This study is in progress, not accepting new patients

Cochlear Implant With Dexamethasone Eluting Electrode Array

a study on Hearing Loss Sensorineural Hearing Loss Cochlear Implant

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Akira Ishiyama

Description

Summary

An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Official Title

Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study

Details

The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.

Keywords

Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implant, Dexamethasone, Hearing Loss, Deafness

Eligibility

You can join if…

Open to people ages 18 years and up

  • Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.
  • 18 years or older at time of consent.

You CAN'T join if...

  • Abnormal cochlear and middle ear anatomy
  • History with cochlear implant surgery
  • Allergy to dexamethasone
  • Women who are pregnant or plan to become pregnant
  • Unable/unwilling to comply to study requirements

Locations

  • University of California Los Angeles(UCLA), Medical center
    Los Angeles California 90095 United States
  • University of Utah Hospital and Clinics
    Salt Lake City Utah 84132 United States

Lead Scientist at UCLA

  • Akira Ishiyama
    Professor, Head and Neck Surgery, Medicine. Authored (or co-authored) 165 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cochlear
ID
NCT04750642
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated