ULTRAQUIET

K021202 · Sound Technique System, LLC · KLW · Jul 13, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K021202
• Device Name: ULTRAQUIET
• Applicant: Sound Technique System, LLC
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Jul 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltraQuiet™ device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuiet™ device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuiet™ is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.

Device Story

UltraQuiet™ is a tinnitus masker used by hearing healthcare professionals to provide relief via bone-conducted sound. Input consists of pre-recorded audio from a CD or MP3 player. An audio amplifier processes this signal, which is then delivered as masking noise to the patient's mastoid region via a behind-the-ear bone-conduction transducer. The device provides broadband masking sound with tunable frequencies (1 kHz – 15 kHz) at intensities up to 76 dB SPL. By masking the patient's tinnitus, the device supports rehabilitation therapy. It is intended for use in clinical settings under the guidance of an audiologist or hearing professional.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and functional comparison to legally marketed predicate devices.

Technological Characteristics

System components: CD or MP3 player, audio amplifier with AC power supply, and headband/bone-conduction transducer assembly. Masking signal: broadband, tunable 1 kHz – 15 kHz, intensity ≤76 dB SPL. Delivery: bone conduction via mastoid transducer.

Indications for Use

Indicated for the treatment of tinnitus in individuals over 18 years of age who report tinnitus.

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.

Predicate Devices

• Siemens TCI Tinnitus Control Instrument (K003559)
• ADM Tronics Aurex-3 tinnitus masker (K981704)
• Starkey TM-3, TM-5 High Frequency Tinnitus Masker (K964216)
• TTC's GHI-T & TN3-T-T tinnitus masker (K982451)

Submission Summary (Full Text)

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K021202

# 'JUL 1 3 2002

# Attachment 7

# 510(k) SUMMARY

# Sound Technique Systems, LLC: UltraQuiet™

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Sound Technique Systems, LLC 710 Denbigh Boulevard, Suite 2C Newport News, VA 23608

Phone: [phone] Facsimile: [phone]

Contact Person: Martin Lenhardt

Date Prepared: March 27, 2002

#### Name of Device and Name/Address of Sponsor

UltraQuiet™

Sound Technique Systems, LLC 710 Denbigh Boulevard, Suite 2C Newport News, VA 23608

### Common or Usual Name

Tinnitus Masker

## Classification Name

Tinnitus Masker Product Code: KLW

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## Predicate Devices

| K003559 | Siemens TCI Tinnitus Control Instrument |
|---------|---------------------------------------------------|
| K981704 | ADM Tronics Aurex-3 tinnitus masker |
| K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus Masker |
| K982451 | TTC's GHI-T & TN3-T-T tinnitus masker |

# Intended Use

The UltraQuiet™ device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuiet™ device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuiet™ is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.

# Technological Characteristics and Substantial Equivalence

The UltraQuiet™ consists of (1) a compact disc (CD) with recorded sound or an MP3 player, (2) an audio amplifier with AC adapter power supply, and (3) a headband/bone-conduction transducer assembly.

The Company's UltraQuiet™ device covered by this submission is substantially equivalent to other legally marketed tinnitus maskers. Specifically, the UltraQuiet™ device is substantially equivalent to Siemens' Tinnitus Control Instrument (TCI) (K003559), ADM Tronics' Aurex-3 Tinnitus Masker (K9817040), Starkey Laboratories' Starkey TM-3, TM-5 High Frequency Tinnitus Masker (K964216), and the Tinnitus Treatment Centers' TTCGHI- and TTCTN3-T-T devices (K982452).

UltraQuiet™ has the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices (K003559, K981704, K964216 and K982452). The UltraQuiet™ device and its predicate devices are all tinnitus maskers. The UltraQuiet™ is functionally equivalent to the Siemens' TCI (K003559) in that it provides broadband masking sound at a similar level of intensity (<76 dB SPL equivalent). It is functionally equivalent to the Aurex-3 (K9817040) in that it delivers the masking sound through bone conduction via the mastoid. It is functionally equivalent to Starkey's TM-5 (K964216) because the masking sound included

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is tunable (1 kHz - 15 kHz) and provides high frequencies in the audible range (≤15 kHz). Finally, UltraQuiet™ is functionally equivalent to the Tinnitus Treatment Centers' tinnitus masker (K982452) because both devices use recorded noise (the former on a CD and the latter on an audio cassette).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2002

Hogan & Hartson L.L.P. c/o Howard M. Holstein Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

Re: K021202

Trade/Device Name: UltraQuiet™ Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: April 15, 2002 Received: April 16, 2002

Dear Mr. Holstein:

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 application (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 such 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 -- Howard M. Holstein

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 and additionally 21 CFR Part 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

A. Ralph Rosenthal

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

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### Attachment 8

### Indications for Use Statement

### Applicant: Sound Technique Systems, LLC

#### 510(k) Number (if known): not yet assigned

# Device Name: UltraQuiet™

The UltraQuiet™ device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuiet™ device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuiet™ is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.

**510(k) Number** K021202

Prescription Use (Per 21 CFR 801.109)