DeviceClearance

Product code OSM— Ear, Nose, Throat

WIDEXLINK IN CLEAR SERIES HEARING AIDS

Classification name
Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Device class
Class 2
Regulation
21 CFR 874.3305
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OSM under 21 CFR 874.3305, via openFDA

Market context for product code OSM

FDA has cleared 1 device under product code OSM, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OSM

Adverse events under product code OSM

product code OSM
Injury
195
Total
195

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OSM

Data sourced from openFDA. This site is unofficial and independent of the FDA.