iHEAR CA 95661 Linx OTC Hearing Aid User Manual

iHEAR CA 95661 Linx OTC Hearing Aid

WARNING INSTRUCTION

1. WARNING: lf you are younger than 18,do not use this. You should go to a doctor, preferably an ear-nose-throat doctor (an ENT), because your condition needs specialized care. Over-the-counter hearing aids are only for users who are age 18 or older. This OTC hearing aid is for users who are 18 and older. People who are younger than 18 with hearing loss should see a doctor, preferably an ENT.because they may need medical testing and management. Hearing loss can affect speech and learning, so professional fitting and continuing care are also important.

2. WARNING: When to see a doctor If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor (an ENT).

   • Your ear has a birth defect or an unusual shape. Your ear was injured or deformed in an accident.
   • You saw blood, pus, or fluid coming out of your ear in the past 6 months.
   • Your ear feels painful or uncomfortable.
   • You have a lot of ear wax, or you think something could be in your ear.
   • You get really dizzy or have a feeling of spinning or swaying (called vertigo).
   • Your hearing changed suddenly in the past 6 months.
   • Your hearing changes: it gets worse then gets better again
   • You have worse hearing in one ear
   • You hear ringing or buzzing in only one ear

3. WARNING: This hearing aid should not cause pain when inserting it. Remove this device from your ear if it causes pain or discomfort when you insert or place it. To try again, make sure to follow the instructions. If you feel pain or discomfort again, contact the manufacturer. If your pain or discomfort doesn’t go away, contact your hearing healthcare professional. You can also report this to FDA as an adverse event according to the instructions that appear later.

4. Caution: This is not hearing protection. You should remove this device if you experience overly loud sounds, whether short or long-lasting. If you’re in a loud place, you should use the right kind of hearing protection instead of wearing this device. In general, if you would use ear plugs in a loud place, you should remove this device and use ear plugs.

5. Caution: The sound output should not be uncomfortable or painful.
   You should turn down the volume or remove the device if the sound output is uncomfortably loud or painful. If you consistently need to turn the volume down, you may need to further adjust your device.

6. Caution: You might need medical help if a piece gets stuck in your ear. If any part of your hearing aid, like the eartip, gets stuck in your ear, and you can’t easily remove ii with your fingers, get medical
   help as soon as you can. You should not try to use tweezers or cotton swabs because they can push the part farther into your ear, injuring your eardrum or ear canal, possibly seriously.

7. Note: If you remain concerned, consult a professional. If you try this device and continue to struggle with or remain concerned about your hearing, you should consult with a hearing healthcare professional.

8. Note: What you might expect when you start using a hearing aid. A hearing aid can benefit many people with hearing loss. However, you should know it will not restore normal hearing, and you may still have some difficulty hearing over noise. Further, a hearing aid will o
   not prevent or imprve a medical condition that causes hearing loss. People who start using hearing aids sometimes need a few weeks to get used to them. Similarly, many people find that training or counseling can help them get more out of their devices. If you have hearing loss in both ears, you might get more out of using hearing aids in both, especially in situations that make you tired from listening – for example, noisy environments.

9. WARNING: Wireless Operation
   Before boarding any aircraft or packing the hearing device in luggage that will be checked, place the hearing devices in the charger case. Listen for the in-flight announcement that tells you if you can use any wireless device during a flight before removing the hearing devices from the case. In-flight wireless hearing device is at the discretion of the airline. Follow all the facility rules and posted instructions in areas where wireless network use its prohibited.

10. WARNING: Battery Safty
    Do not heat, open, puncture, mutilate, or dispose of your hearing device in fire. Do not leave or charge your device in direct sunlight for an extended period of time. Doing so may cause damage to the baiter.

11. Note: Tell FDA about injuries, malfunctions, or other adverse events.
    To report a problem involving your hearing aid, you should submit information to FDA as soon as possible after the problem. FDA calls them “adverse events,” and they might include: skin irritation in your ear, injury from the device(like cuts or scratches, or burns from an overheated battery), pieces of the device getting stuck in your ear, suddenly worsening hearing loss from using the device, etc. Instructions for reporting are available at
    https://www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088. You can also download a form to mail to FDA.

