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Remote Microphone (RM) - A Comparative Study

Primary Purpose

Hearing Loss, Conductive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BAHA
Wireless Audio Streaming Accessory
Digital Adaptive RM System
Hearing Aid
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss, Conductive

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kristine Harris

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remote Microphone (RM) Technology Group

Normal Hearing Controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of Correct Word Responses
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.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2019
Last Updated
April 24, 2023
Sponsor
University of Miami
Collaborators
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT04147611
Brief Title
Remote Microphone (RM) - A Comparative Study
Official Title
Remote Microphone (RM) Technology in Children Using Bone Conduction Devices: A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Cochlear

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Conductive

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Microphone (RM) Technology Group
Arm Type
Experimental
Arm Description
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
Arm Title
Normal Hearing Controls
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
BAHA
Intervention Description
Participant's pediatric bone conduction hearing device.
Intervention Type
Device
Intervention Name(s)
Wireless Audio Streaming Accessory
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Digital Adaptive RM System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hearing Aid
Intervention Description
Participant's unilateral hearing aid with contralateral plug.
Primary Outcome Measure Information:
Title
Percentage of Correct Word Responses
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Snapp, AuD, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kristine Harris
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Remote Microphone (RM) - A Comparative Study

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