Cochlear’s Nucleus Hybrid L24 Cochlear Implant System Wins FDA Approval

New South Wales, Australia, devicemaker Cochlear has gotten a green light to market its Nucleus Hybrid L24 cochlear implant system in the U.S. The device is the first one-ear implant for adults with severe or profound sensorineural hearing loss of high-frequency sounds in both ears.

The agency based its approval on a 50-patient study showing statistically significant improvement in speech recognition among most subjects after six months. Individuals with the device heard twice as well as those with hearing aids in both quiet and noisy settings.

The implant — which combines the functions of a cochlear implant and a traditional hearing aid — employs an external microphone and Cochlear’s Nucleus 6 speech processor, which converts ambient sounds into electrical impulses that are transmitted to the cochlea via implanted electrodes. Users learn to associate the resulting sense of sound with mid- and high-frequency sounds that they remember. The hearing aid portion of the device fits into the outer ear like any other hearing aid, where it amplifies low-frequency sound.

“By amplifying low-frequency hearing and restoring access to high-frequency hearing, this innovative new hybrid hearing solution will help people regain the sounds of life that had previously been lost, and ultimately empower them to connect with others and live a full life,” said Chris Smith, president of Cochlear Americas, the company’s U.S. arm.

Nearly 70 percent of Cochlear recipients in the clinical trial experienced some adverse events, and 22 developed profound or total low-frequency hearing loss in the implanted ear, the FDA notes. The agency advised prospective patients to discuss all benefits and risks with their doctor. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.