FACEPLATE ASSEMBLY

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that converge at the bottom. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Paul Menezes Quality Engineer Finetone Hearing instruments, Inc 301 US Route 1 Scarborough, Maine 04074-9701 K974219 Re: ITE Faceplate Assembly Aid Models: M-LIN, M-H LIN, M-D, M-PP, M-D/ASP, M-D/AGCI, M-K-6AMP and M-EQII Dated: February 9, 1998 Received: February 17, 1998 Regulatory Class: I 21 CFR 874.3300/Procode: 77 LRB Dear Mr. Menezes: FEB 20 1998 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 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}------------------------------------------------ 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, lliam 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 {2}------------------------------------------------ 510(k) Number (if known): K 97 42 / g Device Name: Finetone ITE Faceplate Assembly, Model M-LIN Indications For Use: The M-LIN is a Class A linear circuit. Available options are the Low cut, High cut and Output controls. ## A. General Indications: The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): | Severity: | | |-------------|---| | 1. Slight | ✓ | | 2. Mild | ✓ | | 3. Moderate | ✓ | | 4. Severe | | | 5. Profound | | | Configuration: | | |--------------------------------------------|---| | 1. High frequency<br>Precipitously sloping | ✓ | | 2. Gradually sloping | ✓ | | 3. Reverse Slope | | | 4. Flat | ✓ | | 5. Other | | | Other: | | |---------------------------------|---| | 1. Low tolerance<br>To loudness | | | 2. High Tolerance | | | 3. Normal Tolerance | ✓ | B. Specific Indications (Only appropriate.): 1. (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) - 2. 3. PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David G. Seysman Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number {3}------------------------------------------------ 510(k) Number (if known): | 9742/9 Device Name: Finetone ITE Faceplate Assembly, Model M-PP Indications For Use: The M-PP is a Class B circuit. Available options are the Low cut, High cut and ouput controls. A. General Indications: 2. 3. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): | Severity: | | |--------------------------------------------|---| | 1. Slight | | | 2. Mild | | | 3. Moderate | | | 4. Severe | ✓ | | 5. Profound | | | Configuration: | | | 1. High frequency<br>Precipitously sloping | | | 2. Gradually sloping | ✓ | | 3. Reverse Slope | | | 4. Flat | ✓ | | 5. Other | | | Other: | | | 1. Low tolerance<br>To loudness | | | 2. High Tolerance | ✓ | | 3. Normal Tolerance | ✓ | B. Specific Indications (Only appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1.PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Byrne (Division Sign-Off) Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devi 510(k) Number {4}------------------------------------------------ 510(k) Number (if known): | 97 42/9 Device Name: Finetone ITE Faceplate Assembly, Model M-HLIN Indications For Use: The M-HLIN is a Class A linear circuit utilizing a hybrid amplifier. Available options are the Low cut, High cut and Output controls. A. General Indications: ని. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied 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. High Tolerance | | 3. Moderate | 3. Reverse Slope | 3. Normal Tolerance | | 4. Severe | 4. Flat | | | 5. Profound | 5. Other | | | B. Specific Indications (Only appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) | | | | 1. | | | | 2. | | | PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CØRH, Office of Device Evaluation (ODE) Daniel L. Seymour Division Sign Off (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K974219 {5}------------------------------------------------ 510(k) Number (if known): ├ 97 7 Z / 9 Device Name: Finetone ITE Faceplate Assembly, Model M-D Indications For Use: The M-D is a Class D linear circuit. Available options are the Low cut, High cut and Output controls. A. General Indications: The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied 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 | <div>✓</div> | 1. Low tolerance To loudness | | | 2. Mild | <div>✓</div> | 2. Gradually sloping | <div>✓</div> | 2. High Tolerance | <div>✓</div> | | 3. Moderate | <div>✓</div> | 3. Reverse Slope | | 3. Normal Tolerance | <div>✓</div> | | 4. Severe | <div>✓</div> | 4. Flat | <div>✓</div> | | | | 5. Profound | | 5. Other | | | | B. Specific Indications (Only appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) | 1. | | |----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. | the