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# Positive Gene Therapy Results for Some Hearing Loss
- URL: https://www.fdaweb.com/positive-gene-therapy-results-for-some-hearing-loss/
- Published: 2024-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:21:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156208

Lilly subsidiary Akouos says the Phase 1/2 AK-OTOF-101 study demonstrated pharmacologic hearing restoration within 30 days of administering AK-OTOF, a gene therapy, in the first trial participant, an individual with more than 10 years of profound hearing loss. A company [statement](https://investor.lilly.com/news-releases/news-release-details/positive-phase-12-clinical-trial-data-investigational-gene?ref=fdaweb.com) says the first study participant was age 11 at the time of AK-OTOF administration.

The company reports that hearing was restored against all tested frequencies at the Day 30 visit. The surgical administration procedure and the investigational therapy were well tolerated and no serious adverse events were reported, it says.

AK-OTOF is described as a dual adeno-associated viral vector-based gene therapy designed to restore auditory function by gene transfer and durable expression of normal, functional otoferlin protein to the inner hair cells of the cochlea.