Actively Recruiting
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-27
36
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged 4 to 6 years at the time of inclusion
- Using spoken French as the primary mode of communication
- Diagnosed with unilateral hearing loss defined by severe to profound hearing loss (> 70 dB at 64 frequencies) in the affected ear and normal hearing (thresholds 64 25 dB between 500-4000 Hz) in the better ear
- Diagnosed with asymmetric hearing loss defined by severe to profound hearing loss (> 70 dB at 64 frequencies) in the weaker ear and mild hearing loss (30-40 dB at 64 frequencies) in the better ear
- Written informed consent from both legal guardians or sole guardian
- Affiliated with a health insurance system or entitled to coverage
You will not qualify if you...
- Severe neurological disorder identified by MRI and/or neuro-pediatric assessment
- Severe cognitive, 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 already fitted with a CROS or BiCROS system
- Contraindication to implantation surgery or anesthesia, including lack of meningitis/pneumococcal vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale")
Paris, France, 75014
Actively Recruiting
Research Team
N
Nathalie LOUNDON, MD, PhD
CONTACT
L
Laure CHOUPEAUX, Project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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