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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01861704
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-90 years at the time of enrollment in the study
* Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear
* Fluent in English
* Willingness to comply with all study requirements
Exclusion Criteria:
* Scuba dives or sky dives
* Underwater swimming or dives into the water
* Handicaps that would restrict participation in all the evaluations
* Hearing loss of neural or central origin
* Unrealistic expectations regarding benefits and limitations inherent in the devices
* Chemotherapy within the last six months
* Compromised immune system
* Radiation to head or neck
* Perforated tympanic membrane
* History of cholesteatoma
* Active outer or middle ear pathology
* High levels of anticoagulant therapy
* Insulin-dependent and/or uncontrolled diabetes
* Contact dermatitis
* Bleeding disorder
* Unwillingness or inability to comply with all study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01861704
Study Brief:
Protocol Section:
NCT01861704