AM SERIES HEARING AID

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. The eagle is composed of three curved lines that suggest movement and flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Martin Starkie Customer Service Representative AM Hearing Limited Faraday Road Crawley, West Sussex, England Re: OCT 2 8 1997 K973579 AM14, AM152AGC, AM152 , AGC-D, AM240PPL, AM240PPI, AM240HF, AM260AGC, AM260HF, AM2600HM, AM260K-AMP, AM260XP, AM262T-AGS, AM300XP, AM300AGC, AM300HF, AM300K-AMP, AM400PP, AM400PPL, AM500PP,AM510, AM530, AM550, AM800PPL, AM800T-AGS Hearing Aid Dated: September 19, 1997 Received: September 19, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD Dear Ms. Starkie: 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 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 yitro 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, holliam Yi Lillian Yi, 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 {2}------------------------------------------------ Page / of 2 3 510(k) Number (if known): 973 679 Device Name:_ Indications For Use: 1 5 5 4 - 1 3 2 3 - 1 2 - 1 2 - 1 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - A. General Indications: The indication for use of the air conduction hearing aids in this the indication for ase of chool for individuals with impaired Submission is co ampirity bound rom for individuals with losses in nearing. The devices areas area. (Check appropriate space(s)): | Severity: | Configuration: | Other | |---------------|-------------------------------------------|--------------------------------------| | X 1. Slight | 1. High Frequency - Precipitously Sloping | 1. Low tolerance To Loudness | | X 2. Mild | X 2. Gradually Sloping | X 2. WITH LOUD INPUT LEVELS POSSIBLE | | X 3. Moderate | 3. Reverse Slope | 3. DISTORTION | | 4. Severe | X 4. Flat | X High tolerance to Loudness | | 5. Profound | 5. Other | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech a intelligibility in background noise, must be supported by clinical data.) - 3 . l. 2. (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 | K973579 | {3}------------------------------------------------ Page 2 of 2 5 973579 K 510(k) Number (if known): SUPP Device Name: Indications For Use: 2. 3. 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 | |----------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------| | <div style="text-align: left;">_ 1. Slight</div> | <div style="text-align: left;">X 1. High Frequency - Precipitously Sloping</div> | <div style="text-align: left;">_ 1. Low tolerance To Loudness</div> | | <div style="text-align: left;">_ 2. Mild</div> | <div style="text-align: left;">X 2. Gradually Sloping</div> | <div style="text-align: left;">X 2. High tolerance to Loudness</div> | | <div style="text-align: left;">X 3. Moderate</div> | <div style="text-align: left;">_ 3. Reverse Slope</div> | <div style="text-align: left;">_ 3.</div> | | <div style="text-align: left;">X 4. Severe</div> | <div style="text-align: left;">_ 4. Flat</div> | | | <div style="text-align: left;">_ 5. Profound</div> | <div style="text-align: left;">X 5. Other precipitous beginning @ 1KHz.</div> | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. Good for patients with conductive HL. (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 | K973579 | |---------------|---------| |---------------|---------| {4}------------------------------------------------ Page 30f25 973 579 510(k) Number (if known): Device Name: Sm 152 Alc Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this rne indication roamplify 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 | 3. Reverse Slope | 3. | | X 4. Severe | X 4. Flat | | | 5. Profound | X 5. Other precipitous from 1KHz on | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. Ideal for patients with sensorineural HL. 2. Good for those with narrow dynamic range 3. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrenge of CDRH, Office of Device Evaluation (ODE) Varind A. Leyram --- **(Division Sign-Off)** Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number K973579 {5}------------------------------------------------ Page 4 of 25 510(k) Number (if known): Device Name: Am 152. AltC-1 Comments of the contract of the controlled to the many of the comments of the comments of the comments of the comments of the controlled of the comments of the comments of th 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 | | 1. High Frequency - Precipitously Sloping | | X1. Low tolerance To Loudness | | X2. Mild | | X2. Gradually Sloping | | 2. | | | X3. Moderate | | 3. Reverse Slope | | 3. | | | X4. Severe | | X4. Flat | | | | | 5. Profound | | X5. Other precipitous from 1KHz -> | | | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. Ideal for patients with sensorineural HL. 2. Those who have A NARROW dynamic RANGE. 3. