Skip to main content
OpenTrials
Completed

NCT Number: NCT04953390

Evaluating Benefits of Hearing Aid Microphone Directionality Technologies

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova

Aurora, Illinois, 60505, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phonak Audeo hearing aid

Device

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

Device

Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period.

Primary outcomes

  1. Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment

    Time frame: 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.

  2. Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Speech Reception Threshold

    Time frame: 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.

  2. Observations and Ratings of Satisfaction of Microphone Directionality in Real Life

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2021
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.