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OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Key Details
Gender
All
Age Range
7 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-04
Completion Date
2029-11
Last Updated
2026-02-13
Healthy Volunteers
No
Interventions
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.
Locations (1)
Hôpital Necker Enfants Malades
Paris, Île-de-France Region, France