(196 days)
Not Found
No
The device description and intended use focus on generating broad-band white noise for masking. There is no mention of adaptive algorithms, learning from user input, or any other characteristics typically associated with AI/ML in this context. The performance studies also describe a simple comparison of noise characteristics and subjective perception, not the evaluation of an AI/ML model.
Yes
The device is intended to assist individuals with tinnitus by masking the sound, which is a therapeutic purpose.
No
The device is described as a noise generator used to mask tinnitus or ambient noise, and in some cases, combined with a hearing aid. Its purpose is to provide an alternative sound or amplify hearing, not to diagnose a condition.
No
The device description explicitly states that the tinnitus maskers are "housed in a variety of hearing aid-type shell configurations that can then be worn either in-the-ear or behind-the-ear," indicating a physical hardware component.
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 a tinnitus masker, which generates noise to help individuals manage their tinnitus or mask environmental sounds. It is a physical device worn on or in the ear.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is based on sound generation and perception.
Therefore, the device falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Modelst
Tinnius Maskers:
Desktop/Pillow Masker, C2007M, C2008M, CR2000 Masker, Wonder Bar Masker, Mini Wonder Ear Masker, PT-2 SM, PT3-SM, PT3- LFM, PT3- HFM, PTS -SM. PTS- LFM. PTS- HFM.
Tinaitus Maskers with Compatible Hearing Aid Circultry:
Wonder Bar Masker/Hearing Aid, PT3- CM, PT5- CM
These combination timilas maskers and hearing aid devices can be used by people who not colly have thatias, but who also have a hearing impairment. Those devices will be sold in compliance with CFR 801.420 and will include additional labeling for hearing aids.
The noise is a broad-band white noise signal that can be housed in a variety of In-The-Bar or Behind-The-Bar thessing aid type) shouls. The noise can be used as an adjunct to assist individuals with timing to loarn to reforus that ancation away from their tinnitus and towards an alternate sound such as the noise generated from the tinnitus devices. The level of the noise should be adjusted by the individual to a level below their tinnitus so that both the noise and the linnitus can be heard simulumeously. 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 timnitus. These same tinnitus masking devices can also be used by individuals who desire to mask out ambient environmental noise (e.g. office noise, outside noise, snoring, and other oborusive noises).
Product codes (comma separated list FDA assigned to the subject device)
77KLW, 77 ESD
Device Description
The tinnitus maskers are broad-band white noise signal generators. They are housed in a variety of hearing aid-type shell configurations that can then be worn either in-the-ear or behind-the-ear. In some instances, canal size permitting, the tinnitus masker circuit can also fit inside a hearing aid shell allowing the patient to benefit from amplified hearing while masking their tinnitus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
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)
The results of a recent study (Holmes and Jordan, 1998) comparing several tinnitus maskers, including the C2008M, indicated that those tinnitus maskers, which contained mostly high-frequency energy, were unable to be heard by individuals with a high-frequency hearing loss. Five tinnitus maskers were used in the study. Over 80 subjects listened the various noises emitted from the devices and judged the noise on a five-point scale from "very annoying" to "very soothing". The Puretone Limited C2008M was judged equivalent to all of the tinnitus maskers on this judgement scale. The variety of frequency responses among various circuits has the added advantage of assisting those individuals, who have a variety of hearing losses, in being able to hear the noise generated by different circuits.
In the same study, Holmes and Jordan (1998) found that almost all of the devices evaluated were judged by over 80 individuals to be relatively equivalent in their perception of the noise as either "annoying" or "soothing".
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, K9774751
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
JAN 25 1999
| Device Names: | |
|---|---|
| Trade Names: | C2007M, C2008M, CE2000, Wonder Ear Masker, Mini Wonder Ear Masker, Wonder Ear Masker/Hearing Aid, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT-3CM, PT-5SM, PT-5LFM, PT-5HFM, and PT-5CM. |
| Common Name: | Tinnitus Maskers |
| Classification Name: | Tinnitus Masking |
| Registration Number: | None Assigned |
| 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) | |
| K9774751 (General Hearing Inst. Tranquil Tinnitus Masker) |
Description of Devices:
The tinnitus maskers are broad-band white noise signal generators. They are housed in a variety of hearing aid-type shell configurations that can then be worn either in-the-ear or behind-the-ear. In some instances, canal size permitting, the tinnitus masker circuit can also fit inside a hearing aid shell allowing the patient to benefit from amplified hearing while masking their tinnitus.
