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Thank you very much for choosing this brand hearing aid!
The hearing aid produced by our company is a precision electronic device, which is equipped with experience to compensate the hearing of patients with conductive hearing loss. Our company has been committed to developing and producing products satisfactory to customers. This manual is applicable to FHW120-W, FHW110-W, FHW100-W, FHW90-W, FHW80-W, FHW70-W, FHW60-W, FHW50-W, FHW40-W FHW30-W, FHW12-W, FHW11-W, FHW10-W, FHW09-W, FHW08-W, FHW07-W, FHW06-W, FHW05-W, FHW04-W, FHW03-W Please read the manual carefully before using this product, and be sure to use and maintain it according to the requirements of the manual, so as to prolong the service life of your hearing aid. Hearing aid is fitted according to personal listening conditions and listening habits, so they are not suitable for others. If you have any questions, please consult the fitting center where you purchased the hearing aid, or call our customer service center. Content 1 1. Summary ................................................................................................ 2. Product performance, structure and composition ............................. ............................... 4
.......................................................... 5 2.1 Structure .................................................................................................................................................. 5 2.2 Technology data ................................................................................................................................ 6
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................................ 9 3. Scope of application and object of use ................................................. 4. Contraindication ................................................................................... 5. Attention ................................................................................................. 6. Wearing steps and use of hearing aids ................................................ ............... .................. 7. Simple fault analysis and troubleshooting ................................ ......... 8. Maintenance of hearing aids ................................................................ 6.1 Hearing aid charging .............................................................................................................................. 9 6.2 Power ON/OFF ...................................................................................................................................... 10 6.3 Removing and installing ear domes ...................................................................... ............................... 11 6.4 Wear hearing aids .................................................................................................................................... 12 6.5 Volume control ........................................................................................................................................ 6.6 Program switch ................................................................................................................................ 6.7 APP introduction ................................................................................................................................... 13
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.......... ...............................18 8.1 Cleaning ear domes ...............................................................................................................................19 8.2 Cleaning hearing aid ..............................................................................................................................19 8.3 Moisture proof of hearing aid ................................................................................................................20 9. Electrical safety instructions ................................................................ ............................................................... 20 10. Technical description ........................................................................... .......................................... 20 11.Accessories list ....................................................................................... ............................... 21 12. Unpacking and inspection ................................................................... ............................... 21 13. Hearing aid warranty .......................................................................... ...............................21 14. Production date and service life ......................................................... ...............................21 15. Transportation and storage restrictions ............................................. ............................... 22 16. Interpretation of graphics, symbols, abbreviations and other contents used in medical device labels ................................................................................................. ............................... 22 2 1. Summary 1.1 Product Name: ITE hearing aid 1.2 Features ITE hearing aid is a digital hearing aid with program file and volume memory function. Hearing aid is not only suitable for listening in quiet environment, but also suitable for noisy environment. The shape of the hearing aid conforms to the structure of the human ear canal and is comfortable to wear. 1.3 Software version Software name: embedded sound processing software based on ultra-low power DSP. Version: V1.0 1.4 Model Number:
FHW120-W,FHW110-W,FHW100-W,FHW90-W,FHW80-W,FHW70-W,FHW60-W, FHW50-W,FHW40-W FHW30-W,FHW12-W,FHW11-W,FHW10-W,FHW09-W,FHW08-W, FHW07-W,FHW06-W,FHW05-W,FHW04-W,FHW03-W 1.5 Procedure file information (filled in by Audiologist) Program Number Program Setting 1P1 2P2 3P3 The above shall be filled in by Audiologist according to the program file setting of the hearing aid 1.6 Working environment and conditions Temperature: 0+40 Relative humidity: 80 Voltage: DC 3.7V Atmospheric pressure: 86KPa106 KPa 1.7 Impact on Environment The hearing aid contains rechargeable lithium-ion batteries. Please do not throw away the used hearing aid at will. The disposal of waste batteries must comply with local regulations. 1.8 Safety 3 Danger: do not put the hearing aid into the fire, microwave oven, etc. to avoid explosion. Danger: in order to prevent children from swallowing by mistake, keep the hearing aid away from children. Hearing aid can only be used by people with hearing loss, and the rest are not applicable. Those who have undergone ear canal surgery are not recommended to buy this product directly. They should buy them after consulting the fitting center and the Audiologist. A hearing aid should not be applied to both ears at the same time. Because the hearing loss of the right and left ears is different. In case of battery leakage, please stop using the hearing aid and contact the customer service center. Special users 1Children need to wear hearing aids with the help of adults.
