Trial Outcomes & Findings for Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor (NCT NCT03848910)
NCT ID: NCT03848910
Last Updated: 2021-10-14
Results Overview
Measuring of subscales Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the precursor sound processor at Day 0 and with the Investigational device after 6 weeks with a questionnaire. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problems and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement with the Investigational device, a negative value an impairment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Day 0 (Visit 1) and after 6 weeks (Visit 3)
Results posted on
2021-10-14
Participant Flow
Participant milestones
| Measure |
Investigational Device - Sound Processor
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
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|---|---|
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Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
Baseline characteristics by cohort
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
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|---|---|
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Age, Continuous
|
48.7 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
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5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
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Region of Enrollment
Australia
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11 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 0 (Visit 1) and after 6 weeks (Visit 3)Measuring of subscales Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the precursor sound processor at Day 0 and with the Investigational device after 6 weeks with a questionnaire. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problems and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement with the Investigational device, a negative value an impairment.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
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|---|---|
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
Ease of communication
|
6.3 units on a scale
Standard Deviation 10.1
|
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
Background noise
|
7.0 units on a scale
Standard Deviation 12.6
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Reverberation
|
5.6 units on a scale
Standard Deviation 10.3
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Aversiveness
|
3.5 units on a scale
Standard Deviation 7.5
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Global
|
6.3 units on a scale
Standard Deviation 9.5
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PRIMARY outcome
Timeframe: Day 0 and after 6 weeksMeasuring speech, spatial and hearing experiences with the precursor sound processor at Day 0 (Visit 1) and with Investigational device after 6 weeks (Visit 3) with a questionnaire. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly" is used. An increase of a SSQ value reflects an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement and a negative value an impairment.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
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|---|---|
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Speech, Spatial, and Qualities of Hearing Scale (SSQ)
Spatial score
|
1.0 units on a scale
Standard Deviation 1.6
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Speech, Spatial, and Qualities of Hearing Scale (SSQ)
Quality score
|
0.061 units on a scale
Standard Deviation 1.26
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Speech, Spatial, and Qualities of Hearing Scale (SSQ)
Speech
|
0.96 units on a scale
Standard Deviation 0.89
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Speech, Spatial, and Qualities of Hearing Scale (SSQ)
Total
|
0.68 units on a scale
Standard Deviation 0.62
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PRIMARY outcome
Timeframe: Day 0 and after 6 weeksMeasuring QUEST (Self-reported assessment regarding satisfaction and usability) using a questionnaire, with the precursor sound processor at Day 0 (Visit 1) and with the Investigational device after 6 weeks (Visit 3). The QUEST form displays the scoring of 8 satisfaction items. The satisfaction items related to the characteristics of the device are: 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness. A scale from 1 to 5, where 1 represent not satisfied at all, 2 not very satisfied, 3 more or less satisfied, 4 quiet satisfied and 5 represents very satisfied. The three most important items of 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness were listed by each participant.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
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|---|---|
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Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Weight; very satisfied
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11 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Adjustment; not satisfied at all
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0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Adjustment; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Adjustment; more or less satisfied
|
2 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Adjustment; quiet satisfied
|
3 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Adjustment; very satisfied
|
6 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Adjustment; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Dimension; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Dimension; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Dimension; more or less satisfied
|
3 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Dimension; quiet satisfied
|
4 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Dimension; very satisfied
|
4 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Dimension; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Dimension; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Dimension; more or less satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Dimension; quiet satisfied
|
3 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Dimension; very satisfied
|
8 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Weight; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Weight; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Weight; more or less satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Weight; quiet satisfied
|
3 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Adjustment; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Adjustment; more or less satisfied
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Adjustment; quiet satisfied
|
2 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Adjustment; very satisfied
|
8 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Safety; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Safety; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Safety; more or less satisfied
|
