Cochlear Implant With Dexamethasone Eluting Electrode Array

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

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

Study Overview

• Status: Completed
• Conditions: Sensorineural Hearing Loss; Bilateral Hearing Loss
• Intervention / Treatment: Device: CI632D; Device: CI632

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Murdoch, New South Wales, Australia, 6150
      • Fiona Stanley Hospital
    • Sydney, New South Wales, Australia, 2145
      • Westmead Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Royal Victorian Eye and Ear Hospital
• New Zealand
  • Auckland, New Zealand, 1010
    • Gilles Hospital
• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Ear Centre
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • New York
    • New York, New York, United States, 10017
      • NYU Langone Medical Center
    • New York, New York, United States, 10010
      • New York Eye & Ear infirmary of Mt. Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CI632D Investigational Medical Device (IMD)	Device: CI632D; CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
Active Comparator: CI632 Comparator Device	Device: CI632; CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 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.	Six months postoperative
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	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.	Six months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups	Adverse events were recorded from baseline to 12 months postoperative.	Twelve months postoperative
Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at 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.	Six months postoperative
Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at 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.	Six months postoperative

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Vanderbilt University; NAMSA; Avania
• Investigators: Study Director: Aaron Parkinson, Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: January 31, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Dexamethasone; Cochlear Implant; Sensorineural Hearing Loss; Bilateral Hearing Loss
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Other Study ID Numbers: CLTD5759

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes