Med-El USA wins FDA nod for Synchrony EAS hearing implant

Med-El USA said today it won FDA premarket approval for its Synchrony electric acoustic stimulation hearing implant system. The Synchrony EAS uses both the Synchrony cochlear implant designed to stimulate the auditory nerve for high-frequency hearing loss and the Sonnet EAS audio processor designed 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 prez & 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 f...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Pre-Market Approval (PMA) Regulatory/Compliance Med-El USA Source Type: news