TINNITUS RX

K031624 · Tinnitus Control, Inc. · KLW · Jul 24, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K031624
• Device Name: TINNITUS RX
• Applicant: Tinnitus Control, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Jul 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The recorded sound is equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study (provided in the 510(k)). The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program. The Tinnitus Rx is for home use under the direction of an appropriately qualified healthcare professional. Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management. The Tinnitus Rx is intended for the temporary relief of tinnitus symptoms.

Device Story

Tinnitus Rx provides temporary relief of tinnitus symptoms via personalized sound therapy. Input consists of patient-specific sound profiles derived from clinical protocols; these are recorded onto a standard compact disc (CD). Device is used at home by patients under the direction of a qualified healthcare professional. Operation involves playing the CD on a commercially available player through headphones or speakers. Patients are instructed to maintain volume levels no louder than their own tinnitus. Output is an auditory signal intended to mask or provide relief from tinnitus. Healthcare providers use the device as part of a broader tinnitus management program. Benefit is the temporary reduction of tinnitus symptoms for the patient.

Clinical Evidence

Clinical study provided to support the efficacy of the personalized sound protocol. Study evaluated the relief of tinnitus symptoms using the custom-made CD compared to baseline. No specific statistical metrics (p-values, CIs) provided in the summary.

Technological Characteristics

Digital audio signal technology; delivered via standard compact disc (CD) medium. Requires commercially available CD player and headphones (frequency range 30-20,000 Hz; impedance > 24 ohms). Non-networked, standalone system.

Indications for Use

Indicated for adults (18+) with tinnitus, with or without high-frequency hearing loss, participating in a tinnitus management program. Contraindicated for patients without prior medical evaluation by a licensed physician to rule out treatable underlying conditions.

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

• TTCGHI-T (K982451)
• TTCTM-3 (K982451)
• TinniTech ANMP (K030791)

Submission Summary (Full Text)

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## 510(K) SUMMARY FOR K031624

1. Sponsor

Daniel S. J. Choy, M.D. Chairman

Tinnitus Control, Inc. 170 East 77th Street New York, New York 10021

### 2. Device Name

| Trade Name of Device | Tinnitus Rx |
|----------------------|-----------------|
| Common Name | Tinnitus Masker |
| Classification name | Tinnitus Masker |
| Product Code | KLW |
| Regulation Class | II |
| Regulation Number | §874.3400 |

### 3. Indications for Use

The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The recorded sound is equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study (provided in the The device is indicated for adult (18 years and over) tinnitus sufferers who may or may 210(k)). not suffer higher frequencies hearing loss and are participating in a tinnitus management program,

The Tianitus Rx is for home use under the direction of an appropriately qualified healthcare professional.

Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which timitus is a symptom before proceeding with non-medical tinnitus management.

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The Tinnitus Rx is intendod for the temporary relief of timnitus symptoms.

#### Device Description 4.

The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on any commercially available player and listened to through commercially available headphones or speakers.

#### Basis for Substantial Equivalence র্তা

The Tinnitus Rx is substantially equivalent to the TTCGHI-T and TTCTM-3 tinnitus maskers, devices cleared under K982451 and the TinniTech ANMP device cleared under K030791. All of the devices use sound to temporarily relieve a patient's tinnitus. Since the Tinnitus Rx unlizes a custom sound for each patient as opposed to a generic broadband sound, a clinical study showing that the device relieves tinnitus was included in the submission. A comparison table to the ANMP dovice is provided below.

