AUSTAR 2A445FHW120W-1 ITE Hearing Aid User Guide

User Guide

Dear customer:
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.

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
---|---
1 (P1)|

2 (P2)

|

3 (P3)

|

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°C~+40°C
Relative humidity: ≤80%
Voltage: DC 3.7V
Atmospheric pressure: 86KPa~106 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

• 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:
  (1) Children 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).

1, Battery 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.

2.2 Technology data

IEC 60118-7 (2CC Coupler)

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

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 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

|

electric quantity

---|---
The green flash blinks 3 times within 1 second, and the indicator goes off at an interval of 2 seconds for 20 seconds|

0% – 32%

The green flash blinks 2 times within 1 second, and the indicator goes off at an interval of 2 seconds for 20 seconds|

33% – 65%

The green flash blinks 1 times within 1 second, and the indicator goes off at an interval of 2 seconds for 20 seconds|

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.

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 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.

(1) Open the phone APP, search for hearing AIDS, and see available hearing aid devices. The user clicks to confirm the connection.

(2) 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

FHW110-W, FHW90-W, FHW70-W, FHW50-W, FHW30-W, FHW11-W, FHW09-W, FHW0 7-W, FHW05-W, FHW03-W:  2 models: Quiet and Noise

(3) Volume adjustment: slide left to decrease the volume and right to increase the volume.

(4) Sound quality adjustment: click sound adjustment on the main interface to adjust sound quality, channel, spatial sound source positioning and noise reduction.

(5) Earphone setting: you can set the on and off of in ear detection, earphone debugging, volume on and off, and feedback path calibration test.

(6) Language setting: set app language, traditional Chinese, simplified Chinese and English.

(7) Demonstration mode: experience how to use the APP without connecting to the product.

7. Simple fault analysis and troubleshooting

Fault

| Reason|

Solution

---|---|---

Whistle

| 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

No sound

| Low battery or power off
Sound tube is blocked
Ear dome is blocked| Please recharge hearing aid
Please clean hearing aid’s sound tube
Please clean ear dome

Lower sound

| Volume low
Battery power low
Hearing aid damp
Sound tube is blocked
Ear dome is blocked| Please up volume
Please recharge hearing aid
Please dry hearing aid
Please clean hearing aid’s sound tube
Please clean ear dome

Power consumption high

| Hearing aid keep working
Hearing aid damp| Please put hearing aid into dry box without using
Please dry hearing aid with dryer

Intermittent sound

| Battery power low
Sound tube is blocked
Ear wax is blocked| 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.

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| 1|

PC

User guide

| 1| PC
Charging Box| 1|

PC

Cable

| 1| PC
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°C ~ + 50°C
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 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
| 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.| | IP22: The first number 2: Protected against solid foreign objects of 12,5 mm ϕ and greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15°.
| 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

FCC Statement:

Any Changes or modifications not expressly approved by the party responsible for compliance could void the user’s 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.

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