months and will be followed by a pivotal trial to support a Premarket Approval (PMA) application to the FDA.
 
Of the estimated 1.4-4 million adults with significant hearing loss in the U.S. who could benefit from cochlear implants, only roughly 5% of eligible adult 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
 
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. It is designed to leverage sensor technology from the fully implanted Esteem active middle ear implant. Intended to address the limitations of current microphone-based hearing devices, Envoy Medical’s fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Esteem was approved by the FDA in 2010.
 
The Acclaim Cochlear Implant received FDA Breakthrough Device Designation. 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.
 
The fully implanted Acclaim Cochlear Implant is an investigational device limited by U.S. law to investigational use.
 
Envoy Medical Corporation, headquartered in White Bear Lake, Minn., is a privately held hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss.

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