NCT04953390

Evaluating Benefits of Hearing Aid Microphone Directionality Technologies

Completed NA Results posted Last updated 9 November 2022

What this trial tests

NA trial testing Phonak Audeo hearing aid in Hearing Loss in 19 participants. Completed in 2 July 2021.

Timeline

3 May 2021

Primary endpoint
2 July 2021

2 July 2021

Quick facts

Lead sponsor	Sonova AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	3 May 2021
Primary completion	2 July 2021
Estimated completion	2 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Phonak Audeo hearing aid
• Phonak hearing aid with multiple directionality settings, adjustable via a mobile app

Conditions studied

• Hearing Loss — all drugs for Hearing Loss →

Sponsor

Sonova AG — full company profile →

Who can join

Adults 18 to 90, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment Primary · 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 subje

Perceived narrowness of DIR1 in soft noise

Group	Value	95% CI
Experimental	40.31	± 24.73

Perceived narrowness DIR2 in soft noise

Group	Value	95% CI
Experimental	55.94	± 19.99

Perceived narrowness DIR3 in soft noise

Group	Value	95% CI
Experimental	66.88	± 18.81

Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment Primary · 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 subje

Perceived narrowness DIR1 in loud noise

Group	Value	95% CI
Experimental	35.31	± 26.23

Perceived narrowness DIR2 in loud noise

Group	Value	95% CI
Experimental	48.91	± 22.71

Perceived narrowness DIR3 in loud noise

Group	Value	95% CI
Experimental	57.5	± 19.26

Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments Primary · 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.

Preference for DIR1 in soft noise

Group	Value	95% CI
Experimental	31.41	± 24.22

Preference for DIR2 in soft noise

Group	Value	95% CI
Experimental	53.13	± 21.03

Preference for DIR3 in soft noise

Group	Value	95% CI
Experimental	64.1	± 16.28

Speech Reception Threshold Secondary · 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 set

SNR level for DIR1 in soft noise

Group	Value	95% CI
Experimental	-10.22	± 2.4

SNR level for DIR2 in loud noise

Group	Value	95% CI
Experimental	-12.35	± 1.75

SNR level for DIR3 in loud noise

Group	Value	95% CI
Experimental	-11.85	± 1.94

Observations and Ratings of Satisfaction of Microphone Directionality in Real Life Secondary · 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.

Number of adjustments in which user rated "clear" satisfaction

Group	Value	95% CI
Experimental	113

Number of adjustments in which users rated "slight" satisfaction

Group	Value	95% CI
Experimental	95

Number of adjustments in which user rated "no" satisfaction

Group	Value	95% CI
Experimental	47

Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting Secondary · 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.

Number of times 0 seconds is rated as more noticeable than 2,4,or 8 seconds

Group	Value	95% CI
Experimental	58

Number of times 0 seconds is rated as no different than 2,4, or 8 seconds

Group	Value	95% CI
Experimental	29

Number of times 0 seconds is rated as less noticeable than 2,4, or 8 seconds

Group	Value	95% CI
Experimental	27

Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments Primary · 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.

Preference for DIR1 in loud noise

Group	Value	95% CI
Experimental	26.25	± 26

Preference for DIR2 in loud noise

Group	Value	95% CI
Experimental	43.75	± 20.43

Preference for DIR3 in loud noise

Group	Value	95% CI
Experimental	60.78	± 19.81

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.