MED-EL USA announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for the company’s cochlear implants, making them available for children seven months and older with bilateral sensorineural hearing loss (SNHL).

The company celebrates the regulatory nod because it makes its cochlear implant system the only FDA-approved options for infants of that age. It provides them potential for earlier access to sound and speech development.

The approval also expands audiologic and speech indications for children 12 months and older. Nancy M. Young, MD, said giving infants the opportunity to hear early in life is critical to maximizing development of hearing and spoken language—Dr. Young is a Lillian S. Wells p-professor of pediatric otolaryngology and medical director of the cochlear implant program,  at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“It is extremely gratifying to have led this clinical trial demonstrating the safety and effectiveness of the latest implant technology for children as young as seven months,” Dr. Young told the press. “My hope is this will mean more children will experience the gift of sound soon after birth.”

Data from an FDA study in two groups of children showed MED-EL cochlear implants are safe and effective for children seven-71 months old with bilateral SNHL who cannot hear well enough with hearing aids. 110 of 123 children, including 81% in one group and 88% in the other group, showed clinical success with the cochlear implant in the first year.

The rate of major complications was low in both study groups. All complications were known risks of cochlear implantation, and children implanted under 12 months old did not have more complications than other children.

“Many children with significant hearing loss use hearing aids but cannot hear all the sounds essential for understanding spoken language. They must work so much harder than their hearing peers. Expanding the eligibility of these children for cochlear implantation is so important to improving their hearing, language, literacy, and quality of life,” said Dr. Young.

A post-approval study is planned to collect more data in children implanted at ages seven months to 17 years, 11 months who meet the new labeling criteria for MED-EL cochlear implants.

“This is an incredible step forward for families with young children with hearing loss,” said John Sparacio, president and CEO of MED-EL USA. “Giving children access to sound as early as possible can make a world of difference for their future. We are committed to giving every child the best possible start in life through our closest to natural hearing philosophy paired with our advancements in safety and technology.”

In June, Starkey and MED-EL introduced DualSync, a bimodal streaming partnership enabling Apple technology to seamlessly stream to compatible Starkey hearing aids and MED-EL cochlear implants.