Hearing LossNCT06638840
Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.
An observational study of Hearing Loss, run by Oticon Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to 2 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ponto sound processor users
Who may be able to join
- currently using Oticon Medical Ponto sound processor on Oticon Medical Softband
Who cannot join
- not
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Hearing Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)?"
Measured: 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?"
Measured: Single timepoint for completion of survey
Overall Satisfaction - Ponto Experience
Survey question: "How satisfied overall are you with your child's Ponto experience?"
Measured: Single timepoint for completion of survey
Satisfaction With Softband
Survey question: "How satisfied overall are you with your child's softband?"
Measured: Single timepoint for completion of survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start11 Jul 2023
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638840
- Sponsor's protocol ID
- BC117
- Status last verified
- Apr 2025
- First submitted
- 4 Oct 2024
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.
- ClinicalTrials.gov ID
- NCT06638840
- Acronym / sponsor ID
- BC117
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ponto sound processor users
Key inclusion criteria (1 listed)
- currently using Oticon Medical Ponto sound processor on Oticon Medical Softband
Key exclusion criteria (1 listed)
- not
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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)?"
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?"
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?"
Satisfaction With Softband
Time frame: Single timepoint for completion of survey
Survey question: "How satisfied overall are you with your child's softband?"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Oticon Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEACH Overall Score (time frame: Single timepoint for completion of survey). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.