# K013253: Hisonic-TRD Tinnitus Relief Device

- Pathway: 510(k) (Traditional)
- Applicant: Hearing Innovations, Inc.
- Decided: Apr 5, 2002 after 189 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- 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 K940667 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963838: Starkey TM Air Conduction Tinnitus Masker, Starkey Laboratories, Inc. (1996) Summary page 2.
- K791790: Model TM5 Behind Ear Tinnitus Masker, Starkey Laboratories, Inc. (1979) Summary page 2.
- K981704: AUREX-3, Adm Tronics Unltd, Inc. (1998) Summary page 2.
- K951678: HI Sonic 2000 Digital Hearing Instrument, Hearing Innovations, Inc. (1995) Summary page 2.

## Most influential descendants
- K070648: The Inhibitor, Model 001 (2007), 0 descendants of its own

## Indications for use
The HiSonic-TRD tinnitus masker is a wearable behind-the-ear style ultrasonic, bone conducted broadband noise and/or sweep frequency stimuli noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and is also suitable for tinnitus masking therapy. The HiSonic-TRD 1s intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended use of the HiSonic-TRD includes it’s fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapies. The target population is the adult population over 18 years of age. This product is not intended for use in children under the age of 18.

Source page: https://510kreport.com/device/K013253
Methodology: https://510kreport.com/methodology