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New and experienced hearing aid users will be fit with two hearing devices. One will be labeled as an OTC (Over-The-Counter) device, the other will be labeled as a Prescriptive (i.e. professionally fit) device. Both devices will be generically programmed for a mild to moderate hearing loss. An objective speech in noise test will be completed with both devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naive listeners | Experimental | Participants who have never worn a hearing aid before. This group will be tested with both sets of devices, those labeled as "OTC" and those labeled as "Prescriptive" |
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| Experienced users | Experimental | Participants who have at least six months experience wearing hearing aids. This group will be tested with both sets of devices, those labeled as "OTC", and those labeled as "Prescriptive" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audeo P hearing aid labeled as "Prescriptive" | Device | The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Speech in Noise Test (QuickSIN) | A speech in noise test in which participant repeats sentences in variable levels of background noise. Test result is reported as the signal to noise level at which participant can repeat 50% of the words correctly. A lower score/dB SNR (decibel Signal to Noise Ratio) level indicates better speech in noise perception. For example, a score of 0 dB would indicate that the participant can repeat 50% of the words presented when the speech signal and the noise are presented at the same level. A score of 6 dB would indicate that the participant needs the speech signal 6 dB louder than the noise in order to correctly repeat 50% of the words presented. Scores can range from negative db SNR (e.g. -5 dB, which would be a good score and indicate little difficulty in noise) to quite high (e.g. +15 dB, which would be a poorer score and indicate much difficulty in noise) In this case, the scores ranged from +2 to +18 dB. | 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 |
|---|---|---|---|---|---|---|
| Sonova US | Aurora | Illinois | 60505 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naive Listeners | Participants who have not worn hearing aids before. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive". Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant. Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant. |
| FG001 | Experienced Users | Participants who have at least 6 months experience with hearing aids. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive". Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant. Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Naive Listeners | Participants who have not worn hearing aids before. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive". Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant. Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant. |
| 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 | Quick Speech in Noise Test (QuickSIN) | A speech in noise test in which participant repeats sentences in variable levels of background noise. Test result is reported as the signal to noise level at which participant can repeat 50% of the words correctly. A lower score/dB SNR (decibel Signal to Noise Ratio) level indicates better speech in noise perception. For example, a score of 0 dB would indicate that the participant can repeat 50% of the words presented when the speech signal and the noise are presented at the same level. A score of 6 dB would indicate that the participant needs the speech signal 6 dB louder than the noise in order to correctly repeat 50% of the words presented. Scores can range from negative db SNR (e.g. -5 dB, which would be a good score and indicate little difficulty in noise) to quite high (e.g. +15 dB, which would be a poorer score and indicate much difficulty in noise) In this case, the scores ranged from +2 to +18 dB. | All participants who were tested with the devices labeled as "OTC" and with devices that were labeled as "Prescriptive" in the same test session. | Posted | Mean | Full Range | decibels (dB) | Day 1 of 1 day study |
1 day
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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 | Naive Listeners | Participants who have not worn hearing aids before. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive". Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant. Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principle Investigator | Phonak Audiology Research Center | 630-821-5000 | 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 | May 23, 2022 | May 31, 2023 | Prot_SAP_000.pdf |
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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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A single group of participants will be involved in this study. All participants will be evaluated with both hearing devices.
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Participants will be told they are wearing either a prescriptive hearing aid or an OTC (Over-The-Counter) hearing device based on the labeling of the hearing aids. Both sets of devices will actually be the same. The investigator that is scoring the objective speech in noise test will not know which device the participant is wearing at the time of the test (i.e., the set that is labeled as prescriptive or the set that is labeled as OTC).
| Audeo P hearing aid labeled as "OTC" | Device | The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant. |
|
| BG001 | Experienced Users | Participants who haveat least 6 months of experience with hearing aids. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive". Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant. Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Naive Listeners | Participants who have never worn a hearing aid before. This group will be tested with both sets of devices, those labeled as "OTC" and those labeled as "Prescriptive" Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant. Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant. |
| OG001 | Experienced Users | Participants who have at least six months experience wearing hearing aids. This group will be tested with both sets of devices, those labeled as "OTC", and those labeled as "Prescriptive" Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant. Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant. |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Experienced Users | Participants who have at least 6 months experience with hearing aids. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive". Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant. Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |