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Completed

NCT Number: NCT04147611

Remote Microphone (RM) - A Comparative Study

The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology. In this study, two remote microphone technologies will be evaluated to determine benefit in speech understanding in noise.

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Key information

Conditions

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

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kristine Harris

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

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

Pediatric RM Technology Group:

Inclusion criteria

  • English speaking pediatric conduction device users and their guardian/s will be included for study.
  • We will include pediatric patients 5 years of age to 17 years of age who have a conductive or mixed unilateral or bilateral hearing loss with a minimum of a 30 decibels (dB) air-bone gap.

Exclusion criteria

  • Participants who do not meet the described inclusion criteria.

Normal Hearing Controls:

Inclusion criteria

  • Adults greater than18 years of age.
  • Hearing thresholds < 25 dB 500 - 4,000 Hz.

Exclusion criteria

  • Non-English speakers.

Treatment and study plan

BAHA

Device

Participant's pediatric bone conduction hearing device.

Wireless Audio Streaming Accessory

Device

Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.

Digital Adaptive RM System

Device

Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.

Hearing Aid

Device

Participant's unilateral hearing aid with contralateral plug.

Primary outcomes

  1. Percentage of Correct Word Responses

    Time frame: 2 hours

    Percentage of correct word responses as assessed via the Pediatric AZBio Sentence List test at -10 decibels (dB) signal to noise ratio. The total score ranges from 0-100% with the higher score indicating increased listening in noise performance.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Cochlear

Registry information

Official study title

Remote Microphone (RM) Technology in Children Using Bone Conduction Devices: A Comparative Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2019
Registry last updated
Apr 26, 2023

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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