FDA approves hearing implant for high- and low-frequency hearing loss

Synchrony EAS Hearing Implant System--Courtesy of MED-EL USA

The FDA has approved MED-EL’s hearing implant that combines a cochlear implant and an audio processor for people with both high- and low-frequency hearing loss.

People with high-frequency hearing loss tend to have difficulty understanding speech when there is background noise even with a hearing aid. Enter the Synchrony EAS (electric acoustic stimulation) Hearing Implant System, which stimulates the auditory nerve with a cochlear implant and amplifies sounds with an audio processor, according to a statement.

“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,” said MED-EL North America CEO Raymond Gamble in the statement.

In a clinical trial, 92% of participants said they were better able to hear in background noise and 90% said they were satisfied with the device, MED-EL said in the statement. Patients with the EAS device did twice as well on speech understanding tests as they did with their hearing aids before they received the implant.

The EAS system is approved for patients 18 and older who have normal to moderate hearing loss in low frequencies and sloping or severe to profound hearing loss in high frequencies, according to the statement.