Status:
NOT_YET_RECRUITING
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Unilateral Hearing Loss
Asymmetric Hearing Loss
Eligibility:
All Genders
4-6 years
Phase:
NA
Brief Summary
Today, unilateral hearing loss must be assessed and managed just as bilateral hearing loss is. It is recommended to consider the auditory difficulties caused by the loss of stereophonic hearing and to...
Detailed Description
Unilateral congenital deafness has significant repercussions on a child's development. Numerous studies on this population have demonstrated its impact on speech and language development, as well as a...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06930170
Start Date
June 1 2025
End Date
April 1 2029
Last Update
April 29 2025
Active Locations (1)
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1
Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale")
Paris, France, 75014