# K070648: The Inhibitor, Model 001

- Pathway: 510(k) (Traditional)
- Applicant: Melmedtronics, Inc.
- Decided: Jun 29, 2007 after 113 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: 3 generations back to K940667 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013253: Hisonic-TRD Tinnitus Relief Device, Hearing Innovations, Inc. (2002) Summary page 1.
- K021202: Ultraquiet, Sound Technique System, LLC (2002) Summary page 1.
- K964216: Starkey TM-3, TM-5 High Frequency Tinnitus Masker, Starkey Laboratories, Inc. (1996) Summary page 1.
- K003559: Tci (Tinnitus Control Instrument), Siemens Hearing Instruments, Inc. (2001) Summary page 1.

## Indications for use
The device is intended to be used for the temporary relief of tinnitus. The unit emits an ultrasonic signal that masks or inhibits the sound of tinnitus in many afflicted individuals. The tip of the device is placed firmly against the bone behind the ear and held in place until the device goes off (60-90 seconds). This is a medical device and should only be used with the advice of a physician, audiologist or licensed hearing aid dispenser. Only adults 18 years of age and older should be dispensed an instrument. The following precautions should also be followed: DISCONTINUE USE (IF CURENTLY USING) OR DO NOT BEGIN TO USE IF: 1. You have a pacemaker. 2. You are pregnant. 3. You have any metal bonded teeth retainers. 4. You have any metal implants in your head or neck. 5. You are prone to migraines or headaches. 6. You have had any recent surgeries (last six months) and are still recovering. 7. You have any thrombosis. 8. Your tinnitus becomes louder. 9. You get a headache after using the device. 10. You become nauseous after using the device. i1. You notice any discomfort at the treatment site. 12. You have any medical condition that your physician would advise against its use.

Source page: https://510kreport.com/device/K070648
Methodology: https://510kreport.com/methodology