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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT03904420
Eligibility Criteria:
Inclusion Criteria:
* Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes
* 18 years and older
* Postlingual onset of hearing loss (onset of hearing loss \>two years of age)
* Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria
* Individuals who have recently been implanted but not yet had their external device activated
* Willingness to participate in a study and comply with all study requirements
* Fluent in spoken English
Exclusion Criteria:
* Ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array
* Diagnosis of retro-cochlear pathology
* Diagnosis of auditory neuropathy
* Subject considering an acoustic component in the implanted ear
* 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
* Severe-profound sensorineural hearing loss \>30 years
* Previous cochlear implant in the contralateral ear. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03904420
Study Brief:
Protocol Section:
NCT03904420