Australia’s Cochlear Ltd. (ASX:COH) landed a date with the FDA where experts on the agency’s Ear, Nose & Throat Devices advisory panel will review information and make a recommendation on the company’s Nucleus Hybrid L24 implantable hearing aid.
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.
News of the meeting preceded a boost in COH shares, which rose 1.1% to $58.87 as of the close of the Australian market yesterday. The panel’s public meeting is slated to take place November 8 in Silver Spring, Md., according to the agency notice.
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 panel date is more good news for Cochlear, which in August announced European market approval for the next-generation Nucleus 6, which the company called the smallest behind-the ear sound processor on that market.