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:

For children receiving the cochlear implant (study subjects):

• A parent or guardian has signed and dated the permission form
• The child has severe-to-profound hearing loss in one ear only, present from birth or developed before age 2, with normal or near-normal hearing in the other ear
• The child has not gained enough benefit from hearing aids (based on questionnaire scores or hearing tests showing limited ability to understand speech)
• The child is between 7 months and 2 years and 11 months old at the time of the implant surgery
• The child's hearing nerve looks normal on an MRI scan
• The child's inner ear (cochlea) has no structural abnormalities
• There is no sign that the hearing in the child's better ear is getting worse over time
• The child has tried hearing aids as recommended, or is willing to do so
• Parents understand and can talk about what cochlear implantation can and cannot do — for example, it will not restore fully normal hearing
• The child has received, or parents are willing to get, recommended meningitis vaccinations as advised by the CDC
• The child's development and thinking skills are within the normal range based on a standard assessment (DAYC-2)
• Parents are committed to attending all study appointments, therapy sessions, travel to the study site, and encouraging the child to wear the implant during all waking hours

For comparison group children with one-sided hearing loss (SSD control subjects):

• A parent or guardian has signed and dated the permission form
• The child has severe-to-profound hearing loss in one ear from birth or before age 2, with normal or near-normal hearing in the other ear, and cannot benefit from traditional hearing aids
• The child is 5 years old at the time of testing
• The child's development and thinking skills are within the normal range based on a standard assessment (Early Stanford Binet 2)

For comparison group children with typical hearing (TH control subjects):

• A parent or guardian has signed and dated the permission form
• The child has normal or near-normal hearing in both ears
• The child is 5 years old at the time of testing
• The child's development and thinking skills are within the normal range based on a standard assessment (Early Stanford Binet 2)

Who may not be able to join:

For children receiving the cochlear implant (study subjects):

• English is not the main language spoken at home, as the tests and questionnaires are given in English
• The child has a type of hearing loss caused by a problem in the middle ear (conductive hearing loss) in either ear
• The child's cochlear (hearing) nerve is absent or underdeveloped
• The child's inner ear is blocked by bone or tissue in a way that would prevent implantation
• The family is unable or unwilling to attend follow-up visits, or lives too far away to do so
• The child has a history of persistent ear infections that are hard to treat, or a health condition that makes it unsafe to have anesthesia

For comparison group children (control subjects):

• English is not the main language spoken at home, as the tests and questionnaires are given in English
• The child or family is unable or unwilling to participate in the required testing

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