Remote Microphone (RM) Technology in Children Using Bone Conduction Devices: A Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Percentage of Correct Word Responses
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
Arms & Interventions
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
Intervention: BAHA (Device)
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
Intervention: Wireless Audio Streaming Accessory (Device)
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
Intervention: Digital Adaptive RM System (Device)
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
Intervention: BAHA (Device)
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
Intervention: Wireless Audio Streaming Accessory (Device)
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
Intervention: Digital Adaptive RM System (Device)
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
Intervention: Hearing Aid (Device)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hillary A Snapp
Associate Professor of Clinical
University of Miami