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One-Time injection aims to restore hearing in children born deaf

NCT ID NCT06370351

Ongoing ⭐️ CURE ⭐️ Sponsor: Sensorion Source: ClinicalTrials.gov ↗

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial tests a gene therapy called SENS-501 for children aged 6 to 31 months who are severely or profoundly deaf due to mutations in the otoferlin gene. The therapy is injected directly into one inner ear to deliver a working copy of the gene. The goal is to restore natural hearing, measured by brain response tests and standard hearing tests. The study also closely monitors safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
SENS-501 (gene therapy)
What this could lead to
If successful, this could provide a one-time treatment to restore natural hearing in children born deaf due to otoferlin mutations, potentially eliminating the need for hearing aids or cochlear implants.
What could go wrong
This is an early-phase trial with only 12 children, so safety and effectiveness are not yet proven. The injection procedure carries risks, and the therapy may not work for all participants or could cause side effects.

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Conditions

The condition(s) this trial relates to.

autosomal recessive nonsyndromic hearing loss 9 Deafness Deafness, Autosomal Recessive 9 disorder of ear Ear Diseases hearing disorder hearing loss disorder Hearing Loss, Sensorineural nonsyndromic genetic hearing loss otorhinolaryngologic disease sensorineural hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CONGENITAL DEAFNESS DEAFNESS DFNB9 EAR DISEASES HEARING DISORDERS HEARING LOSS, SENSORINEURAL OTOF GENE MUTATION OTORHINOLARYNGOLOGIC DISEASES

Contacts and locations

Locations

  • Childrens Hospital Westmead

    Westmead, NSW 2145, Australia

  • Hopital Necker Enfants Malades

    Paris, 75015, France

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