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David Lee Lynn Division Sign-Off Division of Reproductive, Abdominal, EN 510(k) Number {6}------------------------------------------------ Page 5 of 25 510(k) Number (if known): 1 - 50 - 19 - 20 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - Device Name: K 973 579 Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this s of the same of the sound for individuals with impaired The indication for use of the arr condividuals with impaired submission is to amplify sound in individuals with losses in hearing. The devices are indicated for individuals with losses in thearing. The devices (is ) (Chock annonriate s hearing. The devices are Indicated for the " the following category(ies). (Check appropriate space(s)): | Severity: | | |--------------------------------------------|--| | 1. Slight | | | 2. Mild | | | X3. Moderate | | | X4. Severe | | | X5. Profound | | | Configuration: | | | X1. High Frequency - Precipitously Sloping | | | X2. Gradually Sloping | | | X3. Reverse Slope | | | X4. Flat | | | X5. Other Scoop | | | Other | | | X1. Low tolerance To Loudness | | | X2. High tolerance to Loudness | | | 3. | | B. Specific Indications (Only if appropriate.): Citic Indications (on) it effress such as improved speech (Host psychoacouscic Indications buck to apported by clinical data.) 1. Good for severe - profound HL. whether conductive mixed or SNHL. - 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, and Radiological Dev 510(k) Number {7}------------------------------------------------ Page 6 of 25 79 510(k) Number (if known): Device Name: Am 2.4c PPi Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this s of the life and for and for individuals with impaired The indication for use of the arr condividuals with impaired submission is to amplify sound for individuals with loss submission is to amplify sound for individuals with losses in hearing. The devices are indicated for individuals with losses in thearing. The devices are indicated on arearia hearing. The devices are indicated as and the following category(s)): Severity: _ 1. Slight _ 2. Mild X 3. Moderate X 4. Severe _ 5. Profound Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping _ 3. Reverse Slope _ 4. Flat X 5. Other: percipitous, scoop Other X 1. Low tolerance To Loudness X 2. High tolerance to Loudness _ 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical 1. (Good for moderate - severe mixed or conductive HL. - 2 . data.) 3 . (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Kyson Division Sign-Off) Division of Reproductive, Abdominal, EN Restricted device (per 21 C {8}------------------------------------------------ Page 7 of 25 AK | 510(k) Number (if known): | k973579 | |---------------------------|---------| |---------------------------|---------| Ang 240 HFF Device Name: Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this ric indication is to amplify sound for individuals with impaired Submission is to any 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 <span style="text-decoration: underline;">X</span> | 1. Low tolerance To Loudness <span style="text-decoration: underline;">X</span> | | 2. Mild | 2. Gradually Sloping | 2. | | 3. Moderate <span style="text-decoration: underline;">X</span> | 3. Reverse Slope | 3. | | 4. Severe | 4. Flat | | | 5. Profound | 5. Other precipitous @ 1.5K/Hz <span style="text-decoration: underline;">X</span> | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. Bene lits a mild-moderate sensorineura 3 . 2. (PLEASE DO NOT FRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HERDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division.co Division of Reproductive, Abdominal, E and Radiological De 510(k) Number K0173579 {9}------------------------------------------------ Page & of 25 973579 510(k) Number (if known): Device Name: Am 260 Ace FOR CONSTITUTION PARTY OF CALL PROPERTY AND PRODUCT CONSULTERS CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION C Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this rne indication is to amplify sound for individuals with impaired Submission is to caps 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 | X 1. Low tolerance To Loudness | | X 2. Mild | X 2. Gradually Sloping | _ 2. | | X 3. Moderate | _ 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. Good for Sensorin 2. 3 . (PLEASE DO NOT GRITE BELOG THIS LINE. CONTINUE ON ANOTHER PAGE IF HEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K973579 {10}------------------------------------------------ Page 9 of 25 | | | ( | | |----------|--------------------------------------------------------------------|---|--| | : ( BMOD | In and the many and in the Millionary 11, mall a work work works w | | | 260 Device Name: Indications For Use: 510(k) Number (if k A. General Indications: The indication for use of the air conduction hearing aids in this the indication to amplify sound for individuals with impaired Submission is to ampirity bound at the individuals with losses in hearing. The devices are indicated for individuals and alle the following category(ies). (Check appropriate space(s)): | Severity: | Configuration: | Other | |---------------|-------------------------------------------|------------------------------| | 1. Slight | 1. High Frequency - Precipitously Sloping | 1. Low tolerance To Loudness | | X 2. Mild | X 2. Gradually Sloping | 2. | | X 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.) 