Deafness Caused by High Grade Microtia or Ear AtresiaAPLOSIANCT07358728
OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia
A study testing Audiological tests and Speech, Spatial and Qualities of Hearing Scale in people with Deafness Caused by High Grade Microtia or Ear Atresia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Deafness Caused by High Grade Microtia or Ear Atresia
- What is being tested?
- Audiological tests and Speech, Spatial and Qualities of Hearing Scale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Already equipped with one (or two) bone conduction implant(s)
- Affiliated with minimum state healthcare (AME)
- To currently be pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Necker Enfants Malades
Paris, Île-de-France Region, 75015
Charlotte CELERIER, MD, 01 71 39 67 85 ext. +33, charlotte.celerier@aphp.fr
About this study
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 the 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.
- Being tested
- Audiological tests, Speech, Spatial and Qualities of Hearing Scale
- Keywords
- Microtia, Ear atresia, Deafness, Surgery, Hearing aid, Hearing implant
- Medical subject headings
- Congenital Microtia, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiological testsOther
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 ScaleBehavioural
The patients will answer the SSQ (Speech, Spatial and Qualities of Hearing Scale) 6 months after his surgery.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral OSIA2 Implantation | Experimental | Bilateral implantation of two OSIA2 implants during a standard care surgery. Receives: Other: Audiological tests; Behavioral: Speech, Spatial and Qualities of Hearing Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
Prosthetic gain
Prosthetic gain measured by preoperative pure-tone and speech audiometry with the removable device preoperatively and with ipsilateral OSIA:
Measured: 5 months
Prosthetic gain
- Prosthetic gain in pure-tone audiometry (difference in mean air conduction with and without the device)
Measured: 6 months
Prosthetic gain
- Prosthetic gain in speech audiometry (difference in SRT (Speech Reception Threshold) with and without the device)
Measured: 6 months
Security and skin tolerance
Occurrence of adverse events/serious adverse events, particularly skin complications (hematoma, local injection, skin erosion related to magnetization)
Measured: 6 months
Sound localization
ERKI localization test with one activated OSIA versus two activated OSIAs
Measured: 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)
Measured: 6 months
Daily use
Time length use of OSIA using the data logging OSIA system
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Deafness Caused by High Grade Microtia or Ear AtresiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Françoise DENOYELLE, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358728
- Sponsor's protocol ID
- APHP250940
- Other IDs
- IDRCB
- Acronym
- APLOSIA
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Snik AF, Mylanus EA, Proops DW, Wolfaardt JF, Hodgetts WE, Somers T, Niparko JK, Wazen JJ, Sterkers O, Cremers CW, Tjellstrom A. Consensus statements on the BAHA system: where do we stand at present? Ann Otol Rhinol Laryngol Suppl. 2005 Dec;195:2-12. doi: 10.1177/0003489405114s1201.
PubMed 16619473Goycoolea M, Ribalta G, Tocornal F, Levy R, Alarcon P, Bryman M, Cagnacci B, Catenacci C, Oyanguren V, Vilches I, Briones V, Garcia R. Clinical performance of the Osia system, a new active osseointegrated implant system. Results from a prospective clinical investigation. Acta Otolaryngol. 2020 Mar;140(3):212-219. doi: 10.1080/00016489.2019.1691744. Epub 2020 Feb 18.
PubMed 32068449Mylanus EAM, Hua H, Wigren S, Arndt S, Skarzynski PH, Telian SA, Briggs RJS. Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System. Otol Neurotol. 2020 Oct;41(9):1249-1257. doi: 10.1097/MAO.0000000000002794.
PubMed 32925852Pla-Gil I, Redo MA, Perez-Carbonell T, Martinez-Beneyto P, Alborch MO, Ventura AM, Monteagudo EL, Ribas IP, Algarra JM. Clinical Performance Assessment of a New Active Osseointegrated Implant System in Mixed Hearing Loss: Results From a Prospective Clinical Investigation. Otol Neurotol. 2021 Aug 1;42(7):e905-e910. doi: 10.1097/MAO.0000000000003116.
PubMed 33710155Rauch AK, Wesarg T, Aschendorff A, Speck I, Arndt S. Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia(R). Eur Arch Otorhinolaryngol. 2022 Sep;279(9):4279-4288. doi: 10.1007/s00405-021-07167-9. Epub 2021 Nov 18.
PubMed 34792628Cushing SL, Gordon KA, Purcell PL, Feness M, Negandhi J, Papsin BC. Surgical Considerations for an Osseointegrated Steady State Implant (OSIA2(R)) in Children. Laryngoscope. 2022 May;132(5):1088-1092. doi: 10.1002/lary.29892. Epub 2021 Oct 23. No abstract available.
PubMed 34687460Stenfelt S, Zeitooni M. Binaural hearing ability with mastoid applied bilateral bone conduction stimulation in normal hearing subjects. J Acoust Soc Am. 2013 Jul;134(1):481-93. doi: 10.1121/1.4807637.
PubMed 23862823Stenfelt S. Transcranial attenuation of bone-conducted sound when stimulation is at the mastoid and at the bone conduction hearing aid position. Otol Neurotol. 2012 Feb;33(2):105-14. doi: 10.1097/MAO.0b013e31823e28ab.
