# Congenital hearing loss can be traced back to a genetic mutation in about half of cases.

*biotech · news · 2026-04-24 · IFLScience*

## Key points

- The FDA has approved Otarmeni, a gene therapy for OTOF-related genetic hearing loss.
- Otarmeni uses two viral vectors to deliver the large OTOF gene into inner ear hair cells.
- Otarmeni is available free to eligible US patients without cochlear implants and severe hearing loss.
- Initial trial results showed 80 percent of treated children experienced hearing improvement within 24 weeks.
- Five of twelve patients followed up to 48 weeks achieved normal hearing, including the ability to hear whispers.

**Companies:** Regeneron Pharmaceuticals
**Countries:** United States

[Read the full story on IFLScience](https://www.iflscience.com/first-of-its-kind-gene-therapy-for-inherited-hearing-loss-approved-by-fda-as-trial-shows-improvement-in-80-percent-of-patients-83301)

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