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Completed

NCT Number: NCT03149484

Use of RM Technology in Pediatric BAI 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.

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Key information

Conditions

Hearing Loss, Unilateral Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami Department of Otolaryngology

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personal remote microphone (RM) system

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

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.

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Remote Microphone Technology in Pediatric Bone Anchored Implant Recipients

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 11, 2017
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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