# The US Food and Drug Administration has approved the first-ever gene therapy designed to treat genetic hearing loss.

*biotech · news · 2026-04-25 · Times Now*

## Key points

- The FDA has approved Otarmeni, the first-ever gene therapy for genetic hearing loss.
- Otarmeni targets OTOF gene mutations, affecting only about 50 babies born in the US annually.
- Regeneron will provide Otarmeni free of cost to eligible patients during its initial rollout phase.
- Clinical trials showed 16 out of 20 children had significant hearing improvement, including whisper detection.

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

[Read the full story on Times Now](https://www.timesnownews.com/health/fda-approves-first-ever-gene-therapy-for-hearing-loss-regeneron-stuns-with-free-treatment-plan-article-154163670)

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