A Pediatric Comparison of Remote Microphone Technologies

NCT ID: NCT06564701

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2025-01-16

Brief Summary

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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

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Phonak Roger TouchScreen Microphone

Intervention Type 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

Intervention Type 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

Participants who are only able to complete the lab testing

Group Type EXPERIMENTAL

Phonak Roger TouchScreen Microphone

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hearts for Hearing

OTHER

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hearts for Hearing

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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SRF-22936

Identifier Type: -

Identifier Source: org_study_id

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