WHITE BEAR LAKE, Minn.–(BUSINESS WIRE)–Envoy Medical® Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, today announced that an independent study published online in The Journal of Laryngology & Otology found that the fully implanted Esteem® osseointegrated active middle ear implant (AMEI) showed statistically significant improvements in post-operative hearing results. The study also reinforced the safety and efficacy of the Esteem® for patients with moderate-to-severe sensorineural hearing loss who have failed to benefit from traditional amplification like hearing aids.
The Esteem osseointegrated AMEI was used in all study patients and this device is the first and only fully implanted AMEI approved by the Food and Drug Administration. The study, “Totally implantable active middle-ear implants: a large, single-surgeon cohort,” represented a large, retrospective, single-surgeon experience which demonstrated that the AMEI provided an overall significant improvement in pure tone average (PTA) and word recognition score at a hearing level of 50 dB.
“These study results provide further evidence to support the use of fully implanted active middle ear implants such as the Esteem for patients with moderate-to-severe sensorineural hearing loss who are unable to use or do not benefit from hearing aids,” said William McFeely, M.D., study author and otolaryngology specialist at North Alabama…
