510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K110831Substantially Equivalent

Soundbite Hearing System by Sonitus Medical

Sonitus Medical, Inc., San Carlos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110831 is the FDA 510(k) clearance record for SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL, a class II device, cleared for Sonitus Medical, Inc. on under FDA product code LXB (Hearing Aid, Bone Conduction). FDA records list 2 510(k) clearances for Sonitus Medical, Inc., from to . As of , FDA records show 5 recalls naming K110831.

Clearance record

Decision date
Received
(88 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
Sonitus Medical, Inc. 25 Hartford Ave., San Carlos CA
510(k) summary
Summary PDF
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