The FDA has approved the first implantable device for individuals ≥18 years of age with severe or profound sensorineural hearing loss of high-frequency sounds in both ears who have not benefited from conventional hearing aids. The device, named the Nucleus Hybrid L24 Cochlear Implant System, is manufactured by Cochlear Ltd.

The Nucleus Hybrid L24 Cochlear Implant System contains an external microphone and speech processor to convert environmental sounds into electrical impulses that are transmitted to the cochlea via implanted electrodes. It is inserted into the outer ear canal similar to a conventional hearing aid and is intended for use in only one ear.

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This approval was based on a clinical study of 50 patients with severe to profound high-frequency hearing loss but significant levels of low-frequency hearing. The majority of participants reported statistically significant improvements in word and sentence recognition at six months post-device activation compared to pre-implant performance with a conventional hearing aid. Non-clinical testing was also conducted regarding the electrical components, biocompatibility, and durability of the device.

Some anticipated adverse events like tinnitus, electrode malfunction, and dizziness were reported in 68% (n=34) of participants and 44% (n=22) had profound or total low-frequency hearing loss in the implanted ear, of which 6 patients had the device replaced with a standard cochlear implant due to the low-frequency hearing loss. The decision to approve the device by the FDA was due to the overall benefits outweighing the risk for patients who do not experience hearing improvement with traditional hearing aids.

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