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 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT03304106
Eligibility Criteria:
Inclusion Criteria:
Newly implanted and existing recipient Groups (Groups 1 and 2):
* Age 12 and older
* Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
* Group 2: 3 months or greater combined experience with commercially available sound processors
* Fluent spoken English skills
Exclusion Criteria:
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations
* Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
* Unwillingness or inability of the subject to comply with all investigational requirements
* Use of an acoustic component in the implanted ear
* Less than 18 active electrodes
* Hybrid L Cochlear Implant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03304106
Study Brief:
Protocol Section:
NCT03304106