Evaluating Benefits of Hearing Aid Microphone Directionality Technologies

NCT04953390 | Completed Results FDA Device

• 1 other identifier: SRF-369
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Speech Reception Threshold

  2nd appointment (Day 14 of study)

• Observations and Ratings of Satisfaction of Microphone Directionality in Real Life

  4 weeks

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

  Third appointment (day 28 of study)

Study Arms (1)

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; Device: Phonak hearing aid with multiple directionality settings, adjustable via a mobile app

Interventions

Phonak Audeo hearing aid DEVICE

Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3

Experimental

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• asymmetrical hearing losses
• unable or unwilling to use app and smart phone

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Sonova

Aurora, Illinois, 60505, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Principal Investigator
• Organization: Sonova USCS

phonakaudiologyresearch@gmail.com

630-821-5000

Study Officials

• Kevin Seitz-Paquette, AuD

  Sonova AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single group of participants will be evaluating different directional microphone settings on commercially available hearing aids

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 8, 2021
• Study Start: May 3, 2021
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: November 9, 2022
• Results First Posted: November 9, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)