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

NCT06936449 | Recruiting

• 1 other identifier: CLTD5759-S1
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Sensorineural Hearing Loss; Bilateral Hearing Loss

Keywords

cochlear implant; dexamethasone; bilateral hearing loss; sensorineural hearing loss

Outcome Measures

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.

  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.

  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.

  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.

  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.

  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.

  5 years post-activation

Study Arms (2)

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

CI632D DEVICE

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

Experimental: CI632D Investigational Medical Device (IMD)

CI632 DEVICE

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

Active Comparator: CI632 Comparator Device

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (3)

Rocky Mountain Ear Center

Englewood, Colorado, 80113, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

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

Central Study Contacts

Aaron Parkinson

CONTACT

800 523 5798; aparkinson@cochlear.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)