Sensorineural Hearing LossNCT04750642
Cochlear Implant With Dexamethasone Eluting Electrode Array
A study testing CI632D and CI632 in people with Sensorineural Hearing Loss and Bilateral Hearing Loss, run by Cochlear at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral Hearing Loss
- What is being tested?
- CI632D and CI632
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 4 Oct 2021to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States4 sites
Rocky Mountain Ear Centre
Englewood, Colorado, 80113
University of Iowa
Iowa City, Iowa, 52242
New York Eye & Ear infirmary of Mt. Sinai
New York, New York, 10010
NYU Langone Medical Center
New York, New York, 10017
Australia3 sites
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002
Fiona Stanley Hospital
Murdoch, New South Wales, 6150
Westmead Hospital
Sydney, New South Wales, 2145
About this study
Official title: 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.
Read the 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.
- Conditions
- Sensorineural Hearing Loss, Bilateral Hearing Loss
- Being tested
- CI632D, CI632
- Keywords
- Cochlear Implant, Dexamethasone, Bilateral Hearing Loss, Sensorineural Hearing Loss
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CI632DDevice
CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
CI632Device
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| CI632D Investigational Medical Device (IMD) | Experimental | Not described Receives: Device: CI632D |
| CI632 Comparator Device | Active comparator | Not described Receives: Device: CI632 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Six months postoperative
Secondary outcomes (3)
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
Adverse events were recorded from baseline to 12 months postoperative.
Measured: 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.
Measured: 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.
Measured: Six months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start4 Oct 2021
- Primary completion7 Jul 2023
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Avania, Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Aaron Parkinson, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750642
- Sponsor's protocol ID
- CLTD5759
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2021
- Last updated
- 22 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study
- ClinicalTrials.gov ID
- NCT04750642
- Acronym / sponsor ID
- CLTD5759
- Conditions
- Sensorineural Hearing Loss, Bilateral Hearing Loss
- Keywords
- Cochlear Implant, Dexamethasone, Bilateral Hearing Loss, Sensorineural Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA, Avania, Vanderbilt University
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Posted 22 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CI632D Investigational Medical Device (IMD) | Experimental | Device: CI632D |
| CI632 Comparator Device | Active comparator | Device: CI632 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CI632DCI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D) | Device | CI632D Investigational Medical Device (IMD) |
| CI632CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone | Device | CI632 Comparator Device |
Primary outcome
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.
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.
3 secondary outcomes
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
Time frame: 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
Time frame: Six months postoperative
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Parkinson study director
Cochlear
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CI632D and CI632 in people with Sensorineural Hearing Loss and Bilateral Hearing Loss, run by Cochlear at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative (time frame: Six months postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.