Envoy Medical announced today that its Esteem middle ear implant showed statistically significant improvements in postoperative results.
White Bear Lake, Minn.–based Envoy’s Esteem osseointegrated active middle ear implant (AMEI) is for patients with moderate-to-severe sensorineural hearing loss who have failed to benefit from traditional amplification like hearing aids. Esteem is the first and only fully implanted AMEI approved by the FDA.
All patients enrolled in the independent study used the device. Results, published in The Journal of Laryngology & Otology, reported overall significant improvement in pure-tone average (PTA) and word recognition scores at a hearing level of 50 dB.
According to a news release, 116 implants were placed between November 2011 and August 2016, including those in many patients who reported subjective suboptimal performance with traditional amplification and a lack of desire to continue using hearing aids.
Other results uncovered in the study aside from the PTA improvement included the device proving safe and effective. An experienced otological surgeon can readily learn implantation. Complication rates were low, while Envoy confirmed the system’s high quality compared to traditional hearing aids.
“We welcome the results of this retrospective study in demonstrating the benefit of a fully implanted active middle ear implant, and hope it helps more people understand that hearing aids and cochlear implants are not the only two options for people with sensorineural hearing loss,” Envoy Medical CEO Brent Lucas said in the release. “There are over 48 million Americans with hearing loss of varying types and degrees – we think hearing professionals and their patients benefit from having more tools in their toolbelt. We support people with hearing loss and other advocates who continue to lobby Congress for better access to treatments that improve hearing health.”