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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT06402994
Eligibility Criteria:
Inclusion Criteria:
1. Subcategory 1 (Infants \& toddlers)
* 0 - 2,5 years of age
* Bilateral hearing loss OR
* Suspicion of hearing loss (at least 1 criteria met): referred after FAIL on the new born hearing screening OR referred by the subject's paediatrician, general practitioner or otolaryngologist
* Voluntary written informed consent of the legally authorised representative
2. Subcategory 2 (Kindergartners)
* 2,5 - 6 years of age
* Going to kindergarten
* Bilateral hearing loss
* Using hearing aids regularly for at least three months
* Would be cooperative in behavioural testing
* Knowledge of Dutch (at least 1 criteria met): Dutch as mother tongue OR enrolled in Dutch speaking education
* Voluntary written informed consent of the legally authorised representative
3. Subcategory 3 (Primary school children)
* 6 - 12 years of age
* Going to primary school
* Bilateral hearing loss
* Using hearing aids regularly for at least three months
* Would be cooperative in behavioural testing
* Knowledge of Dutch (at least 1 criteria met): Dutch as mother tongue OR enrolled in Dutch speaking education
* Voluntary written informed consent of the legally authorised representative
Exclusion Criteria:
* no exposure to Dutch
* known brain injuries
* acute illness
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
12 Years
Study:
NCT06402994
Study Brief:
Protocol Section:
NCT06402994