Remote Microphone (RM) - A Comparative Study

April 24, 2023 updated by: Hillary A Snapp, University of Miami

Remote Microphone (RM) Technology in Children Using Bone Conduction Devices: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Kristine Harris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote Microphone (RM) Technology Group

The RM technology group will limited to the pediatrics participants.

Participants will be tested separately on the three following conditions:

  1. Bone Conduction Device (BAHA) only
  2. BAHA + Wireless Audio-Streaming Accessory
  3. BAHA + Digital Adaptive RM System
Device: BAHA
Participant's pediatric bone conduction hearing device.
Device: Wireless Audio Streaming Accessory
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.
Device: Digital Adaptive RM System
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.
Active Comparator: Normal Hearing Controls

The normal hearing controls will be limited to 15 adults.

Participants will be tested separately on the six following conditions:

  1. Unaided
  2. Unilateral hearing aid with contralateral plug.
  3. Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)
  4. Bone Conduction Device (BAHA) only
  5. BAHA + Wireless Audio-Streaming Accessory
  6. BAHA + Digital Adaptive RM System
Device: BAHA
Participant's pediatric bone conduction hearing device.
Device: Wireless Audio Streaming Accessory
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.
Device: Digital Adaptive RM System
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.
Device: Hearing Aid
Participant's unilateral hearing aid with contralateral plug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Cochlear

Investigators

  • Principal Investigator: Hillary Snapp, AuD, Ph.D., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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