De Sousa, K.C., Manchaiah, V., Moore, D.R., Graham, M.A., & Swanepoel, D.W.
JAMA Otolaryngology – Head & Neck Surgery, 750(9), 765-771. https://doi.org/10.1001/jamaoto.2024.1825
Publication year: 2024

Importance: With the rising interest in Over-the-counter (OTC) hearing aids as an alternative to traditional audiologist-fitted devices, understanding their long-term efficacy is crucial. However, given the novelty of the FDA category of OTC hearing aids, there is currently no evidence on long-term efficacy.

Objective: To compare the long-term (8 months) self-reported outcomes of self-fitting over-the-counter (OTC) hearing aids to the same hearing aids fitted by an audiologist.

Design, Setting, and Participants: Building upon a previous randomized clinical trial, this follow-up study reassessed 44 out of the original 64 participants. Participants were initially divided into two groups: those using self-fitting (SF) OTC hearing aids and those with devices fitted by an audiologist (AF). Approximately 8 months post-fitting, participants completed two self-report outcome measures. Missing data were addressed through multiple imputation.

Interventions: In the original trial, participants in the SF group received a pair of FDA-approved SF OTC hearing aids and fitted them independently with remote support as needed. The audiologist-fitted group received the same hearing aids fitted by a certified audiologist using best practices.

Main outcomes and measures: The primary outcome measure was self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary measures included the International Outcome Inventory for Hearing Aids (IOI-HA), aligned with the original trial.

Results: After approximately 8 months, the SF and AF groups showed no significant differences in the APHAB global score (mean difference, 0.02, d, 0.01 [95% CI -0.5 to 0.5] or the IOI-HA total score (mean difference, 1.5, d, 0.3 [95% CI, -0.2 to 0.8]). From 6 week to 8 months there was no clinically meaningful interaction between group and time (AF vs SF) for the APHAB global score (d, 0.1 [95% CI, -0.2 to 0.3], but there was a significant interaction for the IOI-HA total score (d, -0.6 [95% CI -0.8 to -0.3]), with the SF group generally performing better than the AF group.

Conclusion: This study is the first to demonstrate that self-fitting OTC hearing aids can offer comparable long-term benefits to audiologist-fitted hearing aids for individuals with mild to moderate hearing loss.