510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080955Substantially Equivalent

Zen Program (Mind 440 Hearing Aid)

Widex Hearing Aid Co., Inc., Lisle IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080955 is the FDA 510(k) clearance record for ZEN PROGRAM (MIND 440 HEARING AID), a class II device, cleared for Widex Hearing Aid Co., Inc. on under FDA product code KLW (Masker, Tinnitus). FDA records list 52 510(k) clearances for Widex Hearing Aid Co., Inc., from to . As of , FDA records show no recalls naming K080955.

Clearance record

Decision date
Received
(85 days to decision)
Product code
KLW Masker, Tinnitus
Regulation
21 CFR 874.3400
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Widex Hearing Aid Co., Inc. 2300 Cabot Dr., Suite 415, Lisle IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KLW

Trailing 12 months
2 clearances under product code KLW in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260