Status:
TERMINATED
Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Sensorineural Hearing Loss
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device. The specific aims of the...
Detailed Description
Cochlear implants (CI) are biomechanical sense prostheses approved by the FDA for the treatment of sensorineural hearing loss. CI's function by bypassing the absent or dysfunctional cochlear end organ...
Eligibility Criteria
Inclusion
- Male or female 18 years of age and above.
- Sensorineural hearing loss meeting criteria for cochlear implants, assessed no greater than three months prior to cochlear implant surgery
- Patient schedule to undergo CI surgery using Advanced Bionics SlimJ/L23 device.
- Ability to undergo adequate audiology follow-up or planned follow up for those participants undergoing scanning in the OR.
- Competent in decision making process and able to read and sign a written informed consent form.
- English language proficiency.
- If the patient has already had a fine resolution CT or a fpVCT of the head (more than likely as a participant of another research study) the scan will not be repeated, the images from the previous scan will be used for the purposes of this study.
- If the patient has undergone a conventional CT scan of the head after cochlear implantation as part of their routine care, this scan may be used in place of the research scan or in addition to the research scan.
Exclusion
- Patients who weigh over 300 lbs (when Xoran xCAT headboard is being used). Otherwise, weight is not exclusionary.
- Females who are pregnant. All females of child-bearing age in the study will undergo a pregnancy test.
Key Trial Info
Start Date :
February 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03858647
Start Date
February 21 2019
End Date
December 31 2021
Last Update
February 2 2022
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232