Review of Reported Adverse Events Associated With Prescription Hearing Aids in the Manufacturer and User Facility...

Objective To examine the adverse events reported in the U.S. Food and Drug Administration's (U.S. FDA's) Manufacturer and User Facility Device Experience (MAUDE) database for prescription hearing aids (HA). Methods A retrospective study was performed from January 2014 to September 2024 using the U.S. FDA's MAUDE database. Medical device reports (MDRs) were identified using product codes (ESD, OSM, and QDD) and keywords ("Hearing Aid, Air-Conduction, Prescription; Hearing Aid, Air-Conduction with Wireless Technology, Prescription; and Self-fitting, Air-Conduction Hearing Aid, Prescription"). Exclusion criteria included reports unrelated to the usage of the device or those providing insufficient data. The incidence of adverse events was estimated using the Hearing Industries Association's market data over the last 10 years. Results A total of 586 medical device reports (MDRs) were identified, and 504 met the inclusion criteria. There were 4 (0.8%) MDRs identified in 2014, 7 (1.4%) in 2015, 7 (1.4%) in 2016, 11 (2.2%) in 2017, 7 (1.4%) in 2018, 27 (5.4%) in 2019, 50 (9.9%) in 2020, 24 (4.8%) in 2021, 119 (23.6%) in 2022, 174 (34.5%) in 2023, and 74 (14.7%) in 2024, up to the third quarter. Of the 504 MDRs, 829 total events were identified. The mean number of events per MDR was calculated as 1.9. Four hundred and ninety-four (59.6%) of the 829 events were related to device malfunction, with 180 (21.7%) attributed to charger-related issues and 137 (16.5%) to poor construction/device falling apart, resulting in foreign bodies in the ear for 96 (70.1%) of those 137 cases. A total of 303 (36.6%) events were related to adverse medical effects, 19 (2.3%) were related to customer service issues, and 11 (1.3%) were related to failure to provide hearing benefits. The incidence rate of adverse events over the last decade was calculated as 0.00114%. Conclusions There is a low reported incidence of adverse events associated with prescription hearing aids. Charger issues, possible poor construction and device failing apart, resulting in foreign bodies in the ear, and medical complications, were commonly reported as adverse events. The data can increase providers' awareness of common complaints, enhance targeted monitoring, and advise and manage expectations.