HOW TO USE YOUR DEVICE

1. Microphone 1

2. Volume Adjustment/Hearing Mode Change

3. Microphone 2

4. Ear Dome

5. Microphone 3

6. Charging contacts

7. ln Ear Detection Sensor

8. Upper cover

9. Charging slots

10. Left-side device charging indicator

11. Charging case charging indicator

12. Right-side device charging indicator

13. Type-C connection to external power supply

14. Battery check button/ Charge case ON/OFF

[HOW TO INSERT DOMES]
Please follow these steps to mount domes, because incorrect dome replacement could result in the dome being left in the ear when you remove the device.

• Step 1: Choose a suitable size ear dome.
• Step 2: Push the ear dome rim membrane outward.
• Step 3: Hold on to the end of the device and push firmly to ensure that the dome is fastened securely.
  Notes: After the ear dome is installed, pull the ear dome gently to see if it is firmly installed and ensure the ear dome does not fall off easily.
  WARNING: If the ear dome remains in the ear canal after the device is removed, you many have to have the ear dome removed by a medical professional.

[LEFT & RIGHT DEVICE MARKINGS]
There is a R and L indicator on the charging device and at the beginning of the serial number along the stem of !he dev!ce. This will tell you which one is the left and which Is the right
device.

[WEAR/REMOVE DEVICE] The in-ear detection sensor will carry out real-time intelligent detection on the operation status of the device. When you place the device in the ear, it will automatically turn on; when the device is removed, it will automatically enter standby status.

1. Wearing the device
2. Step 1: Insert the linX into your ear, making sure you match the ear with the marking on the stem of the device: “R” = right and “L” = left
3. Step 2: Adjust until the unit fits comfortably.
4. Removing the device
5. Step 1: Grasp the protruding device and remove it from your ear.

(TURN ON/TURN OFF)

• Turn On:
  When the device is taken out of the charging case, it will enter the standby status. When the device is properly worn in the ear, it will automatically turn on within about seven (7) seconds.

• Turn Off:
  When you remove the device from your ear, the device will automatically enter into standby mode. When the device is placed back in the correct slot of the charging case, the device automatically turns off and starts charging.
  Note: The linX has a built-in 3-second delayed turn on function, allowing you to place the units correctly in your ear canal prior to turning on.

• Charging case Turn On/Off:

  • Press and hold the lower part of button for about 1 second. Until the white hearing amplifier charging indicators flash for three times, the charging case is on.
  • Press and hold the lower part of button for about 5 seconds. Until the blue hearing amplifier charging indicators flash for three times, the charging case is off.

(VOLUME ADJUSTMENT)

• The device has eleven ( 11) volume levels. Adjust the volume until you reach the level you are comfortable with.
• Short press the “+” button to increase the volume Short press the “-” button to decrease the volume.
• You will hear a “Beep” when you turn the volume up or down, and when the volume is adjusted to highest or lowest level, it will give out the prompt tone of “Beep-Beep-Beep”.

(HEARING MODE CHANGE)
The device has 4 different hearing modes. You can cycle through the 4 hearing modes by holding down the “+” button for three (3) seconds to change the hearing mode. The linX has a memory function that will keep the unit in the previously tuned mode when it is cycled on and off.

Note: You need to perform the operation on BOTH of the devices separately to change modes and volume adjustments.

(CHARGING)
Before using your linX for the first time, it is recommended to charge it for 2 hours. On average, a full charge lasts 12 hours. Put the device back into the correct slot of the charging case, they will automatically turn off and start charging. A blue light will indicate devices are charging. When fully charged.the light will turn off indicating charging is complete.
Device Low Power warning: You will hear the notification sound when the device battery drops below 15%, you have to charge the devices.

(CHARGING CASE)
The charging case will charge via the USB port on the case. The rising bars (1 to 4) will indicate the level of charge in the case. When fully charged, the indicator light will be constantly on, i.e. solid blue light. (See details in table for Charging Indicator Changes of the Charging Case)

(HOW TO USE THE CHARGING CASE)

1. Plug the larger end of the charging cable into a power supply such as a power charger or your computer.
2. Plug the smaller end into the type-c port on the charging case.
3. The charging case will charge via the type-c port on the case. The rising bars (1 to 4) will indicate the level of charge in the case. When fully charged, the indicator light will be constantly on, i.e. solid blue light. Once, fully charged, the case can be unplugged from power and the solid blue light will automatically shut off after 10 seconds.

