Actively Recruiting
Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
Led by Cochlear · Updated on 2025-12-15
19
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a long-term follow-up study to monitor adults with bilateral postlinguistic sensorineural hearing loss who have received a cochlear implant electrode array that slowly releases dexamethasone to reduce inflammation. The study focuses on adults who previously participated in a related study involving the CI632D cochlear implant device and its comparator, the CI632 device. This observational study is sponsored by Cochlear and aims to assess the long-term effects of these devices over several years. Participants are grouped based on the type of cochlear implant they received: either the CI632D device, which includes dexamethasone elution in the electrode wells, or the CI632 device, which does not contain dexamethasone but has market approval. The study involves ongoing monitoring of these two groups to compare device performance and safety over a period extending to 5 years after implant activation. During the study, participants will undergo routine follow-ups including measurements of electrode impedance, acoustic hearing thresholds, and speech perception tests in quiet and noisy environments. Researchers will also monitor device-related adverse events and compare outcomes between the two groups to understand the long-term effects of the dexamethasone-eluting electrode array. The study participation lasts through 5 years post-activation, with scheduled assessments during this time frame.
CONDITIONS
Brief Title
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Unrealistic expectations regarding the possible benefits, risks, and limitations of participation as determined by the Investigator.
- Additional disabilities that may affect participation or safety during the clinical investigation.
- Unable or unwilling to comply with all clinical investigation requirements as determined by the Investigator.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation involving an investigational drug or device.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years post-activation
Participants who have previously received cochlear implants are observed through routine follow-up visits to assess device performance and hearing outcomes over time.
Routine follow-up visits through 5 years post-activation
Trial Site Locations
Total: 3 locations
1
Rocky Mountain Ear Center
Englewood, Colorado, United States, 80113
Actively Recruiting
2
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
University Hospitals Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
A
Aaron Parkinson
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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