UPDATED March 21, 2013 with comments from Cochlear Americas president, principal investigator.
The technology is the 1st implantable hearing aid approved for adults who can still hear low-frequency sounds but can’t make out high-frequency sounds in either ear due to damage in the inner ear.
"People with severe or profound sensorineural hearing loss of high-frequency sounds may have difficulty hearing faint sounds, understanding people with higher-pitched voices, hearing certain speech sounds, and, in some cases, hearing high-pitched emergency vehicle sirens or common safety alarms, such as smoke detectors," according to the FDA memo.
The Nucleus Hybrid L24 combines hearing aid and cochlear implant technology, featuring an external microphone and speech processor as well as implanted electrodes to create "a sense of sound that the user learns to associate with the mid- and high-frequency sounds they remember."
Approval was based partly on results from a 50-patient clinical trial in patients, most of which reported significant improvements in word and sentence hearing 6 months following implantation of the technology. Nearly 70% of patients, however, also reported adverse events, including low-frequency hearing loss, tinnitus, electrode malfunction and dizziness, the FDA said. 6 patients underwent revision surgery to replace the Nucleus Hybrid L24 with a standard cochlear implant.
"The launch of the 1st-of-its-kind Nucleus Hybrid system means that we have the opportunity to give people back what they’ve been missing with their hearing aids," Cochlear Americas president Chris Smith said in prepared remarks. "By amplifying low-frequency hearing and restoring access to high-frequency hearing, this innovative new hybrid hearing solution will help people regain the sounds of life that had previously been lost, and ultimately empower them to connect with others and live a full life. We look forward to expanding access to hearing and instilling hope in those who may be suffering without an effective solution."
"The clinical data supporting the FDA approval of the Nucleus Hybrid System is very encouraging as it shows superior hearing performance compared to acoustic amplification alone," added lead investigator Dr. Thomas Roland Jr. of the NYU Langone Medical Center in New York. "What this means is that we now have an effective solution that offers hybrid hearing to patients who may benefit from both electric and acoustic amplification, and that most patients will likely be very satisfied with the results."
The FDA win comes about 4 months after the agency’s Ear, Nose & Throat Devices advisory panel voted in favor of approval. That panel also considered a 66-patient clinical trial in which patients similarly reported "significantly improved" speech perception, sound quality and quality of life compared with preoperative hearing aids.
The company is on a roll, having just won FDA 510(k) clearance for its Baha 4 Attract device, a bone conduction hearing system that uses a series of magnets to conduct sound. Cochlear in August won European approval for its Nucleus 6, the smallest behind-the-ear sound processor to hit European markets at the time.
COH shares closed on the Australian market today at $56.58, down 1% on the day.