CHICAGO, ILLINOIS — Children with severe hearing loss may benefit from cochlear implantation at younger ages and under broader candidacy criteria than traditionally used, according to a multicenter study led by researchers at Ann & Robert H. Lurie Children’s Hospital of Chicago.
The findings, published in The Laryngoscope, evaluated the safety and effectiveness of MED-EL cochlear implants in infants younger than 12 months and in children ages 12 to 71 months with residual hearing who received insufficient benefit from appropriately fitted hearing aids.
The study provided evidence supporting the FDA’s expanded pediatric indications for MED-EL cochlear implants announced in late 2025. That approval lowered the minimum implantation age to 7 months for certain children with profound bilateral sensorineural hearing loss and broadened audiologic and speech criteria for older children.
Evaluating Earlier and Broader Cochlear Implant Candidacy
The multicenter, nonrandomized study included both prospective and retrospective cohorts. The prospective group included 38 children, 26 of whom were younger than 12 months at implantation. The retrospective cohort included 209 children, including 70 who had been implanted before 12 months of age.
All participants received MED-EL cochlear implants before age 6 and were included in the safety analysis. Thirty-six children in the prospective group and 92 in the retrospective group had sufficient 12-month data for the study’s efficacy analysis.
Researchers established a primary effectiveness goal of having at least 75% of participants meet study-specific performance targets in speech recognition or auditory skill development within 12 months after cochlear implant activation.
Overall, 29 of 36 children in the prospective cohort, or 80.6%, met those performance goals. In the retrospective group, 81 of 92 children, or 88%, met the study criteria.
Results Among Infants and Children with Residual Hearing
Positive outcomes were observed across both of the populations targeted by the expanded indications.
- Among children implanted before 12 months of age, 21 of 25 evaluable participants in the prospective group, or 84%, met the study performance goals.
- In the retrospective cohort, 32 of 37 children implanted before 12 months, or 86.5%, met the performance goals.
- Among children ages 12 to 71 months with residual hearing, all six evaluable participants in the prospective group met the study criteria.
- In the retrospective residual-hearing group, 30 of 34 children, or 88.2%, met the performance goals.
The prospective sample was too small for formal hypothesis testing of the primary effectiveness endpoint. The larger retrospective cohort did meet the study’s predefined primary efficacy endpoint.
Safety Findings
Researchers also evaluated adverse device effects and surgical safety. Nine children in the prospective group and 33 in the retrospective group experienced an adverse device effect. Serious adverse device effects occurred in fewer than 6% of participants, and no unanticipated adverse device effects were reported.
Importantly, the researchers found no evidence that children implanted before their first birthday experienced a higher complication rate than older children in the study.
The authors concluded that the findings support expanding pediatric cochlear implant indications to include children ages 7 to 11 months with profound sensorineural hearing loss, as well as children ages 12 to 71 months who have more residual hearing but do not receive sufficient benefit from hearing aids.
Why Earlier Access Matters
Early auditory access is particularly important during periods of rapid speech and language development. The study authors note that previous research has associated cochlear implantation before 12 months of age with better long-term speech perception and language development compared with later implantation, with some studies suggesting additional benefits when implantation occurs before 9 months.
Current early-hearing-intervention recommendations emphasize providing appropriate intervention during the first months of life. For some children with severe-to-profound sensorineural hearing loss, however, hearing aids may not provide sufficient access to the speech cues needed for spoken-language development.
The researchers also point to growing evidence supporting broader cochlear implant evaluation for children who have more residual hearing than historically permitted under FDA labeling but continue to demonstrate limited access to speech with hearing aids.
“The findings are important because hearing plays a critical role in speech, language and learning during the early years of life,” said Nancy M. Young, MD, founder and medical director of the Cochlear Implant Program at Lurie Children’s.
“By expanding access to cochlear implantation, we can give more children the opportunity to develop the listening and spoken language skills that support success in school and everyday life.”
Young led the study alongside investigators from Lurie Children’s, Northwestern University, the University of Mississippi Medical Center, the University of Miami, the University of North Carolina, and other U.S. centers.
The study, “Multicenter Study Results on Expanded Indications in Med-EL Pediatric Cochlear Implant Population,” was first published online August 19, 2026, in The Laryngoscope.
About Ann & Robert H. Lurie Children’s Hospital of Chicago
Ann & Robert H. Lurie Children’s Hospital of Chicago is a nonprofit pediatric hospital focused on clinical care, research, education and advocacy. Research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute, and the hospital serves as a pediatric training affiliate of Northwestern University Feinberg School of Medicine.
Source: Ann & Robert H. Lurie Children’s Hospital
