OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia

NCT07358728 | Not Yet Recruiting

• 2 other identifiers: APHP250940IDRCB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deafness Caused by High Grade Microtia or Ear Atresia

Keywords

Microtia; Ear atresia; Deafness; Surgery; Hearing aid; Hearing implant

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (7)

• Prosthetic gain

  5 months

• Prosthetic gain

  6 months

• Prosthetic gain

  6 months

• Security and skin tolerance

  6 months

• Sound localization

  6 months

Study Arms (1)

Bilateral OSIA2 Implantation

EXPERIMENTAL

Bilateral implantation of two OSIA2 implants during a standard care surgery.

Other: Audiological tests; Behavioral: Speech, Spatial and Qualities of Hearing Scale

Interventions

Audiological tests OTHER

FraSIMAT (French Simplified Matrix Test) and ERKI tests will be performed with one activated implant versus both activated 6 months after surgery

Bilateral OSIA2 Implantation

Speech, Spatial and Qualities of Hearing Scale BEHAVIORAL

The patients will answer the SSQ (Speech, Spatial and Qualities of Hearing Scale) 6 months after his surgery.

Bilateral OSIA2 Implantation

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, Île-de-France Region, 75015, France

Location

Related Publications (9)

• 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.

  PMID: 16619473 BACKGROUND

• Goycoolea 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.

  PMID: 32068449 BACKGROUND

• Mylanus 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.

  PMID: 32925852 BACKGROUND

• Pla-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.

  PMID: 33710155 BACKGROUND

• Rauch 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.

  PMID: 34792628 BACKGROUND

• Cushing 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.

  PMID: 34687460 BACKGROUND

• Stenfelt 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.

  PMID: 23862823 BACKGROUND

• Stenfelt 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.

  PMID: 22193619 BACKGROUND

• Heath 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.

  PMID: 34852723 BACKGROUND

MeSH Terms

Conditions

Congenital Microtia; Deafness

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hearing Loss; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Françoise DENOYELLE, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Charlotte CELERIER, MD

CONTACT

01 71 39 67 85; charlotte.celerier@aphp.fr

Gael PLASTOW

CONTACT

01 44 38 18 57; gael.plastow@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)