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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02470494
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 to 85 years.
2. Mild to severe hearing impairment between 125 to 8000 Hz.
3. Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI.
4. No significant conductive hearing impairment;
* No more than a 10 dB air-bone gap at 3 of 4 tested frequencies (500, 1000, 2000, or 4000 Hz)
* Normal Type A tympanometry (indicating normal mobility of the tympanic membrane and middle ear bones)
5. Greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification;
6. Able and willing to commit to the travel and time demands of the study (available for 5 months or longer) and able to comprehend and comply with the study materials and instructions
7. Experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids;
8. Fluent speaker of American English due to use of American English study materials
Exclusion Criteria:
1. The Subject must not have known or active medical issues that would preclude having a hearing device, including:
* an abnormal TM (deemed perforated, inflamed or has a dimeric or monomeric area, or in any other way abnormal);
* an abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes;
* an ear canal anatomy that prevents the physician from seeing an adequate amount of the tympanic membrane.
* an anatomical configuration of the external auditory canal that prevents satisfactory placement of the TMT
* a history of chronic and recurrent ear infections in the past 24 months;
* a rapidly progressive or fluctuating hearing impairment;
* diagnosed with having a compromised immune system which may impact the tissue of the auricle or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six years.
2. Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02470494
Study Brief:
Protocol Section:
NCT02470494