The Audiogene trial is designed to evaluate the safety, tolerability and efficacy of intra-cochlear injection of SENS-501 for the treatment of OTOF gene-mediated hearing loss in paediatric patients aged between 6 and 31 months at the time of gene therapy treatment. By targeting the first years of life, when brain plasticity is at its peak, the chances of these young children with pre-linguistic hearing loss of acquiring normal speech and language are maximised. The trial is comprised of two cohorts of two doses followed by an expansion cohort at the selected dose.