Australia-based Cochlear has obtained US Food and Drug Administration (FDA) approval for its Nucleus Hybrid L24 Cochlear implant system, which combines the functions of a cochlear implant and a hearing aid.
Nucleus Hybrid L24 is a first-of-its-kind system designed for the treatment of those aged 18 and older, with severe to profound sensorineural hearing loss in the high frequencies and normal to only mild hearing loss in the low frequencies.
According to FDA, Nucleus Hybrid L24 is the first implantable device that may help those with profound sensorineural hearing loss who do not benefit from conventional hearing aids.
FDA Center for Devices and Radiological Health Office of Device Evaluation director Christy Foreman said: "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 combines the natural hearing through acoustic amplification of low frequencies with the electrical stimulation of a cochlear implant for high frequencies in one device.
The device features an external microphone and speech processor, which picks up sounds from the environment and converts them into electrical impulses. A small bundle of implanted electrodes transmits these impulses to the cochlea, creating a sense of sound that the user learns to associate with the mid- and high-frequency sounds they remember.
FDA approval of the Nucleus Hybrid L24 Cochlear implant system is 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. They were tested before and after being implanted with the device.
A majority of the patients reported statistically significant improvements in word and sentence recognition at six months after activation of the device, compared with 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 studied the electrical components, biocompatibility and durability of the device.
Of the 50 individuals, 22 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.
Nearly 70% of the individuals have experienced one or more anticipated adverse events, such as low-frequency hearing loss, tinnitus, electrode malfunction and dizziness.
According to GlobalData estimates, the US cochlear implant market was valued at $357.7m in 2012 and is expected to grow at a CAGR of 14.7% to reach $932.2m by 2019.