Long-term follow-up of cochlear implants with a dexamethasone-releasing electrode in adults with hearing loss
Follows adults with hearing loss over time after receiving a cochlear implant.
Key facts
- Who runs it
- Cochlear
- Where
- Cleveland, Englewood, and Iowa City, United StatesSee the 3 sites
- Trial code
- Registry title
- Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
- Status
- Recruiting
- People taking part
- 19 people, planned
- Started
- 5 May 2025
- Expected to end
- Mar 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- CI632D
- CI632
- Record updated
- 7 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who took part in the CLTD5759 CI-DEX study and received a CI632D or CI632 cochlear implant. It follows them over a long time.
- Age
- 18 years and older
- Sex
- All
- Disease stage
- Hearing loss in both ears from inner ear or nerve damage, starting after learning to speak.
- Earlier treatment
- People must have received a CI632D or CI632 cochlear implant in the CLTD5759 (NCT04750642) study and completed that study.
Main reasons for not taking part
- Expectations about the trial's benefits, risks and limits that the study doctor judges unrealistic
- Other disabilities that may affect taking part or safety
- Unable or unwilling to follow all trial requirements
- In another trial of a test drug or device now, or within the last 30 days
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device
- 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
Where in United States
- University Hospitals ClevelandCleveland, United StatesContact: Aaron ParkinsonTaking people
- Rocky Mountain Ear CenterEnglewood, United StatesContact: Aaron ParkinsonTaking people
- University of IowaIowa City, United StatesContact: Aaron ParkinsonTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Experimental: CI632D Investigational Medical Device (IMD)
Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant
Treatment: CI632D
- Active Comparator: CI632 Comparator Device
Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant
Treatment: CI632
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
- Plain-language title
- Long-term follow-up of cochlear implants with a dexamethasone-releasing electrode in adults with hearing lossGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 7 July 2026