(113 days)
No
The description focuses on the physical properties and function of an ultrasonic device for tinnitus relief. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies. The performance studies describe a clinical trial evaluating the device's effect, not the performance of an AI/ML algorithm.
Yes
The device is intended for "temporary relief of tinnitus" by emitting an ultrasonic signal to "mask or inhibit the sound of tinnitus," directly addressing a health condition.
No
The device is described as providing temporary relief of tinnitus by emitting an ultrasonic signal. It is not used to diagnose a medical condition.
No
The device description explicitly details hardware components such as a hand-held unit, a battery, a piezoelectric element (transducer), and the emission of an ultrasonic signal. This indicates it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The described device, "The Inhibitor," works by emitting an ultrasonic signal that is applied to the body (specifically, the bone behind the ear) to temporarily relieve tinnitus. It does not analyze any biological samples.
The device is a therapeutic medical device, not a diagnostic one.
N/A
Intended Use / 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 timitus 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:
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- You have a pacemaker.
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- You are pregnant.
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- You have any metal bonded teeth retainers.
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- You have any metal implants in your head or neck.
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- You are prone to migraines or headaches.
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- You have had any recent surgeries (last six months) and are still recovering.
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- You have any thrombosis.
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- Your tinnitus becomes louder.
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- You get a headache after using the device.
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- You become nauseous after using the device.
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- You notice any discomfort at the treatment site.
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- You have any medical condition that your physician would advise against its use.
Product codes
77KLW, KLW
Device Description
The Inhibitor" is a hand-held device that emits a ultrasonic signal in the range of 20 – 60 kHz (depending on the resonant frequency of the Piezo element used). It is powered by a 3.6 V Lithium ion rechargeable battery. The transducer is a piezoelectric element. The acoustic output is
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.
0
JUN 2 9 2007
510 (k) Summary
| Applicant's/Submitter's Name/Address: | Melmedtronics, Inc.
1550 Norwood Dr., Suite 100
Hurst, TX 76054 |
|---------------------------------------|---------------------------------------------------------------------------|
| Contact Person: | David W. Holmes, Ph.D. |
| Telephone/Fax: | 817-268-1564 voice
817-285-6182 fax
email: holmes@melmedtronics.com |
| Date of Summary: | March 5, 2007 |
| Device Name: | |
| Trade Name: | The Inhibitor™ |
| Common Name: | Tinnitus Masking Device |
| Classification Name: | Ultra Sonic Tinnitus Masker |
| Registration Number: | None Assigned |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 874.3400 |
| Product Code: | 77KLW |
| Performance Standards: | Substantial Equivalence to the following predicate devices: |
| Device) | K013253 (Hearing Innovations HiSonic TDR Tinnitus Relief |
| | K021202 (Sound Technique Systems, LLC: Ultra Quiet) |
| Starkey Labs) | K964216 (Starkey TM-3, TM-5 High Frequency Tinnitus Masker, |
| | K003559 (Siemens TCI Tinnitus Control Instrument) |
Description of Device
The Inhibitor" is a hand-held device that emits a ultrasonic signal in the range of 20 – 60 kHz (depending on the resonant frequency of the Piezo element used). It is powered by a 3.6 V Lithium ion rechargeable battery. The transducer is a piezoelectric element. The acoustic output is