Cochlear Implant With Dexamethasone Eluting Electrode Array

NCT04750642 | Completed Results DMC FDA Device

• 1 other identifier: CLTD5759
• Study Type: interventional
• Target: 42
• Locations: 3 countries
• Sites: 8

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.

Conditions

Sensorineural Hearing Loss; Bilateral Hearing Loss

Keywords

Cochlear Implant; Dexamethasone; Bilateral Hearing Loss; Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

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

  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

  Six months postoperative

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

  Six months postoperative

Study Arms (2)

CI632D Investigational Medical Device (IMD)

EXPERIMENTAL

Device: CI632D

CI632 Comparator Device

ACTIVE COMPARATOR

Device: CI632

Interventions

CI632D DEVICE

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

CI632D Investigational Medical Device (IMD)

CI632 DEVICE

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

CI632 Comparator Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years or older at time of consent.

You may not qualify 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

Sponsors & Collaborators

• Cochlear: lead
• NAMSA: collaborator
• Avania: collaborator
• Vanderbilt University: collaborator

Study Sites (8)

Rocky Mountain Ear Centre

Englewood, Colorado, 80113, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

New York Eye & Ear infirmary of Mt. Sinai

New York, New York, 10010, United States

Location

NYU Langone Medical Center

New York, New York, 10017, United States

Location

Fiona Stanley Hospital

Murdoch, New South Wales, 6150, Australia

Location

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

Location

Gilles Hospital

Auckland, 1010, New Zealand

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early study termination leading to small number of subjects.

Results Point of Contact

• Title: Aaron Parkinson
• Organization: Cochlear

aparkinson@cochlear.com

13039414951

Study Officials

• Aaron Parkinson

  Cochlear

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 11, 2021
• Study Start: October 4, 2021
• Primary Completion: July 7, 2023
• Study Completion: February 23, 2024
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-04

Locations

US (4); AU (3); NZ (1)