WIDEX SENSO DIGITAL (MINI CANAL)

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, which are enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 6 1997 Ron Meltsner Widex Hearing Aid Co., Inc. 35-53 24th Street Long Island City, N.Y. 11106 Re: K971535 . . . . Widex Senso Digitat (Mini Canal) Dated: April 25, 1997 Received: April 28, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD Dear Mr. Meltsner: 14 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 cleened 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 acnoying to very loud and may reader 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 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. {1}------------------------------------------------ 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. Lillian Yin Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | 510(k) Number (if known): | K971535 | Page of | |---------------------------|------------------------|---------| | Device Name: | Widex Senso MINI CANAL | | | Indications For Use: | | | A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): | Severity: | Configuration: | Other | |--------------|--------------------------------------------------------|-------------------------------------------| | ✓1. Slight | ✓1. High Frequency - Precipitously Sloping | ✓1. Low tolerance To Loudness | | ✓2. Mild | ✓2. Gradually Sloping | 2. __________ | | ✓3. Moderate | ✓3. Reverse Slope | 3. __________ | | ✓4. Severe | ✓4. Flat | | | 5. Profound | 5. Other __________ | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intellicibility in background noise, must be supported by clinical data.) 1. 2. 3. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Restricted device (per 21 CFR 801.420 & 21 CFR 801.421) - N. 4. IN CO . :