510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133352Substantially Equivalent

Hypersound Audio System (Hss)

Hypersound Health, Inc., Poway CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133352 is the FDA 510(k) clearance record for HYPERSOUND AUDIO SYSTEM (HSS), a class II device, cleared for Hypersound Health, Inc. on under FDA product code EPF (Hearing Aid, Group And Auditory Trainer). FDA records list one 510(k) clearance for Hypersound Health, Inc. As of , FDA records show no recalls naming K133352.

Clearance record

Decision date
Received
(104 days to decision)
Product code
EPF Hearing Aid, Group And Auditory Trainer
Regulation
21 CFR 874.3320
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Hypersound Health, Inc. 13771 Danielson St. Suite L, Poway CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EPF

Trailing 12 months

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

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