510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN100025Unknown

Widexlink in Clear Series Hearing Aids

Office Research in Clinical Amplifiction, Lisle IL / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN100025 is the FDA 510(k) clearance record for WIDEXLINK IN CLEAR SERIES HEARING AIDS, a class II device, cleared for Office Research IN Clinical Amplifiction on under FDA product code OSM (Hearing Aid, Air-Conduction With Wireless Technology, Prescription). FDA's definition for product code OSM 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". FDA records list one 510(k) clearance for Office Research IN Clinical Amplifiction. As of , FDA records show no recalls naming DEN100025.

Clearance record

Decision date
Received
(169 days to decision)
Product code
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Regulation
21 CFR 874.3305
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Office Research IN Clinical Amplifiction 2300 Cabot Dr., Suite 415, Lisle IL
Third party review
No

Clearances, product code OSM

Trailing 12 months

FDA records hold no clearances under product code OSM in the trailing twelve months.

FDA records show no clearances under product code OSM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OSM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260