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, as well as the child, must have signed a consent form agreeing to take part.
• The child must be between 12 and 17 years old (inclusive).
• The child must have a specific type of hearing loss that matches the device's approved use — either a conductive or mixed hearing loss where the bone hearing threshold in the affected ear is 45 dB HL or better, OR complete hearing loss in one ear with normal hearing in the other ear (called single-sided deafness), OR a hearing profile that would normally be treated with a type of hearing aid called an AC CROS device but where that option is not suitable or acceptable.
• The child must have had previous experience using some form of hearing device, such as a hearing aid, a CROS device, or a non-surgical bone conduction device (such as a softband or sound arc).
• For children with conductive or mixed hearing loss, there must be a sufficient gap (greater than 25 dB) between air and bone hearing levels in the ear to be treated.
• Both the child and their parent or legal guardian must be willing and able to follow all study procedures as assessed by the study team.

Who may not be able to join:

• The child has a health condition that makes implant surgery or general anaesthetic unsafe.
• The child has an untreated, active middle ear infection at the time of surgery.
• The child has a known or suspected allergy to silicone or other materials used in the Sentio hearing device.
• The child does not have enough bone thickness, quality, or skull size in the implant area to safely receive the implant, based on clinical assessment.
• The child has a condition that may affect wound healing or skin health — such as poorly controlled diabetes over time, or a skin or scalp condition that could interfere with wearing the sound processor, as judged by the study doctor.
• The child has had, or is planned to receive, radiation therapy in the area where the implant would be placed, during the study period.
• For children with hearing that differs significantly between ears, those who have already received a bone-anchored hearing device on the side with better bone hearing are not eligible.
• The child has a known ongoing or permanent problem with balance or dizziness.
• The child has a known progressive worsening of nerve-related hearing loss.
• The child is currently taking part in, or has taken part within the last 30 days in, another clinical study involving an experimental drug or device that could affect the safety or results of this study.
• The child uses an active implanted or body-worn medical device that cannot be removed or turned off for medical reasons, such as a brain fluid shunt, a heart pacemaker, a defibrillator, or a nerve stimulator.
• The child is known to need frequent MRI scans for another medical condition.
• The child is currently using, or is expected to use, medications known to be harmful to hearing, as judged by the study doctor.
• The child has a known condition affecting the hearing nerve or the brain's ability to process sound that may affect study results.
• The child has any other condition — such as a developmental or learning delay or disability — that the study doctor believes could interfere with following study requirements or assessments.
• Any child considered unsuitable for enrolment under the Declaration of Helsinki (an international standard for ethical research involving people) (confirm with trial site).

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