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Use of Amplification in Children With Unilateral Hearing Loss

NCT02269124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-08-11

Study results available
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Summary

Unilateral hearing loss (UHL) in children has been demonstrated to have a negative impact on quality of life, school performance and behavior. Despite this knowledge, it remains unclear how to best manage this common problem. There has been much debate regarding this issue with many programs recommending preferential seating in the classroom and use of a frequency-modulated (FM) system to amplify the teacher's voice in the classroom (conventional measures), and others recommending these accommodations in addition to use of a hearing aid for amplification (amplification). There is very limited research to support or refute the efficacy of a hearing aid in improving measurable academic, behavioral, or quality-of-life (QOL) outcomes in children with UHL. We propose a study evaluating the impact of hearing aid use in school-aged children (ages 6-12 years) with mild to moderately severe UHL. In this study, subjects will be randomized to receive either conventional measures or conventional measures plus amplification. After a three month period, the groups will be reversed, with each subject serving as their own control. Outcome measurements will include patient reported disease-specific QOL reported by patients, parents, and teachers using validated survey instruments at regular intervals throughout the study period.

Conditions

  • Unilateral Hearing Loss

Interventions

DEVICE

Hearing aid

The subject will wear a hearing aid at all times for a 3-month period. At school, he/she will wear this hearing aid in addition to using conventional measures (FM system and preferential seating).

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Michael Cohen, MD · Massachusetts Eye and Ear Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2020-03-16
Completion
2020-03-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02269124 on ClinicalTrials.gov