Nucleus Hybrid L24 For Specific Hearing Loss Approved By FDA

The U.S. Food and Drug Administration (FDA) has granted approval for Nucleus Hybrid L24 Cochlear Implant System, the first implantable hearing device for patients 18 years old and above suffering from severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but can still hear low-frequency sounds with or without the help of a hearing aid.

Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said, “Hearing loss greatly impacts the education, employment, and well-being of many Americans. This device may provide improved speech recognition for people with this kind of hearing loss, who have limited treatment options.”

Sensorineural hearing loss is caused by damage to the inner ear, or cochlea. It is the most common form of hearing loss and may result from aging, heredity, unhealthy exposure to loud noise, drugs that harm the cochlea, and other illnesses. Patients living with severe or profound sensorineural hearing loss of high-frequency sounds may have difficulty hearing faint or high-pitched sounds. This may include failure to hear high-pitched emergency sirens or safety alarms.

The Nucleus Hybrid L24 Cochlear Implant System is an electronic device combining the functions of a cochlear implant and a hearing aid. The device consists of an external microphone and speech processor that picks up and converts sounds into electrical impulses. A small bundle of implanted electrodes transmits the sounds to the cochlea to produce a sense of sound that can be associated with the mid- and high-frequency sounds. The hearing aid portion of Nucleus Hybrid L24 is inserted into the outer ear canal, similar to a conventional hearing aid, and can amplify sounds in the low-frequency range.

The FDA approval is based on a clinical study involving 50 eligible patients with severe to profound high frequency hearing loss, but still possessing significant levels of low-frequency hearing, the majority of which reported statistically significant improvement in hearing after activation of the implanted device.

Cochlear Ltd. in New South Wales, Australia is the manufacturer of the Nucleus Hybrid L24 Cochlear Implant System.