Med-El USA said today that it won pre-market approval from the FDA for its Synchrony electric acoustic stimulation hearing implant system.
The Synchrony EAS uses both the Synchrony cochlear implant to stimulate the auditory nerve for high-frequency hearing loss and the Sonnet EAS audio processor for low-frequency hearing loss, the Durham, N.C.-based company said.
“The EAS system has the potential to close the gap for people who have high-frequency hearing loss, but whose residual low-frequency hearing would have made them ineligible for a cochlear implant up until now. If you struggle with hearing in background noise with hearing aids, you may be a candidate for the EAS System,” Med-El North America president & CEO Raymond Gamble said in a press release.
Data from a clinical trial of the device supported the approval, Med-El USA said, with results indicating that 97% of patients participating in a clinical trial of the device reported a benefit from the device in the 1st 12 months. Trial data also indicated that 92% of participants reported an improvement in their ability to hear in background noise, and 90% reported satisfaction with the device overall.
“Our clinical trial participants were overwhelmingly receptive to this new technology. Historically, it’s been a challenge to help people whose hearing has been ‘too good’ for cochlear implants, but who gain little to no benefit from hearing aids despite having low-frequency hearing. The EAS system fills that unmet need,” Dr. Harold Pillsbury of the University of North Carolina School of Medicine said in prepared remarks.
The device was approved for patients 18 and older with moderate sensorineural hearing loss in low frequencies, sloping to severe-to-profound hearing loss in high frequencies.
