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This study will evaluate the impact of hearing aid microphone directionality technologies and settings on speech understanding in noise for experienced hearing aid users. It will also evaluate the participant's spatial awareness of sounds using these different hearing aid microphone directionality technologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | All study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonak Audeo hearing aid | Device | Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment | Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome. | Third appointment (day 28 of study) |
| Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment | Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome. | Third appointment (day 28 of study) |
| Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments | Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments. This is purely subjective and there is no better or worse answer. | Third appointment (day 28 of study) |
| Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Reception Threshold | Objective measure of speech reception thresholds with all three microphone settings (DIR1,DIR2,DIR3). This is calculated as the Signal to Noise Ratio at which participant can correctly repeat 50% of the words. A negative number (i.e. -10) indicates that the participant correctly repeated 50% of the words when the speech signal was softer or lower than the noise level. For example, an SNR score of -10 means that the the participant correctly repeated 50% of the words when the speech signal was 10 dB softer than the noise level. In this case, the noise level was appropriate to the microphone setting, i.e., DIR1 was tested in softer noise and DIR2 and DIR3 were tested in loud noise. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Seitz-Paquette, AuD | Sonova AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova | Aurora | Illinois | 60505 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | All study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period. Phonak Audeo hearing aid: Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3 Phonak hearing aid with multiple directionality settings, adjustable via a mobile app: Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who were tested using different microphone directionality settings.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | All study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period. Phonak Audeo hearing aid: Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3 Phonak hearing aid with multiple directionality settings, adjustable via a mobile app: Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment | Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome. | Participants who were able to complete the tasks as instructed. | Posted | Mean | Standard Deviation | units on a scale | Third appointment (day 28 of study) |
|
4-6 weeks
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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 | All study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period. Phonak Audeo hearing aid: Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3 Phonak hearing aid with multiple directionality settings, adjustable via a mobile app: Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | 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 | May 24, 2022 | Aug 19, 2022 | 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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A single group of participants will be evaluating different directional microphone settings on commercially available hearing aids
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During lab testing, participants will be aware of the device they are wearing, but will not be aware of which microphone setting is being tested.
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| Phonak hearing aid with multiple directionality settings, adjustable via a mobile app | Device | Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period. |
|
Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments.
| Third appointment (day 28 of study) |
| 2nd appointment (Day 14 of study) |
| Observations and Ratings of Satisfaction of Microphone Directionality in Real Life | Participants made adjustments of microphone directionality via an app, in real world listening situations. When participants adjusted the microphone directionality in real-time, they were also prompted via ecological momentary assessment to rate how satisfied they were with the adjustment. Participants chose one of three satisfaction ratings: no, slight, or clear. "Clear" satisfaction would be the best rating, indicating high satisfaction, "no" would be the worst rating, indicating no satisfaction, and "slight" would indicate somewhat satisfied. | 4 weeks |
| Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting | Participants listen to different samples of transition speed from one mic setting to another in an A/B comparison and rate which sample is more noticeable, i.e. A is more noticeable than B, A is less noticeable than B, or A and B are the same. No statistical analysis was done for this outcome measure. Frequency distribution was completed to record the number of responses in which participants rated a 0 second transition time more noticeable than a 2s, 4s, and 8s transition time. | Third appointment (day 28 of study) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Hearing Loss | All participants with a moderate to moderately severe sensorineural hearing loss, as measured by a recent (less than 12 months) audiogram. | Count of Participants | Participants |
|
All study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period.
Phonak Audeo hearing aid: Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3
Phonak hearing aid with multiple directionality settings, adjustable via a mobile app: Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period.
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| Primary | Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment | Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome. | Participants who were able to complete the task | Posted | Mean | Standard Deviation | units on a scale | Third appointment (day 28 of study) |
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| Primary | Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments | Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments. This is purely subjective and there is no better or worse answer. | All study participants who were able to complete task. | Posted | Mean | Standard Deviation | units on a scale | Third appointment (day 28 of study) |
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| Secondary | Speech Reception Threshold | Objective measure of speech reception thresholds with all three microphone settings (DIR1,DIR2,DIR3). This is calculated as the Signal to Noise Ratio at which participant can correctly repeat 50% of the words. A negative number (i.e. -10) indicates that the participant correctly repeated 50% of the words when the speech signal was softer or lower than the noise level. For example, an SNR score of -10 means that the the participant correctly repeated 50% of the words when the speech signal was 10 dB softer than the noise level. In this case, the noise level was appropriate to the microphone setting, i.e., DIR1 was tested in softer noise and DIR2 and DIR3 were tested in loud noise. | All participants who were able to complete the tasks as instructed. | Posted | Mean | Standard Deviation | dB SNR | 2nd appointment (Day 14 of study) |
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| Secondary | Observations and Ratings of Satisfaction of Microphone Directionality in Real Life | Participants made adjustments of microphone directionality via an app, in real world listening situations. When participants adjusted the microphone directionality in real-time, they were also prompted via ecological momentary assessment to rate how satisfied they were with the adjustment. Participants chose one of three satisfaction ratings: no, slight, or clear. "Clear" satisfaction would be the best rating, indicating high satisfaction, "no" would be the worst rating, indicating no satisfaction, and "slight" would indicate somewhat satisfied. | All participants who wore devices in real world situations during a four week time period, and who were able to access and operate the mobile app. | Posted | Number | adjustments | 4 weeks | adjustments | adjustments |
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| Secondary | Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting | Participants listen to different samples of transition speed from one mic setting to another in an A/B comparison and rate which sample is more noticeable, i.e. A is more noticeable than B, A is less noticeable than B, or A and B are the same. No statistical analysis was done for this outcome measure. Frequency distribution was completed to record the number of responses in which participants rated a 0 second transition time more noticeable than a 2s, 4s, and 8s transition time. | All participants who were able to complete the task as instructed. | Posted | Number | comparisons between two time constants | Third appointment (day 28 of study) | responses | responses |
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| Primary | Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments | Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments. | All study participants who were able to complete task as instructed. | Posted | Mean | Standard Deviation | units on a scale | Third appointment (day 28 of study) |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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