An observational study in Hearing Loss, sponsored by Oticon Medical. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by Oticon Medical · Observational
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 64 is below the median of 87 across 270 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ponto sound processor users
Exclusion Criteria:
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)?"
Time frame: 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?"
Time frame: Single timepoint for completion of survey
Overall Satisfaction - Ponto Experience
Survey question: "How satisfied overall are you with your child's Ponto experience?"
Time frame: Single timepoint for completion of survey
Satisfaction With Softband
Survey question: "How satisfied overall are you with your child's softband?"
Time frame: Single timepoint for completion of survey
| Milestone | Participants |
|---|---|
| Started | 64 |
| Completed | 47 |
| Not completed | 17 |
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.
| Score on a scale | Participants |
|---|---|
| PEACH Overall Score | 76.1 ± 14.4 |
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.
| Score on a scale | Participants |
|---|---|
| Quiet PEACH | 81.0 ± 12.8 |
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.
| Score on a scale | Participants |
|---|---|
| Noise PEACH | 70.3 ± 18.0 |
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.
| Score on a scale | Participants |
|---|---|
| Total GCBI Score | 38.6 ± 27.4 |
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.
| Score on a scale | Participants |
|---|---|
| Psycho Social GCBI Score | 27.9 ± 42.9 |
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.
| Score on a scale | Participants |
|---|---|
| Physical Health GCBI Score | 24.0 ± 13.3 |
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.
| Score on a scale | Participants |
|---|---|
| Behavior GCBI Score | 61.0 ± 34.5 |
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.
| Score on a scale | Participants |
|---|---|
| Vitality GCBI Score | 37.8 ± 30 |
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)?"
| Participants | Participants |
|---|---|
| Less than 1 hour | 1 |
| 1 to 4 hours | 4 |
| 4 to 8 hours | 15 |
| More than 8 hours | 43 |
| None | 1 |
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?"
| Participants | Participants |
|---|---|
| Helped not at all | 0 |
| Helped slightly | 3 |
| Helped moderately | 11 |
| Helped quite a lot | 14 |
| Helped very much | 35 |
| Not answered | 1 |
Survey question: "How satisfied overall are you with your child's Ponto experience?"
| Participants | Participants |
|---|---|
| Very much | 37 |
| Quite a lot | 12 |
| Moderately | 13 |
| Slightly | 1 |
| Not at all | 1 |
Survey question: "How satisfied overall are you with your child's softband?"
| Participants | Participants |
|---|---|
| Very much | 14 |
| Quite a lot | 22 |
| Moderately | 18 |
| Slightly | 5 |
| Not at all | 5 |
Collected over The study is a survey and did not include adverse event assessment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants | — | — | — |
All 64 participants who participated in the survey
| Age, Continuous(years) | Participants |
|---|---|
| Mean | 6.0 ± 4.0 |
| Sex/Gender, Customized(Participants) | Participants |
|---|---|
| Gender — Male | 35 |
| Gender — Female | 28 |
| Gender — Do not wish to say | 1 |
| Race and Ethnicity Not Collected(Participants) | Participants |
|---|
| Region of Enrollment(participants) | Participants |
|---|---|
| United States | 64 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Oticon Medical