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:

• A parent or legal guardian (and the child, where appropriate for their age) must be willing to sign a consent form agreeing to take part
• Children aged 3 to 11 years old
• Children who have a type of hearing loss called conductive or mixed hearing loss, where the inner ear's bone conduction hearing is at a certain level or better (confirm specific threshold with trial site)
• Children who are completely deaf in one ear but have normal or near-normal hearing in the other ear (sometimes called single-sided deafness)
• Children who have been recommended a certain type of hearing aid that redirects sound from one side to the other (called an AC CROS hearing aid), but who cannot or will not use one
• The child and their parent or legal guardian must be willing and able to follow the study's procedures and requirements, as judged by the trial team
• The child must have had some previous experience with sound amplification, such as through a hearing aid, a CROS device, or a non-surgical bone-anchored hearing device worn on a headband
• For children with conductive or mixed hearing loss, there must be a sufficient difference between air and bone conduction hearing levels in the ear being considered for the implant (confirm with trial site)
• The child must have enough bone thickness, quality, and skull size to allow safe placement of the implant, as assessed by the clinical team

Who may not be able to join:

• Children with a medical condition that makes implant surgery or general anaesthesia unsafe, as determined by the treating doctor
• Children who have an untreated active middle ear infection at the time of surgery
• Children with a known or suspected allergy to silicone or other materials used in the device system
• Children with a known condition that could affect wound healing or skin health over time, such as poorly controlled diabetes, as judged by the treating doctor
• Children with known skin or scalp conditions that might prevent the sound processor from being worn or attached properly
• Children where there is evidence suggesting they would not benefit from improved speech understanding, based on clinical judgment
• Children with any other condition the trial doctor believes could interfere with participation or assessment
• Children taking medications known to be potentially harmful to hearing, as judged by the treating doctor
• Children who have had radiation therapy to the area where the implant would be placed, or who are planned to receive such treatment during the trial period
• Children who already have a bone-anchored hearing device fitted on the side with better bone conduction hearing (for those with unequal hearing loss in both ears)
• Children with a known ongoing or permanent disorder affecting balance or the vestibular system
• Children with a known hearing loss that is progressively getting worse over time
• Children who are currently taking part in, or have taken part in within the last 30 days, another clinical trial involving an investigational drug or device that could affect this trial's results
• Children who use an active implanted or body-worn medical device that cannot be removed or switched off for medical reasons, such as a pacemaker, defibrillator, neurostimulator, or cerebrospinal fluid shunt
• Children who are known to need frequent MRI scans for monitoring of another condition
• Children who the trial team considers unsuitable for enrolment based on established ethical research guidelines

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