AUDIFON H20 PC/AUDIFON H32 PP

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ziad Shwiyat Technical Manager Trutone Ltd. 3113 S. 115th E. Ave. Tulsa, OK 74146 Re: K972552 Audiofon H20 PC and H32 PP . . Dated: June 26, 1997 Received: June 30, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD 30 1997 . Dear Mr. Shwiyat: 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 (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: General regulation (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 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 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 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 yitrg diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours h. William Wier, Ph.D. 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 {1}------------------------------------------------ | Page | 2 of 17 | |------|---------| |------|---------| | 510(k) Number (if known): | | |---------------------------|------------------| | Device Name: | H20 PC 2- H32 PP | | 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 intelligibility in background noise, must be supported by clinical data.) 1. 3. : 2. (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 | | | 510(k) Number | K972552 | .. . . . . . . . . Restricted device (per 21 CFR 801.420 & 21 CFR 801.421) :