MED-EL’s cochlear implants secure expanded approval in infants

MED-EL’s cochlear implants are now FDA-approved in children seven months and older with bilateral sensorineural hearing loss (SNHL).

The US Food and Drug Administration (FDA) has approved an expanded indication for MED-EL’s SYNCHRONY cochlea implants in infants aged seven months and older with bilateral sensorineural hearing loss (SNHL).

With the indication expansion, the cochlear implant system becomes the only FDA-approved option for infants of this age, according to the Austria-based hearables company.

MED-EL said the development will offer the potential for earlier access to sound and speech development. This latest FDA approval also includes expansion of audiologic and speech indications for children aged 12 months and older.

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