What this study is
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.
What's being tested
- Image-Guided Cochlear Implant Programming
Intervention · OTHER
Post Cochlear Implant surgery, participant will receive traditional activation and programming per routine. IGCIP will be used to offer alternative programming of the implant.
Study details
- Sponsor
- Vanderbilt University Medical Center
- Conditions
- Cochlear Implant
- Enrolling
- 150 people
- Starts
- 2015-06-23
- Est. completion
- 2027-05-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults aged 18 to 90 years that have undergone diagnostic testing for sensorineural hearing loss and have received a cochlear implant with asymptotic improvement in performance with SOC programming will be considered eligible for the study.
You can't join if
- Age < 18 years or > 90 years
- Non-English speaking (because our audiological speech testing battery is validated for English speakers)
- Pregnancy which is a contraindication for elective CT scanning and surgery
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVanderbilt University Medical Center
Nashville, Tennessee, United States
Study team
Sponsor
Vanderbilt University Medical Center
Study ID 150417
Principal investigator
Jack H. Noble, PhD
Vanderbilt University
Study chair
Rene H. Gifford, PhD
Vanderbilt University Medical Center
Study chair
Robert F. Labadie, MD, PhD
Vanderbilt University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.