Remote Microphone (RM) - A Comparative Study

University of Miami

Status: Completed

Conditions: Hearing Loss, Conductive

Treatments: Device: BAHA; Device: Wireless Audio Streaming Accessory; Device: Digital Adaptive RM System; Device: Hearing Aid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04147611

20190308

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Remote Microphone (RM) Technology Group

Experimental group

Description:

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

Treatment:

Device: BAHA

Device: Wireless Audio Streaming Accessory

Device: Digital Adaptive RM System

Normal Hearing Controls

Active Comparator group

Description:

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

Treatment:

Device: BAHA

Device: Wireless Audio Streaming Accessory

Device: Digital Adaptive RM System

Device: Hearing Aid