Trial Outcomes & Findings for Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users (NCT NCT05150964)
NCT ID: NCT05150964
Last Updated: 2023-05-19
Results Overview
A familiar spondee word list is presented at varying dB (decibel) levels. Threshold is defined as the lowest dB level at which a correct response occurs for two out of three ascending trials. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session, and counterbalanced across participants. Each session consisted of testing with the ASG (Adaptive Situational Gain) feature on and off. The lower the number (dB level), the softer the participant is able to repeat the words correctly two out of three times.
COMPLETED
NA
16 participants
Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)
2023-05-19
Participant Flow
Participant milestones
| Measure |
Experimental
One group will be fit with commercially available hearing aids that will have different program settings. Each participant will be tested with the study hearing devices in the following conditions:
1. Hearing device programmed with the NAL (National Acoustic Laboratory) fitting prescription and with the ASG feature both on and off.
2. Hearing device programmed with the DSL (Desired Sensation Level) fitting prescription and with the ASG feature both on and off.
For certain speech tests the above conditions will apply but will include testing levels at both a louder level and a softer level.
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds
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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Experimental
One group will be fit with commercially available hearing aids that will have different program settings. Each participant will be tested with the study hearing devices in the following conditions:
1. Hearing device programmed with the NAL (National Acoustic Laboratory) fitting prescription and with the ASG feature both on and off.
2. Hearing device programmed with the DSL (Desired Sensation Level) fitting prescription and with the ASG feature both on and off.
For certain speech tests the above conditions will apply but will include testing levels at both a louder level and a softer level.
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds
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|---|---|
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Overall Study
Lost to Follow-up
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2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental
n=16 Participants
One group will be fit with commercially available hearing aids that will have different program settings
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds
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|---|---|
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Age, Continuous
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13.7 years
n=16 Participants
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Sex: Female, Male
Female
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8 Participants
n=16 Participants
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Sex: Female, Male
Male
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8 Participants
n=16 Participants
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Region of Enrollment
United States
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16 participants
n=16 Participants
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PRIMARY outcome
Timeframe: Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)Population: Participants who were fit with study hearing aids and completed at least one two-hour test session.
A familiar spondee word list is presented at varying dB (decibel) levels. Threshold is defined as the lowest dB level at which a correct response occurs for two out of three ascending trials. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session, and counterbalanced across participants. Each session consisted of testing with the ASG (Adaptive Situational Gain) feature on and off. The lower the number (dB level), the softer the participant is able to repeat the words correctly two out of three times.
Outcome measures
| Measure |
Experimental
n=15 Participants
One group will be fit with commercially available hearing aids that will have different program settings. Each participant will be tested with the study hearing devices in the following conditions:
1. Hearing device programmed with the NAL (National Acoustic Laboratory) fitting prescription and with the ASG feature both on and off.
2. Hearing device programmed with the DSL (Desired Sensation Level) fitting prescription and with the ASG feature both on and off.
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds
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|---|---|
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Speech Reception Threshold
NAL Fitting with ASG Off
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27 dB HL (decibels hearing level)
Standard Deviation 8
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Speech Reception Threshold
NAL Fitting with ASG ON
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27 dB HL (decibels hearing level)
Standard Deviation 7
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Speech Reception Threshold
DSL Fitting with ASG Off
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24 dB HL (decibels hearing level)
Standard Deviation 8
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Speech Reception Threshold
DSL Fitting with ASG On
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24 dB HL (decibels hearing level)
Standard Deviation 6
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PRIMARY outcome
Timeframe: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)Population: Participants who were fit with study hearing aids and completed at least one two-hour test session.
Familiar monosyllabic word list presented at 40 dB and 70 dB. Percentage of words correctly repeated is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. The higher the score, the better the word recognition in each condition.
Outcome measures
| Measure |
Experimental
n=15 Participants
One group will be fit with commercially available hearing aids that will have different program settings. Each participant will be tested with the study hearing devices in the following conditions:
1. Hearing device programmed with the NAL (National Acoustic Laboratory) fitting prescription and with the ASG feature both on and off.
