Hearing Loss
Conditions
Brief summary
Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents.
Interventions
DEVICEPhonak Audeo hearing aid
receiver in the canal devices with custom earmolds
Sponsors
Arizona State University
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss * Must use oral mode of communication * must speak English
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Reception Threshold | Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study) | 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. |
| Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL. | Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study) | 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. |
| Multi-word Recognition at 40 dB SPL and 70 dB SPL | Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study) | 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. |
| Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. | Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study) | 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. |
| Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. | Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study) | 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. |
| Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula | 2nd appointment (day 14 of study) | Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental 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 | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Experimental | — |
|---|---|---|
| Age, Continuous | 13.7 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 16 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Multi-word Recognition at 40 dB SPL and 70 dB SPL
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Multi-word Recognition at 40 dB SPL and 70 dB SPL | % correct at 40 dB for NAL fitting, ASG Off | 48 percentage of words correctly repeated | Standard Deviation 20 |
| Experimental | Multi-word Recognition at 40 dB SPL and 70 dB SPL | % correct at 40 dB for NAL fitting, ASG On | 56 percentage of words correctly repeated | Standard Deviation 16 |
| Experimental | Multi-word Recognition at 40 dB SPL and 70 dB SPL | % correct at 40 dB for DSL fitting, ASG Off | 51 percentage of words correctly repeated | Standard Deviation 16 |
| Experimental | Multi-word Recognition at 40 dB SPL and 70 dB SPL | % correct at 40 dB for DSL fitting, ASG On | 54 percentage of words correctly repeated | Standard Deviation 16 |
| Experimental | Multi-word Recognition at 40 dB SPL and 70 dB SPL | % correct at 70 dB, NAL fitting, ASG Off | 66 percentage of words correctly repeated | Standard Deviation 17 |
| Experimental | 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 |
| Experimental | Multi-word Recognition at 40 dB SPL and 70 dB SPL | % correct at 70 dB, DSL fitting, ASG Off | 63 percentage of words correctly repeated | Standard Deviation 13 |
| Experimental | Multi-word Recognition at 40 dB SPL and 70 dB SPL | % correct at 70 dB, DSL fitting, ASG On | 67 percentage of words correctly repeated | Standard Deviation 13 |
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on multi-word recognition scores.p-value: <0.05Mixed Models Analysis
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on multi-word recognition scores.p-value: >0.05Mixed Models Analysis
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on multi-word recognition scores.p-value: >0.05Mixed Models Analysis
Primary
Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | 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 |
| Experimental | Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. | % correct at 40 dB, NAL fitting formula, ASG Off | 65 percentage of correct responses | Standard Deviation 15 |
| Experimental | Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. | % correct at 40 dB, NAL fitting with ASG On | 68 percentage of correct responses | Standard Deviation 13 |
| Experimental | Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. | % correct at 40 dB, DSL fitting, ASG Off | 73 percentage of correct responses | Standard Deviation 18 |
| Experimental | Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. | % correct at 40 dB, DSL fitting, ASG On | 71 percentage of correct responses | Standard Deviation 12 |
| Experimental | Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. | % correct at 70 dB, NAL fitting, ASG Off | 89 percentage of correct responses | Standard Deviation 7 |
| Experimental | Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. | % correct at 70 dB, NAL fitting, ASG On | 87 percentage of correct responses | Standard Deviation 7 |
| Experimental | Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. | % correct at 70 dB, DSL fitting, ASG Off | 88 percentage of correct responses | Standard Deviation 9 |
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Nonword Detection scores.p-value: <0.05Mixed Models Analysis
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on Nonword Detection scores.p-value: <0.05Mixed Models Analysis
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Nonword Detection scores.p-value: >0.05Mixed Models Analysis
Primary
Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. | % correct at 40 dB, NAL fitting, ASG Off | 68 percentage of correct responses | Standard Deviation 23 |
| Experimental | Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. | % correct at 40 dB, NAL fitting, ASG On | 76 percentage of correct responses | Standard Deviation 18 |
| Experimental | Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. | % correct at 40 dB, DSL fitting, ASG Off | 70 percentage of correct responses | Standard Deviation 22 |
| Experimental | Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. | % correct at 40 dB, DSL fitting, ASG On | 73 percentage of correct responses | Standard Deviation 20 |
| Experimental | Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. | % correct at 70 dB, NAL fitting, ASG Off | 69 percentage of correct responses | Standard Deviation 18 |
| Experimental | Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. | % correct at 70 dB, NAL fitting, ASG On | 73 percentage of correct responses | Standard Deviation 16 |
| Experimental | Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. | % correct at 70 dB, DSL fitting, ASG Off | 67 percentage of correct responses | Standard Deviation 20 |
| Experimental | Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. | % correct at 70 dB, DSL fitting, ASG On | 70 percentage of correct responses | Standard Deviation 21 |
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Rapid Word Learning scores.p-value: >0.05Mixed Models Analysis
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Rapid Word Learning scores.p-value: >0.05Mixed Models Analysis
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescripton will have no effect on Rapid Word Learning scores.p-value: >0.05Mixed Models Analysis
Primary
Speech Reception Threshold
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Speech Reception Threshold | NAL Fitting with ASG Off | 27 dB HL (decibels hearing level) | Standard Deviation 8 |
| Experimental | Speech Reception Threshold | NAL Fitting with ASG ON | 27 dB HL (decibels hearing level) | Standard Deviation 7 |
| Experimental | Speech Reception Threshold | DSL Fitting with ASG Off | 24 dB HL (decibels hearing level) | Standard Deviation 8 |
| Experimental | Speech Reception Threshold | DSL Fitting with ASG On | 24 dB HL (decibels hearing level) | Standard Deviation 6 |
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The hearing aid fitting prescription will have no effect on the speech reception thresholds.p-value: <0.05Mixed Models Analysis
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The ASG setting will have no effect on the speech reception threshold.p-value: >0.05Mixed Models Analysis
Primary
Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.
Time frame: 2nd appointment (day 14 of study)
Population: Participants who were fit with study hearing aids and completed both two-hour test sessions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental | Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula | Number of participants preferring ASG Off with NAL fitting | 2 Participants |
| Experimental | Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula | Number of participants preferring ASG On with NAL fitting | 2 Participants |
| Experimental | Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula | Number of participants preferring ASG Off with DSL fitting | 7 Participants |
| Experimental | Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula | Number of participants preferring ASG On with DSL fitting | 3 Participants |
Primary
Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | 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 | 52 percentage of words correctly repeated | Standard Deviation 24 |
| Experimental | 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 | 63 percentage of words correctly repeated | Standard Deviation 26 |
| Experimental | 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 | 69 percentage of words correctly repeated | Standard Deviation 21 |
| Experimental | 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 | 75 percentage of words correctly repeated | Standard Deviation 22 |
| Experimental | 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 | 92 percentage of words correctly repeated | Standard Deviation 10 |
| Experimental | 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 | 95 percentage of words correctly repeated | Standard Deviation 5 |
| Experimental | 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 |
| Experimental | 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 |
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The ASG setting will have no effect on the Word Recognition Scores.p-value: <0.05Mixed Models Analysis
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The presentation level will have no effect on the Word Recognition Scores.p-value: <0.05Mixed Models Analysis
Comparison: A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: Hearing aid prescription will have no effect on the Word Recognition Scores.p-value: <0.05Mixed Models Analysis