The U.S. Food and Drug Administration (FDA) approved the Cochlear™ Nucleus® Hybrid™ L24 Implant System for use in the United States. It is the first implantable device for people 18 and older 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.
“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,” Chris Smith, President of Cochlear Americas, said in a news release.
The Nucleus Hybrid L24 Cochlear Implant System combines the functions of a cochlear implant and a hearing aid. An external microphone and speech processor picks up environmental sounds and converts them into electrical impulses. The impulses are transmitted to the cochlea through a small bundle of implanted electrodes, creating a sense of sound that the user learns to associate with the mid- and high-frequency sounds they remember. The hearing aid portion of the device is inserted into the outer ear canal like a conventional hearing aid, and can amplify sounds in the low-frequency range.
“Hearing loss greatly impacts the education, employment, and well-being of many Americans,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This device may provide improved speech recognition for people with this kind of hearing loss, who have limited treatment options.”
The FDA granted its approval even after a clinical study of 50 patients implanted with the new device demonstrated mixed results. Sixty eight percent of the patients in the study “experienced one or more anticipated adverse events, such as low-frequency hearing loss, tinnitus (ringing in the ear), electrode malfunction and dizziness.” Twenty-two of the patients developed profound or total low-frequency hearing loss in the implanted ear, and six of those patients underwent an additional surgery to replace the Nucleus Hybrid Implant with a standard cochlear implant.
In its news release, the FDA concluded that while the risk of low-frequency hearing loss is of concern, “the overall benefits of the device outweigh this risk for those who do not benefit from traditional hearing aids.”