Evaluating Benefits of Hearing Aid Microphone Directionality Technologies

Evaluating Benefits of Hearing Aid Microphone Directionality Technologies on Spatial Awareness and Speech Intelligibility

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phonak Audeo hearing aid; Device: Phonak hearing aid with multiple directionality settings, adjustable via a mobile app

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Aurora, Illinois, United States, 60505
      • Sonova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Phonak Audeo hearing aid; Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Third appointment (day 28 of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Third appointment (day 28 of study)

Collaborators and Investigators

• Sponsor: Sonova AG
• Investigators: Principal Investigator: Kevin Seitz-Paquette, AuD, Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): July 2, 2021
• Study Completion (Actual): July 2, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: SRF-369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No