Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.

NCT06638840 | Completed Results

• 1 other identifier: BC117
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)?"

  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?"

  Single timepoint for completion of survey

• Overall Satisfaction - Ponto Experience

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

  Single timepoint for completion of survey

• Satisfaction With Softband

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

  Single timepoint for completion of survey

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ponto sound processor users

You may qualify if:

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

You may not qualify if:

• not

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

Oticon Medical

Somerset, New Jersey, 08873, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Oticon medical

studyinfor@oticonmedical.com

+46 31 748 61 00

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: July 11, 2023
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)