A Retrospective Study of the Adverse Events Associated With Over-the-Counter Hearing Aids in the Manufacturer and User Facility Device Experience (MAUDE) Database.

OBJECTIVE

To examine the adverse events reported in the United States Food and Drug Administration (USFDA)'s Manufacturer and User Facility Device Experience (MAUDE) database for over-the-counter (OTC) or non-prescription hearing aids.

METHODS

A retrospective cross-sectional study was performed using the USFDA's MAUDE database from January 2014 to August 2024. Adverse events were identified using the product codes (QUF, QUG, and QUH) and the keywords ("Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter, Hearing Aid, Air-Conduction, Over the Counter, and Self-Fitting Air-Conduction Hearing Aid, Over the Counter"). Exclusion criteria included reports unrelated to OTC hearing aids and the usage of the device, or those providing insufficient information. The incidence of adverse events was estimated using data from market research reports.

RESULTS

A total of 25 adverse events were identified, with 17 reports meeting the inclusion criteria. Medical device reports (MDRs) were available for 2022 (n=1), 2023 (n=9), and 2024 (n=7). Eighteen (60.0%) reports were related to device malfunction, six (20.0%) were regarding poor customer service, three (10.0%) referred to medical adverse events, two (6.7%) were associated with failure to provide hearing benefits, and one (3.3%) referred to incompatibility with other medical equipment. Nine (30.0%) of the device malfunction reports were due to poor construction or the device falling apart, with eight (88.9%) of those cases resulting in foreign bodies in the ear. The incidence rate of adverse events for OTC hearing aids was calculated as 0.00132%.

CONCLUSIONS

There is a low reported incidence of adverse events associated with OTC hearing aids. Possible poor construction of the device and its falling apart, resulting in foreign bodies in the ear, and poor customer service were commonly reported as adverse events. This information can aid providers in advising patients and managing expectations. However, more robust studies are needed to monitor adverse events associated with OTC hearing aids.