Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children. (NCT06930170) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
France36 participantsStarted 2026-03-09
Plain-language 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 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
Who can participate
Age range
4 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
French simplified matrix test (FraSimat) SAABAN condition at Month 18
Timeframe: 18 months after implantation or fitting