(2) Please consult your doctor before using hearing aids. 2. Product performance, structure and composition 2.1 Structural composition The product is mainly composed of microphone, signal amplification and processing circuit, receiver, volume control circuit, lithium battery, shell, earplug and mobile phone app (APP version No.: v1.0). 1Battery contact+ 2,Battery contact - 3,Ear dome 4,Hearing aid body 5,Back microphone 6,Front microphone 7,Touchpad area According to customer requirements, the shell can be configured with white, blue, black three colors. 4 2.2 Technology data IEC 60118-7 (2CC Coupler) Product Model Number Max OSPL9 0 dB OSPL9 Peak 0 Gain dB dB FOGA dB THD 500Hz 800Hz 1600Hz Frequency Range(Hz) Eq.Input Battery Noise Current Level Drain
(dB) mA Attack Release Time
(ms) Time
(ms) FHW120-W 117 107 FHW110-W 117 107 FHW100-W 117 107 FHW90-W 117 107 FHW80-W 117 107 FHW70-W 117 107 FHW60-W 117 107 FHW50-W 117 107 FHW40-W 117 107 FHW30-W 117 107 FHW12-W 115 105 FHW11-W 115 105 FHW10-W 115 105 FHW09-W 115 105 FHW08-W 115 105 FHW07-W 115 105 FHW06-W 115 105 FHW05-W 115 105 FHW04-W 115 105 FHW03-W 115 105 40 40 40 40 40 38 38 38 38 38 35 35 35 35 35 33 33 33 33 33 35 35 35 35 35 33 33 33 33 33 30 30 30 30 30 28 28 28 28 28 5%
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200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 200--6000 26dB 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 85 85 85 85 85 85 85 85 85 85 85 85 85 85 85 85 85 85 85 85 3. Scope of application and object of use 3.1 Scope of application It is used to compensate the hearing of patients with conductive hearing loss. 3.2 Object of use It is suitable for patients with air conduction hearing loss, but children under the age of 12 should be used under the supervision of adults. 4. Contraindications 5 Acute otitis externa, tympanitis, chronic suppurative otitis media (in the period of purulent infection) and acute suppurative otitis media are not suitable for wearing hearing aids. Patients who are allergic to this material. 5. Precautions The optional hearing aids shall be subject to professional hearing test and fitting, and shall be used under the professional guidance of doctors or hearing aid fitters. 5.1 Moisture-proof Any form of moisture has an impact on the hearing aid. Moisture resistance helps to prolong the service life of the hearing aid, avoid use or storage in a humid environment, and dry the hearing aid regularly. 5.2 Waterproof Do not immerse the hearing aid in any liquid. Remove the hearing aid in advance and keep it properly when swimming, bathing, washing hair, washing face, etc. After swimming or washing, wait until the ear canal is dry before wearing a hearing aid. In case the hearing aid falls into the water accidentally, do not dry it in the microwave oven or any dryer. You can dry it with soft and clean cotton cloth and dry it naturally in a ventilated environment. If there is any fault, please contact the fitting center where you purchased the hearing aid or directly contact the customer service center of our company. 5.3 High temperature protection Hearing aid should be protected from high temperature or prolonged sunlight. 5.4 Fall prevention Hearing aid is precision electronic devices, which should avoid falling to the ground or 6 violent vibration and impact. 5.5 Other precautions Do not wear hearing aids when receiving short wave hyperthermia, X-ray, MR scan, CT scan or similar radiotherapy. Keep the outer surface of the hearing aid clean and clean the earwax in the earplugs frequently. Handle with care, use touchpad area correctly, and avoid excessive force or force. Hearing aid shall be regularly sent to the fitting center for maintenance and inspection to ensure that the hearing aid is in good condition. 6. Wearing steps and use of hearing aids 6.1 Hearing aid charging Open the charging box, put the hearing aid into the charging box, and then start charging(The charging box has anti-freeze design, one-to-one correspondence between left and right) The indicator light of the charging box shows: when the charging box is connected to the external power source for charging, the green light blinks during charging, and the green light is steady on when the charging box is full. When the charging box is not connected to the external power supply, long press the charging box button to display the LED indicator status:
LED indicator shows the status The green flash blinks 3 times within 1 second, and the indicator goes off at an interval of 2 seconds for 20 electric quantity 0% - 32%