• The fully charged case offers 3 full charging cycles for a pair of devices. 4. The charging process will automatically stop when the case and device are fully charged, so the device can be safely left in the charger. Place it on a flat even surface away from exposure to moisture, dust, or extreme temperatures.
  Charging Indicator Changes of the Charging Case

*Note:

1. To check the remaining battery status of the charging case, press the battery check button. The indicator will show the status.
2. Charging case – Low Power: The charging case indicator will flash blue when the charging case battery drops below 25%, please charge the case.
3. When the device and case is not functioning properly, please check the “charging case troubleshooting table”. If none of the solutions work, please contact our after-sales service team.

[BLUETOOTH CONNECTION]

• Indicator lights will flash blue for 30 seconds to allow you to make the connection with your phone.
• Turn on Bluetooth on your smartphone to search, and click “linX” to match. If the connection is successful, your smart phone will show “linX”.

Your linX allows for direct communication and control with iPhone, iPad®, iPod touch® or Android devices (5.0 or later).
Note: the above pairing only needs to be done one time with your phone. After that, as long as your phone is nearby and Bluetooth is enabled, the devices will automatically reconnect when taken out of the charging case.
Attention: The Bluetooth function is only to be used with mobile phones and related devices for making and receiving calls or listening to entertainment. They are non-medical device functions, and not meant to have any medical device functionality or purpose. Please use them accordingly .

Note: The Call/Music mode will automatically stop and switch to Amplify mode if the device does not have sufficient power. Recharge it to use Call/Music mode.

(HOW TO USE THE myiHEAR APP)

1. Download the App

   • For iOS, download the App “myiHEAR” in the App Store.
   • For Andriod, download the App “myiHEAR” in Google Play.
   • *iPhone® is a trademark of Apple lnc.,registered in the U.S. and other countries.
   • Android™ is a trademark of Google Inc.
   • IOS is a trademark of Cisco Inc.1

2. Connect the App

   • Step 1: Turn on Bluetooth on your smartphone.
   • Step 2: Indicator lights will flash blue for 30 seconds to allow you to make the connection with your phone.
   • Step 3: Click “Search for a Device” and “Tap to Connect” for connecting the left ear and right ear.
     Note: You can personalize the name as you like (optional).

3. Sound Control

   • Hearing Modes: There are 4 mode options. Click the icon for the desired mode and your device will automatically switch over.
   • Volume Control: Drag the slider up and down to control the Left (Blueslider), or Right (Red slider), device’s volume.
   • Band Control: There are 8 band options that will allow you to customize how the different level frequencies are processed. Drag the slider up and down to control the frequency bands. Variable setting of frequency bands for each device can only be done independently.
   • Loud/Focus/Noise: There are various options that will allow you to set your device for optimal hearing in different environments. Click on the desired icon, and your device will automatically switch over.
   • Tips: Click the icon as indicated below to sync the left and right devices, it will allow you to adjust two aids at same time. This function is available for Volume Control, Loud Sound Protection and Noise Reduction.
   • Note: You may contact us at: 844-443-2744 or support@iHeardirect.com for further support.

MAINTENANCE AND CLEANING

1. Daily maintenance
   It is important to keep your devices clean and dry. On a daily basis, wipe them clean using a soft cloth or tissue. To avoid potential damage from excess humidity or perspiration, the use of a drying kit is also recommended.

2. Care and maintenance
   When not in use, store in a secure area away from small children and pets.

   • Do not place the device or charging case near  high-temperature areas such as stoves or direct sunlight.
   • Do not leave the devices in a humid place for a long time, such as bathroom.
   • Take care not to poke the microphone holes with any sharp objects to avoid damage.
   • Do not disassemble or attempt any repairs by yourself. Doing so will void your warranty.

