Use of RM Technology in Pediatric BAI Recipients

NCT03149484 | Completed FDA Device

• 1 other identifier: 20170224
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Unilateral

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Pediatric Group

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

Device: Personal remote microphone (RM) system; Other: Subjective Questionnaire

Parent/Guardian Group

The parent or guardian of a child with unilateral conductive hearing loss who are treated with bone conductive devices

Other: Subjective Questionnaire

Interventions

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.

Pediatric Group

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.

Parent/Guardian Group; Pediatric Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Department of Otolaryngology

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hearing Loss, Unilateral

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Hillary Snapp, AuD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 11, 2017
• Study Start: May 2, 2017
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

US (1)