An interventional study of Audiological tests and Speech, Spatial and Qualities of Hearing Scale in Deafness Caused by High Grade Microtia or Ear Atresia, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
High grade microtia corresponds to a congenital malformation of the pinna and the external auditory meatus associated with a malformation of the middle ear. Ear atresia a congenital malformation of the external auditory meatus and middle ear, associated to a normal or near norma pinna.
In the case of hearing loss related to high grade microtia or ear atresia, be the type of hearing rehabilitation cannot be achieved with conventional air-conduction hearing aids, due to the absence of an ear canal. Different options are available and reimbursed by French medical insurance system. The Cochlear Osia implant is a semi-implantable bone conduction hearing aids. It is an active, transcutaneous (closed-skin) implant, which has the CE mark and is covered by the Health Insurance Fund for adults.
When deafness is bilateral and unaided, it impacts the development of oral language, daily life, and academic progress. Studies also show that speech perception in noisy environments is impaired. This can be very disabling, especially for young school-aged children. There are also studies showing that sound localization is improved when using two hearing aids.
Although bilateral fitting has benefits, bone conduction hearing aids are not always surgically placed bilaterally in children with ear aplasia and no clinical research has yet been conducted with the OSIA system. The objective of this study is to evaluate the effectiveness of bilateral implantation of the Osia System in children with high grade microtia or ear atresia.
Once the implantation surgery is done, the patient will come back for at least three visits: two adjustment visits, 1 month and 5 months afterwards, and two ENT consultations at 1 month and 6 months. These visits are part of the usual follow-up for children with bone conduction implants. Experimental audiological measurements will be carried out at the 6-month visit.
33 studies on the registry are indexed under Congenital Microtia; 10 are open to participants now.
This study's planned enrollment of 12 is below the median of 34 across 23 interventional studies indexed under Congenital Microtia.
Browse Congenital Microtia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Exclusion Criteria:
Bilateral implantation of two OSIA2 implants during a standard care surgery.
Other: Audiological tests · Behavioral: Speech, Spatial and Qualities of Hearing Scale
FraSIMAT (French Simplified Matrix Test) and ERKI tests will be performed with one activated implant versus both activated 6 months after surgery
The patients will answer the SSQ (Speech, Spatial and Qualities of Hearing Scale) 6 months after his surgery.
Implantation success
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.
Time frame: 6 months
Prosthetic gain
Prosthetic gain measured by preoperative pure-tone and speech audiometry with the removable device preoperatively and with ipsilateral OSIA:
Time frame: 5 months
Prosthetic gain
\- Prosthetic gain in pure-tone audiometry (difference in mean air conduction with and without the device)
Time frame: 6 months
Prosthetic gain
\- Prosthetic gain in speech audiometry (difference in SRT (Speech Reception Threshold) with and without the device)
Time frame: 6 months
Security and skin tolerance
Occurrence of adverse events/serious adverse events, particularly skin complications (hematoma, local injection, skin erosion related to magnetization)
Time frame: 6 months
Sound localization
ERKI localization test with one activated OSIA versus two activated OSIAs
Time frame: 6 months
Hearing quality
Speech and spatial hearing quality scale using the SSQ questionnaire (Speech, Spatial and Qualities of Hearing Scale) scaled between 0 (lowest quality) to 10 points (best quality)
Time frame: 6 months
Daily use
Time length use of OSIA using the data logging OSIA system
Time frame: 6 months
Plan to share: No
Start is estimated for Apr 2026; primary completion for Oct 2026, 6 months later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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