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.

Device Description

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.

AI/ML Overview

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.

Summary

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974287

FEB 1 0 1998

510 K NOTIFICATION

GROUP AUDITORY TRAINER (Group Amplification System)

PHONIC EAR INC.

MODEL PE571R

Submitted by:

PHONIC EAR INCORPORATED 3880 Cypress Drive Petaluma, CA 94954-7600

Establishment Registration No. 2918633

SUMMARY

of the

SAFETY AND EFFECTIVENESS OF THE DEVICE

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SUMMARY OF THE SAFETY OF THE DEVICE

The safety of this auditory trainer FM receiver is equivalent 1. to approved devices and systems of the same type.
While the highest sound pressure level produced by the device 2. is above 132dBSPL, this output can be limited to the output required by the user. Limiting can be accomplished with a control set and locked by a clinician, audiologist or hearing professional prior to use by the hearing impaired person.
A notice of the devices' high output capability and a warning 3. that high sound pressure could damage hearing are contained in the user information.
The audiological controls of the device can be set by a 4 . clinician, audiologist, or hearing professional prior to use These settings provide the by the hearing impaired person. proper amplification to match the hearing loss of the user and to preset the receivers for proper function with the accessories to be used.
The fitter controls are covered to prevent access by the user 5. and can be adjusted only by use of special tools available to the hearing professional making the initial or subsequent adjustments.
Other safety notices as required by FDA rules are contained in 6. the user information.
Device Maintenance and Care instructions are contained in the 7. user information.
Instructions for the user to follow should the device not 8. function as expected are contained in the user information.

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510K NOTIFICATION PHONIC EAR Model PE571R FM Receiver November 7, 1997 (continued)

ﺔ ﻭﻣﻦ ﺍﻟ

SUMMARY OF THE SAFETY OF THE DEVICE

Complete technical specifications required by the FDA rules 9. are contained in the user information. These specifications were obtained by testing devices per ANSI Standard ANSI.S3.22-1987 Specification of Hearing Aid Characteristics.
Devices are distributed directly to qualified schools or 10. institutions or to Hearing Aid Dispensers, Audiologists, Clinics or others who are qualified to fit the devices to the hearing requirements of the user.
The device is powered by low voltage batteries which are 11. 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 which 12. has few known side effects caused by the material. A warning consult a physician should any affect to the skin be to noticed, is contained in the user information.
A complete line of accessories to be used with the device are 13. the manufacturer and a list of these available from accessories is contained in the user information.
Addresses and telephone numbers of authorized service centers 14. are available to the user should any questions arise about the function of the device.
Complete and detailed descriptions on the use, adjustments and 15. functions of the device are contained in the user information.

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SUMMARY OF THE EFFECTIVENESS OF THE DEVICE

The maximum power output of the receiver can be set to the 1. appropriate level required by the user and then locked at that level to prevent over amplification which could cause pain or discomfort to the listener.
The sound pressure level of the built-in receiver microphones 2. and the level of the signal received from the FM transmitter can be independently controlled so that the proper balance between the two signal sources can be achieved.
The CHG/LOW BATT LED located on the front face of the receiver 3. provides a positive indication that the unit's rechargeable batteries are receiving a charge and that the charging circuit It also indicates when the unit's is functioning properly. batteries are low and should be recharged or replaced.
The NO FM LED located on the front face of the receiver 4 . indicates when no FM signal is being received by a receiver..
The enlarging lens on the front face of the receiver enables 5. the FM frequency channel number the user to easily see Receivers and transmitters must be set to the same selected. frequency channel in order to function together as a system.
The inclusion of a 3 position switch allows the receiver to be 6. set to the various operating modes required by the user.
1. The inclusion of a 7 position FM level switch for each ear enables the receivers's audio signals to be attenuated so that the transmitter signals are emphasized over the environmental sounds picked up by the receiver's microphones.
The inclusion of a 7 position SSPL switch for each ear enables 8. the output of the receiver to be limited to the sound pressure level best suited for the user.

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(continued)

SUMMARY OF THE EFFECTIVENESS OF THE DEVICE

1. The inclusion of a 7 position GAIN switch for each ear enables the level of amplification to be set to best suit the users' needs.
10 . The inclusion of a 7 position TONE switch for each ear enables the frequency response of the receiver to be set to best accommodate the specific hearing loss of the user.
1. The inclusion of a 2 position microphone switch which enables the receiver to be set for sound reception through the 2 built environmental microphones or through the microphone in contained in a behind-the-ear (BTE) device connected to the receiver. `
1. The use of solid state surface mount components and integrated circuits allows the size and weight of the devices to be reduced without loss of any of the beneficial features provided in the design. It also allows the unit to be less obtrusive to the user because of smaller size and easier to use because of the reduction in weight.
The use of several optional listening accessories provides a 13. more natural sound to the user in different environments because the ambient sounds are processed more nearly like the sound received by normal hearing persons.
The ability of this device to use a variety of listening 14 . accessories allows the user a wider choice of fitting possibilities to better meet their personal needs.
1. By selecting the mode of operation, FM signal only, FM signal and microphone signal together or microphone signal only, the user will be able to set the unit for optimum performance in most listening environments.

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(continued)

SUMMARY OF THE EFFECTIVENESS OF THE DEVICE

The receiver's FM receiving frequency is controlled by 2 16. rotary switches accessible under a latching cover. This will enable the FM channels to be easily changed by the user as needed in various classroom environments or in other listening situations where multiple FM frequencies may be present.
The use of an FM Auditory Trainer (Group Amplification System) 17. provides increased word impaired in listening for the hearing discrimination environments such as school classrooms, concert halls, noises, similar situations where or other theaters reverberation or poor acoustical treatment may be found. The use of FM Systems also reduce the detrimental effects caused by the distance between the speaker or sound source and the hearing impaired listener.
- Note: 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. 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.

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Image /page/6/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert L. Reinke Director, Regulatory Affairs Phonic Ear, Inc. 3880 Cypress Drive Petaluma, California 94954-7600 Re:

FEB 1 0 1998

K974287 Group Auditory Trainer (Group Amplification System) Model PE571R Dated: November 7, 1997 Received: November 14, 1997 Regulatory class: II Procode: 77EPF, 21 CFR 874.3320

Dear Mr. Reinke:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desemnined the device is substantially equivalent 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: Generalivegulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further smouncements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket actification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premier notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

hDliau Yin

Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page / of /

510(k) Number (if known):_长舟74287

Device Name:_P.E. 571 R

Indications For Use:

This device can also be used with its built-in microphones or plug-in microphones as a stand alone assistive listening device.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

and Radiological Device 510(k) Number

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Restricted Device
Per 874.420 and 421

Regulation Number and Section

§ 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.