ClinicalTrials.gg
RecruitingNCT06936449CI-DEX-LTFUUpdated Jul 7, 2026

Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

An observational study in Sensorineural Hearing Loss and Bilateral Hearing Loss, sponsored by Cochlear. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Cochlear · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 31 studies in Hearing Loss, Sensorineural by Cochlear — 2 open to participants now, 6 under way, none of them phase 3. Hearing Loss, Sensorineural · Cochlear.

Started
2025
with 3 others
Observational
3 of 31
1 open now
Registered
28th of 31
by date

Among the 31 studies in Hearing Loss, Sensorineural by Cochlear, this one is one of 4 that started in 2025, is one of 3 observational ones, and was the 28th registered.

By phase

31 studies; the count open now beside each. This study's row is marked.

No phase27 · 1 open
Observationalthis study3 · 1 open
Other kind1 · 0 open

By the year they started

First in 2006; this study’s year is marked. 4 started in 2025.

Size and results

Median enrollment 20 across the 27 interventional studies, 29 across the 4 observational. Of the 24 that completed or were terminated, 19 (79%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 31 studies in Hearing Loss, Sensorineural by Cochlear, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Sensorineural Hearing Loss
  • Bilateral Hearing Loss

Keywords

  • cochlear implant
  • dexamethasone
  • bilateral hearing loss
  • sensorineural hearing loss
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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 drug or device.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19 participants (estimated)
Patient registry
No

Groups and cohorts

  • Experimental: CI632D Investigational Medical Device (IMD)

    Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant

    Device: CI632D

  • Active Comparator: CI632 Comparator Device

    Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant

    Device: CI632

Interventions

  • DeviceCI632D

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

  • DeviceCI632

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06936449
Lead sponsor
Cochlear
Responsible party
Sponsor
First posted
Apr 20, 2025
Start date
May 5, 2025
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Jul 7, 2026

Study contacts

PRS Specialist
Contact
cltd-prs-admin@cochlear.com
+61 2 9428 6555

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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