Implantable hearing solutions provider Medical Electronics (MED-EL USA) announced on Thursday that the US Food and Drug Administration (FDA) has approved its cochlear implants for children 7 months and older with bilateral sensorineural hearing loss (SNHL).

This expanded indication makes MED-EL's system the only FDA-approved cochlear implant for infants this young, enabling earlier access to sound and speech development.

The approval also expands audiologic and speech indications for children aged 12 months and older, providing the broadest paediatric coverage among hearing implant manufacturers, MED-EL said. FDA studies in children aged 7 to 71 months old showed that 110 of 123 participants achieved clinical success within the first year, with a low rate of major complications.

Complications were consistent with known risks of cochlear implantation, and children implanted before 12 months did not experience higher complication rates. MED-EL plans a post-approval study to collect additional data for children aged 7 months to 17 years and 11 months who meet the new labelling criteria for MED-EL cochlear implants.

Medical experts highlighted the importance of early hearing intervention for language, literacy, and quality-of-life outcomes in children with significant hearing loss.