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:

• People who have a type of hearing loss caused by damage to the inner ear or hearing nerve (called sensorineural hearing loss) and have already received, or are planned to receive, a cochlear implant in one or both ears using one of these specific FDA-approved devices: Advanced Bionics HiFocus SlimJ, Cochlear Slim Straight, or MED-EL Flex 24 and 28.
• People who are 12 years of age or older at the time of their cochlear implant surgery.
• People who are willing to take part in the study and are able to attend the required follow-up visits.

Who may not be able to join:

• People who have previously had a cochlear implant in the ear that is being considered for implantation in this trial.
• People whose inner ear has hardening of tissue (ossification) or other structural changes that could prevent the implant from being fully inserted, or that increase the risk of the device being placed incorrectly.
• People who have certain physical differences in their skull or face structure, a skull that is too thin in a specific area (less than 3mm), significant changes inside the inner ear such as scarring or fractures, or abnormal inner ear development.
• People whose hearing loss is caused by damage to the hearing nerve itself or to hearing pathways in the brain, rather than the inner ear.
• People who have been diagnosed with auditory neuropathy (a specific condition affecting how sound signals travel from the ear to the brain).
• People who have an active infection in the middle ear, or a hole in the eardrum alongside an active middle ear infection.
• People who were born without a developed inner ear (cochlea).
• People who have other health concerns that the trial doctor determines would prevent them from completing the required assessments.
• People who have unrealistic expectations about what the cochlear implant procedure and this trial's investigational device can and cannot do.
• People whose first language is not English and who are unable to read, understand, or speak English well enough to complete the required study procedures.
• People who are currently taking part in, or planning to take part in, another clinical study involving an investigational device or drug.
• People who meet the definition of a "vulnerable subject" under U.S. federal research regulations (confirm with trial site).

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