1. (-Good for SensoriNeural. hearing Loss. 3 . 2. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Waind. h. hyom Division Sign Off ivision Sign-Off) Division of Reproductive, Abdominal. B and Radiological I 510(k) Number {11}------------------------------------------------ Page 10 of 2 5 973579 510(k) Number (if known): Device Name: AM 260 CHM THE CONTRACTOR COLLECTION CONSTITUTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CON Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this The indication for ase of the Stor individuals with impaired Submission is co ampilly bound for andividuals with losses in nearing. The detect areas area. (Check appropriate space(s)): | Severity: | Configuration: | Other | |-------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <span style="text-decoration: line-through;">X</span> 1. Slight | 1. High Frequency - Precipitously Sloping | <span style="text-decoration: line-through;">X</span> 1. Low tolerance To Loudness | | <span style="text-decoration: line-through;">X</span> 2. Mild | <span style="text-decoration: line-through;">X</span> 2. Gradually Sloping | 2. __________ | | <span style="text-decoration: line-through;">X</span> 3. Moderate | <span style="text-decoration: line-through;">X</span> 3. Reverse Slope | 3. __________ | | <span style="text-decoration: line-through;">X</span> 4. Severe | <span style="text-decoration: line-through;">X</span> 4. Flat | | | 5. Profound | 5. Other __________ | | B. Specific Indications (Only if appropriate.): ic Indicatio (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) Vamk. li. Logson --- (Division Sign-Off) ivision of Reproductive, Abdominal, and Radiological D 510(k) Number {12}------------------------------------------------ page 4 of 25 | 510(k) Number (if known): | K973579 | |---------------------------|---------| |---------------------------|---------| Device Name: *AM 24c K-Amp* Comments of the state of the country of the in the state and the comments of the comments of the comments of the comments of the 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: | | |---------------|--| | 1. Slight | | | ❌ 2. Mild | | | ❌ 3. Moderate | | | ❌ 4. Severe | | | 5. Profound | | | Configuration: | | |-------------------------------------------|--| | 1. High Frequency - Precipitously Sloping | | | ❌ 2. Gradually Sloping | | | 3. Reverse Slope | | | ❌ 4. Flat | | | 5. Other | | | Other | | |--------------------------------|--| | ❌ 1. Low tolerance To Loudness | | | 2. | | | 3. | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. SPECIFICALLY FOR those with re 2. Ideal 3. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Urnit Co. Leigman (Division Sign-Off) Division of Reproductive, Abdom and Radiological Dev 510(k) Number {13}------------------------------------------------ Page (2 of 25 | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>510(k) Number (if known): | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | 260 XF Device Name: 1 - 19 1 2 3 3 3 3 3 3 2 2 2 1 2 2 1 1 2 1 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this The indication for use of the arr condividuals with impaired submission is to amplify sound for individuals with loss submission is to amplify sound for individuals with losses in hearing. The devices are indicated for individuals with losses in thearing. The devices (i ) (Check express hearing. The cevices are indicated aspropriate space(s)): the following category(ies). (Check appropriate space(s)): | Severity: | Configuration: | Other | |---------------|-------------------------------------------|--------------------------------| | 1. Slight | 1. High Frequency - Precipitously Sloping | X 1. Low tolerance To Loudness | | 2. Mild | X 2. Gradually Sloping | 2. | | X 3. Moderate | 3. Reverse Slope | 3. | | X 4. Severe | X 4. Flat | | | 5. Profound | X 5. Other scoop precipitous | | B. Specific Indications (Only if appropriate.): Citic Indications (oning such as improved speech intelligibility in background noise, must be supported by clinical 1. Good for mud-severe Sensorine 3. 