Med-El USA said today that the FDA has approved its cochlear implant for single-sided deafness and asymmetric hearing loss, a first for these indications in the U.S., according to the Durham, N.C.-based company. Med-El’s cochlear implant systems, including Synchrony and the recently FDA-approved Synchrony 2, are now indicated for individuals aged 5 years and older […]
Med-El USA
FDA grants de novo clearance to Med-El for Bonebridge hearing implant system
Cochlear implant maker Med-El USA said yesterday it won FDA de novo clearance for its Bonebridge bone conducting hearing implant system, with plans to launch the device this year. The newly cleared system is indicated for individuals 12 years and older with conductive hearing loss, mixed hearing loss or single-sided deafness, the Durham, N.C.-based company said. The […]
Med-El wins FDA nod for Rondo 2 cochlear implant audio processor
Cochlear implant maker Med-El USA said today it won FDA approval for its Rondo 2 cochlear implant audio processor with an expected launch of the device this fall. The Durham, N.C.-based ocmpany said the newly cleared Rondo 2 audio processor features wireless charging capabilities that allow the device to fully recharge in four hours after being […]
Med-El USA wins FDA nod for Synchrony EAS hearing implant
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 […]