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Starting soon Not applicable

OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia

NCT07358728 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-04
Last updated
2026-02-13

Condition(s) studied

Deafness Caused by High Grade Microtia or Ear Atresia

Investigational drug(s) / intervention(s)

Audiological testsSpeech, Spatial and Qualities of Hearing Scale

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

Sex
ALL
Min age
7 Years
Max age
17 Years
Healthy volunteers
No
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

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)

FacilityCityRegionStatus
Hôpital Necker Enfants Malades Paris Île-de-France Region
Official registry record

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