An interventional study of Phonak Audeo hearing aid and Phonak hearing aid with multiple directionality settings, adjustable via a mobile app in Hearing Loss, sponsored by Sonova AG. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Sonova AG · Not applicable, Interventional, and Treatment
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.
1,109 studies on the registry are indexed under Hearing Loss; 233 are open to participants now.
This study's enrollment of 19 is below the median of 40 across 778 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Sonova AG is the lead sponsor of 88 studies on the registry; 6 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
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Exclusion Criteria:
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.
Device: Phonak Audeo hearing aid · Device: Phonak hearing aid with multiple directionality settings, adjustable via a mobile app
Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3
Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period.
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)
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)
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)
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)
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)
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
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)
| Milestone | Experimental |
|---|---|
| Started | 19 |
| Completed | 19 |
| Not completed | 0 |
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.
| units on a scale | Experimental |
|---|---|
| Perceived narrowness of DIR1 in soft noise | 40.31 ± 24.73 |
| Perceived narrowness DIR2 in soft noise | 55.94 ± 19.99 |
| Perceived narrowness DIR3 in soft noise | 66.88 ± 18.81 |
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.
| units on a scale | Experimental |
|---|---|
| Perceived narrowness DIR1 in loud noise | 35.31 ± 26.23 |
| Perceived narrowness DIR2 in loud noise | 48.91 ± 22.71 |
| Perceived narrowness DIR3 in loud noise | 57.5 ± 19.26 |
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.
| units on a scale | Experimental |
|---|---|
| Preference for DIR1 in soft noise | 31.41 ± 24.22 |
| Preference for DIR2 in soft noise | 53.13 ± 21.03 |
| Preference for DIR3 in soft noise | 64.1 ± 16.28 |
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.
| dB SNR | Experimental |
|---|---|
| SNR level for DIR1 in soft noise | -10.22 ± 2.4 |
| SNR level for DIR2 in loud noise | -12.35 ± 1.75 |
| SNR level for DIR3 in loud noise | -11.85 ± 1.94 |
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.
| adjustments | Experimental |
|---|---|
| Number of adjustments in which user rated "clear" satisfaction | 113 |
| Number of adjustments in which users rated "slight" satisfaction | 95 |
| Number of adjustments in which user rated "no" satisfaction | 47 |
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.
| comparisons between two time constants | Experimental |
|---|---|
| Number of times 0 seconds is rated as more noticeable than 2,4,or 8 seconds | 58 |
| Number of times 0 seconds is rated as no different than 2,4, or 8 seconds | 29 |
| Number of times 0 seconds is rated as less noticeable than 2,4, or 8 seconds | 27 |
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.
| units on a scale | Experimental |
|---|---|
| Preference for DIR1 in loud noise | 26.25 ± 26 |
| Preference for DIR2 in loud noise | 43.75 ± 20.43 |
| Preference for DIR3 in loud noise | 60.78 ± 19.81 |
Collected over 4-6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
All participants who were tested using different microphone directionality settings.
| Age, Continuous(years) | Experimental |
|---|---|
| Mean | 72 (39 to 88) |
| Sex: Female, Male(Participants) | Experimental |
|---|---|
| Female | 10 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | Experimental |
|---|
| Region of Enrollment(participants) | Experimental |
|---|---|
| United States | 19 |
| Hearing Loss(Participants) | Experimental |
|---|---|
| Count of participants | 19 |
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