FDA Approves Implantable Device for Certain Type of Hearing Loss

The U.S. Food and Drug Administration has approved the first implantable hearing device geared toward adults who have severe or profound sensorineural hearing loss of high-frequency sounds but can still hear low-frequency sounds, either with or without a hearing aid.

Patients with this type of hearing loss do not benefit from conventional hearing aids, and are often left with limited treatment options.

The newly approved Nucleus Hybrid L24 Cochlear Implant System, manufactured by New South Wales, Australia-based Cochlear, Ltd., combines the functions of a cochlear implant and a hearing aid into one device.

The cochlear element of the device consists of an external microphone and speech processor that converts sounds into electrical impulses. The impulses are transmitted through implanted electrodes in the inner ear, providing a sense of sound the user can associate with mid and high-frequency sounds. The hearing device element is placed in the outer ear canal and functions like a conventional hearing aid, amplifying low-frequency sounds.

While low-frequency hearing loss is a risk of this device, the FDA says the overall benefit of the device outweighs the risk for patients who do not benefit from conventional hearing aids.

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