Recruiting

Cochlear Implant with Dexamethasone

Sponsor:

Cochlear

Code:

NCT06936449

Conditions

Sensorineural Hearing Loss

Bilateral Hearing Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CI632D

CI632

Study Details

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

Study ID

NCT06936449

Start date

May 5, 2025

Status verified date

Jul, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

19 participants

Anticipated

Interventions and Outcome Measures

Arms

Experimental: CI632D Investigational Medical Device (IMD)

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

Active Comparator: CI632 Comparator Device

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

Interventions

CI632D

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

CI632

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

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 ]

Central Contacts and Locations

Central contacts

PRS Specialist

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

Locations

Rocky Mountain Ear Center

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Aaron Parkinson

800 523 5798aparkinson@cochlear.com

Principal Investigator:

David Kelsall, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Aaron Parkinson

800 523 5798aparkinson@cochlear.com

Principal Investigator:

Bruce Gantz, MD

University Hospitals Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Aaron Parkinson

800 523 5798aparkinson@cochlear.com

Principal Investigator:

Alejandro Rivas, MD

More Information

Sponsor

Cochlear

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cochlear on 2026-07-07.