A panel set up by the FDA has recommended by a vote of 15-0 that they will approve the first fully-implantable hearing aid for patients with moderate to severe hearing loss.
The Esteem®-Hearing Implant™ developed by Envoy Medical is different from all other microphone-based hearing devices (hearing aids, other middle ear implants or cochlear implants). This is because it uses the eardrum to process the incoming sound and thereby preserving a natural way of hearing. The Esteem®-Hearing Implant™ is 100% implantable and therefore invisible.
The device works by being implanted under the skin behind the ear. Sound waves travel into the ear canal and set the ear drum into motion by causing the bones of the middle ear to vibrate. The device senses these movements and delivers a customized dose of energy to the cochlea which then transmits the signals to the brain. The brain interprets the signals as hearing, which in turn provides the patient with improved hearing.
The Esteem hearing system was found to improve hearing better than partially-implanted hearing aids, this is dispite some reported side effects including the sense of taste being disrupted for some time. Improvements to hearing was reported by all participants in a company sponsored trial. Envoy Medical Corp. of St. Paul, Minn who make the Esteem hearing system say that Esteem works by replicating the ossicular chain which amplify sound vibrations that enter the middle ear. The device is implanted in the middle ear and requires separating the three bones that make up the ossicular chain of the middle ear, and also removing part of the incus.
The product page for the Esteem can be found at http://www.envoymedical.com/
Related community group -> Hearing Implants
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