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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT05197803
Eligibility Criteria:
Inclusion Criteria:
* Adults (18+ years) with hearing impairment (N2 - N6 hearing loss).
* Healthy outer ear.
* Symmetrical hearing loss.
* Ability to answer questions and repeat sentences.
* Informed consent as documented by signature.
* Willingness to wear different style of hearing aids.
* Willingness to wear a binaural fitting.
* Willingness to wear closed domes.
* Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit
Exclusion Criteria:
* Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product).
* Limited mobility/not able to come to scheduled visits.
* Inability to produce reliable hearing test result.
* Visible congenital or traumatic deformity of the outer ear.
* History of active drainage from the ear in the previous 90 days.
* Abnormal appearance of the eardrum and ear canal.
* Acute or chronic dizziness.
* Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz.
* Known psychological problems.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05197803
Study Brief:
Protocol Section:
NCT05197803