MIRACLE-EAR ITE DIGITAL

{0}------------------------------------------------ **Appendix B** K972346 ## Summary of Safety and Effectiveness | Device Name: | Miracle-Ear Model DSF Hearing Aid | JUL 23 1997 | |---------------------------------|------------------------------------------------------------------------------------------------------------|-------------| | Device Type: | In-the-Ear (ITE) Hearing Aid | | | Classification: | Air Conduction Hearing Aid (77ESD), Class I. | | | Intended Use: | To amplify and transmit sound to the ear. | | | Substantially<br>Equivalent to: | Oticon Digifocus which was cleared for distribution<br>under 510(k) # K964683. | | | Registration<br>Number: | 2110592 | | | Materials: | The hearing aid shells will be manufactured from<br>materials that are commonly used in the industry. | | | Technical<br>Characteristics: | Dahlberg utilizes the ANSI S3.22-1987 methodology to<br>test and obtain performance data for hearing aids. | | | Fit: | Mild to severe as dictated by the individual users<br>audiogram. | | | Power: | Zinc-Air size 13 hearing aid battery standard. Zinc-<br>Air size 312 hearing aid battery is optional. | | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized human figure with three profiles facing right, representing health and human services. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Melanie Raska Manager of Regulatory Affairs Miracle-Ear® Hearing Systems by Bausch & Lomb Dahlberg, Inc. 4101 Dahlberg Drive Golden Valley, MN 55422 Re: K972346 Miracle Ear ITE Digital, Model DSF Date: June 23, 1997 Received: June 24, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD JUL 23 1997 Dear Ms. Raska: 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 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 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 results in a classification for your device and thus, permits your device to proceed to the market. While your device has been decined substantially equivvlent 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. {2}------------------------------------------------ Page 2 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 (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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Sincerely yours, Lillian Yin, 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 {3}------------------------------------------------ 510(k) Number (if known): K972346 Device Name: Miracle-Ear DSF Indications For Use: General Indications: A. 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<br>Precipitously Sloping | ✓ 1. Low tolerance<br>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). ## (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device E Restricted Device (per 21 CFR 801.420 & 421) vision Sign-Off) 'ision of Reproductive, Abdominal, ENT, : Radiological Devices 0(k) Number K972346 J3