PU¶PubMed·Journal article·Regulatory & legal·2w agoLunsotogene Parvec: First ApprovalThis is the first approved dual-AAV gene therapy for congenital profound hearing loss; audiologists and CI teams should familiarise themselves with eligibility criteria and referral pathways as it enters clinical use.
PU¶PubMed·Journal article·Research (general)·4w agoRestoration, Not Bypass: Otoferlin Gene Therapy and a New Era in Hearing Loss TreatmentAudiologists should be aware that FDA-approved otoferlin gene therapy (Otarmeni) is now a biological treatment option for patients with confirmed biallelic OTOF-associated SNHL; refer eligible patients to specialized otolaryngology or gene therapy centers for evaluation.＋Save
Hearing Review·Regulatory·Regulatory & legal·2mo ago· press releaseEMA Accepts Otarmeni Gene Therapy for OTOF-Related Hearing Loss for ReviewEMA acceptance of the first gene therapy marketing application for hereditary hearing loss marks a pivotal regulatory moment that could fundamentally expand treatment options beyond conventional amplification and cochlear implants for a defined genetic subpopulation.＋Save
Hearing Review·Industry news·Research (general)·3mo agoFDA Grants Accelerated Approval to Otarmeni Gene Therapy for OTOF-Related Hearing LossAudiologists should be aware that Otarmeni is now FDA-approved for OTOF-related hearing loss and begin familiarizing themselves with candidate identification (genetic testing referral pathways) and post-treatment audiological monitoring protocols, though prescribing authority...＋Save
Hearing Tracker·Regulatory·Regulatory & legal·3mo agoFDA Approves Regeneron's Otarmeni, First Gene Therapy for Genetic Hearing LossAudiologists 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.＋Save
