A Phase 1/2 interventional study of SENS-501 administration in OTOF Gene Mutation, DFNB9 and Congenital Deafness, sponsored by Sensorion. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 6 Months to 31 Months. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Sensorion · Phase 1/2, Interventional, and Treatment
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
It is a multicenter, adaptive open-label, non-randomized, dose-escalation, and expansion study to assess safety, tolerability, and efficacy following intracochlear administration of SENS-501.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 12 is below the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Sensorion is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Compared within Hearing Loss, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intracochlear administration of a Low dose of SENS-501 in one ear, with a dedicated administration system
Combination Product: SENS-501 administration
Intracochlear administration of a High dose of SENS-501 in one ear, with a dedicated administration system
Combination Product: SENS-501 administration
Intracochlear administration of SENS-501 in one ear, with a dedicated administration system, at the dose recommended following the Dose escalation phase
Combination Product: SENS-501 administration
Administration of SENS-501 with a dedicated administration system
Safety and tolerability of SENS-501
Number of study-related adverse events (AEs) and serious adverse events (SAEs).
Time frame: 5 years
Efficacy of SENS-501 assessed by ABR
Improvement of hearing threshold measured by auditory brainstem response (ABR)
Time frame: 5 years
Safety and tolerability of SENS-501
Number of study-related adverse events (AEs) and serious adverse events (SAEs).
Time frame: 5 years
Efficacy of SENS-501 assessed by ABR
Improvement of hearing threshold measured by auditory brainstem response (ABR)
Time frame: 5 years
Efficacy of SENS-501 assessed by PTA
Improvement of hearing threshold measured by Pure-tone audiometry (PTA)
Time frame: 5 years
Clinical performance of the administration system
Administration success ; Users' feedback questionnaire on the administration and use of the devices
Time frame: 1 day
Safety of the administration system
Adverse device effects and Device deficiencies, Procedure complications
Time frame: 5 years
Usability of the administration system
Usability questionnaire
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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