N/A Completed N=37 Randomized Treatment

Use of Amplification in Children With Unilateral Hearing Loss

Unilateral Hearing Loss

Source: ClinicalTrials.gov NCT02269124 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2021

Primary outcomePrimary: HEAR-QL 26 Questionnaire — 69.61; 74.05; 71.04; 80.21 score on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY HEAR-QL 26 Questionnaire	69.61; 74.05; 71.04; 80.21; 74.31; 87.15	—
PRIMARY CHILD (Child) Questionnaires	69.21; 72.83; 75.23; 82.83; 77.59; 80.13	—
PRIMARY LIFE-R Student Questionnaires	58.83; 67.05; 62.81; 77.05; 64.78; 80.37	—
SECONDARY LIFE-R Teacher	68.69; 83.55; 73.66; 90.61; 74.26; 89.77	—
SECONDARY CHILD (Parent) Questionnaire	68.52; 73.40; 67.24; 81.81; 72.77; 81.73	—

Eligibility Criteria

Inclusion Criteria

Children ages 6-12 years with mild to moderately severe unilateral hearing loss, with thresholds across 4 frequencies ≥ 25 dB but < 70 dB in the worse hearing ear; Normal hearing in the contralateral ear, defined as thresholds ≤ 20 dB from 250 Hz to 8000 Hz; Unaided word recognition scores of ≥ 80% in worse hearing ear

Exclusion Criteria

Contralateral hearing loss; Significant cognitive impairment; Middle ear disease that has not been addressed; Inability to commit to treatment program

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02269124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.