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Steady6 stories4 sourcesLast updated: 6/4/2026

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FDA Approves First Gene Therapy to Restore Hearing for People Born Deaf
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Health·4/23/2026AI summary

FDA Approves First Gene Therapy to Restore Hearing for People Born Deaf

The FDA approved the first gene therapy to restore hearing for people born deaf, developed by Regeneron Pharmaceuticals. The treatment targets a rare genetic defect affecting about 50 U.S. children annually, caused by a defective OTOF gene. In clinical trials, 80% of patients achieved significant hearing restoration and 42% gained normal hearing, with effects lasting at least two years.

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