Cleared Traditional

HYPERSOUND AUDIO SYSTEM (HSS)

K133352 · Hypersound Health, Inc. · Ear, Nose, Throat

Feb 2014

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K133352 is an FDA 510(k) clearance for the HYPERSOUND AUDIO SYSTEM (HSS), a Hearing Aid, Group And Auditory Trainer (Class II — Special Controls, product code EPF), submitted by Hypersound Health, Inc. (Poway, US). The FDA issued a Cleared decision on February 12, 2014, 104 days after receiving the submission on October 31, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number	K133352 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2013
Decision Date	February 12, 2014
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF