Remote Microphone (RM) – A Comparative Study

Overview

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.

Full Title of Study: “Remote Microphone (RM) Technology in Children Using Bone Conduction Devices: A Comparative Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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: Bone Conduction Device (BAHA) only BAHA + Wireless Audio-Streaming Accessory BAHA + Digital Adaptive RM System
  • 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: Unaided Unilateral hearing aid with contralateral plug. Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova) Bone Conduction Device (BAHA) only BAHA + Wireless Audio-Streaming Accessory BAHA + Digital Adaptive RM System

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Miami
  • Collaborator
    • Cochlear
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hillary A Snapp, Associate Professor of Clinical – University of Miami
  • Overall Official(s)
    • Hillary Snapp, AuD, Ph.D., Principal Investigator, University of Miami

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.