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 @ 12:57 PM
Ignite Modification Date:
2025-12-24 @ 12:57 PM
NCT ID:
NCT03685461
Eligibility Criteria:
Inclusion Criteria:
* Pure-tone audiometry thresholds ≤80 dB HL at 500 Hz
* One year of age and older
* Normal candidacy requirements for cochlear implantation met
* No cochlear abnormality that might prevent full insertion of the CI electrode array
* No additional handicap that would prevent study procedures from being followed
Exclusion Criteria:
* Chronic otitis media
* Malformed cochlea
* Auditory neuropathy spectrum disorder (ANSD)
* Presence of ear tubes
* Prior middle ear surgeries or trauma including disruption of ossicles
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT03685461
Study Brief:
Protocol Section:
NCT03685461