AUREX-3

K981704 · Adm Tronics Unltd, Inc. · KLW · Aug 5, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981704
• Device Name: AUREX-3
• Applicant: Adm Tronics Unltd, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Aug 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in treatment and control of tinnitus.

Device Story

Aurex-3 Tinnitus Masker; electronic device used for treatment and control of tinnitus. Operates by generating masking sounds to provide relief to patients suffering from tinnitus. Used under prescription by healthcare providers to manage patient symptoms. Device provides auditory stimulation to mask or distract from tinnitus perception; intended to improve patient quality of life by reducing tinnitus impact.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Electronic tinnitus masker; Class II device (21 CFR 874.3400). Prescription-only. Generates masking sounds for auditory therapy.

Indications for Use

Indicated for the treatment and control of tinnitus in patients requiring a prescription device.

Regulatory Classification

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.

Special Controls

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.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2001

ADM Tronics Unlimited, Inc. c/o Tames E. Lenick, Esq. FDA Counsel to ADM Tronics, Inc. P.O. Box 2002 118 Henry Street Morristown, TN 37814

Re: 510(k) Number: K981704 Trade/Device Name: Aurex - 3 Tinnitus Masker Regulation Number: 21 CFR 874.3400 Regulatory Class: Class II Product Code: KLW Dated: June 26, 1998 Received: June 29, 1998

Dear Mr. Lenick:

This letter corrects our substantially equivalent letter of August 5, 1998, regarding the Aurex -3 Tinnitus Masker. The review forms incorrectly noted this device as over-the-counter (OTC) without requiring a prescription for use. However, tinnitus maskers are Class II prescription devices. The intended use statement did not mention OTC, nor was there any reference to OTC in any other part of the 510(k) submission. Also, the listed predicate device was a prescription device.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation

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Page 2 - James E. Lenick, Esq.

(QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

David M. Whipple

OLA. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): Қ 9 8 / 70 4 ・・

Device Name: AUREX-3

Indications for Use:

.

For use in treatment and control of tinnitus.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINE ON ANOTHER PAGE IF NEEDED)

i:

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Perscription Use (Per 21 CFR 801.109) | |
|---------------------------------------|--|
|---------------------------------------|--|

OR

| | Over-The-Counter use |
|--|--------------------------|
| | (Optional Format 1-2-96) |

| (Division Sign-Off) | |
|--------------------------------|----------|
| Division of Ophthalmic Devices | |
| 510(k) Number | K98 1704 |