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A Pediatric Comparison of Remote Microphone Technologies

A Pediatric Comparison of Remote Microphone Technologies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06564701
Enrollment
25
Registered
2024-08-21
Start date
2024-08-05
Completion date
2025-01-16
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

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.

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.

Interventions

DEVICEPhonak 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.

DEVICEPhonak 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.

Sponsors

Hearts for Hearing
CollaboratorOTHER
Sonova AG
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Speech Intelligibility score using the AZ Bio Sentence Test-teacher conditionOne 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.
Speech Intelligibility score using the AZ Bio Sentence Test- small group conditionOne 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

MeasureTime frameDescription
Listening Fatigue using the Vanderbilt Fatigue Scale for ChildrenTwo 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.
Subjective Preferences of participantsTwo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026