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NCT Number: NCT06936449

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rocky Mountain Ear Center, Englewood, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent.

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 investigational drug or device.

Treatment and study plan

CI632D

Device

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

CI632

Device

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

PRS Specialist

CONTACT

[email protected]

+61 2 9428 6555

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study

Acronym: CI-DEX-LTFU

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 20, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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