Search Results

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.

Ask a specific question about this 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.
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).

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.

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

1. Table of Acceptance Criteria and Reported Device Performance

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.

Ask a specific question about this device