Otarmeni Wins FDA Approval for Genetic Sensorineural Hearing Loss

Summary: The FDA just approved a brand-new gene therapy called Otarmeni. It treats kids and adults with severe hearing loss caused by a specific genetic issue called the OTOF gene. Doctors give it as a one-time injection deep into the ear while the patient is asleep. It works by delivering a healthy copy of the gene to help the ear send sound signals to the brain.

In a study of mostly two-year-olds, 80% had much better hearing after 24 weeks. Some kids even got normal hearing back and could hear whispers! The medicine itself will be given to eligible US patients for free by the maker, Regeneron, though the surgery still costs money. Common side effects include ear infections, dizziness, and an upset stomach.

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