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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT01529333
Eligibility Criteria:
Inclusion Criteria:
* Adult men or women, 18 years of age or older
* Moderate to severe mixed hearing loss, as a result of a combination of sensorineural hearing loss and chronic ear disease, prior failed tympanoplasties, severe otosclerosis, radical mastoidectomy, or congenital abnormality as evidenced by the following in the ear to be implanted:
* Bone conduction thresholds are measurable at 0.5,1,2,3 and 4 kHz
* Bone conduction thresholds are 20 dB or poorer at greater than 2 kHz
* Air conduction thresholds are 35 dB or poorer at 0.5,1,2,3 and 4 kHz
* Air-bone gap in ear to be implanted is greater than 15 dB at three or more frequencies from 0.5 - 4 kHz
* Word recognition appropriate for sensorineural component of loss
* Non-fluctuating and stable hearing status
a. as defined as by no significant change or progression in the bone conduction thresholds \>15dB at two consecutive octaves for at least 12 months.
* English Speaking (fluent)
* Realistic expectations for the device
* Willingness to sign the informed consent and participate in the study
Exclusion Criteria:
* Vestibular disorder, including Meniere's Syndrome
* Recurring otitis media over the past year (\>2/year)
* Non-organic hearing loss
* Retrocochlear hearing loss
* Central auditory nervous system disorder
* Medical contraindications to surgery or use of the device
* Women who are pregnant or at risk of becoming pregnant
* Developmentally delayed or manifesting organic brain dysfunction
* Persons with physical or geographic limitations that may render them incapable of completing scheduled study visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01529333
Study Brief:
Protocol Section:
NCT01529333