Trial Outcomes & Findings for Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband. (NCT NCT06638840)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

64 participants

Primary outcome timeframe

Single timepoint for completion of survey

Results posted on

2025-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Participants who participated in the survey (one armed study)
Overall Study STARTED	64
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants n=64 Participants Participants who participated in the survey (one armed study)
Age, Continuous	6.0 years STANDARD_DEVIATION 4.0 • n=64 Participants
Sex/Gender, Customized Gender · Male	35 Participants n=64 Participants
Sex/Gender, Customized Gender · Female	28 Participants n=64 Participants
Sex/Gender, Customized Gender · Do not wish to say	1 Participants n=64 Participants
Region of Enrollment United States	64 participants n=64 Participants

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Full analysis set of all participants

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.

Outcome measures

Outcome measures
Measure	Participants n=64 Participants Participants who participated in the survey (one armed study)
PEACH Overall Score	76.1 Score on a scale Standard Deviation 14.4

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Full analysis set of all participants

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.

Outcome measures

Outcome measures
Measure	Participants n=64 Participants Participants who participated in the survey (one armed study)
Quiet PEACH	81.0 Score on a scale Standard Deviation 12.8

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Full analysis set of all participants

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.

Outcome measures

Outcome measures
Measure	Participants n=64 Participants Participants who participated in the survey (one armed study)
Noise PEACH	70.3 Score on a scale Standard Deviation 18.0

PRIMARY outcome

Timeframe: Single time point for completing survey

Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.

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.

Outcome measures

Outcome measures
Measure	Participants n=47 Participants Participants who participated in the survey (one armed study)
Total GCBI Score	38.6 Score on a scale Standard Deviation 27.4

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.

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.

Outcome measures

Outcome measures
Measure	Participants n=47 Participants Participants who participated in the survey (one armed study)
Psycho Social GCBI Score	27.9 Score on a scale Standard Deviation 42.9

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.

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.

Outcome measures

Outcome measures
Measure	Participants n=47 Participants Participants who participated in the survey (one armed study)
Physical Health GCBI Score	24.0 Score on a scale Standard Deviation 13.3

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.

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.

Outcome measures

Outcome measures
Measure	Participants n=47 Participants Participants who participated in the survey (one armed study)
Behavior GCBI Score	61.0 Score on a scale Standard Deviation 34.5

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Out of the 64 participants, only 47 completed the GCBI questionnaire.

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.

Outcome measures

Outcome measures
Measure	Participants n=47 Participants Participants who participated in the survey (one armed study)
Vitality GCBI Score	37.8 Score on a scale Standard Deviation 30

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Full analysis set of participants

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)?"

Outcome measures

Outcome measures
Measure	Participants n=64 Participants Participants who participated in the survey (one armed study)
Use of Sound Processor Less than 1 hour	1 Participants
Use of Sound Processor 1 to 4 hours	4 Participants
Use of Sound Processor 4 to 8 hours	15 Participants
Use of Sound Processor More than 8 hours	43 Participants
Use of Sound Processor None	1 Participants

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Full analysis set of

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?"

Outcome measures

Outcome measures
Measure	Participants n=64 Participants Participants who participated in the survey (one armed study)
Hearing Benefit Helped not at all	0 Participants
Hearing Benefit Helped slightly	3 Participants
Hearing Benefit Helped moderately	11 Participants
Hearing Benefit Helped quite a lot	14 Participants
Hearing Benefit Helped very much	35 Participants
Hearing Benefit Not answered	1 Participants

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Full analysis set of 64 participants

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

Outcome measures

Outcome measures
Measure	Participants n=64 Participants Participants who participated in the survey (one armed study)
Overall Satisfaction - Ponto Experience Very much	37 Participants
Overall Satisfaction - Ponto Experience Quite a lot	12 Participants
Overall Satisfaction - Ponto Experience Moderately	13 Participants
Overall Satisfaction - Ponto Experience Slightly	1 Participants
Overall Satisfaction - Ponto Experience Not at all	1 Participants

PRIMARY outcome

Timeframe: Single timepoint for completion of survey

Population: Full analysis set of participants

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

Outcome measures

Outcome measures
Measure	Participants n=64 Participants Participants who participated in the survey (one armed study)
Satisfaction With Softband Very much	14 Participants
Satisfaction With Softband Quite a lot	22 Participants
Satisfaction With Softband Moderately	18 Participants
Satisfaction With Softband Slightly	5 Participants
Satisfaction With Softband Not at all	5 Participants

Adverse Events

Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Affairs

Oticon medical

Phone: +46 31 748 61 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place