OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia (NCT07358728) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia
France12 participantsStarted 2026-04
Plain-language summary
The aim of this study is to compare speech perception in noise with one activated Osia (unilateral) versus two activated Osia (bilateral), in children with high grade microtia/ear atresia fitted with bilateral Osia implants. In order to do these measurements, the enrolled children will get OSIA implants on both sides during a standard surgery procedure. Six months following the implantation, audiologist testing will be done with one implant active compared to both.
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* To be aged between 7 and 17 years old at the time of enrolment
* Use spoken French as primary mode of communication
* Diagnostic of moderate to severe bilateral high grade microtia and/or ear atresia resulting in conductive hearing loss with an ACPTA between 60 and 80 dB and a BCPTA between 0 and 20 dB
* Fitted with a unilateral or bilateral headband/headband/adhesive bone conduction device for more than 12 months.
* In case of microtia: after or before ear reconstruction planned using the conventional costal cartilage graft procedure; anatomical conditions allowing implantation of the OSIA outside the area of a future ear reconstruction.
* To be a medical and audiological candidate for the OSIA system
* To be affiliated with a health insurance plan or be eligible for it
* Signed consent from the legal guardian(s)
Exclusion Criteria:
* Weight less than 7 kg (CE marking limit)
* Diagnosed with a severe neurological condition, identified by an MRI and/or a neuropediatric assessment
* Diagnosed with a severe cognitive impairment, child psychiatric impairment, or developmental delay
* Diagnosed with a severe cochleovestibular or cochlear nerve malformation
* Live in a social context that does not allow for long-term follow-up
* To be part of a family that does not understand spoken French
* Already equipped with one (or two) bone conduction implant(s)
* Affiliated with minimum state healthcare (AME)
* To currently be pregnant or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.