QUIESCENCE
Device Facts
| Record ID | K040330 |
|---|---|
| Device Name | QUIESCENCE |
| Applicant | Spectral Visualization & Development, Inc. |
| Product Code | KLW · Ear, Nose, Throat |
| Decision Date | Apr 12, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3400 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Therapeutic |
Indications for Use
Creating masking sounds to mask tinnitus as part of a tinnitus management program.
Device Story
Quiescence is software for healthcare professionals to generate custom masking sounds for tinnitus patients. Professionals use the software to test various sounds—pure tones, FM tones, pulse pure tones, narrowband noise, speech noise, white noise—until a suitable masking sound is identified. The software allows adjustment of center frequencies (100 Hz to 20,000 Hz). Generated sounds are stored on a computer hard disk and can be transferred to media like CDs or MP3 players for patient home use. The software includes safety features, such as a warning alert if the output level exceeds a user-defined limit, with a default setting ensuring output remains below 85 dBA to prevent hearing damage. Patients use the device at home under the supervision of a healthcare professional to provide symptom relief as part of a tinnitus management program.
Clinical Evidence
Bench testing only. No clinical data provided. Accuracy of masking sounds was verified through engineering spectrum analysis to ensure frequency content matched intended output. Testing confirmed generated sounds matched intended output and remained within safe dBA-weighted output levels.
Technological Characteristics
Digital software-based tinnitus masker. Generates pure tones, FM tones, pulse pure tones, narrowband noise, speech noise, and white noise. Frequency range 100 Hz to 20,000 Hz. Output level monitoring with user-defined limits and automatic warnings for levels exceeding 80 dBSPI. Designed for use on standard computer sound cards.
Indications for Use
Indicated for adults (18+) with tinnitus, with or without hearing loss, participating in a tinnitus management program. Requires prior medical evaluation by a physician specializing in ear diseases to rule out treatable conditions. For use by otolaryngologists, audiologists, and hearing-aid dispensers.
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
- TinniTech ANMP System (K030791)
Submission Summary (Full Text)
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K040330
APR 1 2 2004
# 510(k) Summary for Quiescence Software
| Date summary was prepared | November 13, 2003 |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant's Name & Address | Spectral Visualization and Development (SVD) Inc<br>921 College Hill Road,<br>Fredericton, NB E3B 6Z9<br>Canada |
| Establishment Number: | 3004176728 |
| Contact Person, Telephone and<br>email address: | Dennis Woo<br>506-460-1625<br>dwoo@svdinc.com |
| Device Trade or Proprietary<br>name: | Quiescence |
| Classification name: | Tinnitus masker |
| Classification of Device | Class II |
| Product Code: | KLW |
| Marketed device to which the<br>claim of substantial equivalence is<br>made: | K030791<br>TinniTech ANMP System |
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### Comparison to equivalent device Quicscence vs. TinniTech ANMP System (K030791):
| | Quiescence Software<br>K040330 | TinniTech ANMP System<br>K030791 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Creating masking sound to mask<br>tinnitus as part of tinnitus<br>management program. | Continuously and intermittently<br>mask tinnitus as part of a tinnitus<br>management program with masking<br>noise. |
| Target Population | The software is targeted for<br>healthcare professionals to create<br>custom masking sounds for tinnitus<br>patients.<br><br>The masking sound created by the<br>healthcare professional may be used<br>by adult (age 18 years and over) that<br>are participating in a tinnitus<br>management program. | Adults (18 years and over) with and<br>without high frequency loss, with<br>tinnitus who are participating in a<br>tinnitus management program. |
| | Quiescence Software<br>K040330 | TinniTech ANMP System<br>K030791 |
| Operation | | |
| Audio Signal Technology | Digital | Digital |
| Available noises/sounds | Pure tone, FM tone, pulse pure tone,<br>narrowband noise, speech noise and<br>white noise. Except for speech<br>noise, and white noise, the center<br>frequency of other sounds is<br>adjustable from 100 Hz to 20000 Hz. | Pre-adapted to the patient's hearing<br>characteristics, a wide selection of<br>musical sounds incorporating<br>Tinnitus Masking noise (20Hz - 20<br>kHz) digitally recorded on mini<br>compact disc in MP3 format. |
| Medium | Healthcare professional will use the<br>software to generate the desire<br>masking sound(s). The resulting<br>sound(s) can be saved in any<br>medium that is convenient to the<br>patient. A common medium would<br>be an audio digital compact disc<br>(CD). | Two mini CDs and can be expanded<br>by providing a variety of music on<br>additional discs. |
| Volume Control | Volume is controlled by the patient.<br>Healthcare professionals are<br>provided with warning messages to<br>be included with the masking<br>sounds. | User controlled with warning in the<br>User Instruction Manual. |
| Distribution | The Quiescence software is only<br>available to otolaryngologists,<br>audiologists and hearing-aid<br>dispensers. The masking sound(s)<br>created by the healthcare<br>professional is directed to the<br>tinnitus patient under the direct<br>supervision of the healthcare<br>professional. | To be sold via direct and indirect<br>channels involving an appropriately<br>qualified healthcare professional. |
| | Quiescence Software<br>K040330 | TinniTech ANMP System<br>K030791 |
| Energy delivered | The output of most computer sound<br>card can provide an output<br>exceeding 85 dBA which requires<br>the proper observation of the OSHA<br>permissible noise exposure standard.<br>The user's guide of Quiescence<br>includes the list of permissible noise<br>exposure duration and the<br>corresponding noise level. The<br>software will also display a warning<br>message to alert healthcare<br>professional when the output is<br>going to exceed a user-defined limit.<br>The default limit of the software<br>ensures that the output is below 85<br>dBA. | Max. output could exceed 85 dBA |
