A Pediatric Comparison of Remote Microphone Technologies

NCT06564701 | Completed FDA Device

• 1 other identifier: SRF-22936
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Listening Fatigue using the Vanderbilt Fatigue Scale for Children

  Two days (Visit 2 and Visit 3)

• Subjective Preferences of participants

  Two days (Visit 1 following the lab testing, and Visit 3, following the field trial)

Study Arms (2)

Lab and Home Trial

EXPERIMENTAL

Participants who complete the lab testing, and who are able to use both devices during a field trial period in school

Device: Phonak Roger TouchScreen Microphone; Device: Phonak Partner Mic

Experimental No Field Trial

EXPERIMENTAL

Participants who are only able to complete the lab testing

Device: Phonak Roger TouchScreen Microphone; Device: Phonak Partner Mic

Interventions

Phonak Roger TouchScreen Microphone DEVICE

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 No Field Trial; Lab and Home Trial

Phonak Partner Mic DEVICE

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.

Experimental No Field Trial; Lab and Home Trial

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead
• Hearts for Hearing: collaborator

Study Sites (1)

Hearts for Hearing

Oklahoma City, Oklahoma, 73120, 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Speech intelligibility testing will be conducted on a single group of participants, first using one remote mic system, and then the other. The order of devices will be counter-balanced across participants.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: August 5, 2024
• Primary Completion: November 30, 2024
• Study Completion: January 16, 2025
• Last Updated: March 13, 2025

Record last verified: 2024-08

Locations

US (1)