Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.
- Conditions
- Hearing Loss
- Registration Number
- NCT06638840
- Lead Sponsor
- Oticon Medical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- currently using Oticon Medical Ponto sound processor on Oticon Medical Softband
- not
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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.
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?"
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.
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.
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?"
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oticon Medical
🇺🇸Somerset, New Jersey, United States