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Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode

NCT03858647 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2022-02-02

No results posted yet for this study

Summary

The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device.

The specific aims of the project are as follows:

1. To measure implant audiologic performance as defined by speech performance in standard cochlear implant speech test batteries.
2. To determine scalar location after insertion through either intraoperative or postoperative imaging and correlate this with audiologic outcomes.
3. To assess the rates of preservation of residual acoustic hearing and correlate those with scalar location as determined in specific aim 2 and audiologic performance as determined in specific aim 1.
4. To correlate speech outcomes with quality of life measures, as defined by validated questionnaires including the Tinnitus Handicap Index (THI), Speech and Spatial Qualities (SSQ) Questionnaire, and Nijmegen Questionnaire.
5. To evaluate intraoperative ease of insertion from the surgeon's perspective and correlate this with postoperative electrode location and audiologic performance.

Conditions

  • Sensorineural Hearing Loss

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Alejandro Rivas, MD · Vanderbilt University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-21
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03858647 on ClinicalTrials.gov