510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043090Substantially Equivalent

Easylistener 2 Fm, Radium Fm and Vocalight Infrared Sound Field Systems

Phonic Ear, Inc., Petaluma CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043090 is the FDA 510(k) clearance record for EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS, a class II device, cleared for Phonic Ear, Inc. on under FDA product code LZI (Device, Assistive Listening). FDA records list 31 510(k) clearances for Phonic Ear, Inc., from to . As of , FDA records show no recalls naming K043090.

Clearance record

Decision date
Received
(45 days to decision)
Product code
LZI Device, Assistive Listening
Regulation
21 CFR 874.3320
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Phonic Ear, Inc. 3880 Cypress Dr., Petaluma CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZI

Trailing 12 months

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

FDA records show no clearances under product code LZI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZI, 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