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:

Group 1 – Children who were born with or developed hearing loss very early (from birth to age 5, receiving the device between 18 months and 5 years):

• Children with early hearing loss where brain scans (MRI and/or CT) show a specific inner ear or hearing nerve problem, such as an underdeveloped or absent cochlear nerve, a severely malformed or absent inner ear, or hearing loss caused by meningitis affecting the inner ear structure
• Where the inner ear is present, children who have used a cochlear implant (CI) consistently for more than 6 months but have gained little or no meaningful benefit, shown by very limited ability to recognise sounds or speech, and no clear progress in developing hearing skills

Group 2 – Children and young people under 21 who developed hearing and speech before losing hearing:

• Young people who previously had hearing and spoken language skills, but have since lost benefit from their cochlear implant, and where further cochlear implant surgery (including on the other ear) is not a suitable option — for example, due to meningitis, injury to the hearing nerve from a skull fracture, or a cochlear implant that has failed even after revision surgery
• No medical conditions that would make the procedure unsafe
• Willingness to receive recommended meningitis vaccinations before the procedure
• No significant cognitive or developmental delays
• Strong support from family members
• Parents or guardians who have realistic expectations and a thorough understanding of what the device may and may not achieve, the role of the family in rehabilitation, and that spoken language may not become the child's main way of communicating
• Active participation in a rehabilitation program focused on building hearing and listening skills, with or without the use of visual communication methods
• Ability to attend all required study visits, including travel to the study location
• Written consent provided by the child's parent or legal guardian

Who may not be able to join:

• Children in either group who are currently making clear and meaningful progress with their existing cochlear implant
• Brain scan (MRI) results showing a normal inner ear and hearing nerve, a diagnosis of neurofibromatosis type 2 (NF2), or a brainstem or brain structure problem that makes the surgery not possible
• Cases where the reason for poor cochlear implant performance could be addressed by revising the existing implant or implanting the other ear, rather than needing this device
• Children with uncontrolled seizures or a neurological condition that is progressively worsening
• Children with certain brain or spinal conditions, including Chiari malformation, fluid build-up around the brain (hydrocephalus), or spina bifida
• Children who may need an MRI scan at any point in the future
• Children who are not yet able to participate in the hearing and device testing required by the study — if this is due to age, the trial may be delayed rather than the child being permanently excluded (confirm with trial site)
• Children who cannot safely undergo general anaesthesia due to heart, lung, or blood-clotting concerns
• Children who require radiation treatment to the brainstem
• Families with unrealistic expectations about the benefits, risks, or limitations of the procedure and device
• Parents or guardians who are unwilling to sign the informed consent form
• Families who are unwilling or unable to attend the required follow-up appointments

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