3 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Weight; very satisfied
|
8 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Safety; quiet satisfied
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Safety; very satisfied
|
7 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Safety; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Safety; not very satisfied
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Safety; more or less satisfied
|
2 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Safety; quiet satisfied
|
2 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Safety; very satisfied
|
6 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Durability; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Durability; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Durability; more or less satisfied
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Durability; quiet satisfied
|
4 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Durability; very satisfied
|
6 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Durability; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Durability; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Durability; more or less satisfied
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Durability; quiet satisfied
|
4 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Durability; very satisfied
|
6 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Easy of use; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Easy of use; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Easy of use; more or less satisfied
|
3 Participants
|
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Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Easy of use; quiet satisfied
|
3 Participants
|
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Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Easy of use; very satisfied all
|
5 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Easy of use; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Easy of use; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Easy of use; more or less satisfied
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Easy of use; quiet satisfied
|
3 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Easy of use; very satisfied all
|
7 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Comfort; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Comfort; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Comfort; more or less satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Comfort; quiet satisfied
|
3 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Comfort; very satisfied
|
8 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Comfort; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Comfort; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Comfort; more or less satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Comfort; quiet satisfied
|
2 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Comfort; very satisfied
|
9 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Effectiveness; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Effectiveness; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Effectiveness; more or less satisfied
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Effectiveness; quiet satisfied
|
7 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Effectiveness; very satisfied
|
3 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Effectiveness; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Effectiveness; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Effectiveness; more or less satisfied
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Effectiveness; quiet satisfied
|
3 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Effectiveness; very satisfied
|
7 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Important item, Dimensions
|
2 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Important item, Weight
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Important item, Adjustments
|
2 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Important item, Safety
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Important item, Durability
|
5 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Important item, Easy of use
|
5 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Important item, Comfort
|
7 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 1: Important item, Effectiveness
|
11 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Important item, Dimensions
|
4 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Important item, Weight
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Important item, Adjustments
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Important item, Safety
|
1 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Important item, Durability
|
5 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Important item, Easy of use
|
4 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Important item, Comfort
|
7 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Important item, Effectiveness
|
11 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Weight; not satisfied at all
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Weight; not very satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Weight; more or less satisfied
|
0 Participants
|
|
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Visit 3: Weight; quiet satisfied
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3To measure threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) with both the precursor sound processor and the Investigational device. The units reported for PTA4 are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)
|
-2.5 dB
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 6 weeks after study startTo measure threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz with both the precursor sound processor and the Investigational device. The units reported for threshold audiometry are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
Audiometric Thresholds in Freefield, Individual Frequencies
250 Hz
|
-2.3 dB
Standard Deviation 4.7
|
|
Audiometric Thresholds in Freefield, Individual Frequencies
500 Hz
|
-3.6 dB
Standard Deviation 5.1
|
|
Audiometric Thresholds in Freefield, Individual Frequencies
750 Hz
|
-6.4 dB
Standard Deviation 3.9
|
|
Audiometric Thresholds in Freefield, Individual Frequencies
1000 Hz
|
-3.6 dB
Standard Deviation 3.9
|
|
Audiometric Thresholds in Freefield, Individual Frequencies
1500 Hz
|
-3.6 dB
Standard Deviation 6.0
|
|
Audiometric Thresholds in Freefield, Individual Frequencies
2000 Hz
|
-1.2 dB
Standard Deviation 3.4
|
|
Audiometric Thresholds in Freefield, Individual Frequencies
3000 Hz
|
-4.1 dB
Standard Deviation 3.8
|
|
Audiometric Thresholds in Freefield, Individual Frequencies
4000 Hz
|
-0.9 dB
Standard Deviation 5.4
|
|
Audiometric Thresholds in Freefield, Individual Frequencies
6000 Hz
|
-4.6 dB
Standard Deviation 4.2
|
|
Audiometric Thresholds in Freefield, Individual Frequencies
