Use of Amplification in Children With Unilateral Hearing Loss (UHL)
Unilateral Hearing Loss
About this trial
This is an interventional treatment trial for Unilateral Hearing Loss
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
Sites / Locations
- Massachusetts Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Conventional Measures Only
Conventional Measures + Hearing Aid
In arm 1, the child will utilize conventional measures for management of unilateral hearing loss, such as FM system and preferential seating in the classroom. While two basic types of FM systems exist, personal and sound field, subjects in our study will utilize a personal FM system, worn at the ear-level. This will increase the likelihood that the child will receive amplification in all classes, and will help to standardize this intervention. The HEAR-QL, CHILD (child) questionnaire, and LIFE-R student questionnaire will be administered to the child at the beginning, midpoint, and conclusion of this 3-month arm via Redcap. The CHILD (parent) questionnaire will be administered to the parent and the LIFE-R teacher questionnaire will be administered to the teacher at the same intervals.
In arm 2, the child will use the conventional measures described above in addition to a digital behind-the-ear hearing aid with a standard ear hook and custom ear mold on the affected ear. The hearing instrument will be customized by an audiologist. The subject will be instructed to wear the hearing aid both at home and at school. In both arms, the FM system will be used in school only. As in the first arm, the HEAR-QL, CHILD (child) questionnaire, and LIFE-R student questionnaire will be administered to the child at the beginning, midpoint, and conclusion of this 3-month arm. The CHILD (parent) questionnaire will be administered to the parent and the LIFE-R teacher questionnaire will be administered to the teacher at the same intervals. No washout period will take place between the two arms. Subjects will be randomized to complete one arm first for 3 months, followed immediately by 3 months in the opposite arm.