7 seconds The green flash blinks 2 times within 1 second, and the indicator goes off at an interval of 2 seconds for 20 seconds The green flash blinks 1 times within 1 second, and the indicator goes off at an interval of 2 seconds for 20 seconds 33% - 65%
66% -100%
6.2 Power ON/OFF Power on: take the hearing aid out of the charging box to power on. Power off: put the hearing aid into the charging box to power off. Both ends of the charging line are connected with a power adapter and a charging box. 6.3 Removing and installing ear domes Remove ear domes: pinch the ear domes with your thumb, index finger and middle finger to separate the ear domes from the connector. 8 Install ear domes: select appropriate ear domes according to the size of the ear canal, hold the ear domes and install them into the connector of the hearing aid, which shall be installed in place. 6.4 Wear hearing aid Hold the hearing aid with your thumb and index finger and gently push it into the ear canal until it feels comfortable in the ear canal. Open and close your mouth several times and check whether the hearing aid is well worn. 6.5 Volume Control Slide the hearing aid touch pad: the volume of up stroke increases and the volume of down 9 stroke decreases. There are 10 volume levels in total, and each volume level changes by 1dB. Slide up the volume to increase the volume level by one level. When the volume reaches the maximum, the volume will not change again. Decrease the volume by one level. When the volume reaches the minimum, the volume will remain the same again. 6.6 Program switching Short press the touch pad (0.5s), and the hearing aid will switch from Bluetooth mode to hearing aid mode. Long press the touch panel (3S) to cycle the set listening program, and long press to switch one program at a time. 6.7 APP usage Use the mobile APP for volume control and program control, which will be more convenient for adjustment. For the download and use of mobile app, please contact the matching engineer. Open the phone APP, search for hearing AIDS, and see available hearing aid devices. The user clicks to confirm the connection. Program switching: different programs for different models of products. FHW120-W,FHW100-W,FHW80-W,FHW60-W,FHW40-W,FHW12-W,FHW10-W,FHW 08-W,FHW06-W,FHW04-W. 3 models: Quiet, Noise, Custom 10 FHW110-W,FHW90-W,FHW70-W,FHW50-W,FHW30-W,FHW11-W,FHW09-W,FHW0 7-W,FHW05-W,FHW03-W2 models: Quiet and Noise Volume adjustment: slide left to decrease the volume and right to increase the volume. 11 Sound quality adjustment: click sound adjustment on the main interface to adjust sound quality, channel, spatial sound source positioning and noise reduction. Earphone setting: you can set the on and off of in ear detection, earphone debugging, volume on and off, and feedback path calibration test. 12 Language setting: set app language, traditional Chinese, simplified Chinese and English. Demonstration mode: experience how to use the APP without connecting to the product. 13 7. Simple fault analysis and troubleshooting Fault Whistle No sound Lower sound Power consumption high Intermittent sound Reason Solution Hearing aid without wearing correctly Many ear wax Ear dome is not suitable Please wear hearing aid correctly Clean ear canal Please use ear dome with suitable size Low battery or power off Sound tube is blocked Ear dome is blocked Volume low Battery power low Hearing aid damp Sound tube is blocked Ear dome is blocked Hearing aid keep working Hearing aid damp Battery power low Sound tube is blocked Ear wax is blocked 14 Please recharge hearing aid Please clean hearing aids sound tube Please clean ear dome Please up volume Please recharge hearing aid Please dry hearing aid Please clean hearing aids sound tube Please clean ear dome Please put hearing aid into dry box without using Please dry hearing aid with dryer Recharging Please clean sound tube Please clean or change ear wax If the above methods still can not eliminate the fault, please contact the fitting center where you purchased the hearing aid, or directly contact the customer service center of our company. 8. Maintenance of hearing aids During the use of hearing aids, earwax (cerumen) produced by the ear will accumulate in the ear canal and the sound hole of the hearing aid. A large amount of accumulated earwax will affect the use effect of the hearing aid, so please clean your ear canal and maintain the hearing aid every one month. 