← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OSM — Hearing Aid, Air-Conduction With Wireless Technology, Prescription

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 874.3305
MEDICAL SPECIALTY
Ear, Nose, Throat
REVIEW PANEL
EN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →