First in Nation to Deliver FDA-Approved Gene Therapy for Genetic Hearing Loss

First in Nation to Deliver FDA-Approved Gene Therapy for Genetic Hearing Loss

First in Nation to Deliver FDA-Approved Gene Therapy for Genetic Hearing Loss

September 2026

Children’s Wisconsin recently became the first center in the United States to provide FDA-approved Otarmeni™ gene therapy outside of a clinical trial, offering new hope for children with OTOF-related hearing loss, a rare genetic condition that affects sound transmission from the inner ear to the brain.

One of only five Activated Treatment Centers in the country, Children’s Wisconsin helped lead the clinical research that contributed to the therapy’s approval and is now bringing this breakthrough treatment directly to patients.

Otarmeni delivers a healthy copy of the OTOF gene to the inner ear, addressing the underlying genetic cause of hearing loss. Identifying eligible patients requires specialized audiologic and genetic evaluation, areas in which Children’s Wisconsin has extensive expertise.

For referring providers, early identification and referral of children with congenital or early-onset sensorineural hearing loss may help determine eligibility for this innovative treatment.

As a national leader in pediatric hearing care, Children’s Wisconsin offers comprehensive audiology, genetic testing, otolaryngology and long-term hearing support services, providing patients and families across Wisconsin and the Midwest access to advanced care close to home.

Learn more or refer a patient.

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