| Characteristic | New device | Predicate device |
| Where used | The healthcare professional will use<br>Quiescence to generate suitable<br>masking sound(s) for the tinnitus<br>patient to use at home under<br>direction supervision of the<br>healthcare professional. | Home used under the management of<br>an appropriately qualified healthcare<br>professional. |
| Instructions | The Quiescence device comes with a<br>User's Manual. | The TinniTech ANMP System<br>comes with a User's Guide. |
| Risk | There is no risk associated to the masking sounds\ that Quiescence created<br>if they are used as directed by the healthcare professional. | |
| Hearing Healthcare<br>Professional diagnosis | The masking sound is only available though qualified healthcare<br>professionals such as audiologist or otolaryngologist. | |
| Benefits | Like other tinnitus maskers, the masking sound generated by the Quiescence<br>software may provide relief to tinnitus symptoms when utilized properly<br>under the directions of the healthcare professional. | |
| Warnings | The Quiescence software is capable of delivering sound output level of over<br>85 dBA which exceed the OSHA standard. To avoid hearing damage,<br>Quiescence will alert the healthcare professional when the output level is set<br>beyond 80 dBSPI. This output level is chosen to ensure that the | |
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Description of Device
Quiescence provides a means for healthcare professionals to custom-make masking sounds for tinnitus patients. This software allows the healthcare professional to try different masking sounds on the patients until one or
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more suitable ones are found. The masking sounds will be stored to the computer hard disk. This allows the stored masking sound to be written or recorded into other convenient formats such as CD and MP3 player for playback.
Intended Use of Device Creating masking sounds to mask tinnitus as part of a tinnitus management program.
Brief discussion and conclusion of non-clinical tests and their results.
The key to a tinnitus masker is the accuracy of the masking sound. There is no better way to qualify the accuracy of the masking sound using engineering tests. The masking sound produced by the Quiescence software was tested repeatedly to ensure that the sound matched the intended output. The algorithms that generate the masking sound were analysed and the generated sound was also analysed before and after it passed through the sound output device (headset). When analyzing the masking sound, spectrum analysis was used to ensure the proper frequency content in the masking sound.
The results indicated that all the masking sounds generated matched the intended masking sound output. This clearly indicates the masking sound generated by the Quiescence software will be as effective as what other masking devices would generate.
### Information required under Title 21, Section 874.3400 and not already provided above
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corresponding dBA-weight output level will not be exceeded throughout the frequency range of Quiescence. The following warning label is proposed to be included with the recording of the masking sounds generated by Quiescence:
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF AN OTOLARYNGOLOGIST, AUDIOLOGIST OR HEARING-AID DISPENSER. FURTHEREMORE, THIS DEVICE MAY HARM YOUR HEARING IF IT IS NOT USED AS DIRECTED BY YOUR OTOLARYNGOLOGIST, AUDIOLOGIST OR HEARING-AID DISPENSER.
Furthermore, the healthcare professional should provide the patient with adequate instruction to use the masking sound(s) at home. Appendix A of the Quiescence User's Guide contains cautionary and usage information for tinnitus patients that healthcare professionals should distribute before handing out the hard copy of the masking sounds to patients.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with the bird symbol placed inside the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2004
Spectral Visualization Ndd Development (SVD) Inc. c/o Dennis Woo, Ph.D., P.Eng. 921 College Hill Road Fredericton, NB E3B 6Z9 Canada
Re: K040330
Trade/Device Name: Quiescence™ Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: February 9, 2004 Received: February 25, 2004
Dear Dr. Woo:
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 cither 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 (OS) 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 - Dennis Woo, Ph.D., P.Eng.
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 (301) 594-594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
David Th. Whizzle
A. Ralph Rosenthal, M.D.
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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040330
## Indications for Use
510(k) Number (if known): K040330
Device Name: Quiescence
This software device, Quiescence™, is indicated for use by otolaryngologists, and hearing-aid dispensers (collectively referred to as healthcare professionals) for generating custom masking sounds to mask timitus as part of a tinnitus management program. The target population of the device is adults (18 years and over) who report experiencing timitus, which may or may not be accompanied with hearing loss. Patients should receive a medical evaluation by a licensed physician who specializes in diseases of the ear to rule-out medically or surgically reatable diseases for which tinaitus is a symptom before proceeding with non-medical tinnitus management.
Prescription Use: (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use:
(21 CFR 807 Subpart C)
starite below this line - continue on another page if needed) (Division Sign-Off) Division of Ophthalmic Er Concurrence of CDRH, Office of Device Evaluation ODE Nose and Throat-Devises 510(k) Numbe TOTAL P.03
