Hearing Loss Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You (or your child's legal guardian) must be willing to give written consent to take part and attend all scheduled follow-up visits.
• You or your child must be able to communicate and follow instructions from the study team, with the help of a guardian if needed.
• You or your child's guardian must have a clear understanding of the study and realistic expectations about what it may or may not achieve.
• The participant must be at least 6 months old; there are no restrictions on gender.
• The participant must have been diagnosed with a specific type of inherited deafness called DFNB9, confirmed by a genetic test showing particular changes (mutations) in a gene called OTOF.
• The participant must have severe or profound hearing loss, meaning hearing loss of 65 decibels (dB) or greater.
• The participant must be considered suitable for surgery, with no structural problems in the ear or hearing nerve, no ear infections, and a recent CT or MRI scan (within 3 months) confirming this.

Who may not be able to join:

• The genetic test does not show an OTOF gene mutation.
• Scans show structural problems with the ear or hearing nerve that would make ear surgery unsuitable.
• The participant has existing ear conditions that could affect the surgery or results, such as ear infections, Meniere's disease, a benign ear tumour (acoustic neuroma), or sudden hearing loss that has not fully resolved.
• The participant has a history of substance misuse, or has recently taken certain medications — including specific antibiotics or cancer drugs known to harm hearing (within 6 months), antiviral or immune-modifying treatments (within 3 months), or vaccines (within 1 month).
• The participant has a weakened immune system, a known immune disorder, is HIV-positive, or has had an organ transplant.
• The participant has a serious ongoing illness such as tuberculosis, active hepatitis B or C, active shingles, pancreatitis, kidney problems, or stomach/intestinal ulcers.
• The participant has a condition that makes surgery or anaesthesia unsafe, or has had a serious heart or stroke-related event (such as a heart attack or stroke) within the last 6 months, or has an allergy to any medications planned for use in the study.
• The participant is currently in another clinical trial involving a drug or medical device, has received an experimental treatment within a certain recent timeframe, or plans to join another such trial within the next year.
• The participant already has an implant (such as a cochlear implant) in the ear being considered for surgery.
• Blood tests show a high level of antibodies against the virus used to deliver the gene therapy (AAV1 neutralising antibody titre greater than 1:2000) (confirm with trial site).
• The participant has another serious condition present from birth.
• The participant has a confirmed history of a neurological or psychiatric condition, such as epilepsy or dementia.
• The participant requires long-term blood-thinning medication that cannot be safely stopped temporarily.
• The participant has previously had chemotherapy or radiation therapy.
• The study team considers the participant unsuitable for any other medical reason.

Important: Always verify eligibility with the trial site directly before applying.