PubMed 22193619Heath E, Dawoud MM, Stavrakas M, Ray J. The outcomes of bilateral bone conduction hearing devices (BCHD) implantation in the treatment of hearing loss: A systematic review. Cochlear Implants Int. 2022 Mar;23(2):95-108. doi: 10.1080/14670100.2021.2001926. Epub 2021 Dec 1.
PubMed 34852723
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia
- ClinicalTrials.gov ID
- NCT07358728
- Acronym / sponsor ID
- APLOSIA / APHP250940
- Keywords
- Microtia, Ear atresia, Deafness, Surgery, Hearing aid, Hearing implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral OSIA2 Implantation | Experimental | Other: Audiological tests, Behavioral: Speech, Spatial and Qualities of Hearing ScaleBilateral implantation of two OSIA2 implants during a standard care surgery. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiological testsFraSIMAT (French Simplified Matrix Test) and ERKI tests will be performed with one activated implant versus both activated 6 months after surgery | Other | Bilateral OSIA2 Implantation |
| Speech, Spatial and Qualities of Hearing ScaleThe patients will answer the SSQ (Speech, Spatial and Qualities of Hearing Scale) 6 months after his surgery. | Behavioural | Bilateral OSIA2 Implantation |
Primary outcome
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.
7 secondary outcomes
Prosthetic gain
Time frame: 5 months
Prosthetic gain
Time frame: 6 months
Prosthetic gain
Time frame: 6 months
Security and skin tolerance
Time frame: 6 months
Sound localization
Time frame: 6 months
Hearing quality
Time frame: 6 months
Daily use
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 16619473Snik AF, Mylanus EA, Proops DW, Wolfaardt JF, Hodgetts WE, Somers T, Niparko JK, Wazen JJ, Sterkers O, Cremers CW, Tjellstrom A. Consensus statements on the BAHA system: where do we stand at present? Ann Otol Rhinol Laryngol Suppl. 2005 Dec;195:2-12. doi: 10.1177/0003489405114s1201.
- Background: PubMed 32068449Goycoolea M, Ribalta G, Tocornal F, Levy R, Alarcon P, Bryman M, Cagnacci B, Catenacci C, Oyanguren V, Vilches I, Briones V, Garcia R. Clinical performance of the Osia system, a new active osseointegrated implant system. Results from a prospective clinical investigation. Acta Otolaryngol. 2020 Mar;140(3):212-219. doi: 10.1080/00016489.2019.1691744. Epub 2020 Feb 18.
- Background: PubMed 32925852Mylanus EAM, Hua H, Wigren S, Arndt S, Skarzynski PH, Telian SA, Briggs RJS. Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System. Otol Neurotol. 2020 Oct;41(9):1249-1257. doi: 10.1097/MAO.0000000000002794.
- Background: PubMed 33710155Pla-Gil I, Redo MA, Perez-Carbonell T, Martinez-Beneyto P, Alborch MO, Ventura AM, Monteagudo EL, Ribas IP, Algarra JM. Clinical Performance Assessment of a New Active Osseointegrated Implant System in Mixed Hearing Loss: Results From a Prospective Clinical Investigation. Otol Neurotol. 2021 Aug 1;42(7):e905-e910. doi: 10.1097/MAO.0000000000003116.
- Background: PubMed 34792628Rauch AK, Wesarg T, Aschendorff A, Speck I, Arndt S. Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia(R). Eur Arch Otorhinolaryngol. 2022 Sep;279(9):4279-4288. doi: 10.1007/s00405-021-07167-9. Epub 2021 Nov 18.
- Background: PubMed 34687460Cushing SL, Gordon KA, Purcell PL, Feness M, Negandhi J, Papsin BC. Surgical Considerations for an Osseointegrated Steady State Implant (OSIA2(R)) in Children. Laryngoscope. 2022 May;132(5):1088-1092. doi: 10.1002/lary.29892. Epub 2021 Oct 23. No abstract available.
- Background: PubMed 23862823Stenfelt S, Zeitooni M. Binaural hearing ability with mastoid applied bilateral bone conduction stimulation in normal hearing subjects. J Acoust Soc Am. 2013 Jul;134(1):481-93. doi: 10.1121/1.4807637.
- Background: PubMed 22193619Stenfelt S. Transcranial attenuation of bone-conducted sound when stimulation is at the mastoid and at the bone conduction hearing aid position. Otol Neurotol. 2012 Feb;33(2):105-14. doi: 10.1097/MAO.0b013e31823e28ab.
- Background: PubMed 34852723Heath E, Dawoud MM, Stavrakas M, Ray J. The outcomes of bilateral bone conduction hearing devices (BCHD) implantation in the treatment of hearing loss: A systematic review. Cochlear Implants Int. 2022 Mar;23(2):95-108. doi: 10.1080/14670100.2021.2001926. Epub 2021 Dec 1.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Françoise DENOYELLE, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiological tests and Speech, Spatial and Qualities of Hearing Scale in people with Deafness Caused by High Grade Microtia or Ear Atresia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte CELERIER, MD (01 71 39 67 85 ext. +33, charlotte.celerier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358728, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.