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The FDA has expanded approval of MED-EL cochlear implants for use in infants as young as seven months old with bilateral sensorineural hearing loss who receive limited benefit from hearing aids. This makes MED-EL the youngest-age cochlear implant indication currently cleared in the United States. The decision was based on pediatric data from 123 children aged 7 to 71 months, where about 81 to 88 percent showed meaningful hearing improvement within one year after implantation. Safety outcomes were strong, including for infants under 12 months, with no higher complication rates than in older children. The expanded approval also broadens audiologic and speech criteria for children 12 months and older, supporting earlier access to sound during a critical period for speech and language development.
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