FDA product code · Ear, nose and throat

Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)

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

LFAClass U2 decisions since 19780 recalls

2 FDA decisions since 1978. No recall names this code.

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 LFA 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 · LFA

FDA has decided no LFA device since 2007.

Median 510(k) review, days · LFA

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

Recalls per year · LFA

No recall names LFA since 2007.

Adverse event reports per year · LFA

No MAUDE report names LFA since 2007.

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	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in LFA? 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

Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)

What has FDA decided in LFA lately?