510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OSMClass II

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

21 CFR 874.3305 / Ear, Nose, Throat
FDA source (opens on fda.gov)

OSM is the FDA product code for Hearing Aid, Air-Conduction With Wireless Technology, Prescription, a class II device type, regulated under 21 CFR 874.3305. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OSM
Device name
Hearing Aid, Air-Conduction With Wireless Technology, Prescription
FDA definition
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.
Regulation
21 CFR 874.3305
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OSM

By decision year
1 clearance under product code OSM with a decision year between 2011 and 2011, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OSM by decision year
YearClearances
20111

Applicants with the most clearances

Product code OSM
Applicants holding the most 510(k) clearances under product code OSM
ApplicantClearances
Office Research in Clinical Amplifiction1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 77 companies shown, in name order