Bilateral bone conduction implant in children with missing or closed ear canals
Part of Brain & nervous system, Ear, nose & throat, Genetic & congenital clinical trials.
This trial tests a bone conduction implant called the OSIA system, which bypasses the damaged outer or middle ear to send sound directly to the inner ear. It is for children with microtia or ear atresia (underdeveloped or missing ear structures) who have hearing loss but have been using a bone conduction device on a headband. The goal is to see if getting the implant on both sides improves hearing and quality of life for these children.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Aged 7 to 17 years at the start of the trial
- Uses spoken French as the main way of communicating
- Has moderate to severe microtia (underdeveloped outer ear) or ear atresia (closed ear canal) causing hearing loss, with specific hearing test results (60–80 dB air conduction and 0–20 dB bone conduction)
- Has used a bone conduction hearing device (on a headband or adhesive) for at least 12 months
- If microtia: fits in with plans for ear reconstruction surgery, and ear anatomy allows the implant to be placed away from the future reconstruction area
- No severe neurological, cognitive, or developmental conditions; no severe inner ear or hearing nerve malformations; child not pregnant or breastfeeding
- Family understands spoken French and is able to participate in long-term follow-up
- Not already implanted with a bone conduction device; no weight below 7 kg (CE mark safety limit)
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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