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The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in adults with cochlear implants.
The study will include two groups of adult cochlear implant recipients: veterans and non-veterans. Comparing these groups will help researchers understand how these sound processors perform in veteran populations as well as the broader adult cochlear implant community.
Participants will use each sound processor and then take part in speech understanding tests in background noise. They will also complete questionnaires about their listening experiences with each processor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veterans | Experimental |
| |
| Non-veterans | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus 7 Sound Processor | Device | While the user can turn ForwardFocus on from any program in the Nucleus 7 Sound Processor, for the duration of this study, SCAN will be used as the default program and ForwardFocus will be turned on for testing. This setting will be referred to as SCAN ForwardFocus (SCAN FF). |
| Measure | Description | Time Frame |
|---|---|---|
| Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N90 spatial configuration | The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words. | Week 2 and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S90N180 spatial configuration | The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | Contact | +61294286555 | cltd-prs-admin@cochlear.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Research and Technology Lab | Lone Tree | Colorado | 80124 | United States |
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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|
| Nucleus 8 Sound Processor | Device | Nucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance. |
|
| Week 2 and week 4 |
| Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N180 spatial configuration | The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words. | Week 2 and week 4 |
| Paired difference in AzBio improvement (percentage-point change) for the Nucleus 8 Sound Processor (SCAN 2 FF minus SCAN 2) compared to the Nucleus 7 Sound Processor (SCAN FF minus SCAN) in the S0N180 spatial configuration | The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words. | Week 2 and week 4 |
| Paired difference in CNC percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration | The consonant-nucleus-consonant (CNC) monosyllabic word test will be used to assess speech perception of words in quiet. The test consists of 10 recorded lists of 50 monosyllabic words, produced by a male talker. | Week 2 and week 4 |
| Paired difference in AzBio percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration | The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words. | Week 2 and week 4 |
| Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N0 spatial configuration | The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words. | Week 2 and week 4 |
| Proportion of participants preferring each sound processor in various listening domains | The Device Preference Questionnaire is a custom self-assessment to evaluate participants' preference between the Nucleus 8 and Nucleus 7 Sound Processors, or "no preference". | Week 4 |
| Mean difference in SSQ-12 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor | The SSQ-12 is a validated 12-item abbreviated form of the Speech, Spatial, and Qualities of Hearing scale that measures self-reported hearing ability across speech, spatial, and sound quality domains, with each item rated from 0 (poor) to 10 (excellent). Total scores are calculated by averaging responses across relevant items. | Week 2 and Week 4 |
| Mean difference in VFS-A-10 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor | The Vanderbilt Fatigue Scale-10-Item Adult (VFS-A-10) is a validated 10-item subjective scale designed to assess listening-related fatigue in adults with hearing loss. The scale provides a total score based on all 10 questions rated on a Likert scale from 0 (no listening-related fatigue) to 4 (severe listening-related fatigue). | Week 2 and Week 4 |
| 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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