2. Hearing device programmed with the DSL (Desired Sensation Level) fitting prescription and with the ASG feature both on and off.
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds
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|---|---|
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Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
% correct at 40 dB, NAL fitting, ASG Off
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52 percentage of words correctly repeated
Standard Deviation 24
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Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
% correct at 40 dB, NAL fitting, ASG On
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63 percentage of words correctly repeated
Standard Deviation 26
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Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
% correct at 40 dB, DSL fitting, ASG Off
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69 percentage of words correctly repeated
Standard Deviation 21
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Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
% correct at 40 dB, DSL fitting, ASG On
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75 percentage of words correctly repeated
Standard Deviation 22
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Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
% correct at 70 dB, NAL fitting, ASG Off
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92 percentage of words correctly repeated
Standard Deviation 10
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Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
% correct at 70 dB, NAL fitting, ASG On
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95 percentage of words correctly repeated
Standard Deviation 5
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Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
% correct at 70 dB, DSL fitting, ASG Off
|
95 percentage of words correctly repeated
Standard Deviation 6
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Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
% correct, DSL fitting, ASG On
|
96 percentage of words correctly repeated
Standard Deviation 7
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PRIMARY outcome
Timeframe: Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)Population: Participants who were fit with study hearing aids and completed at least one two-hour test session.
Out of a list of seven words, the participant repeats back as many words as they can recall. Percentage of correct words repeated back is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. One fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. A higher percentage score indicates better multi-word recognition.
Outcome measures
| Measure |
Experimental
n=15 Participants
One group will be fit with commercially available hearing aids that will have different program settings. Each participant will be tested with the study hearing devices in the following conditions:
1. Hearing device programmed with the NAL (National Acoustic Laboratory) fitting prescription and with the ASG feature both on and off.
2. Hearing device programmed with the DSL (Desired Sensation Level) fitting prescription and with the ASG feature both on and off.
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds
|
|---|---|
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Multi-word Recognition at 40 dB SPL and 70 dB SPL
% correct at 70 dB, DSL fitting, ASG On
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67 percentage of words correctly repeated
Standard Deviation 13
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Multi-word Recognition at 40 dB SPL and 70 dB SPL
% correct at 40 dB for NAL fitting, ASG Off
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48 percentage of words correctly repeated
Standard Deviation 20
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Multi-word Recognition at 40 dB SPL and 70 dB SPL
% correct at 40 dB for NAL fitting, ASG On
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56 percentage of words correctly repeated
Standard Deviation 16
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Multi-word Recognition at 40 dB SPL and 70 dB SPL
% correct at 40 dB for DSL fitting, ASG Off
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51 percentage of words correctly repeated
Standard Deviation 16
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Multi-word Recognition at 40 dB SPL and 70 dB SPL
% correct at 40 dB for DSL fitting, ASG On
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54 percentage of words correctly repeated
Standard Deviation 16
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Multi-word Recognition at 40 dB SPL and 70 dB SPL
% correct at 70 dB, NAL fitting, ASG Off
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66 percentage of words correctly repeated
Standard Deviation 17
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Multi-word Recognition at 40 dB SPL and 70 dB SPL
% correct at 70 dB, NAL fitting, ASG On
|
67 percentage of words correctly repeated
Standard Deviation 13
|
|
Multi-word Recognition at 40 dB SPL and 70 dB SPL
% correct at 70 dB, DSL fitting, ASG Off
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63 percentage of words correctly repeated
Standard Deviation 13
|
PRIMARY outcome
Timeframe: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)Population: Participants who were fit with study hearing aids and completed at least one two-hour test session.
A list of 10 3-word phrases are presented to the participant. The participant indicates if the phrase contains a nonsense word by selecting the numbered response button (i.e. "1", "2", or "3") that corresponds to the position oof the nonsense word in the phrase. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. . The score is the percent correct, a higher score is better.
Outcome measures
| Measure |
Experimental
n=15 Participants
One group will be fit with commercially available hearing aids that will have different program settings. Each participant will be tested with the study hearing devices in the following conditions:
1. Hearing device programmed with the NAL (National Acoustic Laboratory) fitting prescription and with the ASG feature both on and off.