submit and the submit of the submit of the submit of the subscription of the sub- | | 3. | . company with the country of the country of the submit and the submit and the submit of the submit of the submit of the submit of the subsequence of<br>the submit and the submit and the submit of the submit of the submit of | PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Segerson (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K974719 {6}------------------------------------------------ 510(k) Number (if known): ★タア 42/ 9 Device Name: Finetone ITE Faceplate Assembly, Model M-D/ASP. Indications For Use: The M-D/ASP is a Automatic Signal Processing circuit utilizing Class D technology. Available options are the Asp, Low cut and High cut controls. A. General Indications: ్రస్స The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied 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. High Tolerance | | | 3. Moderate | ✓ | 3. Reverse Slope | | 3. Normal Tolerance | ✓ | | 4. Severe | | 4. Flat | ✓ | | | | 5. Profound | | 5. Other | | | | B. Specific Indications (Only 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 ØDRH, Office of Device Evaluation (ODE) Daniel A. Seymour --- (Division Sign-Off) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K974219 {7}------------------------------------------------ 510(k) Number (if known): K 97 4 Z 1 9 Device Name: Finetone ITE Faceplate Assembly, Model M-D/AGCI Indications For Use: The M-D/AGCI is an input compression circuit utilizing Class D technology. Available iptions are the Low cut and High cut controls. A. General Indications: The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): | Severity: | | |-------------|----------------------------------------------------| | 1. Slight | <span style="text-decoration: underline;">✓</span> | | 2. Mild | <span style="text-decoration: underline;">✓</span> | | 3. Moderate | <span style="text-decoration: underline;">✓</span> | | 4. Severe | | | 5. Profound | | | | Configuration: | |-----------------------------------------|----------------------------------------------------| | 1. High frequency Precipitously sloping | <span style="text-decoration: underline;">✓</span> | | 2. Gradually sloping | <span style="text-decoration: underline;">✓</span> | | 3. Reverse Slope | | | 4. Flat | <span style="text-decoration: underline;">✓</span> | | 5. Other | | | | Other: | |------------------------------|----------------------------------------------------| | 1. Low tolerance To loudness | <span style="text-decoration: underline;">✓</span> | | 2. High Tolerance | | | 3. Normal Tolerance | | B. Specific Indications (Only 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) Daniel A. Seymore (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number {8}------------------------------------------------ 510(k) Number (if known): Device Name: Finetone ITE Faceplate Assembly, Model M-KAMP. Indications For Use: The M-KAMP detects and amplifies quiet sounds. In loud situations it provides low distortion and high fedelity sound. Available options are the Threshold Kneepoint and low cut controls. ## A. General Indications: The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied 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. High Tolerance | | | 3. Moderate | ✓ | 3. Reverse Slope | | 3. Normal Tolerance | ✓ | | 4. Severe | | 4. Flat | ✓ | | | | 5. Profound | | 5. Other | | | | B. Specific Indications (Only 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 | K974219 | {9}------------------------------------------------ 510(k) Number (if known): 1997 4219 Device Name: Finetone ITE Faceplate Assembly, Model M-EQII. Indications For Use: The M-EQII is a Wide Dynamic Range, duel channel, input compression circuit which utilizes Class D technology. Available options are the Threshold Kneepoint, Low Frequency Gain, High Frequency Gain, Crossover and Output controls. - 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 | <div> </div> | 1. High frequency Precipitously sloping | <div> </div> | 1. Low tolerance To loudness | <div> </div> | | 2. Mild | <div> </div> | 2. Gradually sloping | <div> </div> | 2. High Tolerance | <div> </div> | | 3. Moderate | <div> </div> | 3. Reverse Slope | <div> </div> | 3. Normal Tolerance | <div> </div> | | 4. Severe | | 4. Flat | | | | | 5. Profound | | 5. Other | | | | B. Specific Indications (Only appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) - 1. 2. - ತ. PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Eyaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devi 510(k) Number K974639