Skip to main content
OpenTrials
Completed

NCT Number: NCT04750642

Cochlear Implant With Dexamethasone Eluting Electrode Array

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sensorineural Hearing Loss Bilateral Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Bilateral Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fiona Stanley Hospital, Murdoch, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CI632D

Device

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

CI632

Device

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

Primary outcomes

  1. Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative

    Time frame: Six months postoperative

    The impedance was measured across the active electrodes of the cochlear implant for each participant. Reduced impedances indicate less fibrotic obstruction caused by trauma associated with the electrode insertion.

  2. Change in Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Compared to Pre-operative Baseline Measured at 6 Months Postoperative With CI632D

    Time frame: Six months postoperative

    Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. This outcome measure included the CI632D group only.

Secondary outcomes

  1. Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups

    Time frame: Twelve months postoperative

    Adverse events were recorded from baseline to 12 months postoperative.

  2. Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative

    Time frame: Six months postoperative

    Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance.

  3. Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative

    Time frame: Six months postoperative

    Scores from the AzBio Sentences in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Avania
  • NAMSA
  • Vanderbilt University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 11, 2021
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.