FDA product code · Ear, nose and throat

Hearing Aid, Tactile

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

LRAClass U510(k) required8 decisions since 19810 recalls

8 FDA decisions since 1981. 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 LRA 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 · LRA

FDA has decided no LRA device since 2007.

Median 510(k) review, days · LRA

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

Recalls per year · LRA

No recall names LRA since 2007.

Adverse event reports per year · LRA

No MAUDE report names LRA 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 — LRA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LRA? 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

Hearing Aid, Tactile

What has FDA decided in LRA lately?