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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT02004535
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older at time of surgery
* The poorer ear (implant ear) will have a severe-to-profound hearing loss and meet current cochlear implant candidacy criteria.
* The better ear (contralateral ear) will have hearing levels less than current cochlear implant candidacy criteria and stable/non-fluctuating hearing levels for at least the previous year
* Normal/patent cochlear anatomy
* Fluent in English
* Desire to have more functional binaural hearing and willingness to comply with all of the study requirements
Exclusion Criteria:
* Medical or psychological conditions that contraindicate undergoing surgery
* Additional handicaps that would prevent or restrict participation in the audiological evaluations
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Hearing loss of neural or central origin, including auditory neuropathy
* Chronic and severe tinnitus in the ear to be implanted
* Unwillingness or inability to comply with all investigational requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02004535
Study Brief:
Protocol Section:
NCT02004535