2. Hearing device programmed with the DSL (Desired Sensation Level) fitting prescription and with the ASG feature both on and off.
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds
|
|---|---|
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Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
% correct at 40 dB, NAL fitting formula, ASG Off
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65 percentage of correct responses
Standard Deviation 15
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Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
% correct at 40 dB, NAL fitting with ASG On
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68 percentage of correct responses
Standard Deviation 13
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Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
% correct at 40 dB, DSL fitting, ASG Off
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73 percentage of correct responses
Standard Deviation 18
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|
Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
% correct at 40 dB, DSL fitting, ASG On
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71 percentage of correct responses
Standard Deviation 12
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Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
% correct at 70 dB, NAL fitting, ASG Off
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89 percentage of correct responses
Standard Deviation 7
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Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
% correct at 70 dB, NAL fitting, ASG On
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87 percentage of correct responses
Standard Deviation 7
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|
Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
% correct at 70 dB, DSL fitting, ASG Off
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88 percentage of correct responses
Standard Deviation 9
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Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
% correct at 70 dB, DSL fitting, ASG On
|
87 percentage of correct responses
Standard Deviation 7
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PRIMARY outcome
Timeframe: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)Population: Participants who were fit with study hearing aids and completed at least one two-hour test session.
A word learning task used to determine participant's ability to associate novel/nonsense words with novel images as rapidly as possible. Five nonsense words are paired with five novel images displayed on response buttons. The words are presented randomly 10 times each. The participant selects one picture per word. Scores are presented as percent correct. A higher percentage indicates better word learning. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off.
Outcome measures
| Measure |
Experimental
n=15 Participants
One group will be fit with commercially available hearing aids that will have different program settings. Each participant will be tested with the study hearing devices in the following conditions:
1. Hearing device programmed with the NAL (National Acoustic Laboratory) fitting prescription and with the ASG feature both on and off.
2. Hearing device programmed with the DSL (Desired Sensation Level) fitting prescription and with the ASG feature both on and off.
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds
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|---|---|
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Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
% correct at 40 dB, NAL fitting, ASG Off
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68 percentage of correct responses
Standard Deviation 23
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Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
% correct at 40 dB, NAL fitting, ASG On
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76 percentage of correct responses
Standard Deviation 18
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Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
% correct at 40 dB, DSL fitting, ASG Off
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70 percentage of correct responses
Standard Deviation 22
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Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
% correct at 40 dB, DSL fitting, ASG On
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73 percentage of correct responses
Standard Deviation 20
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Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
% correct at 70 dB, NAL fitting, ASG Off
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69 percentage of correct responses
Standard Deviation 18
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Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
% correct at 70 dB, NAL fitting, ASG On
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73 percentage of correct responses
Standard Deviation 16
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Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
% correct at 70 dB, DSL fitting, ASG Off
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67 percentage of correct responses
Standard Deviation 20
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Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
% correct at 70 dB, DSL fitting, ASG On
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70 percentage of correct responses
Standard Deviation 21
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PRIMARY outcome
Timeframe: 2nd appointment (day 14 of study)Population: Participants who were fit with study hearing aids and completed both two-hour test sessions.
Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.
Outcome measures
| Measure |
Experimental
n=14 Participants
One group will be fit with commercially available hearing aids that will have different program settings. Each participant will be tested with the study hearing devices in the following conditions:
1. Hearing device programmed with the NAL (National Acoustic Laboratory) fitting prescription and with the ASG feature both on and off.
2. Hearing device programmed with the DSL (Desired Sensation Level) fitting prescription and with the ASG feature both on and off.
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds
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|---|---|
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Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
Number of participants preferring ASG Off with NAL fitting
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2 Participants
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Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
Number of participants preferring ASG On with NAL fitting
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2 Participants
|
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Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
Number of participants preferring ASG Off with DSL fitting
|
7 Participants
|
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Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
Number of participants preferring ASG On with DSL fitting
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3 Participants
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Adverse Events
Experimental
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place