A Pediatric Comparison of Remote Microphone Technologies

Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phonak Partner Mic; Device: Phonak Roger TouchScreen Microphone

Detailed Description

Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone. The simulated classroom environment will include a teacher condition, in which speech is presented from a distance in front of the participant, and a small-group condition, in which speech is presented randomly from three different speakers around the participant. Both conditions will have diffuse background noise, and the various SNR (Signal to Noise Ratio) levels will be tested.

Subjective preference and fatigue questionnaires will also be collected from the participants after the use of each transmitter.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Hearts for Hearing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Healthy middle and outer ear
• Mild, moderate or moderate-severe binaural sensorineural hearing loss
• Minimum AZ Bio score of 70% at 60 dB in quiet
• Experienced hearing aid users (6+ months)
• Able to read and follow directions
• English speakers with ability to communicate easily

Exclusion Criteria:

• Active middle ear infection
• Temporary or unilateral hearing loss
• Unable to follow verbal directions
• Unable to communicate easily
• Unable to tolerate the physical fit of the hearing aids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lab and Home Trial; Participants who complete the lab testing, and who are able to use both devices during a field trial period in school	Device: Phonak Partner Mic; Wireless microphone that uses Phonak proprietary AirStream technology to connect to Phonak hearing aids. It uses a fixed directional microphone, and is paired to the hearing aids such that the hearing aid microphones are attenuated at a fixed level when the microphone is in use.; Device: Phonak Roger TouchScreen Microphone; Transmitter microphone system operating on the 2.4 GHz band, which allows for low-delay and reliable long-range broadcast to a compatible Roger receiver, designed to be used in educational settings. It features six microphones and adaptive technology in which speech signals are increased when background noise increases to ensure that the speech signal is always above the noise level.
Experimental: Experimental No Field Trial; Participants who are only able to complete the lab testing	Device: Phonak Partner Mic; Wireless microphone that uses Phonak proprietary AirStream technology to connect to Phonak hearing aids. It uses a fixed directional microphone, and is paired to the hearing aids such that the hearing aid microphones are attenuated at a fixed level when the microphone is in use.; Device: Phonak Roger TouchScreen Microphone; Transmitter microphone system operating on the 2.4 GHz band, which allows for low-delay and reliable long-range broadcast to a compatible Roger receiver, designed to be used in educational settings. It features six microphones and adaptive technology in which speech signals are increased when background noise increases to ensure that the speech signal is always above the noise level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Intelligibility score using the AZ Bio Sentence Test-teacher condition	Sentences are presented from a front speaker located 8.5 feet away from participant. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better.	One day (Visit 1)
Speech Intelligibility score using the AZ Bio Sentence Test- small group condition	Sentences are presented randomly from three different speakers, located around a small table with the participant, simulating a small group at a table. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better.	One day (Visit 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Listening Fatigue using the Vanderbilt Fatigue Scale for Children	Ten questions related to fatigue, answers rank from 1 (never) to 5 (almost always). Total scores can range from 10 to 50, with higher scores indicating more self-perceived fatigue.	Two days (Visit 2 and Visit 3)
Subjective Preferences of participants	Participants will be asked to rank their preference for the microphone systems using a Likert type of rating scale (1-5), where a lower score (<3) would indicate preference for the partner mic and a higher score (>3) will indicate preference for the Roger Touchscreen.	Two days (Visit 1 following the lab testing, and Visit 3, following the field trial)

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: Hearts for Hearing

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): January 16, 2025

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: SRF-22936

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.: Yes