8000 Hz
|
-1.8 dB
Standard Deviation 14.7
|
PRIMARY outcome
Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3To measure Adaptive speech recognition in noise with the precursor sound processor and the Investigational device. Measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech and noise presented from the front (0 degrees azimuth). The speech is kept constant at 65 dB Sound Pressure Level (SPL) and the noise is adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
Adaptive Speech Recognition in Noise Ratio
Visit 1
|
-1.3 SNR
Standard Deviation 1.2
|
|
Adaptive Speech Recognition in Noise Ratio
Visit 3
|
-1.2 SNR
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3To measure Speech in quiet at 50, 65 and 80 dB with the precursor sound processor and the Investigational device. Speech in Quiet presents a list of words in a quiet environment at three different presentations levels, 50, 65 and 80 dB (decibel). The number of correct words perceived at each presentation level are counted and the percentage in relation to the total presented amount of words is calculated. A higher score reflects a higher percentage of correct words perceived, i.e. better hearing in a quiet environment.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
Speech in Quiet
50 dB visit 1
|
82.5 % correct perceived words
Standard Deviation 6.8
|
|
Speech in Quiet
50 dB visit 3
|
83.3 % correct perceived words
Standard Deviation 7.2
|
|
Speech in Quiet
65 dB visit 1
|
93.7 % correct perceived words
Standard Deviation 2.4
|
|
Speech in Quiet
65 dB visit 3
|
96.9 % correct perceived words
Standard Deviation 2.4
|
|
Speech in Quiet
80 dB visit 1
|
94.4 % correct perceived words
Standard Deviation 4.1
|
|
Speech in Quiet
80 dB visit 3
|
96.9 % correct perceived words
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: 6 weeks after study startThe test subject will be asked a question regarding preferred choice made by selection between Investigational device and the precursor sound processor (comparator). Three boxes can be ticked; Precursor Sound Processor, Investigational Device, No preference.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor
No preference
|
0 Participants
|
|
To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor
Precursor sound processor
|
0 Participants
|
|
To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor
Investigational device
|
11 Participants
|
PRIMARY outcome
Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3Measure Comfort by a visual analogue scale (VAS) 100 mm at Day 0 regarding the precursor sound processor and after 6 weeks regarding the Investigational device. Subject will be asked to put a line where they find most appropriate where 0 mm represents Not comfortable at all and 100 represents Most comfortable imaginable. The distance will be measured with a ruler and presented as a value between 0 and 100. A higher score reflects higher comfort.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
To Assess the Subject's Experience Regarding Comfort
Precursor sound processor
|
84.9 units on a scale
Standard Deviation 16.8
|
|
To Assess the Subject's Experience Regarding Comfort
Investigational device
|
87.5 units on a scale
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: 6 weeks after study startMagnet choice will be entered; four boxes are available, 1, 2, 3 and 4, the box with the strength chosen by the patient will be ticked. Magnet strength 1 is the weakest and 4 is the strongest.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
To Assess the Subject's Experience Regarding Usage; Magnet Choice
Strength 1
|
1 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Magnet Choice
Strength 2
|
3 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Magnet Choice
Strength 3
|
3 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Magnet Choice
Strength 4
|
4 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after study startThe patient will be asked a question regarding battery life; "How often was the battery changed". A free text field is available for answer.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
To Assess the Subject's Experience Regarding Usage; Battery Life Time
Every day
|
2 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Battery Life Time
1.5 days
|
2 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Battery Life Time
Every 2 days
|
3 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Battery Life Time
Every 3 days
|
1 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Battery Life Time
Every 3-4 days
|
1 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Battery Life Time
1-2 times a week
|
1 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Battery Life Time
Two work days (16 hours)
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after study startThe patient will be asked a question "Did you use a SoftWear Pad in the last 6 weeks". The patient can tick a "Yes" or "No" box.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
To Assess the Subject's Experience Regarding Usage; Softwear Pad
Yes
|
2 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Softwear Pad
No
|
9 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after study startThe patient will be asked a question "Did you use a safety line in the last 6 weeks". The patient can tick a "Yes" or "No" box.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
To Assess the Subject's Experience Regarding Usage; Safety Line
Yes
|
9 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Safety Line
No
|
2 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after study startThe patient will be asked a question "Did you use a Wireless accessory during the last 6 weeks". The patient can tick a "Yes" or "No" box.
Outcome measures
| Measure |
Investigational Device - Sound Processor
n=11 Participants
Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
To Assess the Subject's Experience Regarding Usage; Wireless Accessories
Yes
|
11 Participants
|
|
To Assess the Subject's Experience Regarding Usage; Wireless Accessories
No
|
0 Participants
|
Adverse Events
Investigational Device - Sound Processor
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigational Device - Sound Processor
n=11 participants at risk
Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation-test ear
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
|
Ear and labyrinth disorders
Fluid in middle ear
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Mastoid cavity infection
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
|
Ear and labyrinth disorders
Fall due to SCCD
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution must give a copy of any proposed Publication to the Sponsor at least 40 days before forwarding it to any person that is not bound by the confidentiality obligations The Sponsor may, within that 40-day period: 1. provide comments; 2. request delay of Publication for no more than 120 days, or 3. request that the Discloser remove specified Confidential Information from the Publication.
- Publication restrictions are in place
Restriction type: OTHER