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Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

Study acronym: DEE-REX
StatusActive, Not Recruiting
PhaseNot applicable
SponsorCochlear
Started
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Record History

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  1. Primary completion date: Jan 13, 2026 to Feb 2, 2026v15
  2. Primary completion date changed from estimate of Dec 2025 to Jan 13, 2026v14
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 11 of 11 sites
    v13
  4. Study sites: 9 to 11v12
  5. Study sites: 8 to 9v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 7 to 8v10
  2. Study sites: 6 to 7v9
  3. Study sites: 5 to 6v8
  4. Primary endpoints revised (2)v7 Show 5 more changesShow less
    • Primary completion date: Oct 2025 to Dec 2025
    • Study completion date: Aug 2026 to Sep 2026
    • Eligibility criteria expanded, about 293 words
    • Secondary endpoints revised (3)
    • Collaborators: 1 to 4
  5. Study sites: 4 to 5v6
  6. Start date changed from estimate of Nov 2024 to Jan 3, 2025
    • Study sites revised (4)
    v5
  7. Study sites: 3 to 4
    • Start date: Oct 2024 to Nov 2024
    v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    v3
  9. Start date: Sep 2024 to Oct 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cochlear
28 trials monitored
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This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation and reduce tissue injury, which is common after any type of surgery. The goal is to learn if the dexamethasone in the CI632D implant lessens these reactions inside the ear following surgery and if this makes the implant work as well, or even better, in improving hearing than what would be expected with a standard cochlear implant. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). The study participants will receive the CI632D experimental implant and will complete tests to see how well they are hearing and how well the implant is working.
Trial Details
NCT Number NCT06598059
Lead Sponsor Cochlear
Collaborators: University of Iowa, LWB Consulting, Althea Anagnostopoulos Harrington, MV Clinical Research, LLC
Conditions
(from sponsor)		 Hearing Loss
Related terms Fibrosis, Hearing Loss
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov