A Multisite Randomized Controlled Trial Comparing the Effectiveness of Two Self-Fit Methods to the Best-Practices Method of Hearing Aid Fitting
Abstract
TRIAL DESIGN
This is a randomized multisite noninferiority comparative-effectiveness clinical trial with three parallel branches comparing a best-practices audiologist-fit method to two experimental self-fit (person-fit) methods. Outcomes were measured at 6 weeks and 6 months post-fit.
METHOD
Participants: Five hundred eighty-four participants met the following inclusion criteria and enrolled: (a) age between 50 and 79 years; (b) never used or tried hearing aids previously; (c) can speak, read, and understand English well; (d) willing to purchase the study hearing aids for $650/pair; (e) no diagnosis of a memory or cognitive impairment; (f) 25-item Hearing Handicap Inventory for the Elderly (HHIE) score > 4; (g) Montreal Cognitive Assessment score ≥ 23; and (h) not excluded due to specific audiometric criteria. The audiometric exclusion criteria, based on air-conduction pure-tone thresholds, were as follows: (a) thresholds at all frequencies (250-8000 Hz) 50 dB HL (greater than moderate hearing loss); and (c) interaural difference > 20 dB at three or more frequencies or ≥ 40 dB at 500 or 1000 Hz. Interventions: Three groups received the same hearing aids fitted either by an audiologist using best practices (Group AB) or by themselves using one of two efficacious self-fit methods (Groups CD and EF). Objectives: The effectiveness of each of the self-fit methods, CD and EF, was hypothesized to be noninferior to the professional-fit method, AB. Outcomes: The primary outcome…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,000 participants or records.
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