Use of RM Technology in Pediatric BAI Recipients

Completed

• Conditions: Hearing Loss, Unilateral
• Interventions: Device: Personal remote microphone (RM) system; Other: Subjective Questionnaire

• Registration Number: NCT03149484
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this research study is to learn about the hearing outcomes of children with conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology.

Detailed Description

The purpose of this research study is to learn about the hearing outcomes of children with unilateral conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology. It has been shown that the use of intervention (hearing aids, cochlear implants, bone conduction devices) alone does not alleviate the difficulties children with hearing loss encounter in noisy environments such as a classroom or restaurant. One of the most common methods to help children hear better in these types of environments is the use of a personal remote microphone (RM) system. This study will evaluate how much benefit children are getting from their bone conduction device alone compared to the bone conduction device with a personal RM system.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Primary Completion: 2019-04-11
• Study Completion: 2019-04-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• English speaking
• unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap and their parent/guardian

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Exclusion Criteria

• Do not meet inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Group	Personal remote microphone (RM) system	Children with unilateral conductive hearing loss who are treated with bone conductive devices
Parent/Guardian Group	Subjective Questionnaire	The parent or guardian of a child with unilateral conductive hearing loss who are treated with bone conductive devices
Pediatric Group	Subjective Questionnaire	Children with unilateral conductive hearing loss who are treated with bone conductive devices

Primary Outcome Measures

Name	Time	Method
Parent and Child Perception of Hearing Loss Questionnaire	20 minutes	Determine the parent and child perception of the hearing loss and its impact pre- and post-evaluation using a subjective questionnaire created to further understand the child and parent's perception of their disability.
Speech Understanding in Noise	40 minutes	Investigate benefit of remote microphone (RM) for listening in noise in children with bone conduction hearing devices by calculating SNR loss

Trial Locations

Locations (1)

University of Miami Department of Otolaryngology; 🇺🇸 Miami, Florida, United States