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.
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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.
Bilateral SNHL is a condition where both ears experience permanent hearing loss due to damage to the inner ear’s hair cells or the auditory nerve. It can be caused by factors including viral infections, autoimmune disorders, and head or ear trauma.
The World Health Organization (WHO) estimates that up to 900 million worldwide could be affected by disabling SNHL by 2050.
MED-EL’s Synchrony implant system features an audio processor worn on the outer ear that converts sound waves into electrical signals. These signals travel from the audio processor to the implant under the skin, which uses electrical pulses to stimulate the cochlea and send sound signals to the brain.
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By GlobalDataMED-EL USA’s president and CEO John Sparacio commented: “This is an incredible step forward for families with young children with hearing loss.
“Giving children access to sound as early as possible can make a world of difference for their future.”
In 2024, MED-EL received an indication expansion for its cochlear implant to cover adults with bilateral moderate-to-profound sensorineural hearing loss who have aided word recognition scores of 50% or less in the ear to be implanted and 60% or less in the non-implant ear.
In addition, Apple entered the hearables market last year following FDA authorisation for the first over-the-counter (OTC) hearing aid software, designed for use with compatible versions of Apple’s AirPods Pro headphones.
According to GlobalData analysis, the smartwatches and hearables segments are the largest segments of wearables and have displayed the most significant growth in the sector in recent years. A 2023 report from GlobalData reveals that the overall global wearable technology market is forecast to grow from $99.5bn in 2022 to $290.6bn in 2030.
