Trial Outcomes & Findings for Evaluating Benefits of Hearing Aid Microphone Directionality Technologies (NCT NCT04953390)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Third appointment (day 28 of study)

Results posted on

2022-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=19 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.
Age, Continuous	72 years n=19 Participants
Sex: Female, Male Female	10 Participants n=19 Participants
Sex: Female, Male Male	9 Participants n=19 Participants
Region of Enrollment United States	19 participants n=19 Participants
Hearing Loss	19 Participants n=19 Participants

PRIMARY outcome

Timeframe: Third appointment (day 28 of study)

Population: Participants who were able to complete the tasks as instructed.

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.

Outcome measures

Outcome measures
Measure	Experimental n=16 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.
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
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
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

PRIMARY outcome

Timeframe: Third appointment (day 28 of study)

Population: Participants who were able to complete the task

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.

Outcome measures

Outcome measures
Measure	Experimental n=16 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.
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
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
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

PRIMARY outcome

Timeframe: Third appointment (day 28 of study)

Population: All study participants who were able to complete task.

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.

Outcome measures

Outcome measures
Measure	Experimental n=16 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.
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
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
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

PRIMARY outcome

Timeframe: Third appointment (day 28 of study)

Population: All study participants who were able to complete task as instructed.

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.

Outcome measures

Outcome measures
Measure	Experimental n=16 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.
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
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
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

SECONDARY outcome

Timeframe: 2nd appointment (Day 14 of study)

Population: All participants who were able to complete the tasks as instructed.

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.

Outcome measures

Outcome measures
Measure	Experimental n=17 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.
Speech Reception Threshold SNR level for DIR1 in soft noise	-10.22 dB SNR Standard Deviation 2.4
Speech Reception Threshold SNR level for DIR2 in loud noise	-12.35 dB SNR Standard Deviation 1.75
Speech Reception Threshold SNR level for DIR3 in loud noise	-11.85 dB SNR Standard Deviation 1.94

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Experimental n=255 adjustments 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.
Observations and Ratings of Satisfaction of Microphone Directionality in Real Life Number of adjustments in which user rated "clear" satisfaction	113 adjustments
Observations and Ratings of Satisfaction of Microphone Directionality in Real Life Number of adjustments in which users rated "slight" satisfaction	95 adjustments
Observations and Ratings of Satisfaction of Microphone Directionality in Real Life Number of adjustments in which user rated "no" satisfaction	47 adjustments

SECONDARY outcome

Timeframe: Third appointment (day 28 of study)

Population: All participants who were able to complete the task as instructed.

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.

Outcome measures

Outcome measures
Measure	Experimental n=114 responses 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.
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
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
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

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

Sonova USCS

Phone: 630-821-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place