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 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT06167161
Eligibility Criteria:
Inclusion Criteria:
* Adults, 18 years of age or older
* Apple iPhone X or newer (iOS 14 compatible or greater)
* Mix of male and female subjects
* Willing and able to perform all tests required for the study
* Signed and dated informed consent before the start of any study specific procedure
* Able to read and comprehend English
* Mild-to-moderate bilateral sensorineural hearing loss (defined according to thresholds from 250-8000 Hz with at least one threshold greater than 20 dB HL and thresholds at 500, 1000, 2000 and 4000 Hz less than or equal to 55, 65, 70, and 80 dB HL, respectively)
Exclusion Criteria:
* Hearing outside of limits noted, above
* Visible deformities of the ear since birth or from injury
* Fluid, pus, or blood coming out of the ear within the previous six months
* Sudden, quickly worsening, or fluctuating hearing loss within the previous six months
* Dizziness or periodic vertigo associated with hearing loss
* Hearing loss in only one ear or a large difference in hearing between ears
* Ear wax build up or feeling that something is in the ear canal
* Pain or discomfort in the ear
* Inability to follow the procedures of the study due to language problems, or other cognitive problems
* Any other history of chronic middle and outer ear disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06167161
Study Brief:
Protocol Section:
NCT06167161