2. data.) (PLEASE DO NOT FRITE BELOG 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 | <strong>Labels</strong> | <strong>Values</strong> | |-------------------------|-------------------------| | 510(k) Number | K913579 | {14}------------------------------------------------ Pace / Sof 25 973579 510(k) Number (if known): BECOME CONSTITUTION OF THE COLLECTION CONSULTION CANAL CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIO Device Name: An 2u TALS 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 | 1. High Frequency<br>- Precipitously Sloping | X 1. Low tolerance To Loudness | | X 2. Mild | X 2. Gradually Sloping | 2. | | X 3. Moderate | 3. Reverse Slope | 3. | | X 4. Severe | 4. Flat | | | 5. Profound | 5. Other precipitous beginning @ 1kHz -> | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. Appropriate HA for those exposed to ConAnvous Mist as well as. 2. Short and Abrupt sudden Noises. 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. K973579 {15}------------------------------------------------ Parcly of 25 510(k) Number (if known): Device Name: frn 300 XP Comprehender of the contraction of the services and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen 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 | |---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span>1. Slight</span></div> | <div style="display:flex; align-items:center;"><span>✗</span><span>1. High Frequency - Precipitously Sloping</span></div> | <div style="display:flex; align-items:center;"><span>✗</span><span>1. Low tolerance To Loudness</span></div> | | <div style="display:flex; align-items:center;"><span>✗</span><span>2. Mild</span></div> | <div style="display:flex; align-items:center;"><span>✗</span><span>2. Gradually Sloping</span></div> | 2. | | <div style="display:flex; align-items:center;"><span>✗</span><span>3. Moderate</span></div> | 3. Reverse Slope | 3. | | <div style="display:flex; align-items:center;"><span>✗</span><span>4. Severe</span></div> | 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.) MIN: Arukt l . 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 2973579 {16}------------------------------------------------ page 15 of 25 4973579 510(k) Number (if known): Device Name: the state of the state of the same of the same of the many of the many of the management with and would and would and comment Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this The Indication for asc of the of che of individuals with impaired Submission is to ampilly sound for individuals with losses in hearing. The devices are indicated for succe(c)); nearing. The devices are mazers appropriate space(s)): | Severity: | Configuration: | Other | |---------------|-------------------------------------------|--------------------------------| | 1. Slight | 1. High Frequency - Precipitously Sloping | X 1. Low tolerance To Loudness | | X 2. Mild | X 2. Gradually Sloping | 2. | | X 3. Moderate | 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. Miniature Size - Good for non-addicts 2. Good for Smith 3 . (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Lynn Division Sign-Off) ivision of Reproductive, Abdominal 510(k) Number {17}------------------------------------------------ page // of 25 579 973 510(k) Number (if known) Device Name: The state of the may be and on the comments of the same of the many of the world of the many of the mail of the comments of the mail of the comments of the mail of the commen Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this The indication for ase of the sound for individuals with loss submission is to amprily sound for individuals with losses in hearing. The devices are indicated for individuals anaoo(s)); neating. The devices are = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = | Severity: | | |---------------|--| | 1. Slight | | | X 2. Mild | | | X 3. Moderate | | | 4. Severe | | | 5. Profound | | | Configuration: | | |---------------------------------------------|--| | X 1. High Frequency - Precipitously Sloping | | | 2. Gradually Sloping | | | 3. Reverse Slope | | | 4. Flat | | | 5. Other | | | Other | | |---------------------------------|--| | 1. Low tolerance To Loudness | | | X 2. high frequency empha | | | X 3. high tolerance to Loudness | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 2. 1. 3. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elnid A. Seymm (Division Sign-Off) Division of Reproductive, Abdomina {18}------------------------------------------------ Parie /7 of 25 973 519 510(k) Number (if known): Device Name: AAM 300 K-AMP would and the controlled of the same of the comments of the most of the latest hands and Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this The Indication for use of the stor individuals with Impaired submission IS to amprily sound for individuals with losses in hearing. The devices are indicated for individuals ansoco(s)); nealing. "The devices are indestered appropriate space(s)): | Severity: | Configuration: | Other | |-------------|---------------------------|------------------------------| | 1. Slight | 1. High Frequency | 1. Low tolerance To Loudness | | | - Precipitously Sloping - | | | 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 (now poyendatoding in background noise, must be supported by clinical data.) 1. Specifically for those inf reavirement. 