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Cochlear’s Nucleus Hybrid L24 Cochlear implant system gets FDA approval

Cochlear’s Nucleus Hybrid L24 Cochlear implant system has been approved by the US Food and Drug Administration (FDA) for the treatment of adults with severe or profound sensorineural hearing loss of high frequencies sounds.

The Nucleus Hybrid L24 Cochlear implant system combines the functions of a cochlear implant. According to FDA, Nucleus Hybrid L24 is the first implantable device designed to help those who do not benefit from conventional hearing aids.

FDA has approved the device based on its evaluation of a clinical study involving 50 individuals with severe to profound high-frequency hearing loss who still had significant levels of low-frequency hearing. The individuals were tested before and after being implanted with the device.

At six months after activation of the device, a majority of the patients reported statistically significant improvements when compared to their baseline pre-implant performance using a conventional hearing aid.

Non-clinical testing of the Nucleus Hybrid L24 Cochlear implant system has also been conducted, which included the electrical components, biocompatibility and durability of the device.

Of the 50 individuals, nearly 70% of the individuals have experienced one or more anticipated adverse events, such as low-frequency hearing loss, tinnitus, electrode malfunction and dizziness.

A total of 22 individuals suffered profound or total loss of low-frequency hearing in the implanted ear. Six of these patients underwent additional surgery to replace the device with a conventional cochlear implant.

FDA Center for Devices and Radiological Health Office of Device Evaluation director Christy Foreman noted this device may provide improved speech recognition for people with this kind of hearing loss, who have limited treatment options.

Nucleus Hybrid L24 Cochlear implant system features an external microphone and speech processor that picks up sounds from the environment and converts them into electrical impulses.

These electrical impulses are then transmitted to cochlea, creating a sense of sound that the user learns to associate with the mid- and high-frequency sounds they remember.