(23 days)
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: 2. Mild, Configuration: 1. High Frequency - Precipitously Sloping, 3. Reverse Slope, 5. Other, Other: 1. Low tolerance To Loudness, 2., 3.
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech (Most psychoacouscic Indications back as supported by clinical data.) 1., 2., 3.
Not Found
This document is a 510(k) premarket notification from the FDA for a hearing aid, which approves the device based on its substantial equivalence to previously marketed devices. It does not contain a study describing acceptance criteria or device performance in the way requested.
Therefore, I cannot extract the information to complete the table and answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria."
The document primarily focuses on:
- Regulatory approval: Stating that the Philips S1694, S1695 Body Worn Hearing Aids are substantially equivalent to devices marketed prior to May 28, 1976.
- General controls: Listing requirements like annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
- Electromagnetic interference (EMI): Warning about potential EMI from digital cellular telephones and encouraging labeling modifications, noting that claims of compatibility would require a new 510(k) submission with supporting data.
- Indications for Use: Specifying the general indications for use as "air conduction hearing aids" for individuals with "impaired hearing" and outlining the severity and configuration of hearing loss these devices are indicated for (slight, moderate, severe, profound range; gradually sloping, flat configurations).
To reiterate, there is no information about specific performance metrics, acceptance criteria, or a study demonstrating the device meets those criteria within this FDA letter.
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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 (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 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 (800) 638-2041 or at (301) 443-6597 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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| LA MER AND ANNA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 1 |
510(k) Number (if known):
Device Name: `PHILIPS S/654-S/656
Indications For Use:
યુવ
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 |
|---|---|---|
| X 1. Slight | 1. High Frequency - Precipitously Sloping | 1. Low tolerance To Loudness |
| 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | 3. Reverse Slope | 3. |
| X 4. Severe | X 4. Flat | |
| X 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.)
3 .
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)
§ 874.3300 Air-conduction hearing aid.
(a)
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.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.