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AK-OTOF at COSM 2026: 8 of 10 children on the higher dose gained hearing, with no therapy-related adverse events
Updated AK-OTOF-101 results covered 18 participants across two dose levels, including early two-ear treatments. At the higher dose, 80% improved to at least a moderate level of hearing loss, with brainstem responses from about 30 days. A long-term study will follow patients about 4 more years and track speech and language.
- 8 of 10 higher-dose children improved on the four-frequency average hearing test.
- Earliest participants have been followed for up to 2 years.
- No serious adverse events related to the gene therapy, the device or the procedure.
- Delivered with a single-use device needing no skin incisions or bone drilling.