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ENROLLING BY INVITATION
NCT03306082
NA

Image-guided Cochlear Implant Programming (IGCIP)

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

Summary

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. While remarkably successful, even in the best of performers restoration of hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery, cochlear implants are activated via mapping - a process in which each individual electrode (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At present, this standard of care mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. The research team has developed a new method of mapping using post-operative CT scans and image processing to specify the physical relationship between the cochlear implant electrodes and the neural interface allowing customized mapping. Using this information, the investigators deactivate sub-optimally positioned electrodes. The investigators term this "Image-guided Cochlear Implant Programming" (IGCIP). The study collects data in a prospective fashion for those CI recipient undergoing IGCIP.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2015-06-23

Completion Date

2027-05-31

Last Updated

2025-07-17

Healthy Volunteers

No

Interventions

OTHER

Image-Guided Cochlear Implant Programming

Post Cochlear Implant surgery, participant will receive traditional activation and programming per routine. IGCIP will be used to offer alternative programming of the implant.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States