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FDA PRODUCT CODE · CLASS II

SCR — Air-Conduction Hearing Aid Software

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 hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325.

DEVICE CLASS
Class II
REGULATION
21 CFR 874.3335
MEDICAL SPECIALTY
Ear, Nose, Throat
REVIEW PANEL
EN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K254044Meta Platform Technologies, LLC · 510k2026-07-13
K251208Tuned , Ltd. · 510k2025-09-26
K243150Luxottica Group S.P.A. · 510k2025-01-31

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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