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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT05973669
Eligibility Criteria:
Inclusion Criteria:
* Implanted with at least one MED-EL cochlear implant
* ≥ 2 weeks since activation of the cochlear implant
* Availability of existing aided Pediatric/AZ Bio (quiet and/or noise) and CNC word scores, or the ability to complete these at baseline
* Utilizing a compatible audio processor in the SONNET or RONDO product lines
* Ability to complete app-based hearing assessments
* Commitment to comply with all study procedures for the duration of the study
* Access to the internet via a smartphone that meets the following requirements:
* Android or iOS operating systems
* A smartphone supporting Bluetooth® 4.2 or higher
* A minimum of 200 MB free storage space
Exclusion Criteria:
* Inability or unwillingness to perform the requirements of the clinical investigation
* Unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care
* Inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05973669
Study Brief:
Protocol Section:
NCT05973669