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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT02042404
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 85 years
* Mild to severe hearing impairment between 125 to 4000 Hz
* No significant conductive hearing impairment
* Able and willing to commit to travel and time demands of the study
Exclusion Criteria:
* Must not have known or active medical issues that would preclude having a device including:
1. an abnormal tympanic membrane
2. an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes
3. an ear canal anatomy that prevents physicians from seeing adequate amount of the tympanic membrane
* Must not have other known or active medical issues including:
1. history of chronic and recurrent ear infections in the past 24 mouths
2. history of dizziness and/or vertigo in the past 24 months
3. taking medications/treatments with known ototoxic effects
4. a rapidly progressive or fluctuating hearing impairment
5. having been diagnosed with having a compromised immune system
* Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
* Must not have an ear canal anatomy that preclude manufacture of the device as determined by EarLens manufacturing personnel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02042404
Study Brief:
Protocol Section:
NCT02042404