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Completed

NCT Number: NCT06564701

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.

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Key information

Conditions

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

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hearts for Hearing

Oklahoma City, Oklahoma, 73120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Speech Intelligibility score using the AZ Bio Sentence Test-teacher condition

    Time frame: One day (Visit 1)

    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.

  2. Speech Intelligibility score using the AZ Bio Sentence Test- small group condition

    Time frame: One day (Visit 1)

    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.

Secondary outcomes

  1. Listening Fatigue using the Vanderbilt Fatigue Scale for Children

    Time frame: Two days (Visit 2 and Visit 3)

    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.

  2. Subjective Preferences of participants

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

    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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • Hearts for Hearing

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 21, 2024
Registry last updated
Mar 13, 2025

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.

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