FDA product code · Ear, nose and throat

Air-Conduction Hearing Aid Software

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

SCRClass II21 CFR 874.3335510(k) required5 decisions since 20240 recalls

5 FDA decisions since 2024. 510(k) reviews decided 2021–2025 took a median of 142 days (half between 133 and 152). No recall names this code. The most-cited predicate is DEN230081, named by 4 later devices.

Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with…

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 SCR 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 · SCR

2in 2025

2007high 2 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SCR

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

Recalls per year · SCR

No recall names SCR since 2007.

Adverse event reports per year · SCR

4in 2025

2007high 4 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	2	—	4
2026	2	—	—

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

Planning a device in SCR? 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

Air-Conduction Hearing Aid Software

Which predicates do SCR devices cite most?

Which SCR devices have the deepest lineage?

What has FDA decided in SCR lately?