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The study is a non-interventional, observational, study on users of Ponto sound processors who use their sound processors on a softband solution. The purpose of this study is to assess subjective benefit by evaluating performance and overall satisfaction of the Ponto on a Ponto Softband in pediatric users.
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| Measure | Description | Time Frame |
|---|---|---|
| PEACH Overall Score | Overall score from the Parents' Evaluation of Aural/Oral Performance of Children questionnaire (PEACH questionnaire). PEACH score is calculated as percentage of the maximum score (thus score is on a scale of 0-100%). Higher score indicate better performance. | Single timepoint for completion of survey |
| Quiet PEACH | Quiet score from the Parents' Evaluation of Aural/Oral Performance of Children questionnaire (PEACH questionnaire). PEACH score is calculated as percentage of the maximum score (thus score is on a scale of 0-100%). Higher score indicate better performance. | Single timepoint for completion of survey |
| Noise PEACH | Overall score from the Parents' Evaluation of Aural/Oral Performance of Children questionnaire (PEACH questionnaire). PEACH score is calculated as percentage of the maximum score (thus score is on a scale of 0-100%). Higher score indicate better performance. | Single timepoint for completion of survey |
| Total GCBI Score | Total score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. | Single time point for completing survey |
| Psycho Social GCBI Score | Psycho social score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. | Single timepoint for completion of survey |
| Physical Health GCBI Score | Physical health score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. |
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Inclusion Criteria:
Exclusion Criteria:
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Ponto sound processor users
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oticon Medical | Somerset | New Jersey | 08873 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | Participants who participated in the survey (one armed study) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 64 participants who participated in the survey
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Participants who participated in the survey (one armed study) |
| 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 | PEACH Overall Score | Overall score from the Parents' Evaluation of Aural/Oral Performance of Children questionnaire (PEACH questionnaire). PEACH score is calculated as percentage of the maximum score (thus score is on a scale of 0-100%). Higher score indicate better performance. | Full analysis set of all participants | Posted | Mean | Standard Deviation | Score on a scale | Single timepoint for completion of survey |
|
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The study is a survey and did not include adverse event assessment
The study is a survey and did not include adverse event assessment
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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 | Participants | Participants who participated in the survey (one armed study) | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Oticon medical | +46 31 748 61 00 | studyinfor@oticonmedical.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 | Jun 26, 2023 | Apr 22, 2025 | 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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| Single timepoint for completion of survey |
| Behavior GCBI Score | Behavior score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. | Single timepoint for completion of survey |
| Vitality GCBI Score | Vitality score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. | Single timepoint for completion of survey |
| Use of Sound Processor | Survey question: "Think about how much your child used their sound processor(s) over the past two weeks. On an average day, how many hours did they use the sound processor(s)?" | Single timepoint for completion of survey |
| Hearing Benefit | Survey question: "Think about a situation where your child wanted to hear better, before receiving their sound processor. Over the past two weeks, how much has the sound processor(s) helped in that situation?" | Single timepoint for completion of survey |
| Overall Satisfaction - Ponto Experience | Survey question: "How satisfied overall are you with your child's Ponto experience?" | Single timepoint for completion of survey |
| Satisfaction With Softband | Survey question: "How satisfied overall are you with your child's softband?" | Single timepoint for completion of survey |
| years |
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| Sex/Gender, Customized | 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 |
|
| Region of Enrollment | Number | participants |
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| Primary | Quiet PEACH | Quiet score from the Parents' Evaluation of Aural/Oral Performance of Children questionnaire (PEACH questionnaire). PEACH score is calculated as percentage of the maximum score (thus score is on a scale of 0-100%). Higher score indicate better performance. | Full analysis set of all participants | Posted | Mean | Standard Deviation | Score on a scale | Single timepoint for completion of survey |
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| Primary | Noise PEACH | Overall score from the Parents' Evaluation of Aural/Oral Performance of Children questionnaire (PEACH questionnaire). PEACH score is calculated as percentage of the maximum score (thus score is on a scale of 0-100%). Higher score indicate better performance. | Full analysis set of all participants | Posted | Mean | Standard Deviation | Score on a scale | Single timepoint for completion of survey |
|
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| Primary | Total GCBI Score | Total score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. | Out of the 64 participants, only 47 completed the GCBI questionnaire. | Posted | Mean | Standard Deviation | Score on a scale | Single time point for completing survey |
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|
| Primary | Psycho Social GCBI Score | Psycho social score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. | Out of the 64 participants, only 47 completed the GCBI questionnaire. | Posted | Mean | Standard Deviation | Score on a scale | Single timepoint for completion of survey |
|
|
|
| Primary | Physical Health GCBI Score | Physical health score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. | Out of the 64 participants, only 47 completed the GCBI questionnaire. | Posted | Mean | Standard Deviation | Score on a scale | Single timepoint for completion of survey |
|
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| Primary | Behavior GCBI Score | Behavior score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. | Out of the 64 participants, only 47 completed the GCBI questionnaire. | Posted | Mean | Standard Deviation | Score on a scale | Single timepoint for completion of survey |
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| Primary | Vitality GCBI Score | Vitality score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit. | Out of the 64 participants, only 47 completed the GCBI questionnaire. | Posted | Mean | Standard Deviation | Score on a scale | Single timepoint for completion of survey |
|
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| Primary | Use of Sound Processor | Survey question: "Think about how much your child used their sound processor(s) over the past two weeks. On an average day, how many hours did they use the sound processor(s)?" | Full analysis set of participants | Posted | Count of Participants | Participants | Single timepoint for completion of survey |
|
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|
| Primary | Hearing Benefit | Survey question: "Think about a situation where your child wanted to hear better, before receiving their sound processor. Over the past two weeks, how much has the sound processor(s) helped in that situation?" | Full analysis set of | Posted | Count of Participants | Participants | Single timepoint for completion of survey |
|
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| Primary | Overall Satisfaction - Ponto Experience | Survey question: "How satisfied overall are you with your child's Ponto experience?" | Full analysis set of 64 participants | Posted | Count of Participants | Participants | Single timepoint for completion of survey |
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| Primary | Satisfaction With Softband | Survey question: "How satisfied overall are you with your child's softband?" | Full analysis set of participants | Posted | Count of Participants | Participants | Single timepoint for completion of survey |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| More than 8 hours |
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| None |
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| Helped quite a lot |
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| Helped very much |
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| Not answered |
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| Not at all |
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| Not at all |
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