MED-EL's cochlear implants receive approval for use in infants

The U.S. Food and Drug Administration (FDA) has authorized a broader use of MED-ELs SYNCHRONY cochlear implants for infants starting at seven months old who have bilateral sensorineural hearing loss (SNHL). With this update, the device is now the sole FDA-approved cochlear implant option for infants in this age group, according to the Austria-based hearing technology company.

MED-EL highlighted that the expanded approval could allow children to access sound earlier, supporting the development of speech and language. The new FDA clearance also broadens the audiologic and speech-related criteria for children aged 12 months and above.

Bilateral SNHL occurs when both ears suffer permanent hearing impairment due to damage to the inner ears hair cells or the auditory nerve. Causes can include viral infections, autoimmune conditions, or physical trauma to the head or ear. The World Health Organization (WHO) estimates that by 2050, up to 900 million people globally could experience disabling SNHL.

The SYNCHRONY implant system uses an external audio processor to convert sound waves into electrical signals, which are then transmitted to the implant beneath the skin. The device stimulates the cochlea with these signals, enabling the brain to perceive sound.

John Sparacio, President and CEO of MED-EL USA, said, This approval represents a major advancement for families with young children experiencing hearing loss. Early access to sound can significantly impact a childs future development.

Previously in 2024, MED-EL expanded its cochlear implant indication to include adults with bilateral moderate-to-profound SNHL who have limited aided word recognition scores. This development further reinforces MED-ELs commitment to providing solutions across age groups.

Author: Lucas Grant