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.
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.
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).

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.
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.

AI/ML Overview

The acceptance criteria and the study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
A. Acoustic Spectral Characteristics: Similar to approved predicate devices.	The study by Holmes and Jordan (1998) found that the C2008M (one of the devices under review) was judged equivalent to other tinnitus maskers on a "very annoying" to "very soothing" five-point scale. This implies similar acoustic characteristics and user perception of the emitted noise. The submission explicitly states: "All of the PMN tinnitus masking devices have similar acoustic spectral characteristics as the approved devices."
B. Physical Style (In-The-Ear or Behind-The-Ear): Similar to approved predicate devices.	The submission states: "All of the PMN tinnitus masking devices are similar in style (ITE or BTE) as the approved devices."
C. Material: Similar to approved predicate devices.	The submission states: "All of the PMN tinnitus masking devices are similar in material as the approved devices."
D. Intended Use: Similar to approved predicate devices.	The stated intended use for the new devices (adjunct to refocus attention away from tinnitus, adjusting noise level below or above tinnitus, and potentially for masking ambient environmental noise) is consistent with the general function of tinnitus maskers. The submission states: "All of the PMN tinnitus masking devices are similar in intended use as the approved devices."
E. Targeted Population: Similar to approved predicate devices.	The devices are intended for individuals with tinnitus, potentially also with hearing impairment if integrated with hearing aids. This aligns with the target population for existing tinnitus maskers. The submission states: "All of the PMN tinnitus masking devices have the same targeted population as the approved devices." Additionally, for combination devices, it notes they are for "people who not only have tinnitus, but who also have a hearing impairment."
F. User Perception/Acceptance: The noise from the devices should be perceived similarly to predicate devices regarding annoyance/soothing.	The study by 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'". The Puretone Limited C2008M was judged equivalent to all other tinnitus maskers on this scale.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Over 80 subjects.
Data Provenance: The study was conducted by Holmes and Jordan (1998). The location or country of origin is not explicitly stated in the provided text, but the authors are affiliated with "Tinnitus Treatment Centers Incorporated" in Dallas, TX, suggesting a US origin. The study appears to be prospective, as subjects "listened [to] the various noises emitted" and "judged the noise."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The study primarily relies on subjective patient perception (judgments of "annoying" to "soothing") rather than expert-established ground truth.
No specific number or qualifications of "experts" are mentioned for establishing a ground truth based on a predefined medical standard for the study. The study methodology focuses on user feedback and comparison between devices.

4. Adjudication Method for the Test Set:

No formal adjudication method (like 2+1 or 3+1 consensus) is described. The study design gathered individual subject judgments on a five-point scale. The "ground truth" (or outcome) was based on a collective assessment of these individual judgments to determine equivalence in perception.

5. 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:

This is not an MRMC comparative effectiveness study, nor does it involve AI. The study directly compares several tinnitus maskers (including the C2008M) to each other based on user perception. It assesses the devices' inherent characteristics relative to each other and predicate devices, not the improvement of human readers with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not a standalone algorithm performance study. The devices are hardware signal generators, and the study evaluates their acoustic output and human perception of that output. There is no algorithm being tested in isolation.

7. The Type of Ground Truth Used:

The primary "ground truth" (or basis for comparison) used in the Holmes and Jordan (1998) study was subjective user perception/judgment of the emitted noise, specifically how "annoying" or "soothing" it was, and the ability to hear the noise. This was then used to infer equivalence in acoustic characteristics and user experience compared to other tinnitus maskers.
The overall substantial equivalence determination for the PMN devices also relies on a comparison of their inherent technological characteristics (acoustic spectral characteristics, style, material) and intended use with those of predicate devices (K964216, K974501, K963838, K791790, K9774751) rather than a separate, independent ground truth.

8. The Sample Size for the Training Set:

The provided text does not describe a "training set" in the context of machine learning or algorithm development. The study by Holmes and Jordan (1998) is a comparative user perception study, not an AI model development study. Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" in the context of AI/machine learning described in the provided text, this question is not applicable.

Summary

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JAN 25 1999

K982432

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:

Intended Use of Device

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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:

1. All of the PMN tinnitus masking devices have similar acoustic spectral characteristics as the approved devices.
1. All of the PMN tinnitus masking devices are similar in style (ITE or BTE) as the approved devices.
1. All of the PMN tinnitus masking devices are similar in material as the approved devices.
1. 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.
1. All of the PMN tinnitus masking devices have the same targeted population as the approved devices.

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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 Administration9200 Corporate BoulevardRockville MD 20850
David W. Holmes, Ph.D.	Re: K982432
Tinnitus Treatment Centers Incorporated	Tinnitus Masker/Hearing Aids, Models: Desktop/PillowMasker, C2007M, C2008M, CE2000 Masker, WonderEar Masker, Mini Wonder Ear Masker, PT-2SM, PT-3SMPT-3CM, PT-3LFM, PT-3HFM, PT-5SM, PT-5CM, PT-5LFMPT-5HFM and Wonder Masker Hearing Aid
8215 WestchesterSuite 150Dallas, TX 75225	Dated: July 13, 1998Received: July 13, 1998Regulatory class: III21 CFR 874.3400/Procode: 77 KLW21 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

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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

Regulation Number and Section

§ 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.