Hearing Loss
Conditions
Brief summary
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.
Interventions
DEVICEPhonak Audeo hearing aid
Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3
DEVICEPhonak 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.
Sponsors
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
A single group of participants will be evaluating different directional microphone settings on commercially available hearing aids
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 18 years or older * experienced hearing aid users * moderate to moderate severe sensorineural symmetrical hearing loss defined as a difference of less than 10 dB between ears * must be able to use app and smart phone
Exclusion criteria
* asymmetrical hearing losses * unable or unwilling to use app and smart phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment | Third appointment (day 28 of study) | 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. |
| Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment | Third appointment (day 28 of study) | 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. |
| Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments | Third appointment (day 28 of study) | 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. |
| Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments | Third appointment (day 28 of study) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observations and Ratings of Satisfaction of Microphone Directionality in Real Life | 4 weeks | 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. |
| Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting | Third appointment (day 28 of study) | 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. |
| Speech Reception Threshold | 2nd appointment (Day 14 of study) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Experimental | — |
|---|---|---|
| Age, Continuous | 72 years | — |
| Hearing Loss | 19 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 19 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: Third appointment (day 28 of study)
Population: Participants who were able to complete the task
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment | Perceived narrowness DIR1 in loud noise | 35.31 units on a scale | Standard Deviation 26.23 |
| Experimental | Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment | Perceived narrowness DIR2 in loud noise | 48.91 units on a scale | Standard Deviation 22.71 |
| Experimental | Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment | Perceived narrowness DIR3 in loud noise | 57.5 units on a scale | Standard Deviation 19.26 |
p-value: 0.029ANOVA
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.
Time frame: Third appointment (day 28 of study)
Population: Participants who were able to complete the tasks as instructed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment | Perceived narrowness of DIR1 in soft noise | 40.31 units on a scale | Standard Deviation 24.73 |
| Experimental | Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment | Perceived narrowness DIR2 in soft noise | 55.94 units on a scale | Standard Deviation 19.99 |
| Experimental | Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment | Perceived narrowness DIR3 in soft noise | 66.88 units on a scale | Standard Deviation 18.81 |
p-value: 0.004ANOVA
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.
Time frame: Third appointment (day 28 of study)
Population: All study participants who were able to complete task as instructed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments | Preference for DIR1 in loud noise | 26.25 units on a scale | Standard Deviation 26 |
| Experimental | Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments | Preference for DIR2 in loud noise | 43.75 units on a scale | Standard Deviation 20.43 |
| Experimental | Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments | Preference for DIR3 in loud noise | 60.78 units on a scale | Standard Deviation 19.81 |
p-value: 0.0003ANOVA
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.
Time frame: Third appointment (day 28 of study)
Population: All study participants who were able to complete task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments | Preference for DIR1 in soft noise | 31.41 units on a scale | Standard Deviation 24.22 |
| Experimental | Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments | Preference for DIR2 in soft noise | 53.13 units on a scale | Standard Deviation 21.03 |
| Experimental | Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments | Preference for DIR3 in soft noise | 64.1 units on a scale | Standard Deviation 16.28 |
p-value: 0.0002ANOVA
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental | Observations and Ratings of Satisfaction of Microphone Directionality in Real Life | Number of adjustments in which user rated clear satisfaction | 113 adjustments |
| Experimental | Observations and Ratings of Satisfaction of Microphone Directionality in Real Life | Number of adjustments in which users rated slight satisfaction | 95 adjustments |
| Experimental | Observations and Ratings of Satisfaction of Microphone Directionality in Real Life | Number of adjustments in which user rated no satisfaction | 47 adjustments |
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.
Time frame: 2nd appointment (Day 14 of study)
Population: All participants who were able to complete the tasks as instructed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Speech Reception Threshold | SNR level for DIR1 in soft noise | -10.22 dB SNR | Standard Deviation 2.4 |
| Experimental | Speech Reception Threshold | SNR level for DIR2 in loud noise | -12.35 dB SNR | Standard Deviation 1.75 |
| Experimental | Speech Reception Threshold | SNR level for DIR3 in loud noise | -11.85 dB SNR | Standard Deviation 1.94 |
Comparison: All three DIR settings were tested, but only the DIR2 and DIR3 were compared in t-test. This is because DIR1 mic setting was tested in a different condition (i.e. softer noise).p-value: 0.14t-test, 2 sided
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.
Time frame: Third appointment (day 28 of study)
Population: All participants who were able to complete the task as instructed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental | Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting | Number of times 0 seconds is rated as more noticeable than 2,4,or 8 seconds | 58 comparisons between two time constants |
| Experimental | Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting | Number of times 0 seconds is rated as no different than 2,4, or 8 seconds | 29 comparisons between two time constants |
| Experimental | Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting | Number of times 0 seconds is rated as less noticeable than 2,4, or 8 seconds | 27 comparisons between two time constants |