ArticleCureus2024
A Retrospective Study of the Adverse Events Associated With Over-the-Counter Hearing Aids in the Manufacturer and User Facility Device Experience (MAUDE) Database.
Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effects of Hearing Devices for Adults With Mild-to-Severe Hearing Loss: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Journal of speech, language, and hearing research : JSLHR · 2026Pooled it
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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.
methodsA 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.
resultsA 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%.
conclusionsThere 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.