US-based Cochlear has announced that an advisory committee to the US Food and Drug Administration (FDA) voted favorably on the Cochlear Nucleus Hybrid L24 implant system.
This is a first of its kind system designed for the treatment of adults with severe to profound sensorineural hearing loss in the high frequencies and normal to only mild hearing loss in the low frequencies, often referred to as ‘ski-slope’ hearing loss.
The panel, comprised of leading physicians and researchers, voted in favor of the new hybrid device based on substantial clinical evidence demonstrating the safety and efficacy of the Nucleus Hybrid System in patients who met the candidacy criteria.
The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the final review of the new hybrid device.
Cochlear Americas president Chris Smith noted the company is pleased with the panel’s vote for the Nucleus Hybrid System.
"The notion of hybrid hearing is truly a novel one that addresses an unmet need for people with hearing loss by bridging the gap between hearing aids and cochlear implants.
This first-of-its-kind technology consists of a unique combination of solutions to overcome high frequency hearing loss, which impairs a person’s ability to hear voices clearly and understand speech in noise.
This positive recommendation is an important first step to giving thousands of patients the opportunity to hear much better than was possible even with the most advanced hearing aids," Smith added.
The Nucleus Hybrid System combines the natural hearing via acoustic amplification of low frequencies with the electrical stimulation of a cochlear implant for high frequencies in one device.
It is designed to deliver patients superior quality and clarity of sound in even the most difficult hearing situations, especially hearing in noisy environments.