# Otarmeni (DB-OTO) by Regeneron Pharmaceuticals Canonical page: https://technooptimist.io/neurotech/otarmeni Frontier: [Neurotech](https://technooptimist.io/neurotech.md) · Field: Hearing implants · Company: [Regeneron Pharmaceuticals](https://technooptimist.io/companies/regeneron.md) Stage: Deploy (4 of 5: Research → Proto → Pilot → Deploy → Scaling) Updated: last update 2026-04-23, facts checked 2026-10-11 Goal: Give natural hearing, with one treatment, to people born deaf from OTOF mutations, instead of a lifelong cochlear implant. It is the first proof that a gene therapy can switch hearing on in a human ear. Status: FDA accelerated approval April 2026; free in the US; durability and speech data still owed to the FDA. Next milestone: US use at no cost to eligible patients, target Apr 2026 ## Milestones | Status | Milestone | Date | Slip | | --- | --- | --- | --- | | Done | Regeneron agrees to buy Decibel, DB-OTO's developer | Aug 2023 | | | Done | CHORD interim data in NEJM: 11 of 12 children improved | 12 Oct 2025 | | | Done | Licence application filed under national priority voucher | Feb 2026 | | | Done | FDA accelerated approval as Otarmeni | 23 Apr 2026 | | | Current | US use at no cost to eligible patients | Apr 2026 | | | Planned | Confirmatory data: durability, speech, quality of life | | | ## Upcoming events - **Apr 2026**: US use at no cost to eligible patients ## Most important updates - **23 Apr 2026**: FDA grants accelerated approval to Regeneron's Otarmeni, the first gene therapy for inherited deafness. The FDA granted accelerated approval to Otarmeni (formerly DB-OTO), a one-time gene therapy infused into the cochlea for hearing loss caused by OTOF mutations. ([our story](https://technooptimist.io/stories/fda-grants-accelerated-approval-to-regeneron-s-otarmeni-the-first-gene-1aa93211.md) · [original source](https://medcitynews.com/2026/04/regeneron-gene-therapy-hearing-loss-otarmeni-fda-approval-otof-otoferlin-db-oto-regn/)) - **12 Oct 2025**: NEJM: Regeneron's DB-OTO gave clinically meaningful hearing to 11 of 12 children born deaf from OTOF mutations. Interim results of the CHORD trial, presented at the AAO-HNSF meeting and published in NEJM, showed that a one-time dual-AAV gene therapy restored meaningful hearing in 11 of 12 children with OTOF deafness. ([our story](https://technooptimist.io/stories/nejm-regeneron-s-db-oto-gave-clinically-meaningful-hearing-to-11-of-12-42362ae8.md) · [original source](https://www.cgtlive.com/view/regeneron-gene-therapy-db-oto-improves-speech-perception-children-otoferlin-related-hearing-loss)) ## Current obstacles - **Conditional approval**: To keep the label, Regeneron must show the hearing gains last and lead to speech development and better quality of life. - **Small, hard-to-find patient pool**: About 200,000 people worldwide have OTOF deafness, and the treated ear must not already have a cochlear implant. - **Surgery on the inner ear**: Common side effects: middle ear infection, nausea, vomiting, dizziness, procedure pain. Rarer risks include meningitis, spinal fluid leak and facial weakness. ## Physics limits - **Needs living hair cells**: Adding a gene only helps when the hair cells are still alive and lack one protein. Most deafness comes from dead hair cells or other genes, which this kind of therapy cannot rescue. - **Language has a timing window**: The brain's language circuits mature in early childhood, so hearing restored later may not bring normal speech. Years of follow-up are needed to see how much age at treatment matters. ## How it works ### Problem: Hair cells that cannot pass the signal on Inner hair cells turn sound into signals for the hearing nerve. They need the protein otoferlin to pass them on; two broken OTOF genes leave a child deaf. ### Vector: The gene split across two viruses OTOF is too large for one adeno-associated virus (AAV), so it is split across two; a hair cell that takes up both rebuilds the full gene. ### Delivery: One infusion into the cochlea Under general anesthesia, surgeons infuse it into the cochlea, much like cochlear implant surgery. The trial treated one ear first; its Part B treats both. ### Effect: Hearing within weeks, still rising Children began responding to sound within weeks. In 8 followed 36 weeks or more, hearing kept improving or held steady for up to 72 weeks. ## Spec sheet | Spec | Otarmeni (DB-OTO) | Provenance | | --- | --- | --- | | Patient population | Severe-to-profound hearing loss, biallelic OTOF | reported | | CHORD trial participants | 25 (ages 10 months to 16 years) | reported | | Hearing ≤70 dB HL at 24 weeks | 80% (16 of 20) | reported | | Brainstem response ≤90 dB, week 24 | 70% (14 of 20) | reported | | Normal hearing (≤25 dB HL), week 48 | 42% (5 of 12) | reported | | Filing to approval | 61 days | reported | | US price | Free (administration costs extra) | reported | Provenance: reported = stated by the company; estimated = our estimate; sample = a sample figure. ## About Regeneron Pharmaceuticals Regeneron Pharmaceuticals, based in Tarrytown, NY and traded on Nasdaq, received FDA approval for Otarmeni (DB-OTO) in April 2026, the first gene therapy for inherited deafness. It advances programs in gene editing, RNA medicines, and synthetic biology. - Regeneron has $10B+ annual revenue, spanning monoclonal antibodies (Eylea, Dupixent), RNA therapeutics, and gene therapies. - Otarmeni is the first FDA-approved gene therapy for inherited deafness, delivering OTOF gene to inner ear hair cells. - In CHORD, 80% (16 of 20) reached the hearing target at 24 weeks; 5 of 12 had normal hearing at 48 weeks. - Founded: 1988 - Headquarters: US - Status: public - Website: https://www.regeneron.com - People: George D. Yancopoulos (President and Chief Scientific Officer) - Partners, customers, investors: FDA (customer) Company page: https://technooptimist.io/companies/regeneron.md ## Related programs Everything in Neurotech: https://technooptimist.io/neurotech.md --- The Techno Optimist tracks every frontier of technology, program by program: https://technooptimist.io/ (a Markdown version of any page: add .md to its URL; site map for agents: https://technooptimist.io/llms.txt). Data API (JSON, realtime stream): https://technooptimist.io/developers. People read 5 pages free, then Reader $10/month; these Markdown pages are open to agents.