Status:
COMPLETED
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant
Lead Sponsor:
Cochlear
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this...
Detailed Description
This is a feasibility, prospective, multi-country, multi-centre, cross-sectional interventional clinical investigation in adults with a CE labelled cochlear implant. No Randomisation nor blinding to ...
Eligibility Criteria
Inclusion
- Aged 18 years or older (no upper age limit).
- Implanted with CIC4-based implant with a Contour Advance, Slim Straight or Slim Modiolar electrode array with at least 6 months experience.
- Candidate is a fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- Willing and able to provide written informed consent.
Exclusion
- Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (digital literacy check).
- A failed ECE1 or ECE2 (i.e. flagged, open circuit or short circuit)
- Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- 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 Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation)
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06173687
Start Date
January 29 2024
End Date
October 24 2024
Last Update
December 3 2025
Active Locations (4)
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1
Cochlear Macquarie
Sydney, New South Wales, Australia, 2109
2
HEARnet
Carlton, Victoria, Australia, 3052
3
ENT Department, Sint-Augutinus Antwerp
Wilrijk, Antwerp, Belgium, 2610
4
Cochlear Bone Anchored Solutions AB (CBAS)
Mölnlycke, Västergötland, Sweden, 43533