FDA Approves Cochlear Implants for Babies as Young as Seven Months

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In a major step forward for pediatric hearing care, the U.S. Food and Drug Administration (FDA) has approved MED-EL cochlear implants for babies as young as 7 months old who have bilateral sensorineural hearing loss (SNHL). This makes MED-EL the first and only cochlear implant system cleared in the U.S. for infants this young, offering families the opportunity to introduce sound much earlier in a child’s life.

“Giving infants the opportunity to hear early in life is critical to maximizing the development of hearing and spoken language,” said Nancy M. Young, M.D., Lillian S. Wells Professor of Pediatric Otolaryngology, medical director of Cochlear Implant Program, Ann and 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 7 months. My hope is this will mean more children will experience the gift of sound soon after birth.”

Sensorineural hearing loss happens when the inner ear or auditory nerve does not function properly. While hearing aids can help some children, others are unable to hear important speech sounds clearly enough to develop spoken language in the same way as their peers. For these children, a cochlear implant — a surgically placed electronic device that directly stimulates the auditory nerve — may provide stronger access to sound than hearing aids alone.

This new FDA decision allows more babies to qualify for cochlear implants earlier, during a critical window for brain and language development. According to Young, research has consistently shown that earlier access to sound can support better outcomes in speech, language, reading and overall communication skills. That’s why this approval is considered a significant milestone in pediatric hearing care.

In the clinical study reviewed by the FDA, 123 children between 7 and 71 months of age who could not hear well enough with hearing aids were evaluated. Results showed that 110 of the 123 children (between 81% and 88% across groups) achieved “clinical success” after receiving a MED-EL cochlear implant — meaning their ability to hear and respond to sound improved in a meaningful way within the first year.

Safety was also closely monitored, which is especially important when surgery is involved in very young children. The rate of major complications was low, and importantly, babies implanted before 12 months of age did not experience more complications than older children. All reported complications were already known and recognized risks of cochlear implant surgery.

In addition, the FDA expanded MED-EL’s approved use for children 12 months and older, giving the company the broadest pediatric indications of any hearing implant manufacturer to date.

To continue studying long-term outcomes, a postapproval follow-up study is planned for children who receive implants between 7 months and nearly 18 years of age under the new approval guidelines.

“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.”