Image-guided Cochlear Implant Programming (IGCIP)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cochlear Implant
• Intervention / Treatment: Other: Image-Guided Cochlear Implant Programming

Detailed Description

Over 320,000 individuals have received cochlear implants (CIs) to restore hearing to the hearing impaired. Commercially available CIs have 12, 16, or 22 independent electrodes (the number is dependent on the manufacturer of the CI) which cover the entire frequency spectrum of the cochlea from 20,000 Hertz (Hz) at the base of to 200Hz at the apex. After implantation, an audiologist individually adjusts stimulation levels of each electrode following which all electrodes are turned on such that the whole frequency spectrum of speech can be appreciated. This is known as "standard of care" (SOC) programming. While postoperative speech understanding is significantly better than preoperative levels, even the best performers complain that the fidelity of natural hearing is not reproduced. Additionally, a significant minority achieves poor outcomes despite normally functioning equipment for reasons that are unknown but likely relate to poor neural survival; however, this cannot be confirmed as postmortem histopathology is required to accurately document spiral ganglion cell count. In recent years much attention has focused on the interface between the cochlear implant electrodes and the auditory neurons they are stimulating. Technological improvements at Vanderbilt in imaging processing have made it possible to determine the location of each electrode array in relationship to the frequency spectrum of the cochlea. Using this information, the investigators have developed a new method of CI programming which they call image-guided cochlear implant programming, or IGCIP in which sub-optimally placed electrodes are turned-off or deactivated. Sub-optimally placed electrodes are defined as ones for which their neighboring electrodes are in closer proximity to the site of their neural stimulation. By deactivating sub-optimally positioned electrodes, channel interaction is reduced allowing a cleaner signal to be presented to the auditory nerve. The purpose of the study is to prospectively collect audiological outcomes on patients undergoing IGCIP. The investigators hypothesize that CI recipients will perform better with IGCIP as compared to SOC.

Cochlear implant recipients who have reached asymptotic improvement in performance with SOC will be offered enrollment. They will undergo post-operative CT scanning to determine the relationship between the cochlear implant electrodes and the neural interface. Recommendations regarding deactivation of sub-optimally placed electrodes will be communicated to the audiology team who, if in their clinical judgement deems deactivation of these electrodes reasonable, will implement the changes for a 1 month trial. The participant will return at 1 month to have audiological assessment as per the clinical standard of care. Based on these results, which will be shared with the patient, the patient can choose to use IGCIP or SOC for long term cochlear implant programming.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Image-guided Cochlear Implant Programming (IGCIP); Cochlear implant programming using IGCIP.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)	Month 1 post cochlear implant activation

Secondary Outcome Measures

Outcome Measure	Time Frame
Minimum Speech Test Battery	Month 1 post cochlear implant activation

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2015
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 150417; R01DC014037 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No