NCT03149484

Use of RM Technology in Pediatric BAI Recipients

Remote Microphone Technology in Pediatric Bone Anchored Implant Recipients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2017-05-02
• Primary completion: 2019-04-11
• Completion: 2019-04-11
• First posted: 2017-05-11
• Last updated: 2023-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study