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| Name | Class |
|---|---|
| Hearts for Hearing | OTHER |
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Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roger On microphone | Device | Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lateralization Hearing Ability | Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select) | Day 1 of 1 day study |
| Spatial Hearing Ability | Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select) | Day 1 of 1 day study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hearts for Hearing | Oklahoma City | Oklahoma | 73120 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. Roger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids Roger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adults with moderate-severe bilateral sensorineural hearing loss
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. Roger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids Roger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids |
| 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 | Lateralization Hearing Ability | Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select) | Posted | Mean | Full Range | percent correct responses | Day 1 of 1 day study |
|
1 day
All participants underwent testing with both the Roger On Microphone and the Roger Select Microphone during one day testing session. Therefore, all participants are combined for the Adverse Event Reporting.
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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 | Experimental | All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. Roger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids Roger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lead Investigator | Hearts for Hearing | 405-548-4335 | phonakaudiologyresearch@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 26, 2022 | Apr 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Roger Select microphone | Device | Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Spatial Hearing Ability | Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select) | Posted | Mean | Full Range | percentage of words correctly repeated | Day 1 of 1 day study |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |