Over-The-Counter Hearing Aids: Are They Safe and Effective?

Objective: In 2022, the Food and Drug Administration established a new regulatory category for over-the-counter (OTC) hearing aids for mild to moderate hearing loss. Herein, we aim to better compare the safety and efficacy of these devices to that of prescription hearing aids.

Study design: Comparative-effectiveness model.

Setting: Academic Audiology Center.

Methods: The safety and efficacy of prescription and OTC hearing aids was compared using the AudioScan Verifit 2 Testbox software. Three types of hearing loss (downsloping, sharp downsloping, and reverse sloping) were analyzed. Efficacy was tested at 3 volume inputs and was measured by calculating the average difference in test points (produced by the devices) and target points (estimated by the software). Safety was assessed by calculating the average difference in test points and the maximally safe hearing level (produced by the software).

Results: Prescription hearing aids were found to have a better safety profile by being further from the safety threshold compared to OTC devices at the 8000 Hz frequency for the 2 types of downsloping hearing loss patterns studied (48 vs 30.5 dB, P = .04; 51 vs 32.5 dB, P = .03). Prescription hearing aids also carried a statistically significant advantage at 3 test points. OTC hearing aids generally had a greater difference between test and target points.

Conclusion: OTC and prescription hearing aids are comparably safe, though OTC hearing aids are slightly less efficacious. Further evaluation of the OTC hearing aid efficacy is warranted to ensure it provides the gain of benefit needed for different types of hearing loss.