(88 days)
This device is a receiver for an FM group auditory trainer. It is intended to be used with the Phonic Ear PE 571t group auditory trainer transmitter. Auditory trainers are used primarily in institutions (schools, churches, theaters, etc.) to allow teachers, ministers, etc. to communicate with individuals with hearing deficits.
This device can also be used with its built-in microphones or plug-in microphones as a stand alone assistive listening device.
This device is a receiver for an FM group auditory trainer. It is intended to be used with the Phonic Ear PE 571t group auditory trainer transmitter. The device is powered by low voltage batteries which are contained within a battery compartment that is fitted with a locking cover to prevent inadvertent opening. The battery circuit is fused to prevent over heating should a short circuit occur. The devices' plastic housing is made of Cycolac plastic. The device includes controls for maximum power output, sound pressure level of built-in receiver microphones and FM signal, CHG/LOW BATT LED, NO FM LED, enlarging lens for FM frequency channel number, a 3 position switch for operating modes, a 7 position FM level switch for each ear, a 7 position SSPL switch for each ear, a 7 position GAIN switch for each ear, a 7 position TONE switch for each ear, and a 2 position microphone switch. It uses solid state surface mount components and integrated circuits. The receiver's FM receiving frequency is controlled by 2 rotary switches accessible under a latching cover.
The provided document is a 510(k) notification for a medical device (Group Auditory Trainer, Model PE571R). It describes the safety and effectiveness of the device, but it does not contain the specific acceptance criteria or a study designed to prove the device meets these criteria in the typical sense of a clinical trial with predefined metrics.
Instead, the document focuses on demonstrating substantial equivalence to previously approved devices, a requirement for 510(k) submissions. The "effectiveness" section lists various features and functionalities of the device and how they contribute to its intended use. For these effectiveness claims, the document refers to existing clinical studies that support the general concept of FM Auditory Training Systems, rather than a single study specifically designed for this particular device model and its acceptance criteria.
Therefore, many of the requested information points cannot be directly extracted from this document in the way they would be from a clinical trial report.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics with thresholds (e.g., "sensitivity must be >X%"). The criteria for acceptance are implicitly that the device is safe and effective, and substantially equivalent to predicate devices.
- Reported Device Performance: The document describes various features and functionalities as contributing to the device's effectiveness. These are qualitative descriptions of performance rather than quantitative measurements against specific criteria. For example, "The maximum power output of the receiver can be set to the appropriate level required by the user and then locked at that level to prevent over amplification..." describes a safety/effectiveness feature without providing a specific quantitative performance value or an acceptance threshold for that value.
| Acceptance Criteria (Implicit from Effectiveness Claims) | Reported Device Performance (as described) |
|---|---|
| Prevention of over-amplification/pain | Maximum power output can be set and locked. |
| Proper balance between signal sources | Independent control of receiver microphones and FM transmitter signal levels. |
| Indication of battery status | CHG/LOW BATT LED provides positive indication of charge and low battery. |
| Indication of FM signal reception | NO FM LED indicates when no FM signal is received. |
| Easy visibility of FM frequency channel | Enlarging lens on front face. |
| Multiple operating modes | 3-position switch for various operating modes. |
| Attenuation of audio signals for emphasis | 7-position FM level switch for each ear. |
| Limiting output to appropriate sound pressure level | 7-position SSPL switch for each ear. |
| Adjustable amplification level | 7-position GAIN switch for each ear. |
| Adjustable frequency response | 7-position TONE switch for each ear. |
| Options for microphone input | 2-position microphone switch for built-in or BTE device microphone. |
| Compact size and light weight | Use of solid state surface mount components and integrated circuits. |
| Natural sound in different environments | Use of several optional listening accessories. |
| Wide choice of fitting possibilities | Ability to use a variety of listening accessories. |
| Optimum performance in most listening environments | Selection of operating modes (FM only, FM+mic, mic only). |
| Easy change of FM channels | 2 rotary switches under a latching cover. |
| Improved word discrimination in noisy environments, reduced effects of distance/reverberation | "Effectiveness claims outlined in paragraph 17 have been substantiated by the results of many clinical studies made over the years since the introduction of FM Auditory Training Systems." (General claim, not device-specific study) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this document. The safety and effectiveness claims are based on substantial equivalence to predicate devices and general understanding of FM Auditory Training Systems, supported by existing literature. There is no specific "test set" for this particular device's performance in a clinical study detailed here. The technical specifications were obtained by testing devices per ANSI Standard ANSI.S3.22-1987, which is a standard for hearing aid characteristics, not a clinical test set in the usual sense.
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 specific test set with ground truth established by experts for this device is detailed in the submission. The acceptance of the device relies on its technical specifications meeting standards and its features aligning with established principles of FM auditory trainers, as judged by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No specific test set requiring adjudication is detailed.
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 an auditory trainer, not an AI-powered diagnostic tool for interpretation by human readers. It's designed to assist hearing, not assist interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device with specific audio processing capabilities, not an algorithm in the sense of AI. Its "performance" is its ability to transmit and amplify sound according to its design, which is tested against engineering standards (like ANSI S3.22-1987).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the claims of improved word discrimination, reduced effects of distance/reverberation (paragraph 17), the document references "many clinical studies made over the years since the introduction of FM Auditory Training Systems." It specifically mentions "Three such study reports by Dr. David Hawkins, Dr. Mark Ross, Robert Benoit, M.A. and Dr. Thomas Giolas form a part of this 510K submission." These studies would likely use outcomes data (e.g., speech recognition scores in various conditions) as their ground truth for demonstrating the effectiveness of FM systems in general. However, the details of how ground truth was established in those specific studies are not provided in this document.
- For the technical specifications, the "ground truth" is adherence to the ANSI Standard ANSI.S3.22-1987, which defines objective measurement methods for hearing aid characteristics.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary, this 510(k) notification primarily relies on demonstrating that the device's design, features, and technical specifications are substantially equivalent to legally marketed predicate devices and adhere to relevant engineering standards. The effectiveness claims for FM auditory trainers in general are supported by existing clinical literature, rather than a new, dedicated clinical study specifically for this model with defined acceptance criteria and a test set.
§ 874.3320 Group hearing aid or group auditory trainer.
(a)
Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.