FDA has approved the first implantable device for adults with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System, manufactured by Australian firm Cochlear Ltd., combines the functions of a cochlear implant and a hearing aid. The technology includes an external microphone and speech processor that picks up sounds from the environment and converts them into electrical impulses. The impulses are transmitted through small implanted electrodes to create a sense of sound that the user learns to associate with the mid- and high-frequency sounds they remember. Of the 50 people studied in the clinical trial, 68% experienced some adverse events such as low-frequency hearing loss, ringing in the ear, electrode malfunction and dizziness. However, the FDA determined that the overall benefits outweighed this risk for people who do not benefit from traditional hearing aids.
[1] FDA News Release, "FDA approves first implantable hearing device for adults with a certain kind of hearing loss" (March 20, 2014).
[1] FDA News Release, "FDA approves first implantable hearing device for adults with a certain kind of hearing loss" (March 20, 2014).
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