Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
NCT ID: NCT06936449
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
19 participants
OBSERVATIONAL
2025-05-05
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Experimental: CI632D Investigational Medical Device (IMD)
Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant
CI632D
CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells
Active Comparator: CI632 Comparator Device
Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant
CI632
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).
* Willing and able to provide written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Locations
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Rocky Mountain Ear Center
Englewood, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLTD5759-S1
Identifier Type: -
Identifier Source: org_study_id
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