Pediatric Image-Guided Cochlear Implant Programming

Summary

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Recent literature has indicated that children receiving cochlear implants (CIs) often have dramatically improved speech and language ability relative to previous generations of children with hearing loss; however, many pediatric CI recipients display persistent speech and language disorders despite early implantation and associated speech/language intervention. Cochlear implants are programmed 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 (SOC) mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. Our 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). This project provides a unique opportunity to examine whether individualized, image-guided CI programming (IGCIP) significantly improves outcomes in pediatric CI patients.

Conditions

• Cochlear Implant

Interventions

OTHER

Signal processing intervention of a biomedical device

This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Rene Gifford, PhD · Vanderbilt University Medical Center

• Stephen Camarata, PhD · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

4 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-30

Primary Completion

2025-03-31

Completion

2025-06-30

Countries

• United States

Study Locations