Use of RM Technology in Pediatric BAI Recipients

Hearing Loss, Unilateral Clinical Trial

Official title:

Remote Microphone Technology in Pediatric Bone Anchored Implant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149484
• Other study ID #: 20170224
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: April 11, 2019

Study information

• Verified date: April 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 11, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Unilateral

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami Department of Otolaryngology	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech Understanding in Noise	Investigate benefit of remote microphone (RM) for listening in noise in children with bone conduction hearing devices by calculating SNR loss	40 minutes
Primary	Parent and Child Perception of Hearing Loss Questionnaire	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