TRANQUIL TRI-BTE

K061459 · General Hearing Instruments, Inc. · KLW · Jun 30, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K061459
• Device Name: TRANQUIL TRI-BTE
• Applicant: General Hearing Instruments, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Jun 30, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tranquil TRI-BTE is for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.

Device Story

Tranquil TRI-BTE is a behind-the-ear (BTE) sound generator used for tinnitus management. Device produces sound therapy signals to assist in tinnitus retraining therapy or masking. Operated by patient under guidance of physician, audiologist, or tinnitus specialist. Device provides auditory stimulation to help patients manage tinnitus symptoms. Used in clinical or home settings as part of a broader tinnitus treatment program.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Behind-the-ear (BTE) sound generator. Class II device (21 CFR 874.3400). Product code KLW. Operates as a tinnitus masker.

Indications for Use

Indicated for patients requiring sound therapy for tinnitus retraining therapy, masking, or other recognized tinnitus treatments. Must be used in conjunction with professional counseling from a physician, audiologist, or qualified tinnitus specialist.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 30 2006

General Hearing Instruments Inc. c/o Roger P. Juneau President P.O. Box 23748 New Orleans, LA 70183

Re: K061459

Trade/Device Name: Tranquil TRI-BTE Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: May 25, 2006 Received: June 05. 2006

Dear Mr. Juneau.

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 - Roger P. Juneau

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.

M.B. Egelman, M.D.

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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## Indications for Use

510(k) number: K061459

Device name: Tranquil TRI-BTE

Indication for Use: The Tranquil TRI-BTE is for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

> Concurrence of CDRH, Office of Device Evaluation (ODE) Brooms of Jan-Sifi

Prescription Use
✓

(Pes 2 . . . . 001.109)

(Division Sign-Off)

Division of Ophthalmic Ear Nose and Throat Devises K 061459

510(k) Number

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