Use of RM Technology in Pediatric BAI Recipients

April 25, 2023 updated by: Hillary A Snapp, University of Miami

Remote Microphone Technology in Pediatric Bone Anchored Implant Recipients

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Department of Otolaryngology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

English speaking pediatric conduction device users ages 5 to 18 and their parent/guardian will be included for study. These pediatric patients have a unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Do not meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric Group
Children with unilateral conductive hearing loss who are treated with bone conductive devices
Speech perception in noise performance will be evaluated in the unaided, bone conduction device (BAHA) aided, and bone conduction device (BAHA) + RM conditions. All test measures are non-experimental and commercially available.
These subjective questionnaires will be given pre- and post-evaluation to both the subject and their guardian in order to determine the impact of RM on subject and guardian perceptions of listening in noise.
Parent/Guardian Group
The parent or guardian of a child with unilateral conductive hearing loss who are treated with bone conductive devices
These subjective questionnaires will be given pre- and post-evaluation to both the subject and their guardian in order to determine the impact of RM on subject and guardian perceptions of listening in noise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Understanding in Noise
Time Frame: 40 minutes
Investigate benefit of remote microphone (RM) for listening in noise in children with bone conduction hearing devices by calculating SNR loss
40 minutes
Parent and Child Perception of Hearing Loss Questionnaire
Time Frame: 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.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hillary Snapp, AuD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

April 11, 2019

Study Completion (Actual)

April 11, 2019

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Loss, Unilateral

Clinical Trials on Personal remote microphone (RM) system

3
Subscribe