3. Cleaning
   Cleaning the ear domes:

4. Remove any earwax buildup using the enclosed tool. Wipe clean with a tissue or soft cloth.

5. Remove ear dome from the device before cleaning, and push the ear dome rim membrane outward.

6. Please use the thin side of the cleaning brush to clean the ear dome of earwax and debris.

7. Wipe away earwax with alcohol and a dry cloth. Wait for the ear domes to dry before attaching them to the device.
   *Note: We recommend that you change the dome every three months. If the domes get stiff, brittle or discolored over time, please change them more frequently.

Cleaning the Tool
Use a soft cloth or tissue to wipe any moisture, perspiration, or debris from the surface of the tool.
Note: Do not use alcohol or other cleaning solvents to clean the hook as this could damage the protective covering.

PRODUCT CARE

• Keep your linX clean. Extreme temperatures (hot or cold), moisture, and foreign substances can result in poor performance.
• Use the cleaning brush tool or soft cloth to clean debris from around the buttons, microphones, and charging contacts; inspect the receiver, ear tips, and charging case regularly.
• Never use water, solvents, cleaning fluids or oils to clean your devices.
• Charging contacts should always be kept clean and dry.
• Always store your devices in the charging case when not in use or cleaning.

Charging Case Care

• Keep your charger clean. Heat, moisture and foreign materials can result in poor performance.
• Using the provided cleaning brush, keep the charging ports clear of debris.
• Do not use water, solvents or cleaning fluids to clean the charging ports.
• Keep lid closed as much as possible to avoid dust and debris build up.
• Store your charger in a clean and dry location, i.e. a dresser or shelf rather than the bathroom or kitchen.
• To ensure the longest life of your rechargeable batteries and the batteries in the charger, fully charge batteries every night.

Service and Repair
If, for any reason, your linX does not operate properly, do NOT attempt to fix it yourself. Not only are you likely to violate any applicable warranties or insurance, you could easily cause further damage. Should your device fail or perform poorly, check the Troubleshooting Guide on the next page for possible solutions. If problems continue, contact us or your hearing professional for advice and assistance. Many common problems may be solved right in your hearing professional’s office or clinic.

WARNING: DO NOT OPEN DEVICE OR CHARGER, NO USER-SERVICEABLE PARTS INSIDE.

TROUBLESHOOTING GUIDE

Device fault self-checking table

Charging case fault self-checking table

*Note: If the problem persists, contact your hearing care professional for assistance.

BLUETOOTH CONNECTION TROUBLESHOOTING

NOTE: You may contact us at: 844-443-2744 or support@iHEARdirect.com for further support if there are any questions.

TECHNICAL SPECIFICATION

Frequency response bandwidth

Frequency response smoothness

| F1:200Hz
F2:7000Hz

4dB

NORMALIZED SYMBOLS

MAINTENANCE, STORAGE, AND DISPOSAL

Maintenance

1. We do not authorize any institution or individual to maintain and/or repair the product. If you suspect that the products may be in question, please contact us immediately.
2. The user must not attempt any repairs to the device or any of its accessories. Please contact us for any repair needs.
3. Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty. Warning: No modification of this equipment is permitted.

Storage

1. Always store your devices in the Charging Case when not in use.
2. Do not store or expose the devices and/or case to extreme hot/cold temperatures, moist/humid environments, or shock/vibration.
3. Keep the devices and case in following environmental ranges: -10°C-55°C, 10%-90%RH, 700-1060 hPa

Disposal
Please dispose of the device in accordance with the directive 2002/96/EC – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please refer to your local authority responsible for waste disposal.

WARRANTY

This limited warranty covers defects in material and workmanship for a period of one (1) year from the dale of purchase, which includes the hearing devices, charger case, and cord within the warranty period.
Any damage caused by improper handling and care, exposure to elements or chemicals, or unauthorized service will not be covered by the warranty. All other damage claims excluded. A warranty claim must be submitted with the purchase receipt.

IMPORTANT SAFETY INSTRUCTIONS

Read all the information in this instruction manual and any other literature included in the box before using the device.

