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The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Clinical Investigation will be comprised of several arms which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A) | Experimental |
| |
| Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B) | Experimental |
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| Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D) | Experimental |
| |
| Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C) | Experimental |
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| Investigational Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Pre-Processing Algorithm (Sub A) | Device | DNR algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Australian Sentence Test in Noise (AuSTIN) | To determine whether the research algorithm provides non-inferior performance to the standard-of-care algorithm for sentences in noise using an adaptive sentence test in noise scores. Scoring: AuSTIN is scored as a Speech Reception Threshold (SRT), which reflects the volume of speech signal (in decibels, dB) relative to the background noise required for the subject to achieve 50% correct. For example, a score of 2dB SRT means the subject requires the speech to be 2dB louder than the background noise in order to correctly identify 50% of the target sentence. Range: -30dB to +30dB. Lower scores reflect a better outcome. | 1 day - Immediately post-screening |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Melbourne | Melbourne | Victoria | 3002 | Australia | ||
| HEARnet Clinical Studies |
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Order of IMD and comparator is blinded.
| Cochlear Limited standard-of-care pre-processing algorithms | Device | Standard-of-care sound path as implemented in the N8 system |
|
| Investigational Pre-Processing Algorithm (Sub B) | Device | Spatial Automation profile |
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| Investigational pre-processing algorithm (Sub D) | Device | Microphone miscalibration profile with applied correction method |
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| Investigational Pre-Processing Algorithm (Sub C) | Device | Spatial Automation profile and DNR algorithm |
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| Investigational Pre-Processing Algorithm (Sub E) | Device | CUSP reference sound path |
|
| Melbourne |
| Victoria |
| 3053 |
| Australia |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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