Cochlear implant for children with single-sided or asymmetric hearing loss
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
This trial will test whether cochlear implants help children aged 4–6 with unilateral or asymmetric hearing loss improve speech understanding in noise and sound localization.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06930170 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 4–6 who use spoken French and have severe-to-profound hearing loss in one ear with normal or only mild hearing in the other ear, with written consent from their legal guardians.
Not a fit: Children with bilateral hearing loss, severe neurological disorders, or those who already obtain good functional benefit from CROS/BAHA systems are unlikely to gain additional benefit from implantation.
Why it matters
Potential benefit: If successful, the implant could restore contralateral auditory input and improve speech understanding in noise, sound localization, and downstream language and school performance.
How similar studies have performed: Adult studies have demonstrated improved speech-in-noise performance and localization with cochlear implants, and pediatric data are promising but still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Child aged 4 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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.