Cochlear implant for children with single-sided or asymmetric hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children aged 4–6 who speak French and have severe-to-profound unilateral or asymmetric hearing loss will be offered cochlear implantation with comparisons to conventional rerouting devices (CROS/BiCROS) when appropriate, and followed over time. Outcomes include speech perception in noise (FraSimat), sound localization (ERKI), and cortical auditory evoked potentials (PEAc), together with routine audiometry. Testing and surgery are performed at the Audiophonology Unit of Assistance Publique - Hôpitaux de Paris with scheduled pre- and post-implant assessments. The protocol seeks to show whether implantation can restore aspects of binaural hearing not achievable with CROS or BAHA devices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Child aged 2 to 6 years at the time of inclusion
* Using spoken French as the primary mode of communication
* Diagnosed with unilateral or asymmetric hearing loss :

Unilateral is defined by severe to profound hearing loss in the affected ear (thresholds \> 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and normal hearing in the better ear (thresholds ≤ 25 dB between 500-4000 Hz, established by audiometry or ASSR).

Asymmetric is defined by severe to profound hearing loss in the weaker ear (thresholds \> 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and mild hearing loss in the better ear (thresholds between 30-40 dB at ≤ 4 frequencies, established by audiometry or ASSR).

* Written informed consent from both legal guardians (or the sole guardian, if applicable)
* Affiliated with a health insurance system or entitled to coverage

Exclusion Criteria:

* Severe neurological disorder, identified by MRI and/or a neuro-pediatric assessment
* Severe cognitive, child psychiatric, or developmental delay
* Severe cochleo-vestibular malformation
* Severe cochlear nerve malformation
* Social circumstances preventing long-term follow-up
* Family not proficient in spoken French
* Patient fitted with a CROS or BiCROS system
* Patient with a contraindication to implantation surgery or anesthesia (including lack of meningitis/pneumococcal vaccination)

Where it's running

• Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale")
  Paris, France Recruiting

Study contacts

• Study coordinator: Nathalie LOUNDON, MD, PhD
• Email: natalie.loundon@aphp.fr
• Phone: 01 71 39 67 82

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.