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Evaluating Benefits of Hearing Aid Microphone Directionality Technologies

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phonak Audeo hearing aid
Phonak hearing aid with multiple directionality settings, adjustable via a mobile app
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sonova

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 9, 2021
Last Updated
October 13, 2022
Sponsor
Sonova AG
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1. Study Identification

Unique Protocol Identification Number
NCT04953390
Brief Title
Evaluating Benefits of Hearing Aid Microphone Directionality Technologies
Official Title
Evaluating Benefits of Hearing Aid Microphone Directionality Technologies on Spatial Awareness and Speech Intelligibility
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group of participants will be evaluating different directional microphone settings on commercially available hearing aids
Masking
None (Open Label)
Masking Description
During lab testing, participants will be aware of the device they are wearing, but will not be aware of which microphone setting is being tested.
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Phonak Audeo hearing aid
Intervention Description
Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3
Intervention Type
Device
Intervention Name(s)
Phonak hearing aid with multiple directionality settings, adjustable via a mobile app
Intervention Description
Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period.
Primary Outcome Measure Information:
Title
Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment
Description
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)
Title
Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment
Description
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)
Title
Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments
Description
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)
Title
Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments
Description
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)
Secondary Outcome Measure Information:
Title
Speech Reception Threshold
Description
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)
Title
Observations and Ratings of Satisfaction of Microphone Directionality in Real Life
Description
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
Title
Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Seitz-Paquette, AuD
Organizational Affiliation
Sonova AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonova
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating Benefits of Hearing Aid Microphone Directionality Technologies

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