RESOUND STEALTH CIC

{0}------------------------------------------------ K97408 DEC 1 2 1997 Image /page/0/Picture/1 description: The image shows the logo for ReSound Hearing Health Care. The word "ReSound" is in a large, bold, sans-serif font, with the registered trademark symbol next to the "D". Below "ReSound" is the phrase "HEARING HEALTH CARE" in a smaller, sans-serif font. ## RESOUND® STEALTH CIC HEARING DEVICE ## SUMMARY OF SAFETY AND EFFECTIVENESS Substantial equivalence for the ReSound® Stealth CIC, a completely-in-the-canal hearing device, to the currently marketed predicate hearing device, the Philips XP CIC, 510(k) No. K921725, August 11, 1992, is based on the following: - The effectiveness of this air-conduction hearing instrument, intended to amplify and transmit ● sound to the ear, is equivalent to devices of the same type designed for hearing losses from mild to moderate up to 70 dB HL. - The device is powered by a standard hearing aid battery (type 5A). . - 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® . Stealth CIC is substantially equivalent to the predicate device. - The device is a completely in-the-canal one-channel device with K-Amp™ technology. - The safety of this device is equivalent to devices of the same type with maximum SSPL90 of . less than 132 dB SPL. - . Proper fitting of this hearing aid (deep canal aid) requires the taking of a deep canal impression. Hearing health professionals should not attempt this type of fitting unless they have developed the necessary skills to take this type of impression safely. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 2 1997 Rocky Mountain Regulatory Consulting c/o Krista M. Buckles, M.A. CCC-A ReSound® Hearing Health Care 220 Saginaw Drive Seaport Centre Redwood City, CA 94063 Dear Ms. Buckles: Re: K974081 Resound® Stealth CIC Dated: October 17, 1997 Received: October 29, 1997 Regulatory class: I 21 CFR 874.3300/ 77 ESD We have reviewed your Section 510(k) notification of intent to market the device 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 (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS 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 does not affect any obligation you might have under sections 531 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 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. {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, William 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}------------------------------------------------ --- ! CDRE DRAERD | 510(k) Number (if known): | K974087 | Page 1 of 1 | |---------------------------|---------------------|-------------| | Device Name: | ReSound Stealth CIC | | | 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 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. | | _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 of Reproductive, Abdominal, ENT, and Radiological Devices | | 510(k) Number | K974087 | Reserieted device (per 21 Cara 801.410 & 21 Cra 801.421)