Intended Use of Device
The tinnitus masking noise is used as an adjunct to assist individuals with tinnitus to learn to refocus their attention away from their timitus 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.
1
Technological Characteristics of Devices
The results of a recent study (Holmes and Jordan, 1998) comparing several tinnitus maskers, including the C2008M, indicated that those tinnitus maskers, which contained mostly high-frequency energy, were unable to be heard by individuals with a high-frequency hearing loss. Five tinnitus maskers were used in the study. Over 80 subjects listened the various noises emitted from the devices and judged the noise on a five-point scale from "very annoying" to "very soothing". The Puretone Limited C2008M was judged equivalent to all of the tinnitus maskers on this judgement scale. The variety of frequency responses among various circuits has the added advantage of assisting those individuals, who have a variety of hearing losses, in being able to hear the noise generated by different circuits.
In the same study, Holmes and Jordan (1998) found that almost all of the devices evaluated were judged by over 80 individuals to be relatively equivalent in their perception of the noise as either "annoying" or "soothing".
Conclusions:
-
- All of the PMN tinnitus masking devices have similar acoustic spectral characteristics as the approved devices.
-
- All of the PMN tinnitus masking devices are similar in style (ITE or BTE) as the approved devices.
-
- All of the PMN tinnitus masking devices are similar in material as the approved devices.
-
- All of the PMN tinnitus masking devices are similar in intended use as the approved devices.
- న. All of the PMN tinnitus masking devices are similar in style (ITE or BTE) as the approved devices.
-
- All of the PMN tinnitus masking devices have the same targeted population as the approved devices.
2
Image /page/2/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-like symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Public Health Service
| JAN 25 1999 | | Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| David W. Holmes, Ph.D. | Re: K982432 | |
| Tinnitus Treatment Centers Incorporated | Tinnitus Masker/Hearing Aids, Models: Desktop/Pillow
Masker, C2007M, C2008M, CE2000 Masker, Wonder
Ear Masker, Mini Wonder Ear Masker, PT-2SM, PT-3SM
PT-3CM, PT-3LFM, PT-3HFM, PT-5SM, PT-5CM, PT-5LFM
PT-5HFM and Wonder Masker Hearing Aid | |
| 8215 Westchester
Suite 150
Dallas, TX 75225 | Dated: July 13, 1998
Received: July 13, 1998
Regulatory class: III
21 CFR 874.3400/Procode: 77 KLW
21 CFR 874.3300/Procode: 77 ESD | |
Dear Dr. Holmes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and 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 (Special Controls) or class III (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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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/odrh/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
ﺪ ﺍﻟ
| 510 (K) NUMBER (IF KNOWN) : | K962432 |
|---|---|
| ----------------------------- | --------- |
DEVICE NAME: Tinnitue Masker / Hearing Aids
INDICATIONS FOR USE:
Modelst
Tinnius Maskers:
Desktop/Pillow Masker, C2007M, C2008M, CR2000 Masker, Wonder Bar Masker, Mini Wonder Ear Masker, PT-2 SM, PT3-SM, PT3- LFM, PT3- HFM, PTS -SM. PTS- LFM. PTS- HFM.
Tinaitus Maskers with Compatible Hearing Aid Circultry:
Wonder Bar Masker/Hearing Aid, PT3- CM, PT5- CM
These combination timilas maskers and hearing aid devices can be used by people who not colly have thatias, but who also have a hearing impairment. Those devices will be sold in compliance with CFR 801.420 and will include additional labeling for hearing aids.
The noise is a broad-band white noise signal that can be housed in a variety of In-The-Bar or Behind-The-Bar thessing aid type) shouls. The noise can be used as an adjunct to assist individuals with timing to loarn to reforus that ancation away from their tinnitus and towards an alternate sound such as the noise generated from the tinnitus devices. The level of the noise should be adjusted by the individual to a level below their tinnitus so that both the noise and the linnitus can be heard simulumeously. 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 timnitus. These same tinnitus masking devices can also be used by individuals who desire to mask out ambient environmental noise (e.g. office noise, outside noise, snoring, and other oborusive noises).
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Fer 21 CFR Bol.109 Tinnitus ma
Restricted Device Per 874.420 and 421 OR
Over - The - Councer - Use (Optional Format 1-2-96)
Yind C. Skymm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
N,S,E,W