2. Ident for new hearing Aid users. - 3. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David h. Seymour (Division Sign-Off) Division of Reproductive, Abdomina 510(k) Numbe {19}------------------------------------------------ Page 18 of 25 973579 510(k) Number (if known): Device Name: 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 | |---------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <br>1. Slight | 1. High Frequency<br>- Precipitously Sloping | <span style="text-decoration: overline;">X</span> 1. Low tolerance<br>To Loudness | | 2. Mild | <span style="text-decoration: overline;">X</span> 2. Gradually Sloping | <span style="text-decoration: overline;">X</span> 2. High tolerance<br>to Loudness | | <span style="text-decoration: overline;">X</span> 3. Moderate | <span style="text-decoration: overline;">X</span> 3. Reverse Slope | 3. ____________ | | <span style="text-decoration: overline;">X</span> 4. Severe | <span style="text-decoration: overline;">X</span> 4. Flat | | | <span style="text-decoration: overline;">X</span> 5. Profound | <span style="text-decoration: overline;">X</span> 5. Other (Scoop) | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. Good for profound conductive 9 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 and Radiological I 510(k) Number {20}------------------------------------------------ Page 4 of 25 | 510(k) Number (if known): | K 973 579 | |---------------------------|-----------| |---------------------------|-----------| Device Name: 1 BS State 13 12 2 3 2 2 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 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 | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"></span> 1. Slight | <span style="text-decoration: underline;"></span> 1. High Frequency<br>- Precipitously Sloping | <span style="text-decoration: underline;">X</span> 1. Low tolerance<br>To Loudness | | <span style="text-decoration: underline;"></span> 2. Mild | <span style="text-decoration: underline;">X</span> 2. Gradually Sloping | <span style="text-decoration: underline;">X</span> 2. High tolerance to<br>LOUDNESS | | <span style="text-decoration: underline;">X</span> 3. Moderate | <span style="text-decoration: underline;">X</span> 3. Reverse Slope | <span style="text-decoration: underline;"></span> 3. ________ | | <span style="text-decoration: underline;">X</span> 4. Severe | <span style="text-decoration: underline;">X</span> 4. Flat | | | <span style="text-decoration: underline;">X</span> 5. Profound | <span style="text-decoration: underline;">X</span> 5. Other: Scoop | | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. Good for profound conductive HL. 3 . 2. (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 K973579 {21}------------------------------------------------ Page 200f 25 | 510(k) Number (if known): | K973579 | |---------------------------|---------| |---------------------------|---------| International construction and the are and the are and the are a Device Name: and the started on the see of the promote of the comments of the same of the comment of concerners of concerners 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 bearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): | Severity: | Configuration: | Other | |--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span>1. Slight</span></div> | <div style="display:flex; align-items:center;"><span>1. High Frequency - Precipitously Sloping</span></div> | <div style="display:flex; align-items:center;"><span>1. Low tolerance To Loudness</span><span style="text-decoration: overline;">X</span></div> | | <div style="display:flex; align-items:center;"><span style="text-decoration: overline;">X</span><span>2. Mild</span></div> | <div style="display:flex; align-items:center;"><span style="text-decoration: overline;">X</span><span>2. Gradually Sloping</span></div> | 2. | | <div style="display:flex; align-items:center;"><span style="text-decoration: overline;">X</span><span>3. Moderate</span></div> | 3. Reverse Slope | 3. | | <div style="display:flex; align-items:center;"><span style="text-decoration: overline;">X</span><span>4. Severe</span></div> | <div style="display:flex; align-items:center;"><span style="text-decoration: overline;">X</span><span>4. Flat</span></div> | | | 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. Good for mild - severe HL' because gmn control can be manipulated 2. to give less gain for those who don't need. 3. