Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking into the effects of cochlear implants for children who have hearing loss in one ear or unequal hearing abilities between their ears. It aims to understand how cochlear implants can help restore hearing for kids who struggle with severe to profound hearing loss on one side. The trial emphasizes the importance of early intervention, as addressing hearing issues as soon as possible can lead to better outcomes for these children.

To participate, children must be between 4 and 6 years old, primarily communicate in spoken French, and have been diagnosed with specific types of hearing loss. They should have significant hearing loss in one ear while having normal or only mild hearing in the other. Parents or guardians will need to provide consent for their child to join the study. It's important to note that children with certain medical conditions or who do not meet specific criteria will not be eligible. Participants will have the opportunity to explore how this treatment could improve their hearing, but the trial is not yet open for recruitment.

Gender

ALL

Eligibility 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)