FDA product code · Ear, nose and throat

Hearing Aid, Air-Conduction, Over The Counter

Name: FDA decisions, review times, recalls and adverse event reports for product code QUF
Creator: 510(k) Report

QUFClass I21 CFR 874.3300510(k) exempt0 decisions0 recalls

FDA lists QUF as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 874.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ear, nose and throat panel

Twenty years of QUF at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QUF

FDA has decided no QUF device since 2007.

Median 510(k) review, days · QUF

Too few QUF 510(k)s in any year since 2007 to give a median.

Recalls per year · QUF

No recall names QUF since 2007.

Adverse event reports per year · QUF

15in 2025

2007high 15 (2025) · low 0 (2007)2025

MAUDE reports naming product code QUF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	7
2024	—	9
2025	—	15
2026	—	—

FIG. 1 — QUF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QUF? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 874.3300.

LDG Kit, Earmold, Impression LRB Face Plate Hearing Aid ESD Hearing Aid, Air-Conduction, Prescription