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K973579 {22}------------------------------------------------ Page 21 of 25 K 973 579 510(k) Number (if known): ml 5/C) Device Name:___ Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this The Indication for ase of cho of or individuals with impaired Submission is to ampilly sound for individuals with losses in hearing. The devices are indicated for individuals with losses in nearing. The detegory(ies). (Check appropriate space(s)): | Severity: | Configuration: | Other | |---------------------------|------------------------------------------------------------|-----------------------------------------------| | <span></span> 1. Slight | <span></span> 1. High Frequency<br>- Precipitously Sloping | <span></span> 1. Low tolerance<br>To Loudness | | X 2. Mild | X 2. Gradually Sloping | X 2. high tolerance<br>to Loudness | | X 3. Moderate | <span></span> 3. Reverse Slope | <span></span> 3. | | <span></span> 4. Severe | X 4. Flat | | | <span></span> 5. Profound | <span></span> 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 K973579 {23}------------------------------------------------ Page 920f 25 | 510(k) Number (if known): | K973579 | |---------------------------|---------| |---------------------------|---------| . STORES OF THE COLLECTION CONSULTION CONSULTION CONSULTERS CONSULTERS CONSULTERS CONSULTURAL CONSULTURAL CONSULTURAL CONSULTURAL CONSULTURAL CONSULTURAL CONSULTURAL CONSULTU Device Name: _________________________________________________________________________________________________________________________________________________________________ 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 | |---------------------------------------------------------------|--|---------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------| | <span style="text-decoration:underline;"> </span> 1. Slight | | <span style="text-decoration:underline;"> </span> 1. High Frequency - Precipitously Sloping | | <span style="text-decoration:underline;"> </span> 1. Low tolerance To Loudness | | <span style="text-decoration:underline;"> </span> 2. Mild | | X2. Gradually Sloping | | X2. High tolerance to Loudness | | X3. Moderate | | <span style="text-decoration:underline;"> </span> 3. Reverse Slope | | <span style="text-decoration:underline;"> </span> 3. | | X4. Severe | | <span style="text-decoration:underline;"> </span> 4. Flat | | | | <span style="text-decoration:underline;"> </span> 5. Profound | | X5. Other precintous (@ 1KHz-on | | | 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) Eluned A. Kejosm (Division Sign-Off) Division of Reproductive, Abdominal, EN and.Radiological Dev 510(k) Number {24}------------------------------------------------ Page 230f25 | 510(k) Number (if known): | K973579 | |---------------------------|---------| |---------------------------|---------| An 250 Device Name: Indications For Use: BE IT THE SECT FOR THE SERVED THE SECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTURAL CONSULTURAL A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired Submiories are indicated for 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 | X2. Keep tolerance to Loudness | | 3. Moderate | 3. Reverse Slope | 3. | | X4. Severe | X4. 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) of Reproductive, Abdominal, EN 510(k) Number {25}------------------------------------------------ 510(k) Number (if known): FORMS 1893 Device Name: Indications For Use: A. General Indications: The indication for use of the air conduction hearing aids in this rne indical 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 - Precipitously Sloping | 1. Low tolerance To Loudness | | 2. Mild | 2. Gradually Sloping | 2. High tolerance To Loudness | | 3. Moderate | 3. Reverse Slope | 3. | | 4. Severe | 4. Flat | | | 5. Profound | 5. Other Scoop | | B. Specific Indications (Only if appropriate.): 1973 579 (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. Good for love uctive /i. 3. 2. (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 D 510(k) Number {26}------------------------------------------------ Page 25 of 25 993379 510(k) Number (if known): 1800 1 Indications For Use: Device Name: 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: | |-------------------------------------------------------------| | 1. Slight | | 2. Mild | | 3. Moderate | | <div style="text-decoration: overline;">X</div> 4. Severe | | <div style="text-decoration: overline;">X</div> 5. Profound | | Configuration: | |----------------------------------------------------------------------| | 1. High Frequency - Precipitously Sloping | | <div style="text-decoration: overline;">X</div> 2. Gradually Sloping | | <div style="text-decoration: overline;">X</div> 3. Reverse Slope | | <div style="text-decoration: overline;">X</div> 4. Flat | | <div style="text-decoration: overline;">X</div> 5. Other Scoop | | Other | |------------------------------------------------------------------------------| | <div style="text-decoration: overline;">X</div> 1. Low tolerance To Loudness | | 2. | | 3. | B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. Appropriate for those with IHL exposed f CorHauces as well as ahrull Lord 2. NCISP SIMUL HARDOubly. 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 K973579