WARNINGS

• Not for use by anyone under 18 years old.
• Keep small parts (hearing instrument, ear domes, battery or other detachable parts) that can be swallowed, out of children’s reach. Dropping, immersing in liquid, exposure to strong electromagnetic fields or excessive heat will damage the product. Remove devices prior to any type of X-ray, MRI, or CT scan. If parts become stuck in the ear canal, seek medical assistance – do not attempt to remove by yourself.

Notice

• Do not use at high volume for extended periods of time – ear injury can result.
• If you experience any pain or strong discomfort using the devices, remove and consult a doctor.
• Routine maintenance to keep the device clean is required. Ensure that ear domes are free of debris and moisture at all times.
• Avoid shocks or dropping the product.
• Do not store or use the product in environments of high humidity or temperature (such as sauna room), to avoid damage.
• Batteries should be properly recycled and not disposed of in the trash.
• Keep the devices away from small children. Injury or damage may result.
• Do not set volume levels too high. Listening with high-output devices for extended periods at high volume levels can cause further hearing damage.
• Monitor for any unusual skin reaction. If you notice any allergic reaction (itchiness, swelling, or rash), stop wearing and consult a medical specialist.
• Keep away from magnets, magnetized objects or strong magnetic fields.
• Do not attempt to open or repair the devices yourself. Damage can result and will void the warranty.
• Do not store your devices in hot or humid locations.
• Do not leave your linX units in the car as inside temperatures can reach extreme levels, which could damage the devices.
• Please contact the MANUFACTURER:
  • For assistance, if needed, in setting up, using or maintaining your devices or to report any unexpected operation or events.

Specific warnings/statements

• Keep small parts away from and out of children’s reach to avoid accidental ingestion.
• Warning: do not use in explosive or oxygen-enriched atmospheres, as doing so may damage the device.

DO NOT USE IF ANY OF THE FOLLOWING APPLY TO YOU

1. Congenital atresia of external ear or deformity of any part of the ear canal;
2. Persistent headaches, dizziness, earaches, tinnitus or other symptoms that are not suitable for adaptation;
3. Sudden onset of hearing loss within the past 3 months; rapid progressive deafness; unilateral hearing loss or other acute ear disease;
4. Effusion (secretions/discharge) in the ear and/or frequent purulence (pus);
5. Central deafness (central nervous system) or non-organic deafness;
6. Patients with acute otitis externa and tympanitis;
7. Patients with acute and chronic suppurative otitis media (in the period of purulent infection); and/or
8. Patients who are allergic to the materials of this product.

MATTERS NEEDING ATTENTION, WARNINGS AND TIPS

1. Do not immerse the device in any liquid. Remove the device before swimming or bathing. After swimming or washing, wait for the ear canal to dry before wearing the device.
2. After removing the device at night, it should be placed in a case with a desiccant if possible, protected from light, high temperature and/or a high humidity environment.
3. The external surfaces of the device should be kept clean, and earwax in the ear domes should be cleaned out daily
4. Applicable objects: Suitable for people with air-conducting hearing loss of about 30-50dB
5. When you do not use device, please charge the product regularly to avoid battery damage; the recommended charging time interval for the device is less than 28 days.

REGULATORY AND LEGAL INFORMATION

This part applies to the product with Bluetooth or APP function. 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.
• Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate this 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.

This device complies with FCC radiation exposure limits set forth for general population. This transmitter must not beco-lo­cated or operating in conjunction with anyother antenna or transmitter.
FCC ID: 2A39M-W3HEARING
Radio Technology: Bluetooth Low Energy (BLE) and propri­etary technologies.
Radio Transceiver Frequency Range: 2.4 to 2.480 GHz Radio
Receiver Bandwidth: 2MHz.
Modulation Type: 1 Mb/s GFSK Peak Effective Isotropic
Radiated Power: 0 dBm.
This equipment has been tested and found to comply with the limits per CISPR 11 class B.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The device is intended for use in the electromagnetic environment specified below . The user of the device should assure that it is used in such an environment.
Emissions Test| IEC60601 Test Level| Compliance Level| Electromagnetic Environment Guidance

The device uses RF energy only for its internal function. Therefore, its

RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11| Group 1| Group 1
RF emissions CISPR 11| