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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT05377359
Eligibility Criteria:
Inclusion Criteria:
* Hearing aid candidate
* Meets the fitting requirements for novel and traditional coupling options
* Healthy outer ear - no visible congenital or traumatic deformity
* Symmetrical hearing loss
* No air-bone gap greater than 10 dB at 500, 1000, 2000, and 4000 Hz
* Ability to answer questions and repeat sentences
* No history of problematic tinnitus or pain/discomfort from loud sounds
* No history of active drainage from the ears in the past 90 days
* Informed consent as documented by signature.
Exclusion Criteria:
* Limited mobility (not able to attend scheduled visits)
* Inability to produce reliable hearing test results
* History of active drainage from the ear in the previous 90 days
* Abnormal appearance of the eardrum and ear canal
* Known psychological problems.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05377359
Study Brief:
Protocol Section:
NCT05377359