(296 days)
Not Found
No
The device description and intended use clearly state that the device is a broad-band noise recorded on an audio cassette, played on standard audio equipment. There is no mention of any computational or adaptive elements that would suggest AI/ML.
Yes
The intended use explicitly states that the device is "indicated for the temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus adaptation process," which describes a therapeutic purpose.
No
The device is described as providing "temporary relief of tinnitus symptoms and the promotion of relaxation" through the use of broad-band noise, relaxation exercises, and cognitive retraining. It does not measure, analyze, or provide information about a patient's medical condition.
No
The device description explicitly states the noise is recorded onto a standard audio cassette, which is a physical medium, and is played on commercially available audio cassette players and listened to through headphones or speakers, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is an audio cassette containing broad-band noise, relaxation exercises, and cognitive retraining lessons. Its purpose is to provide sound and therapeutic content to assist individuals with tinnitus in managing their symptoms.
- Lack of Biological Sample Analysis: The device does not involve the analysis of any biological samples from the patient. It is an external therapeutic aid.
Therefore, the device falls outside the scope of an In Vitro Diagnostic. It is a therapeutic device intended for symptom management.
N/A
Intended Use / Indications for Use
The noise used in the Tinnitus Adaptation Therapy program is a broad-band noise that has been recorded onto a standard audio cassette and can be played on any commercially available audio cassette player and listened to through any commercially available headphones or speakers. The noise is used as an adjunct to assist individuals with tinnitus to learn to refocus their attention away from their tinnitus and towards an alternate sound such as the recorded noise. The level of the noise should be adjusted by the individual to a level below their tinnitus so that both the noise and the tinnitus can be heard simultaneously. However, if the individual wishes to completely "mask-out" the tinnitus then the noise could be adjusted so that the noise is louder than the tinnitus.
The other audio tapes in the Tinnitus Adaptation Therapy program consist of relaxation exercises and cognitive retraining lessons to further assist the individual with tinnitus to learn to refocus their attention away from their tinnitus.
The noise and the relaxation/cognitive tapes, when used in a comprehensive tinnitus adaptation therapy program, are indicated for the temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus adaptation process.
Product codes (comma separated list FDA assigned to the subject device)
77KLW
Device Description
The noise used in the Tinnitus Adaptation Therapy program is a broad-band noise that has been recorded onto a standard audio cassette and can be played on any commercially available audio cassette player and listened to through any commercially available headphones or speakers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose and Throat
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K964216, K974501, K963838, K791790, K974751
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.3400 Tinnitus masker.
(a)
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.(b)
Classification. Class II. 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.
0
Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K', '9', '8', '2', '4', '5', and '1'. The characters are written in black ink on a white background.
Premarket Notification [510 (k)] Summary
Applicant's/Submitter's Name/Address:
Contact Person:
Tinnitus
Treatment C
Telephone/Fax:
Date of Summary:
১ ১০১৬
Tinnitus Treatment Centers, Inc. 8215 Westchester, Suite 150 Dallas, TX 75225
David W. Holmes, Ph.D.
800-871-4327 voice 214-373-7451 fax
July 10, 1998
1
| Device Name: | |
|---|---|
| Trade Names: | TTCGHI-T and TTCTM3-T |
| Common Name: | Tape Recorded Noise |
| Classification Name: | Tinnitus Masking |
| Registration Number: | None Assigned (submitted and pending) |
| Classification: | Class III, Tier 2 |
| Panel: | Ear, Nose and Throat 874.3400 |
| Product Code: | 77KLW |
| Performance Standards: | Substantial Equivalence to: |
| K964216 (Starkey TM-3, TM-5 High Frequency Masker) | |
| K974501 (Digital Tinnitus Masking System) | |
| K963838 (Starkey TM Air Conduction Tinnitus Masker) | |
| K791790 (Starkey TM-5 Behind Ear Tinnitus Masker) | |
| K974751 (General Hearing Inst. Tranquil Tinnitus Masker) |
Description of Device
్రస్సుల
The noise used in the Tinnitus Adaptation Therapy program is a broad-band noise that has been recorded onto a standard audio cassette and can be played on any commercially available audio cassette player and listened to through any commercially available headphones or speakers.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 MAY
David W. Holmes, Ph.D. President Tinnitus Treatment Centers Inc. 8215 Westchester Suite 150 Dallas. TX 75225
Re:
Tinnitus Maskers (Model: TTCGHI-T and TTCTM3-T) Dated: July 10, 1998 Received: July 15, 1998 Regulatory class: III 21 874.3400/Procode: 77 KLW
Dear Dr. Holmes:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odri/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K982461/A1
Page 1 of 1
510(k) NUMBER (IF KNOWN): [K982451](https://510k.innolitics.com/search/K982451)
DEVICE NAME: Tinnitus Maskers Models TTLGHI-T & T TCTM3-T-T
INDICATIONS FOR USE:
The noise used in the Tinnitus Adaptation Therapy program is a broad-band noise that has been-
recorded onto a standard audio cassette and can be played on any commercially available audio
cassette player and listened to through any commercially available headphones or speakers. The
noise is used as an adjunct to assist individuals with tinnitus to learn to refocus their attention
away from their tinnitus and towards an alternate sound such as the recorded noise. The level of
the noise should be adjusted by the individual to a level below their tinnitus so that both the noise
and the tinnitus can be heard simultaneously. However, if the individual wishes to completely
"mask-out" the tinnitus then the noise could be adjusted so that the noise is louder than the
tinnitus.
The other audio tapes in the Tinnitus Adaptation Therapy program consist of relaxation exercises
and cognitive retraining lessons to further assist the individual with tinnitus to learn to refocus
their attention away from their tinnitus.
The noise and the relaxation/cognitive tapes, when used in a comprehensive tinnitus adaptation
therapy program, are indicated for the temporary relief of tinnitus symptoms and the promotion of
relaxation during the tinnitus adaptation process.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | \checkmark |
| Over-The-Counter-Use (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number [K982451](https://510k.innolitics.com/search/K982451)
K-33