FDA Approves Med-El PMA for Hearing Device

FDA has approved a Med-El USA PMA for the Synchrony EAS (Electric Acoustic Stimulation) Hearing Implant System. The device combines two technologies — a Synchrony cochlear implant that stimulates the auditory nerve for high-frequency hearing loss, and the Sonnet EAS audio processor, with built-in acoustic amplification for low-frequency hearing loss. “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,” the company says.

Approval was based on data that demonstrated 97% of patients participating in the MED-EL EAS clinical trial reported a benefit from the device within the first 12 months. The study also showed that 92% of participants reported an improvement in their ability to hear while there is background noise, and 90% reported satisfaction with the device overall.