Hearing Loss
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Oticon Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* currently using Oticon Medical Ponto sound processor on Oticon Medical Softband
Exclusion criteria
* not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PEACH Overall Score | Single timepoint for completion of survey | 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. |
| Quiet PEACH | Single timepoint for completion of survey | 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. |
| Noise PEACH | Single timepoint for completion of survey | 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. |
| Total GCBI Score | Single time point for completing survey | 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. |
| Psycho Social GCBI Score | Single timepoint for completion of survey | 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. |
| Physical Health GCBI Score | Single timepoint for completion of survey | 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. |
| Behavior GCBI Score | Single timepoint for completion of survey | 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. |
| Vitality GCBI Score | Single timepoint for completion of survey | 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. |
| Use of Sound Processor | Single timepoint for completion of survey | 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)? |
| Hearing Benefit | Single timepoint for completion of survey | 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? |
| Overall Satisfaction - Ponto Experience | Single timepoint for completion of survey | Survey question: How satisfied overall are you with your child's Ponto experience? |
| Satisfaction With Softband | Single timepoint for completion of survey | Survey question: How satisfied overall are you with your child's softband? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Participants who participated in the survey (one armed study) | 64 |
| Total | 64 |
Baseline characteristics
| Characteristic | Participants | — |
|---|---|---|
| Age, Continuous | 6.0 years STANDARD_DEVIATION 4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 64 participants | — |
| Sex/Gender, Customized Gender Do not wish to say | 1 Participants | — |
| Sex/Gender, Customized Gender Female | 28 Participants | — |
| Sex/Gender, Customized Gender Male | 35 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Single timepoint for completion of survey
Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants | Behavior GCBI Score | 61.0 Score on a scale | Standard Deviation 34.5 |
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?
Time frame: Single timepoint for completion of survey
Population: Full analysis set of
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants | Hearing Benefit | Helped slightly | 3 Participants |
| Participants | Hearing Benefit | Helped not at all | 0 Participants |
| Participants | Hearing Benefit | Helped moderately | 11 Participants |
| Participants | Hearing Benefit | Helped quite a lot | 14 Participants |
| Participants | Hearing Benefit | Helped very much | 35 Participants |
| Participants | Hearing Benefit | Not answered | 1 Participants |
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.
Time frame: Single timepoint for completion of survey
Population: Full analysis set of all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants | Noise PEACH | 70.3 Score on a scale | Standard Deviation 18 |
Primary
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
Population: Full analysis set of 64 participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants | Overall Satisfaction - Ponto Experience | Moderately | 13 Participants |
| Participants | Overall Satisfaction - Ponto Experience | Very much | 37 Participants |
| Participants | Overall Satisfaction - Ponto Experience | Quite a lot | 12 Participants |
| Participants | Overall Satisfaction - Ponto Experience | Slightly | 1 Participants |
| Participants | Overall Satisfaction - Ponto Experience | Not at all | 1 Participants |
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.
Time frame: Single timepoint for completion of survey
Population: Full analysis set of all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants | PEACH Overall Score | 76.1 Score on a scale | Standard Deviation 14.4 |
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.
Time frame: Single timepoint for completion of survey
Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants | Physical Health GCBI Score | 24.0 Score on a scale | Standard Deviation 13.3 |
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.
Time frame: Single timepoint for completion of survey
Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants | Psycho Social GCBI Score | 27.9 Score on a scale | Standard Deviation 42.9 |
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.
Time frame: Single timepoint for completion of survey
Population: Full analysis set of all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants | Quiet PEACH | 81.0 Score on a scale | Standard Deviation 12.8 |
Primary
Satisfaction With Softband
Survey question: How satisfied overall are you with your child's softband?
Time frame: Single timepoint for completion of survey
Population: Full analysis set of participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants | Satisfaction With Softband | Very much | 14 Participants |
| Participants | Satisfaction With Softband | Quite a lot | 22 Participants |
| Participants | Satisfaction With Softband | Moderately | 18 Participants |
| Participants | Satisfaction With Softband | Slightly | 5 Participants |
| Participants | Satisfaction With Softband | Not at all | 5 Participants |
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.
Time frame: Single time point for completing survey
Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants | Total GCBI Score | 38.6 Score on a scale | Standard Deviation 27.4 |
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)?
Time frame: Single timepoint for completion of survey
Population: Full analysis set of participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants | Use of Sound Processor | Less than 1 hour | 1 Participants |
| Participants | Use of Sound Processor | 1 to 4 hours | 4 Participants |
| Participants | Use of Sound Processor | 4 to 8 hours | 15 Participants |
| Participants | Use of Sound Processor | More than 8 hours | 43 Participants |
| Participants | Use of Sound Processor | None | 1 Participants |
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.
Time frame: Single timepoint for completion of survey
Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants | Vitality GCBI Score | 37.8 Score on a scale | Standard Deviation 30 |