FM RECEIVER - AUDITORY TRAINER

K974287 · Phonic Ear, Inc. · EPF · Feb 10, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K974287
• Device Name: FM RECEIVER - AUDITORY TRAINER
• Applicant: Phonic Ear, Inc.
• Product Code: EPF · Ear, Nose, Throat
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3320
• Device Class: Class 2

Indications for Use

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 Story

FM receiver for group auditory trainer system; receives audio signals from compatible FM transmitter or built-in/plug-in microphones; processes audio via user-adjustable controls for gain, tone, and output limiting; output delivered to listening accessories (e.g., headphones/earpieces). Used in classrooms, theaters, and similar environments to improve word discrimination by reducing effects of distance and poor acoustics. Operated by hearing-impaired users or adjusted by clinicians/audiologists using special tools to lock settings. Features include LED indicators for battery status and FM signal reception, frequency channel selection via rotary switches, and multi-mode operation (FM only, FM + mic, or mic only). Benefits include improved speech intelligibility and personalized amplification matching specific hearing loss.

Clinical Evidence

Effectiveness substantiated by clinical study reports by Dr. David Hawkins, Dr. Mark Ross, Robert Benoit, M.A., and Dr. Thomas Giolas, demonstrating improved word discrimination in reverberant or poor acoustic environments.

Technological Characteristics

Solid-state surface mount components; integrated circuits; Cycolac plastic housing; powered by low-voltage rechargeable batteries with fused circuit; FM frequency reception; manual rotary/switch controls for gain, tone, SSPL, and FM level; ANSI S3.22-1987 compliant.

Indications for Use

Indicated for individuals with hearing deficits in institutional settings (e.g., schools, churches, theaters) to facilitate communication with speakers; also functions as a standalone assistive listening device.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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

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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)

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### 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.
- 7. 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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#### SUMMARY OF THE EFFECTIVENESS OF THE DEVICE

- 9. 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.
- 11. 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. `
- 12. 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.
- 15. 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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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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 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.

(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)

.

:

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

**Restricted Device**
Per 874.420 and 421