PHILIPS S1694, S1695

K971804 · Philips Hearing Instruments Co. · ESD · Jun 6, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971804
• Device Name: PHILIPS S1694, S1695
• Applicant: Philips Hearing Instruments Co.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Jun 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The indication for use of the air conduction hearing aids in this The indication for use of the individuals with impaired The devices are indicated for individuals with losses in hearing. nearing. The devices are indicated appropriate space(s)):

Device Story

Philips S1694 and S1695 are body-worn air conduction hearing aids. Devices amplify sound for individuals with hearing impairment. Operated by the patient to assist with hearing loss. Output is amplified acoustic signal delivered to the ear. Used in daily life settings. Benefit is improved auditory perception for the user.

Clinical Evidence

No clinical data provided; substantial equivalence determined via 510(k) regulatory pathway.

Technological Characteristics

Air conduction hearing aid; body-worn form factor. Class I device (21 CFR 874.3300).

Indications for Use

Indicated for individuals with impaired hearing, specifically those with slight, moderate, severe, or profound hearing loss, and configurations including high frequency precipitously sloping, gradually sloping, or flat hearing loss.

Regulatory Classification

Identification

An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is rendered in black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

JUN - 6 1997

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ted Miksiewicz Philips Hearing Instruments Co. 91 McKee Drive Mahwah, NJ 07430

Re: K971804

Philips S1694, S1695 Body Worn Hearing Aids Dated: May 13, 1997 . ... ... ... . Received: May 14, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Miksiewicz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 II (Special Controls) or 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device in a classification for your device and thus, permits your device to proceed to the market.

While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources, is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporarily ineffective for the wearer. Because electromagnetic interference may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 premarket 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 at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

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

Enclosure

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510(k) Number (if known):

Device Name: `PHILIPS S/654-S/656

Indications For Use:

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A. General Indications:

The indication for use of the air conduction hearing aids in this The indication for use of the individuals with impaired The devices are indicated for individuals with losses in hearing. nearing. The devices are indicated appropriate space(s)):

| Severity: | Configuration: | Other |
|------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------|
| <span style="text-decoration:line-through;">X</span> 1. Slight | 1. High Frequency - Precipitously Sloping | 1. Low tolerance To Loudness |
| 2. Mild | <span style="text-decoration:line-through;">X</span> 2. Gradually Sloping | 2. |
| <span style="text-decoration:line-through;">X</span> 3. Moderate | 3. Reverse Slope | 3. |
| <span style="text-decoration:line-through;">X</span> 4. Severe | <span style="text-decoration:line-through;">X</span> 4. Flat | |
| <span style="text-decoration:line-through;">X</span> 5. Profound | 5. Other | |

B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech (Most psychoacouscic Indications back as supported by clinical data.)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Seysson
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971804

Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)