FDA expands indication for MED-EL cochlear implants to infants 7 months or older

The FDA has approved an expanded indication for MED-EL cochlear implants, authorizing their use in children 7 months or older with bilateral sensorineural hearing loss (SNHL). According to the company, this approval makes the MED-EL cochlear implant system the only FDA-approved option for infants as young as 7 months, allowing for earlier access to sound during a critical period of speech and language development.

John Sparacio, president and CEO of MED-EL US, noted the potential developmental impact of early intervention. “Giving children access to sound as early as possible can make a world of difference for their future,” he said.

Early access to sound and speech development

Clinicians involved in the supporting clinical trial emphasized the importance of early hearing access for language outcomes. Nancy M. Young, MD, Lillian S. Wells Professor of Pediatric Otolaryngology and medical director of the Cochlear Implant Program at Ann & Robert H. Lurie Children’s Hospital of Chicago in Illinois, said, “Giving infants the opportunity to hear early in life is critical to maximizing the development of hearing and spoken language. 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.”

Young added that broader eligibility criteria may help children who do not achieve adequate benefit from hearing aids. “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,” she said.

Expanded audiologic and speech indications

The FDA authorization includes expansion of audiologic and speech indications for children 12 months or older, giving MED-EL what the company states are the broadest pediatric indications of any hearing implant manufacturer. Sparacio described the approval as meaningful for families seeking earlier options for auditory access. “This is an incredible step forward for families with young children with hearing loss,” he said. “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.”

Clinical data supporting approval

The FDA decision was supported by data from 2 pediatric study groups evaluating the safety and effectiveness of MED-EL cochlear implants in children aged 7 to 71 months with bilateral SNHL who did not achieve sufficient hearing with hearing aids. Across both groups, 110 of 123 children demonstrated clinical success within the first year of implantation, representing 81% and 88% success rates in the respective cohorts.

Major complications were uncommon and consistent with known risks of cochlear implantation. Children given implants before the age of 12 months did not experience higher complication rates than older children.

Ongoing data collection

A postapproval study is planned to further assess outcomes in children given implants between 7 months and 17 years and 11 months who meet the updated labeling criteria. The study will collect additional safety and effectiveness data to inform longer-term outcomes across a broader pediatric population.

Reference

MED-EL cochlear implant becomes first FDA-approved option for children seven months and older. News release. MED-EL USA. December 4, 2025. Accessed December 4, 2025. https://www.businesswire.com/news/home/20251204357286/en/MED-EL-Cochlear-Implant-Becomes-First-FDA-Approved-Option-for-Children-Seven-Months-and-Older