CompletedNot Applicable

CT Guided CI Programming

United States19 participantsStarted 2021-09-01

Plain-language summary

The current standard of care for cochlear implants (CI) does not address the significant pitch-place mismatch that is inherent in cochlear implantation (see detailed description below). The present study uses postoperative Flat Panel (higher resolution than standard) CT imaging to measure where CI electrodes sit within an individual's cochlea; doing so allows for more accurate frequency mapping (and thus pitch perception). The hypothesis of this study is that long-term (1 year) use of CT image-based frequency maps, beginning on the first day of CI activation, will improve user performance in the areas of speech and music perception, as compared to the use of default programming settings.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has or plans to have a MED-EL cochlear implant (CI) * Has not yet had their CI activated * Be able and willing to participate in all of the research appointments for follow-up testing (e.g., 1, 3, 6, 12, and 13 months post-CI activation) * Be willing to use the CI full-time (during waking hours) for 13 months post-activation * Is able to speak and read American English * Uses oral/aural communication as primary communication modality Exclusion Criteria: * Intra-cochlear electrodes known to be open or short-circuits * Partially-inserted CI with fewer than 10 intra-cochlear electrodes * Any concomitant condition(s) that may affect performance on speech and music test battery (e.g., cognitive impairment) * Atypical cochlear anatomy (e.g., fewer than 2 turns of the cochlea) * Pregnancy (a contraindication for CT scan)

What they're measuring

Change in score on the Consonant-Nucleus-Consonant (CNC) Test between chronic use of the CT-based program (~12 months post-activation) and chronic use of the clinical default program (~1 month post-switchover)

Timeframe: Baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)

Trial details

NCT IDNCT04506424

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-08

View on ClinicalTrials.gov More Cochlear Implants trials