TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05

{0} DEPARTMENT OF HEALTH &amp; HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 20 1997 Paul Menezes Quality Engineer National Hearing Aid Distributors 301 U.S. Route One Scarborough, ME 04074 Re: K971296 Tondi BTE Hearing Aids Dated: April 7, 1997 Received: April 7, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD Dear Mr. Menezes: 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 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. {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. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Page 1 of 6 510(k) Number (if known): K971296 Device Name: Tondi BTE Hearing Aid, Models U-2M1, U-2M4 Indications For Use: The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). | Severity: | Configuration: | Other: | | --- | --- | --- | | ☐ 1. Slight | ☐ 1. High frequency Precipitously sloping | ☐ 1. Low tolerance to loudness | | ☑ 2. Mild | ☑ 2. Gradually sloping | ☐ 2. High Tolerance | | ☑ 3. Moderate | ☐ 3. Reverse Slope | ☑ 3. Normal Tolerance | | ☐ 4. Severe | ☑ 4. Flat | | | ☐ 5. Profound | ☐ 5. Other | | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)  Hearing aid part is Restricted device (per 21 CFR 801.420 &amp; 21 CFR 801.431)<br/> Masker portion is Prescription device (per 21 CFR 801.109) TOTAL F.84 {3} Page 2 of 6 510(k) Number (if known): K971296 Device Name: Tondi BTE Hearing Aid, Model U-03 Indications For Use: The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). | Severity: | Configuration: | Other: | | --- | --- | --- | | 1. Slight | 1. High frequency Precipitously sloping | 1. Low tolerance to loudness | | 2. Mild | 2. Gradually sloping | 2. High Tolerance | | 3. Moderate | 3. Reverse Slope | 3. Normal Tolerance | | 4. Severe | 4. Flat | | | 5. Profound | 5. Other | | (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 K971296 Hearing aid part is Restricted device (per 21 CFR 801.420 &amp; 21 CFR 801.421 Masker portion is Prescription device (per 21 CFR 801.109) TOTAL F. 04 {4} Page 3 of 6 510(k) Number (if known): K971296 Device Name: Tondi BTE Hearing Aid, Model KA-02 Indications For Use: The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). | Severity: | Configuration: | Other: | | --- | --- | --- | | 1. Slight | 1. High frequency Precipitously sloping | 1. Low tolerance to loudness | | 2. Mild | 2. Gradually sloping | 2. High Tolerance | | 3. Moderate | 3. Reverse Slope | 3. Normal Tolerance | | 4. Severe | 4. Flat | | | 5. Profound | 5. Other | | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)  Hearing aid part is Restricted device (per 21 CFR 801.420 &amp; 21 CFR 801.421)<br/> Masker portion is Prescription device (per 21 CFR 801.109) TOTAL F. 04 {5} Page 4 of 6 510(k) Number (if known): K971296 Device Name: Tondi BTE Hearing Aid Models KA-03, KA-USA Indications For Use: The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). | Severity: | Configuration: | Other: | | --- | --- | --- | | 1. Slight | 1. High frequency Precipitously sloping | 1. Low tolerance (to loudness) | | 2. Mild | 2. Gradually sloping | 2. High Tolerance | | 3. Moderate | 3. Reverse Slope | 3. Normal Tolerance | | 4. Severe | 4. Flat | | | 5. Profound | 5. Other | | (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 K971296 Hearing aid part is Restricted device (per 21 CFR 801.420 &amp; 21 CFR 801.421) Masker portion is Prescription device (per 21 CFR 801.109) TOTAL 5.04 {6} Page 5 of 6 510(k) Number (if known): K971296 Device Name: Tondi BTE Hearing Aid, Models KA-01, KA-04, KA-04A Indications For Use: The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). | Severity: | Configuration: | Other: | | --- | --- | --- | | 1. Slight | 1. High frequency Precipitously sloping | 1. Low tolerance to loudness | | 2. Mild | 2. Gradually sloping | 2. High Tolerance | | 3. Moderate | 3. Reverse Slope | 3. Normal Tolerance | | 4. Severe | 4. Flat | | | 5. Profound | 5. Other | | (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 K971296 Hearing aid part is Restricted device (per 21 CFR 801.420 &amp; 21 CFR 801.421 Masker portion is Prescription device (per 21 CFR 801.109) TOTAL F. 01 {7} Page 6 of 6 510(k) Number (if known): K971296 Device Name: Tondi BTE Hearing Aid, Model KA-05 Indications For Use: The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). | Severity: | Configuration: | Other: | | --- | --- | --- | | 1. Slight | 1. High frequency Precipitously sloping | 1. Low tolerance to loudness | | 2. Mild | 2. Gradually sloping | 2. High Tolerance | | 3. Moderate | 3. Reverse Slope | 3. Normal Tolerance | | 4. Severe | 4. Flat | | | 5. Profound | 5. Other | | (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 K971296 Hearing aid part is Restricted device (per 21 CFR 801.420 &amp; 21 CFR 801.431 Masker portion is Prescription device (per 21 CFR 801.109) TOTAL. 5.04