510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212609Substantially Equivalent

BHA100 Series Braun Clear Hearing Aid

Kaz USA, Inc., A Helen of Troy Company, Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212609 is the FDA 510(k) clearance record for BHA100 Series Braun Clear Hearing Aid, a class II device, cleared for Kaz USA, Inc., A Helen of Troy Company on under FDA product code QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription). FDA's definition for product code QDD reads: "A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This...". FDA records list 8 510(k) clearances for Kaz USA, Inc., A Helen of Troy Company, from to . As of , FDA records show no recalls naming K212609.

Clearance record

Decision date
Received
(141 days to decision)
Product code
QDD Self-Fitting Air-Conduction Hearing Aid, Prescription
Regulation
21 CFR 874.3325
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Kaz USA, Inc., A Helen of Troy Company 400 Donald Lynch Blvd., Suite 300, Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDD

Trailing 12 months

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

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