# K133352: Hypersound Audio System (HSS)

- Pathway: 510(k) (Traditional)
- Applicant: Hypersound Health, Inc.
- Decided: Feb 12, 2014 after 104 days
- Product code: EPF (Hearing Aid, Group And Auditory Trainer)
- Device class: 2
- Regulation: 21 CFR 874.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974287 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043090: Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems, Phonic Ear, Inc. (2004) Summary page 1.

## Indications for use
The HyperSound Group Auditory Trainer is indicated for use as a group auditory trainer or group hearing aid used to communicate simultaneously with one or more listeners with or without hearing loss and with or without the use of hearing aids in order to improve clarity and comprehension of sounds generated from sources such as a microphone, CD/DVD player, TV, Stereo System or other sound generation systems.

Source page: https://510kreport.com/device/K133352
Methodology: https://510kreport.com/methodology