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| Name | Class |
|---|---|
| Arizona State University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | One group will be fit with commercially available hearing aids that will have different program settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonak Audeo hearing aid | Device | receiver in the canal devices with custom earmolds |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study) |
| 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. | Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Tempe | Arizona | 85281 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who were fit with study hearing aids and completed at least one two-hour test session. | Posted | Mean | Standard Deviation | dB HL (decibels hearing level) | Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study) |
|
5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 custom earmolds |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Sonova USCS | 630-821-5000 | phonakaudiologyresearch@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2021 | Mar 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study) |
| 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. | Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study) |
| 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. | Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study) |
| 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. | 2nd appointment (day 14 of study) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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:
Phonak Audeo hearing aid: receiver in the canal devices with non-custom earmolds |
|
|
|
| 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. | Participants who were fit with study hearing aids and completed at least one two-hour test session. | Posted | Mean | Standard Deviation | percentage of words correctly repeated | Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study) |
|
|
|
|
| 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. | Participants who were fit with study hearing aids and completed at least one two-hour test session. | Posted | Mean | Standard Deviation | percentage of words correctly repeated | Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study) |
|
|
|
|
| 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. | Participants who were fit with study hearing aids and completed at least one two-hour test session. | Posted | Mean | Standard Deviation | percentage of correct responses | Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study) |
|
|
|
|
| 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. | Participants who were fit with study hearing aids and completed at least one two-hour test session. | Posted | Mean | Standard Deviation | percentage of correct responses | Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study) |
|
|
|
|
| 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. | Participants who were fit with study hearing aids and completed both two-hour test sessions. | Posted | Count of Participants | Participants | 2nd appointment (day 14 of study) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| % correct at 40 dB, DSL fitting, ASG On |
|
| % correct at 70 dB, NAL fitting, ASG Off |
|
| % correct at 70 dB, NAL fitting, ASG On |
|
| % correct at 70 dB, DSL fitting, ASG Off |
|
| % correct, DSL fitting, ASG On |
|
| 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. | Mixed Models Analysis | <0.05 | Significance was indicated by p <. 05 and Cohen's d was calculated to indicate effect size. | Other |
| 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. | Mixed Models Analysis | <0.05 | Significance was indicated by p <. 05 and Cohen's d was calculated to indicate effect size. | Other |
|
| % correct at 40 dB for DSL fitting, ASG On |
|
| % correct at 70 dB, NAL fitting, ASG Off |
|
| % correct at 70 dB, NAL fitting, ASG On |
|
| % correct at 70 dB, DSL fitting, ASG Off |
|
| % correct at 70 dB, DSL fitting, ASG On |
|
| 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. | Mixed Models Analysis | >0.05 | Significance was indicated by p <. 05 and Cohen's d was calculated to indicate effect size. | Other |
| 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. | Mixed Models Analysis | >0.05 | Significance was indicated by p <. 05 and Cohen's d was calculated to indicate effect size. | Other |
|
| % correct at 40 dB, DSL fitting, ASG On |
|
| % correct at 70 dB, NAL fitting, ASG Off |
|
| % correct at 70 dB, NAL fitting, ASG On |
|
| % correct at 70 dB, DSL fitting, ASG Off |
|
| % correct at 70 dB, DSL fitting, ASG On |
|
| 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. | Mixed Models Analysis | <0.05 | Significance was indicated by p <. 05 and Cohen's d was calculated to indicate effect size. | Other |
| 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. | Mixed Models Analysis | >0.05 | Significance was indicated by p <. 05 and Cohen's d was calculated to indicate effect size. | Other |
|
| % correct at 40 dB, DSL fitting, ASG On |
|
| % correct at 70 dB, NAL fitting, ASG Off |
|
| % correct at 70 dB, NAL fitting, ASG On |
|
| % correct at 70 dB, DSL fitting, ASG Off |
|
| % correct at 70 dB, DSL fitting, ASG On |
|
| 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. | Mixed Models Analysis | >0.05 | Significance was indicated by p <. 05 and Cohen's d was calculated to indicate effect size. | Other |
| 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. | Mixed Models Analysis | >0.05 | Significance was indicated by p <. 05 and Cohen's d was calculated to indicate effect size. | Other |
|
| Number of participants preferring ASG On with DSL fitting |
|