(386 days)
The Evok series is designed for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.
The target population for this product is primarily the adult population 18 vears of age and older. The target group for this product includes individuals reporting tinnitus who can also benefit from an air conduction hearing aid.
Our devices are a combination of a hearing aid and a tinnitus masker in the same instrument. They are prescribed for those people with hearing loss who do not have significant relief with a hearing aid alone.
Dispenser or user adjustments permit selection of broad band or high or low frequency emphasis noise and aid response. It is essentially a tinnitus masker with a hearing aid added. Programmable volume controls are provided: one for noise level and the other for hearing aid gain. The dispenser, audiologist or user can mix the amount of noise and amplification as required.
The provided document does not contain a study or data proving the device meets specific acceptance criteria. Instead, it is a 510(k) summary, which is a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria (e.g., specific auditory thresholds, SNR, or masking effectiveness levels) based on which the device's performance was evaluated. The primary "acceptance criterion" for a 510(k) submission is showing substantial equivalence to predicate devices.
- Reported Device Performance:
- The document states, "The non-clinical tests submitted in this 510(k) demonstrate the electroacoustic properties of our devices and how similar in test results parameters they are." However, specific electroacoustic parameters or numerical results are not provided in this summary.
- The document emphasizes the device's function: "The Evok 900 series are designed to provide tinnitus masking and amplification for hearing loss in the same device." Its effectiveness is inferred from its similarity to predicate devices that perform these functions.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No specific test set or clinical study data is described. The submission relies on "non-clinical tests" demonstrating electroacoustic properties and the established safety record of Class I hearing aids. There is no mention of a human subject test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No human subject test set or ground truth establishment by experts is described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No human subject test set or adjudication method is described.
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
- Not applicable. This device is a hearing aid/tinnitus masker, not an AI diagnostic tool that would typically involve human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the AI sense. The device is a physical medical device. While it functions independently, it requires fitting and recommendations by a qualified hearing healthcare professional. Its "performance" refers to its acoustical output and masking capabilities, not an algorithmic assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- No explicit ground truth established for a test set. The basis for substantial equivalence is the similarity in "materials, construction and internal circuits" and "electroacoustic properties" to predicate devices, and the established safety of Class I hearing aids. The "truth" here is essentially compliance with engineering specifications and demonstrated functional equivalence to existing, approved devices.
8. The sample size for the training set
- Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. (See point 8)
Summary of Device and Evidence:
The Persona Medical Evok series (Evok 900, 913r, 923, 928, 933) is a combination hearing aid and tinnitus masker. The submission is a 510(k) premarket notification asserting substantial equivalence to existing predicate devices (General Hearing Instruments Tranquil Combo Devices and GN Resound TSG Module/Live TS series).
The "study that proves the device meets acceptance criteria" is primarily the non-clinical testing demonstrating the electroacoustic properties of the Evok devices and their similarity to the predicate devices. The document explicitly states:
- "The non-clinical tests submitted in this 510(k) demonstrate the electroacoustic properties of our devices and how similar in test results parameters they are."
- "Since these devices are basically Class I device Hearing Aids, the years these devices have been in market have established a safety track record that substantiates they are safe to market."
- "The technological similarities to the predicate are based on the materials, construction and internal circuits used by Class I Hearing aids..."
- "The testing performed on the Evok 900 series are evidence that these devices are safe when used in accordance with the guidance of a qualified audiologist or other hearing healthcare professional..."
The FDA's decision to clear the device (K093715) indicates that they agreed the device was substantially equivalent to the predicate devices based on this non-clinical data and the established safety records.
§ 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.