Audiologists and ENT teams treating patients with the relevant genetic form of hearing loss should become familiar with Otarmeni's approved indication and refer eligible patients to gene therapy specialists; this is a practice-changing regulatory milestone.

This is the first FDA-approved gene therapy for genetic hearing loss, marking a paradigm shift from amplification-based management toward curative intervention for eligible patients.

1. 01FDA approved Regeneron's Otarmeni as the first gene therapy for genetic hearing loss.
2. 02Approval marks a historic shift toward potentially curative treatment rather than amplification alone.