Envoy Medical® Corporation tells us the first patient has been enrolled and implanted in the Acclaim® Cochlear Implant early feasibility study.
An estimated 1.4-4 million adults with significant hearing loss in the U.S. could benefit from cochlear implants. However only roughly 5 percent of eligible adult candidates use them. Potential adult recipients often wait longer than they should to get existing partially implanted cochlear implants. One reason often cited is the amount of external hardware.
Envoy Medical® is a hearing health company focused on providing innovative technologies across the hearing loss spectrum.
The company’s fully implanted Acclaim® Cochlear Implant is a first-of-its-kind cochlear implant. It has been developed to address the hearing of adults diagnosed with severe to profound sensorineural hearing loss. The system’s design leverages unique 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 completely unique sensor. It relies on the natural anatomy of the ear instead of a microphone to capture sound. The Esteem was FDA-approved in 2010.
The U.S. FDA has granted the Acclaim Cochlear Implant 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.
Acclaim Cochlear Implant
Colin Driscoll, MD, conducted the first implantation surgery and is principal investigator. Dr Driscoll is practicing neurotologist, professor of otolaryngology – head and neck surgery at Mayo Clinic. After a healing period, Aniket Saoji, PhD, will activate the implant. Dr Saoji is 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 FDA Investigational Device Exemption (IDE), the early feasibility study for the Acclaim is expected to last 18 months. A subsequent pivotal trial will support a Premarket Approval (PMA) application to the FDA.
“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,” said Brent Lucas, CEO of Envoy Medical. “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.”
Patients interested in learning more about the study should contact Amy Pajula, customer experience manager, at email@example.com for more information.
Source: Envoy Medical® Corporation