Sensorineural Hearing LossCI-DEX-LTFUNCT06936449
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
An observational study of Sensorineural Hearing Loss and Bilateral Hearing Loss, run by Cochlear at 3 sites in United States.
Trial summary
A long-term follow-up 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
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 May 2025to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Individuals available from those sites invited to participate in the study consisting of up to 10 subjects implanted with the CI632D and up to 9 subjects with the CI632 in the CIDEX study (NCT04750642)
Who may be able to join
- Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.
- Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).
- Willing and able to provide written informed consent.
Who cannot join
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.
- Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
- Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University Hospitals Cleveland
Cleveland, Ohio, 44106
Aaron Parkinson, 800 523 5798, aparkinson@cochlear.com
Alejandro Rivas, MD
- Recruiting
Rocky Mountain Ear Center
Englewood, Colorado, 80113
Aaron Parkinson, 800 523 5798, aparkinson@cochlear.com
David Kelsall, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Aaron Parkinson, 800 523 5798, aparkinson@cochlear.com
Bruce Gantz, MD
About this study
Official title: Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
A long-term follow-up 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
- 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
CI632Device
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CI632D Investigational Medical Device (IMD) | Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant Receives: Device: CI632D | |
| Active Comparator: CI632 Comparator Device | Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant 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 groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits.
Measured: 5 years post-activation
Secondary outcomes (5)
Comparison of CI632D and CI632 device-related adverse events between groups from enrolment in this study through 5 years postactivation.
Measured: 5 years post-activation
Comparison of Four-point Impedance Measurement between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Measured: 5 years post-activation
Comparison of low-frequency acoustic hearing between groups as measured by pure tone average thresholds over the range 125 through 500 Hz, obtained in the CLTD5759 (NCT04750642) study and from enrolment in this study through 5 years postactivation.
Measured: 5 years post-activation
Comparison of speech perception in quiet (CNC word scores) for the best unilateral listening condition in the implanted ear between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Measured: 5 years post-activation
Speech perception in noise (AzBio sentence scores) for the best bilateral listening condition obtained between groups in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Measured: 5 years post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start5 May 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936449
- Sponsor's protocol ID
- CLTD5759-S1
- Acronym
- CI-DEX-LTFU
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
- ClinicalTrials.gov ID
- NCT06936449
- Acronym / sponsor ID
- CI-DEX-LTFU / CLTD5759-S1
- Conditions
- Sensorineural Hearing Loss, Bilateral Hearing Loss
- Keywords
- cochlear implant, dexamethasone, bilateral hearing loss, sensorineural hearing loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: CI632D Investigational Medical Device (IMD) | – | Device: CI632DAdults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant |
| Active Comparator: CI632 Comparator Device | – | Device: CI632Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals available from those sites invited to participate in the study consisting of up to 10 subjects implanted with the CI632D and up to 9 subjects with the CI632 in the CIDEX study (NCT04750642)
Key inclusion criteria (3 listed)
- Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.
- Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).
- Willing and able to provide written informed consent.
Key exclusion criteria (4 listed)
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.
- Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
- Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
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 | Device | Experimental: CI632D Investigational Medical Device (IMD) |
| CI632CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone | Device | Active Comparator: CI632 Comparator Device |
Primary outcome
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) between groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits.
Time frame: 5 years post-activation
5 secondary outcomes
Comparison of CI632D and CI632 device-related adverse events between groups from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Comparison of Four-point Impedance Measurement between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Comparison of low-frequency acoustic hearing between groups as measured by pure tone average thresholds over the range 125 through 500 Hz, obtained in the CLTD5759 (NCT04750642) study and from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Comparison of speech perception in quiet (CNC word scores) for the best unilateral listening condition in the implanted ear between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Speech perception in noise (AzBio sentence scores) for the best bilateral listening condition obtained between groups in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss and Bilateral Hearing Loss, run by Cochlear at 3 sites in United States.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PRS Specialist (+61 2 9428 6555, cltd-prs-admin@cochlear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) between groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits. (time frame: 5 years post-activation). 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 7 Jul 2026.