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

University of Miami1 site in 1 country22 target enrollmentOctober 21, 2019

ConditionsHearing Loss, Conductive

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hearing Loss, Conductive
Sponsor: University of Miami
Enrollment: 22
Locations: 1
Primary Endpoint: Percentage of Correct Word Responses
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 21, 2019

End Date

June 30, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Hillary A Snapp

Associate Professor of Clinical

University of Miami

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.