Clinical Trial

OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia

Study acronym: APLOSIA
Not Yet Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-14.
Trial Details
NCT Number NCT07358728
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions Deafness Caused by High Grade Microtia or Ear Atresia
Enrollment 12 participants
Start Date 2026-04
Primary Completion 2026-10 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-02-13