Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.

April 22, 2025 updated by: Oticon Medical
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Oticon Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ponto sound processor users

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • not

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single timepoint for completion of survey
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.
Single timepoint for completion of survey
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.
Single timepoint for completion of survey
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.
Single time point for completing survey
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.
Single timepoint for completion of survey
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.
Single timepoint for completion of survey
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.
Single timepoint for completion of survey
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.
Single timepoint for completion of survey
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)?"
Single timepoint for completion of survey
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?"
Single timepoint for completion of survey
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?"
Single timepoint for completion of survey
Satisfaction With Softband
Time Frame: Single timepoint for completion of survey
Survey question: "How satisfied overall are you with your child's softband?"
Single timepoint for completion of survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oticon Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Actual)

October 2, 2024

Study Completion (Actual)

October 2, 2024

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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