Status:
COMPLETED
Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
Lead Sponsor:
Cochlear
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environmen...
Eligibility Criteria
Inclusion
- Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding
- At least three months of experience with the cochlear implant.
- Older than 18 years when entering the study.
- Subject is fluent speaker in the language used for assessments.
- Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
- Willing and able to provide written informed consent
Exclusion
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05270876
Start Date
October 19 2020
End Date
March 6 2023
Last Update
March 10 2025
Active Locations (5)
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1
HEARnet Clinical Studies - The University of Melbourne
Carlton, Victoria, Australia, 3052
2
Cochlear Ltd. Melbourne
East Melbourne, Victoria, Australia, 3002
3
AZ Sint-Jan Brugge-Oostende AV
Bruges, België, Belgium, 8000
4
Sint-Augustinus Antwerpen
Wilrijk, België, Belgium, 2610