Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT06400992
Eligibility Criteria:
Inclusion Criteria:
* Be between 6 and 16 years of age at the time of inclusion
* Use spoken French as their primary mode of communication
* Ability to perform the Simplified French Matrix test in Noise
* Bimodal group: use the Sky CI processor or be eligible for a Sky CI processor upgrade on one side and use a contralateral hearing aid
* Bilaterally implanted group: use two Sky CI processors or be eligible for an upgrade to two Sky CI processors
* Obtain signed consent from legal guardian(s)
* Be enrolled in a health insurance plan or eligible for coverage
Exclusion Criteria:
* Severe neurological pathology identified prior to inclusion identified by MRI + /- neuro-pediatric workup
* Severe cognitive, psychiatric, or developmental disabilities identified prior to inclusion
* Family does not understand French
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT06400992
Study Brief:
Protocol Section:
NCT06400992