(296 days)
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.
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 provided text is a 510(k) summary for a medical device called "Tinnitus Maskers" (Models: TTCGHI-T and TTCTM3-T). This document is a premarket notification to the FDA for a device that claims substantial equivalence to existing devices.
The document does NOT contain information regarding a study with acceptance criteria and reported device performance in the traditional sense of a clinical trial or performance study for a novel device. Instead, it relies on demonstrating "substantial equivalence" to predicate devices.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This is not available as no specific performance metrics or acceptance criteria for a new device study are presented. The device is being cleared based on substantial equivalence to existing devices.
- Sample sized used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-based device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Explanation based on the provided text:
This 510(k) submission is for a "Tinnitus Masker" which is essentially a tape-recorded broad-band noise intended to be played on a standard audio cassette player. The regulatory approach here is to show "substantial equivalence" to other legally marketed tinnitus maskers, rather than conducting new clinical performance studies with specific acceptance criteria.
The substantial equivalence is claimed against the following predicate devices:
- 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)
The FDA's letter (K982451) states they "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)."
The indications for use are: "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."
In summary, the document describes a regulatory pathway based on substantial equivalence, not a performance study with acceptance criteria.
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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.
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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
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K982461/A1
Page 1 of 1
510(k) NUMBER (IF KNOWN): [K982451](https://510k.innolitics.com/device/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/device/K982451)
K-33
§ 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.