8.1 Clean ear dome 1. Please remove the ear domes from the hearing aid 2. Please clean the earwax with a cleaning cloth or flush the ear domes with clean water 3. Dry the ear domes and make sure there are no water drops left. If there is a balloon blowing tool, you can use the balloon to dry the water droplets. 8.2 Clean hearing aid Use the small brush delivered in the packing box to clean the earwax at the sound outlet of the hearing aid. 15 Clean the hearing aid with a dry and soft cloth. Wipe or clean the hearing aid on a soft desktop (e.g. a soft towel can be padded on the desktop) to avoid damage caused by accidental falling of the hearing aid. Remember: do not use any liquid to clean the hearing aid. 8.3 Shock resistance of hearing aid When you go out and do not need to use the hearing aid, please put the hearing aid into the charging box. 9. Electrical safety instructions Classification by anti electric shock type: internal power supply equipment Classification according to the degree of protection against electric shock: type B application part Classified according to the safety degree when using flammable anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or nitrous oxide: equipment that cannot be used when there is flammable anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or nitrous oxide. Classification by operation mode: continuous operation equipment 10. Technical description The supplier may provide circuit diagrams, component lists, drawing notes, correction rules, or other data necessary for qualified technicians to help the user repair the repairable equipment parts designated by the manufacturer. 11. Accessories list Item Quantity Unit Ear dome User guide Charging Box Cable 1 1 1 1 PC PC PC PC 16 Brush 1 PC 12. Unpacking and inspection After unpacking, please check whether the actual parts are consistent according to the parts list. Check whether the product model marked on the warranty card is consistent with that of the hearing aid. Check whether the body number marked on the warranty card is consistent with the body number of the hearing aid. Warranty 13.1 Free warranty coverage All hearing aids produced by our company enjoy free warranty for faults caused by non-human factors from the date of purchase. 13.2 Warranty period. 2 years 13.3 Any of the following situations is not covered by the free warranty. Damage caused by incorrect use or improper operation according to the instructions. Damage caused by self disassembly and assembly of hearing aids. Damage caused by force majeure (flood, fire, earthquake, etc.). 13. Production date and service life That is, the normal working time of the product. The product needs to be stored and used as required. After exceeding the specified service time, its expected function will be affected. (e.g. unable to meet the requirements of product performance indicators, etc.). The service life of hearing aid products is 5 years. See the label for the production date. 14. Transportation and storage restrictions Temperature: - 20 ~ + 50 Relative humidity: 93%
Atmospheric pressure: 86kpa 106 kPa Storage conditions: room temperature, clean, dark, no corrosive gas and well ventilated room. Transportation conditions: the packaged hearing aids can be transported by general cargo transportation method, and shall be protected from rain, exposure and collision during 17 transportation. 15. Interpretation of graphics, symbols, abbreviations and other contents used in medical device labels. Symbol for User Guide must be read Symbol for Consult instructions for use Symbol for Manufacturer Symbol for Fragile, handle with care Symbol for Keep dry Symbol for Caution Symbol for Date of manufacture Symbol for Serial number Symbol for Use-by date Type B Applied Part IP22 IP22: The first number 2:
Protected against solid foreign objects of 12,5 mm and greater. The second number:
Protected against vertically falling water drops when enclosure titled up to 15. This marking shown on the product or its literature, indicates that it should not be disposed of, with other household wastes at the end of its working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources. The harmful substances in the product meet the limited requirements. Manufacture: Austar Hearing Science & Technology(Xiamen) Co., Ltd. Address: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang District, Xiamen, Fujian, China Post code: 361028 Preparation date: 2022.01 18 FCC Statement:
Any Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operation. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. 19