The new approval lowers the age from the original 12 months for children with bilateral, profound sensorineural hearing loss.
Cochlear implants have been FDA approved for use in children since 1990.
“In light of all that has happened, access to hearing and hearing healthcare is more important now than ever. Hearing connects us to people and access to sound for those with hearing loss is important for connection as we continue to socially distance ourselves to mitigate this virus,” chief od audiology and research at Hearts of Hearing Jace Wolfe said in a news release. “For children especially, having access to sound during the important language development stages is critical. We know for children born with profound hearing loss, the earlier they receive cochlear implants, the greater their opportunity for success with hearing, speech and language.”
An estimated three in 1,000 babies are born with moderate, severe or profound hearing loss in the U.S. each year, according to the American Academy of Pediatrics. It is one of the most common congenital conditions in the U.S.
“As states begin to allow more surgeries, we hope this expanded indication will help hospitals to prioritize pediatric cochlear implant surgeries. Our hopes are that children get access to hearing technology that will help them obtain age-appropriate speech and language as soon as they can,” VP of product management and marketing of Cochlear Americas Patricia Trautwein said.
The Cochlear Nucleus Implant System is currently intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from binaural hearing aids, according to the company.