FDA product code · Ear, nose and throat

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

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

OSMClass II21 CFR 874.3305510(k) exempt1 decision0 recalls

FDA lists OSM 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. 1 FDA decision. No recall names this code.

A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is a prescprition hearing aid.

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 OSM 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 · OSM

FDA has decided no OSM device since 2007.

Median 510(k) review, days · OSM

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

Recalls per year · OSM

No recall names OSM since 2007.

Adverse event reports per year · OSM

71in 2025

2007high 188 (2024) · low 0 (2007)2025

MAUDE reports naming product code OSM, 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	—	1
2014	—	0
2015	—	3
2016	—	2
2017	—	1
2018	—	2
2019	—	14
2020	—	59
2021	—	16
2022	—	101
2023	—	158
2024	—	188
2025	—	71
2026	—	—

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

Planning a device in OSM? 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 874.3305.

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