NSW-based Cochlear has received a major boost with the US FDA approving its Nucleus Hybrid L24 Implant System yesterday.
This opens up new markets for one of Australia's leading medical device manufacturers. In February this year, the company recorded a 73 percent fall in interim net profit. This was partly attributed to delays in receiving US FDA approval.
Cochlear will now be able to market 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.
The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids.
The Nucleus Hybrid L24 Cochlear Implant System combines the functions of a cochlear implant and a hearing aid. This electronic device consists of an external microphone and speech processor that picks up sounds from the environment 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.
Last year, Australian academic and commercial researchers developed designs for higher-performance electrodes which substantially improve sound perception in cochlear implants.
At the time of the disappointing half-year results announcement in mid-February, Cochlear chief executive Chris Roberts told The Australian Financial Review that approval of the Hybrid system was “very close”. “When they approve that we’ll go after that very hard,” Roberts said at the time.