Evaluating Benefits of Hearing Aid Microphone Directionality Technologies

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Phonak Audeo hearing aid; Device: Phonak hearing aid with multiple directionality settings, adjustable via a mobile app

• Registration Number: NCT04953390
• Lead Sponsor: Sonova AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-03
• Study First Submitted: 2021-06-09
• Status Verified: 2021-07
• Primary Completion: 2021-07-02
• Study Completion: 2021-07-02
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-08
• Results First Submitted: 2022-08-22
• Results First Submitted QC: 2022-10-13
• Last Update Submitted: 2022-10-13
• Results First Posted: 2022-11-09
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Phonak hearing aid with multiple directionality settings, adjustable via a mobile app	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.
Experimental	Phonak Audeo hearing aid	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.

Primary Outcome Measures

Name	Time	Method
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 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 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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Sonova; 🇺🇸 Aurora, Illinois, United States