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Groundbreaking Gene Therapy Approved to Restore Hearing in Children

KVIA•Thursday, April 23, 2026 at 5:28 PM•CNN Newsource

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The FDA has approved Otarmeni, the first gene therapy for inherited hearing loss, which could significantly change the lives of children born with a rare genetic condition affecting their hearing. This therapy targets mutations in the OTOF gene and has shown remarkable results in clinical trials, with 16 out of 20 children experiencing hearing improvements after treatment. Notably, Regeneron, the company behind the therapy, announced it will be provided at no cost to patients in the U.S. This groundbreaking approval is part of a broader effort to make advanced treatments more accessible and affordable. The therapy is administered through a surgical procedure similar to cochlear implants, with potential out-of-pocket costs for the surgery itself.

Key Details: • FDA approved Otarmeni for inherited hearing loss on Thursday. • 16 out of 20 children in trials showed hearing improvements. • Regeneron will offer the therapy free of charge to U.S. patients. • Surgical procedure similar to cochlear implants is required for administration.

health fda children gene-therapy hearing-loss

People & Organizations

FDADr. Marty MakaryDr. George YancopoulosKerriRegeneron

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