510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K953872Substantially Equivalent

Second Ear Bone Conduction Hearing Aid

Wordcomp International Communication Group (Wicg), Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953872 is the FDA 510(k) clearance record for SECOND EAR BONE CONDUCTION HEARING AID, a class II device, cleared for Wordcomp International Communication Group (Wicg) on under FDA product code LXB (Hearing Aid, Bone Conduction). FDA records list one 510(k) clearance for Wordcomp International Communication Group (Wicg). As of , FDA records show no recalls naming K953872.

Clearance record

Decision date
Received
(239 days to decision)
Product code
LXB Hearing Aid, Bone Conduction
Regulation
21 CFR 874.3302
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Wordcomp International Communication Group (Wicg) 1000 Bunnett Ave., Concord CA
510(k) summary
Summary
Third party review
No

Clearances, product code LXB

Trailing 12 months
4 clearances under product code LXB in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LXB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20261
August 20261
September 20260
October 20260