RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for ReSound Hearing Health Care. The word "ReSound" is in a bold, italicized font, with a registered trademark symbol to the right of the word. Below the logo is the text "HEARING HEALTH CARE" in a smaller, non-italicized font. JUL - 3 1997 K971605 ## ReSound® ED4 Personal Hearing System™ ## SUMMARY OF SAFETY AND EFFECTIVENESS Substantial equivalence for the ReSound® ED4 Personal Hearing System™ to the predicate device, the ReSound® Personal Hearing System ED3a (marketed as the ED3), 510(k) No. K951379, April 27, 1995, is based on the following: - This air-conduction in-the-ear hearing instrument, intended to amplify sound pressure waves . and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe. - The device is powered by a standard type 13 hearing aid battery (type 312 for the half-shell . option). - The device is manufactured and delivered completely assembled to the hearing aid dispenser ● using materials and techniques widely used by other manufacturers of hearing devices. - The intended use, performance specifications, functions and operations of the ReSound® ED4 . Personal Hearing System™ are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System™ ED3. - The ability to program digitally the fitting parameters of the hearing device is the same as in . the ReSound® Personal Hearing System™ ED3, as is the ability to change the characteristics of the sound processing and adjust the volume via an ultrasound remote control. {1}------------------------------------------------ Image /page/1/Picture/0 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 in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Krista M. Buckles, M.A., CCC-A Director, Regulatory Affairs ReSound® Corporation 220 Saginaw Drive Seaport Centre Redwood City, CA 94063 Re: K971605 ReSound® ED4 Personal Hearing System™ Dated: April 30, 1997 Received: May 1, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD JUL = 3 1997 Dear Ms. Buckles: 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 decraed substantially oquivalent to other legally marketed hearing aids, alease be advised that electroniagnetic interference from digital celielar 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, ho'lliau Yi 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}------------------------------------------------ 44 : ﺩ : 46 CDKE DRAERD | 510(k) Number (if known): | K971605 | | Page 1 of 1 | |---------------------------|-------------------------------------|--|-------------| | Device Name: | ReSound Personal Hearing System ED4 | | | | 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 | X 1. High Frequency - Precipitously Sloping | X 1. Low tolerance To Loudness | | X 2. Mild | X 2. Gradually Sloping | 2. | | X 3. Moderate | X 3. Reverse Slope | 3. | | X 4. Severe | X 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. 2. 3. (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 Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K971605 Rescribted device (per 21 CER 801.410 & 21 CFR 801.421)