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NOT YET RECRUITING
NCT07358728
NA

OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

OTHER

Audiological tests

FraSIMAT (French Simplified Matrix Test) and ERKI tests will be performed with one activated implant versus both activated 6 months after surgery

BEHAVIORAL

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