CRESCENT TINNITUS RETAINING SOUND GENERATOR

K030180 · Starkey Laboratories, Inc. · KLW · Sep 17, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K030180
• Device Name: CRESCENT TINNITUS RETAINING SOUND GENERATOR
• Applicant: Starkey Laboratories, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Crescent Sound Generator is an electronic, air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Crescent Sound Generator is intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus.

Device Story

Crescent Sound Generator is an electronic, air-conduction device; generates broadband noise for tinnitus masking therapy. Used by adults (18+) experiencing tinnitus; excludes patients requiring amplification. Device fitted by audiologists or hearing healthcare professionals. Provides sound output to mask tinnitus symptoms; assists in patient management of tinnitus. No amplification functionality.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic, air-conduction broadband noise generator. Form factor: wearable sound generator. Energy source: battery-powered electronic circuitry. No amplification components.

Indications for Use

Indicated for adult population over 18 years of age experiencing tinnitus who do not require or desire hearing amplification.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a black and white logo. The logo consists of a circle with text around the perimeter. Inside the circle is a stylized image of three curved lines that resemble a bird in flight. The text around the circle is not clear enough to read.

Public Health Service

SEP 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Starkey Laboratories, Inc. c/o Scott LaPointe Regulatory Affairs Coordinator 6700 Washington Ave. South Eden Prairie, MN 55344

Re: K030180

Trade/Device Name: Crescent Sound Generator Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: September 4, 2003 Received: September 5, 2003

Dear Mr. LaPointe:

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.

{1}------------------------------------------------

Page 2 - Scott LaPointe

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/dsma/dsmamain.html

Sincerely yours,

A. Palagi firen. Tbal

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

Enclosure

{2}------------------------------------------------

Page I of I

## 510(k) Number (if known): K030180

Device Name: Crescent Sound Generator

Indications For Use:

The Crescent Sound Generator is an electronic, air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Crescent Sound Generator is intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus.

The target population is the adult population over 18 years of age.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vient Hbolu

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

510(k) Number

(Optional Epriat 3-10-98)