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A multicenter study led by researchers at Ann & Robert H. Lurie Children's Hospital of Chicago found that children with hearing loss may benefit from cochlear implants at a younger age than previously recognized.
The study, led by Dr. Nancy M. Young, evaluated outcomes in two groups not previously covered under FDA criteria: infants aged 7 to 11 months with profound sensorineural hearing loss, and children aged 12 to 71 months who had more residual hearing but for whom hearing aids did not provide enough access to the sounds of spoken language.
Most children showed clinically meaningful improvements in hearing and listening skills within a year. About 81 percent of the prospective group and 88 percent of the retrospective group met the study's success measures. The researchers also reported that implantation was safe in these groups and that infants implanted before their first birthday did not have more complications than older children.
Based on the FDA's action, MED-EL became the first cochlear implant system cleared in the United States for infants as young as 7 months with bilateral sensorineural hearing loss. The authors note that hearing plays a critical role in speech, language, and learning in the early years, which is the basis for supporting earlier intervention.
Some caveats apply. The study used a non-randomized design with prospective and retrospective cohorts rather than a randomized controlled trial. The expanded FDA indication applies to MED-EL devices, and candidacy for a cochlear implant is determined by a hearing health team based.
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