Remote Microphone (RM) - A Comparative Study

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.

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

Conditions
-----------------
Hearing Loss, Conductive

Intervention / Treatment
-----------------
* Device: BAHA
* Device: Wireless Audio Streaming Accessory
* Device: Digital Adaptive RM System
* Device: Hearing Aid


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Microphone (RM) Technology Group<br>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 | Device: BAHA<br>* Participant's pediatric bone conduction hearing device.<br>Device: Wireless Audio Streaming Accessory<br>* 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.<br>Device: Digital Adaptive RM System<br>* 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.<br>|
| Active Comparator: Normal Hearing Controls<br>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 | Device: BAHA<br>* Participant's pediatric bone conduction hearing device.<br>Device: Wireless Audio Streaming Accessory<br>* 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.<br>Device: Digital Adaptive RM System<br>* 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.<br>Device: Hearing Aid<br>* Participant's unilateral hearing aid with contralateral plug.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours |