Cochlear Ltd. (ASX:COH) said an advisory committee to the FDA this week voted favorably on the Nucleus Hybrid L24 implant system, which combines acoustic amplification of low frequencies and electrical stimulation for high frequencies in a single device.
The panel, made up of physicians and researchers, voted in favor of the new hybrid device based on clinical results demonstrating the safety and efficacy of the Nucleus system in patients who met the criteria.
In a study of 66 adult hearing-impaired subjects, researchers determined that the Nucleus Hybrid L24 device resulted in "significantly improved" speech perception, sound quality and quality of life compared with preoperative hearing aids, according to a study published online in PubMed. Nearly 90% of the study participants maintained "useful residual hearing," researchers reported.
“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," company president Chris Smith said in prepared remarks. "This 1st-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 1st step to giving thousands of patients the opportunity to hear much better than was possible even with the most advanced hearing aids."
Cochlear hopes to win approval to treat patients over the age of 18 who are suffering from residual low- frequency hearing sensitivity and bilateral severe to profound high frequency sensorineural hearing loss, according to a notice in the Federal Register.
The FDA is not bound by panel recommendations, but does consider the opinion towards deciding on regulatory clearance.