An interventional study of Contour Advance electrode with controlled dose of dexamethasone base and Contour Advance electrode in Hearing Loss, sponsored by The Hearing Cooperative Research Centre. Completed at 1 site in Australia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-07-06.
Sponsored by The Hearing Cooperative Research Centre · Not applicable, Interventional, and Treatment
In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device.
In the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 48 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →The Hearing Cooperative Research Centre is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Contour Advance electrode with controlled dose of dexamethasone base
Device: Contour Advance electrode with controlled dose of dexamethasone base
Standard Contour Advance electrode array
Device: Contour Advance electrode
The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.
Standard Contour Advance electrode
Surgical feedback
Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode
Time frame: During surgery
Safety of Combined Device
Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device
Time frame: Monitoring over 24 months
Electrode impedance
Time frame: Testing over 24 months
Electrically evoked compound action potential (ECAP)
Time frame: Testing over 24 months
Plan to share: No
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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The Hearing Cooperative Research Centre