DIGITAL TINNITUS MASKING SYSTEM

K974501 · Petroff Audio Technologies · KLW · Jan 20, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K974501
• Device Name: DIGITAL TINNITUS MASKING SYSTEM
• Applicant: Petroff Audio Technologies
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Jan 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Each of the four CDs included in the DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and each of the four tapes included the DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4), provide digital tinnitus masking when operated on any commercially available CD or tape player respectively, using any commercially available headphones or speakers. CD#1 and TAPE#1 provide digital tinnitus masking sounds only and are indicated for temporary relief of tinnitus symptoms. CD#2, CD#3, CD#4, TAPE#2, TAPE#3 and TAPE#4 provide digital tinnitus masking sounds plus relaxation messages, alpha-rhythms (a gentle musical sound generated on electronic musical instruments), music and/or nature sounds, and are indicated for temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus masking process.

Device Story

DTM-4 consists of a set of four CDs and four tapes containing pre-recorded digital tinnitus masking sounds; relaxation messages; alpha-rhythms; music; and nature sounds. Device operates via standard commercially available CD or tape players; headphones; or speakers. Intended for patient self-use to provide temporary relief of tinnitus symptoms and promote relaxation. Output is auditory stimulation designed to mask tinnitus perception.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Audio media (CDs/tapes) containing pre-recorded masking sounds, relaxation messages, and musical/nature sounds. Operates via standard consumer audio playback hardware. No active electronic circuitry or software within the device itself.

Indications for Use

Indicated for temporary relief of tinnitus symptoms in patients requiring tinnitus masking; may also be used for promotion of relaxation during the masking process.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

OCT 16 2006

Michael L. Petroff
Petroff Audio Technologies
6520 Platt Ave., #813
West Hills, California 91307

Re: K974501
Trade/Device Name: Digital Tinnitus Masking System
Regulation Number: 21 CFR 874.3400
Regulation Name: Tinnitus Masker
Regulatory Class: II
Product Code: 77 KLW
Dated: November 24, 1997
Received: January 20, 1998

Dear Mr. Petroff:

This letter corrects our substantially equivalent letter of January 20, 1998.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Michael L. Petroff

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Eydelman, 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): K974501

Device Name: DTM-4

Indications For Use:

Each of the four CDs included in the DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and each of the four tapes included the DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4), provide digital tinnitus masking when operated on any commercially available CD or tape player respectively, using any commercially available headphones or speakers. CD#1 and TAPE#1 provide digital tinnitus masking sounds only and are indicated for temporary relief of tinnitus symptoms. CD#2, CD#3, CD#4, TAPE#2, TAPE#3 and TAPE#4 provide digital tinnitus masking sounds plus relaxation messages, alpha-rhythms (a gentle musical sound generated on electronic musical instruments), music and/or nature sounds, and are indicated for temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus masking process.

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974501

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)