OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia
Condition(s) studied
Investigational drug(s) / intervention(s)
Audiological tests: FraSIMAT (French Simplified Matrix Test) and ERKI tests will be performed with one activated implant versus both activated 6 months after surgery
Speech, Spatial and Qualities of Hearing Scale: The patients will answer the SSQ (Speech, Spatial and Qualities of Hearing Scale) 6 months after his surgery.
Study 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.
Eligibility
Primary outcome measure(s)
- Implantation success — 6 months
Successful bilateral versus unilateral implantation identified as an increase of at least 3 dB RSB (signal-to-noise ratio) with bilateral conditions compared to unilateral condition value.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital Necker Enfants Malades | Paris | Île-de-France Region |
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07358728 on ClinicalTrials.gov ↗ ← All trials in France