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OpenTrials
Completed

NCT Number: NCT06638840

Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.

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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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Oticon Medical

Somerset, New Jersey, 08873, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • currently using Oticon Medical Ponto sound processor on Oticon Medical Softband

Exclusion criteria

  • not

Treatment and study plan

Primary outcomes

  1. PEACH Overall Score

    Time frame: 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.

  2. Quiet PEACH

    Time frame: 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.

  3. Noise PEACH

    Time frame: 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.

  4. Total GCBI Score

    Time frame: 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.

  5. Psycho Social GCBI Score

    Time frame: 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.

  6. Physical Health GCBI Score

    Time frame: 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.

  7. Behavior GCBI Score

    Time frame: 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.

  8. Vitality GCBI Score

    Time frame: 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.

  9. Use of Sound Processor

    Time frame: 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)?"

  10. Hearing Benefit

    Time frame: 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?"

  11. Overall Satisfaction - Ponto Experience

    Time frame: Single timepoint for completion of survey

    Survey question: "How satisfied overall are you with your child's Ponto experience?"

  12. Satisfaction With Softband

    Time frame: Single timepoint for completion of survey

    Survey question: "How satisfied overall are you with your child's softband?"

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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