| Characteristic | Tinnitus Rx | TinniTech ANMP System |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Provide temporary relief of<br>tinnitus symptoms | Continuously and<br>intermittently mask tinnitus as<br>part of a tinnitus management<br>program with masking noise<br>and selected music to promote<br>the relaxation of the patient<br>during delivery of the<br>Tinnitech ANMP therapy |
| Target Population | Adults (18 years and over)<br>both with and without high<br>frequency loss, with tinnitus<br>who are participating in a<br>tinnitus management program | Adults (18 years and over)<br>both with and without high<br>frequency loss, with tinnitus<br>who are participating in a<br>tinnitus management program |
| Operation | | |
| Audio signal<br>technology | Digital | Digital |
| Available<br>noises/sounds | A personalized sound<br>matching the pitch of the<br>patient's tinnitus derived by<br>following a scientifically<br>studied clinical protocol | Pre-adapted to the patient's<br>hearing characteristics. A<br>wide selection of musical<br>sounds incorporating Tinnitus<br>Masking noise (20Hz - 20<br>kHz) digitally recorded on<br>mini compact discs in MP3<br>format. |
| Medium | One CD | Two mini CDs |
| Volume Control | Patient labeling warns patient<br>against playing the CD at a<br>level louder than his/her<br>tinnitus | Warning in manual against<br>playing CDs at uncomfortable<br>levels |
| Distribution | The sale of the custom-made<br>Tinnitus Rx CD will only be<br>through a qualified healthcare<br>professional | Sold via direct and indirect<br>channels involving an<br>appropriately qualified<br>healthcare professional |
| Components | The components of the<br>Tinnitus Rx include:<br>• Customized CD<br>• User Manual for<br>physician<br>• Patient labeling | The components of the<br>complete TinniTech ANMO<br>system include:<br>• Sound files on storage<br>(mini CDs)<br>• MP3 mini CD player<br>• User Manual |
| Equipment used | • A commercially<br>available CD player<br>that is capable of<br>producing the sounds<br>generated from the<br>customized CD (Aiwa<br>XP-R232<br>recommended).<br>• Headphones with a<br>frequency range of 30 | • Philips eXpanium 40<br>mini-disc player with<br>headphones. |
| - 20000 HZ and an<br>impedance > 24 ohms. | | |
| Characteristic | New device | Predicate device (K030791) |
| Where used | Home use under an<br>appropriately qualified<br>healthcare professional | Home use under an<br>appropriately qualified<br>healthcare professional |
| Safety | The Tinnitus RX is to be used<br>in a quiet environment.<br>The patient is instructed to<br>use the Tinnitus Rx at levels<br>no louder than his/her own<br>tinnitus. | The ANMP therapy should<br>never be undertaken when the<br>tinnitus masking sounds might<br>prevent the patient from<br>hearing cues or warnings of<br>likely harm or danger. |
| Performance | The pre-CD evaluations at the<br>physician's office provides<br>the patient with a benchmark<br>of the effect he/she should<br>experience with the at-home<br>CD. | The TinniTech ANMP system<br>enables the user to determine<br>whether the delivered therapy<br>assists in the management of<br>their tinnitus. |
| Instructions | The Tinnitus Rx comes with<br>both physician and patient<br>instruction guides. | The TinniTech ANMP<br>System comes with a User's<br>Guide. |

# Comparison of Tinnitus Rx and TTCGHI-T / TTCTM3-T

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2003

Tinnitus Control, Inc. c/o Dr. Daniel S.J. Choy 170 East 77th Street New York, NY 10021

Re: K031624

Trade/Device Name: Tinnitus Rx Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: May 22, 2003 Received: June 5, 2003

Dear Dr. Choy:

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 - Dr. Choy

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,

Alegi 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

Enclosure

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Indications for Use

510(k) Number (if known): K031624 Tinnitus Rx Device Name:

Indications for Use:

The Tinaltus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The rocorded sound is equivalent to that generated by a qualified houring healthcare professional who has followed the reatment regimen utilized in the clinical study (provided in the The device is indicated for adult (18 years and over) tinnitus sufferers who may or may 210(k)). not suffer higher frequencies hearing loss and are participating in a tinnitus management program.

The Tianitus Rx is for home use under the direction of an appropriately qualified healthcare professional.

Paticats should receive a medical evaluation by a licensed physician (proferably a physician who specializes in discases of the car) to rule out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management.

The Tinnitus Rx is intonded for the temporary relief of tinnitus symptoms.

Jannz K. Rose, M.O.

**510(k) Number**