Use of RM Technology in Pediatric BAI Recipients

NCT ID: NCT03149484

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2019-04-11

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.

Conditions

Hearing Loss, Unilateral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric Group

Children with unilateral conductive hearing loss who are treated with bone conductive devices

Personal remote microphone (RM) system

Intervention Type: DEVICE

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.

Subjective Questionnaire

Intervention Type: OTHER

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

Subjective Questionnaire

Intervention Type: OTHER

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.

Interventions

Personal remote microphone (RM) system

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.

Intervention Type: DEVICE

Subjective Questionnaire

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Hillary A Snapp

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hillary Snapp, AuD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Department of Otolaryngology

Miami, Florida, United States

Countries

United States

Other Identifiers

20170224

Identifier Type: -

Identifier Source: org_study_id