OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia (APLOSIA)

February 11, 2026 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75015
        • Hôpital Necker Enfants Malades
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral OSIA2 Implantation
Bilateral implantation of two OSIA2 implants during a standard care surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation success
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthetic gain
Time Frame: 5 months
Prosthetic gain measured by preoperative pure-tone and speech audiometry with the removable device preoperatively and with ipsilateral OSIA:
5 months
Prosthetic gain
Time Frame: 6 months
- Prosthetic gain in pure-tone audiometry (difference in mean air conduction with and without the device)
6 months
Prosthetic gain
Time Frame: 6 months
- Prosthetic gain in speech audiometry (difference in SRT (Speech Reception Threshold) with and without the device)
6 months
Security and skin tolerance
Time Frame: 6 months
Occurrence of adverse events/serious adverse events, particularly skin complications (hematoma, local injection, skin erosion related to magnetization)
6 months
Sound localization
Time Frame: 6 months
ERKI localization test with one activated OSIA versus two activated OSIAs
6 months
Hearing quality
Time Frame: 6 months
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)
6 months
Daily use
Time Frame: 6 months
Time length use of OSIA using the data logging OSIA system
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Study Director: Françoise DENOYELLE, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP250940
  • IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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