Remote Microphone (RM) - A Comparative Study

Hearing Loss, Conductive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147611
• Other study ID #: 20190308
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Conductive

Intervention

Device:
• BAHA
Participant's pediatric bone conduction hearing device.
• Wireless Audio Streaming Accessory
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.
• Digital Adaptive RM System
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.
• Hearing Aid
Participant's unilateral hearing aid with contralateral plug.

Locations

Country	Name	City	State
United States	Kristine Harris	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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