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:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
NCT ID:
NCT06841900
Eligibility Criteria:
Inclusion Criteria:
General
* Children aged \< 18 years with prelingual bilateral severe-to-profound HL
* Signed and dated informed consent, informed permission and/or minor's assent.
* Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol.
* Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol.
Audiological
* Completion of hearing assessment battery showing suitability of the CI candidates.
* Compliance with cochlear implant candidate selection criteria of the implanting centre.
* First cochlear implantation Medical
* Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).
Exclusion Criteria:
General
* Re-implantation of the cochlear implant
* No motivation to participate in the study and/or unreasonable expectations. Medical
* Presence of contra-indications for surgery in general and cochlear implantation in particular.
* Presence of central auditory lesions.
* Any disorder that may relate to an increased risk of skin flap problems Use of one of the following electrodes for implantation
* Compressed
* Split
* Any type of custom made electrodes
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06841900
Study Brief:
Protocol Section:
NCT06841900