Remote Microphone (RM) - A Comparative Study

Not Applicable

Completed

• Conditions: Hearing Loss, Conductive
• Interventions: Device: BAHA; Device: Wireless Audio Streaming Accessory; Device: Digital Adaptive RM System; Device: Hearing Aid

• Registration Number: NCT04147611
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-21
• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Results First Submitted: 2021-06-30
• Results First Submitted QC: 2021-07-22
• Results First Posted: 2021-07-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Microphone (RM) Technology Group	BAHA	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
Normal Hearing Controls	BAHA	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
Normal Hearing Controls	Wireless Audio Streaming Accessory	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
Remote Microphone (RM) Technology Group	Wireless Audio Streaming Accessory	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
Remote Microphone (RM) Technology Group	Digital Adaptive RM System	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
Normal Hearing Controls	Digital Adaptive RM System	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
Normal Hearing Controls	Hearing Aid	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

Primary Outcome Measures

Name	Time	Method
Percentage of Correct Word Responses	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.

Trial Locations

Locations (1)

Kristine Harris; 🇺🇸 Miami, Florida, United States