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Cochlear Implant With Dexamethasone Eluting Electrode Array

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Join this Trial

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Study Stats
Protocol No.
21-000776
Category
Head & Neck Surgery
Contact
Qianjie Fu
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04750642
For detailed technical eligibility, visit ClinicalTrials.gov.