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| Name | Class |
|---|---|
| Cochlear | INDUSTRY |
| Royal Victoria Eye and Ear Hospital | OTHER_GOV |
| Royal Prince Alfred Hospital, Sydney, Australia | OTHER |
| St Vincent's Hospital Melbourne |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA with dexamethasone base | Experimental | Contour Advance electrode with controlled dose of dexamethasone base |
|
| Contour Advance | Active Comparator | Standard Contour Advance electrode array |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contour Advance electrode with controlled dose of dexamethasone base | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Monitoring over 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Electrode impedance | Testing over 24 months | |
| Electrically evoked compound action potential (ECAP) | Testing over 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The HEARing CRC | Melbourne | Victoria | 3053 | Australia |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| OTHER |
| Westmead Hospital | OTHER |
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| Contour Advance electrode | Device | Standard Contour Advance electrode |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |