(267 days)
The combined devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a of a slight to a profound hearing loss (see table below). The products may also be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
The above mentioned TRT devices are digital noise generators and hearing aids which were developed to be used in a tinnitus retraining therapy. These products have up to 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 low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrument housing (CIC, IS+ housing) or in a standard behind-the-ear instrument housing (S, S+, M and X housing).
This 510(k) Premarket Notification is for a set of Tinnitus Retraining Therapy (TRT) devices (various models under audifon arriva, elia, prado, and vico brands). The submission claims substantial equivalence to a predicate device, the audifon switch 8 TRT (K091552).
The core of the study is a comparison of technical specifications and performance against a predicate device, as opposed to a clinical trial with acceptance criteria for a new device's performance. The acceptance criteria are implicit in demonstrating that the new devices are "as safe, as effective, and perform as well as the predicate device."
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This study does not define explicit performance acceptance criteria in terms of sensitivity, specificity, accuracy, or similar metrics for diagnostic devices. Instead, the acceptance criteria are based on demonstrating equivalence in technical specifications and functionality to the predicate device. The "reported device performance" section will therefore compare the key characteristics of the new devices to the predicate.
| Feature/Acceptance Criterion (Implicit) | Predicate Device (audifon switch 8 TRT) Performance | New Devices (audifon arriva, elia, prado, vico TRT models) Performance | Meets Criterion? |
|---|---|---|---|
| Indications for Use (Adult population, chronic tinnitus, amplification, TRT protocol) | Adult population, chronic tinnitus, amplification (mild to moderate hearing loss), TRT program. | Adult population, chronic tinnitus, amplification (slight to profound hearing loss), TRT protocol. | Yes, with an expanded range for hearing loss amplification (slight to profound vs. mild to moderate). This expansion is acceptable as it addresses a broader patient need. |
| Operation/Mechanism (Broadband noise, digital, programmable, 4 noises) | Uses broadband noise; digital; programmable; 4 noises. | Uses broadband noise; digital; programmable; 4 noises. | Yes |
| Adjustable white-noise | Yes | Yes | Yes |
| Programmable noise level | Yes | Yes | Yes |
| Adjustable Low Battery Indicator | Yes | Yes | Yes |
| Programmable Program Switch Tones | Yes | Yes | Yes |
| Where Used (May be used anywhere) | May be used anywhere | May be used anywhere | Yes |
| Physical Description (Housing) | Standard receiver-in-the-ear instrument housing | Standard In-the-ear (CIC, IS, IS+) or Behind-the-ear (S, S+, M, X) instrument housing. | Yes, devices are similar in style (ITE or BTE) to the predicate. |
| Maximum Output (White noise SPL) | 100 dB SPL | arriva: 70-74 dB SPL | |
| elia/prado: 71-72 dB SPL | |||
| vico: 107-113 dB SPL | Yes. The submission argues that for TRT only low sound levels below 80 dB SPL are needed, and that the lower maximum output of many models has no influence on effectiveness. For vico models exceeding predicate, OSHA limits are noted in context of hearing loss. | ||
| Frequency Range | 200 - 6000 Hz | 200 - 8000 Hz | Yes, the new devices offer a wider frequency range, which is demonstrably "equivalent white noise with the same sound quality" (stated in comparison text). |
| Power Source | Standard 312 zinc air 1.4V battery | Various standard zinc air 1.4V batteries (10, 312, 13, 675). | Yes, uses standard hearing aid batteries. |
| Quality Assurance Standard | ANSI S3.22-2009 | ANSI S3.22-2009 | Yes |
| Similar Acoustic Characteristics | N/A (predicate comparison) | Non-clinical performance data measured according to ANSI S3.22-2009 verify similar effectiveness. | Yes |
| Similar Material | N/A (predicate comparison) | Similar | Yes |
| Similar Intended Use | N/A (predicate comparison) | Similar | Yes |
| Same Targeted Population | N/A (predicate comparison) | Same | Yes |
| Special Controls (21 CFR 874.3400) | Applied for predicate | Identically applied | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The submission relies on non-clinical performance data measured according to official standards (ANSI S3.22-2009) to demonstrate equivalence. This is not a test set of patient data. The data provenance is from the device manufacturer, and it is a retrospective comparison against published standards and the predicate device's specifications. No specific "sample size" in terms of patients or independent measurements is provided, other than the implication of standard compliance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on non-clinical performance data measured against engineering standards (ANSI S3.22-2009) and direct comparison of specifications to a predicate device, rather than expert-established ground truth from clinical data.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the context of clinical data requiring adjudication. The assessment is based on technical specifications and compliance with recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC comparative effectiveness study was not done. The submission is based on technical and functional equivalence to a predicate device, not on clinical effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the devices are "algorithm only" in the sense that they are hardware that generates sounds, the evaluation itself is not about an "algorithm's diagnostic performance." Instead, it's a standalone technical evaluation of the device's acoustic characteristics and features against industry standards and a predicate device.
7. The Type of Ground Truth Used
The "ground truth" used is defined by:
- Official standards: Specifically, ANSI S3.22-2009 for the proper functioning of hearing aids.
- Predicate device specifications: The audifon switch 8 TRT (K091552) serves as the benchmark for comparison of features and performance characteristics.
- Regulatory requirements: Compliance with "special controls" as defined in 21 CFR 874.3400 for tinnitus maskers and OSHA noise exposure guidelines (29CFR 1910.95) for maximum output levels.
8. The Sample Size for the Training Set
Not applicable. These are not AI/ML devices that require a training set in the conventional sense. The "development" of these devices would involve engineering design and testing, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model for this type of device submission.
§ 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.