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The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N6 Input Processing Features | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus 6 Sound Processor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction | Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off. | Visit 2, 1 month after baseline testing |
| Endpoint 2: Evaluation of SCAN | Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off. | Visit 2, 1 month after baseline testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Ear Center | Englewood | Colorado | 80113 | United States | ||
| Center for Hearing and Balance |
As of the date of database closure, 34 of the 40 enrolled subjects completed Visit Two (endpoint testing).
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| ID | Title | Description |
|---|---|---|
| FG000 | N6 Input Processing Features - SNR-NR & SCAN | Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) and SCAN (endpoint 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N6 Input Processing Features - SNR-NR & SCAN | Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) and SCAN (endpoint 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction | Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off. | Posted | Mean | 95% Confidence Interval | difference in percent correct scores | Visit 2, 1 month after baseline testing |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N6 Input Processing Features - SNR-NR | Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori O'Neill Director of Research | cochlear | 8005235798 | loneill@cochlear.com |
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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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| Chesterfield |
| Missouri |
| 63017 |
| United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Houston Ear Research Foundation | Houston | Texas | 77074 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Endpoint 2: Evaluation of SCAN | Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off. | Posted | Mean | 95% Confidence Interval | difference in percent correct scores | Visit 2, 1 month after baseline testing |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | N6 Input Processing Features - SCAN | Testing of the Nucleus 6 sound processing SCAN (endpoint 2) | 0 | 40 | 0 | 40 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |