MED-EL USA has received approval from the US Food and Drug Administration (FDA) for its Synchrony electric acoustic stimulation (EAS) hearing implant system.
The system features Synchrony cochlear implant that stimulates the auditory nerve for high-frequency hearing loss, as well as Sonnet EAS audio processor with built-in acoustic amplification for low-frequency hearing loss.
The EAS System has secured approval for people aged 18 years and older who have normal to moderate sensorineural hearing loss in the low frequencies, sloping to a severe-to-profound hearing loss in the high frequencies.
MED-EL said that around 97% of patients participating in its clinical trial reported a benefit from EAS within the first 12 months.
MED-EL North America CEO and president Raymond Gamble 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.”
With 29 subsidiaries across the globe, Austria-based MED-EL Medical Electronics supplies hearing implant systems.
The firm offers a range of implantable solutions to treat various degrees of hearing loss, including cochlear and middle ear implant systems.
In July this year, MED-EL acquired a novel non-surgical bone conduction system from the Swedish medical device company Otorix.
Image: MED-EL Synchrony electric acoustic stimulation hearing implant system. Photo: courtesy of Business Wire.