Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Recruiting now · Not applicable
Conditions studied: Unilateral Hearing Loss, Asymmetric Hearing Loss
In brief
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 offer auditory rehabilitation as early as possible. Studies show that hearing devices can be effective in certain cases and for specific auditory modalities. The prognostic factors for successful hearing aid adaptation are linked to early intervention and the presence of residual hearing (using a BiCROS system). However, the cochlear implant remains the only device capable of potentially restoring contralateral auditory function in cases of single-sided deafness (SSD) and severe to profound unilateral hearing loss with asymmetrical deafness
Key facts
- Study ID
- NCT06930170
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 36
- Starts
- 2026-03-09
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 4 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale") — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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