(77 days)
The switch 8 TRT is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a mild to a moderate hearing loss. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
The switch 8 TRT is a digital noise generator and hearing aid that was developed to be used in a tinnitus retraining therapy. This product has four different programs, which can be programmed in shape and level to fit the individual users' needs. The programming can be done with a standard HI-PRO and the audifit software. Within the software the amplification of the combi-masker can be fitted to the individual needs. The noise can be adjusted in shape with lowcut and high-cut filters and in the output level. It is housed in a standard receiver-in-the-ear instrument housing.
The provided text is a 510(k) Summary for the audifon switch 8 TRT personal sound amplifier. This document focuses on demonstrating substantial equivalence to a predicate device (Siemens TCI Combi, K003558), rather than proving the device meets a specific set of quantitative acceptance criteria through a clinical study.
Therefore, the requested information for acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from this document as it describes a device comparison rather than a performance study.
Here's a breakdown of what can be inferred from the document regarding "acceptance" in the context of substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are not explicit performance metrics for the device itself, but rather the features and performance parity with the predicate device. The "reported device performance" is a comparison to the predicate.
| Feature/Criterion (Acceptance in context of Substantial Equivalence) | audifon switch 8 TRT Performance (as reported) | Predicate Device (Siemens TCI Combi, K003558) Performance |
|---|---|---|
| Intended Use | Mask tinnitus as part of tinnitus management program | Mask tinnitus as part of tinnitus management program |
| Indications For Use | Chronological persistent ringing in the ears, Tinnitus patients with or without a hearing loss; also need or desire amplification for mild to moderate hearing loss | Tinnitus patients with or without a hearing loss (Predicate does not explicitly mention "need or desire amplification") |
| Target Population | Adults with tinnitus that are participating in a tinnitus management program | Adults and children (≥ 5 years) with tinnitus that are participating in a tinnitus management program (Note: Predicate includes children, which is a broader claim) |
| Operation / Mechanism | Uses broadband noise; Manages tinnitus through masking and distraction; Digital; Programmable (4 noises); white-noise adjustable; noise level programmable; etc. | Uses broadband noise; Manages tinnitus through masking and distraction; Digital; Programmable (4 noises); Volume control (Yes, programmable OFF, 8 dB, 16 dB, 32 dB) |
| Physical Description | Standard receiver-in-the-ear instrument housing | Standard behind-the-ear instrument housing (Note: Different physical form factor, but both are "standard") |
| Maximum Output Characteristics (White noise) | 100 dB SPL (maximum output fixed at 80dB); Frequency range: 200 - 6000 Hz | 102 dB SPL |
| Power Source | Standard 312 zinc air 1.4V hearing aid battery | Standard zinc air 1.4V hearing aid battery |
| Quality Assurance Standard | ANSI S3.22-2003 | ANSI 3.21-2003 |
| Risk to Health | No more risk than conventional hearing aid or tinnitus masker; cannot deliver damaging sound intensity (OSHA Regs 29 CFR 1910.95) | (Implied safe, as it's a marketed predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a clinical performance study with a test set of data. It relies on a comparison of device specifications and intended use.
- Data Provenance: Not applicable. The data presented is a comparison of product specifications, not clinical trial data. The device itself is manufactured in Kölleda, Germany.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. No ground truth for a test set was established as part of this submission. The FDA evaluates the substantial equivalence claim based on the provided technical and descriptive information.
- Qualifications: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable. No clinical data required adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, there is no mention of an MRMC comparative effectiveness study. This submission is for a device with a different mechanism of action than typical AI-assisted diagnostic tools. It's a tinnitus masker/hearing aid, not a diagnostic imaging device.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, there is no mention of a standalone performance study. The device is a physical instrument, not an algorithm being tested in isolation.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. The "ground truth" in this context is the FDA's acceptance of the predicate device's safety and effectiveness and the demonstration that the new device is substantially equivalent in its design, function, and intended use.
8. Sample Size for the Training Set
- Sample Size: Not applicable. The device is a hardware product, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. No training set for an algorithm was used.
§ 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.