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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT02755935
Eligibility Criteria:
Inclusion Criteria:
* Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
* Post-linguistically deafened
* Ability to complete age appropriate testing
Exclusion Criteria:
* Previous cochlear implantation in the ear to be implanted
* Pre-linguistically deafened (onset of hearing loss at less than two years of age)
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Diagnosis of retro-cochlear pathology
* Diagnosis of auditory neuropathy
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
* Unwillingness or inability to comply with all investigational requirements
* Additional cognitive handicaps that would prevent participation on all study requirements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Study:
NCT02755935
Study Brief:
Protocol Section:
NCT02755935