OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia
Key facts
- Where
- Paris, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 17 years old?
Source: NCT07358728, who can take part
Where in France
- Hopital Necker Enfants MaladesParis, FranceContact: Charlotte CELERIER, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT07358728
- Record updated
- 13 February 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Already equipped with one (or two) bone conduction implant(s); 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; Weight less than 7 kg (CE marking limit); 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; Affiliated with minimum state healthcare (AME); To currently be pregnant or breastfeeding.