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 range7 Years – 17 Years
SexALL
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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