(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.
§ 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.