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Cochlear Implant With Dexamethasone Eluting Electrode Array

NCT04750642 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-04-22

Study results available
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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.

Conditions

  • Sensorineural Hearing Loss
  • Bilateral Hearing Loss

Interventions

DEVICE

CI632D

CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)

DEVICE

CI632

CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Avania

    collaborator INDUSTRY

  • Vanderbilt University

    collaborator OTHER

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Aaron Parkinson · Cochlear

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2023-07-07
Completion
2024-02-23
FDA Device
Yes

Countries

  • United States
  • Australia
  • New Zealand

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 NCT04750642 on ClinicalTrials.gov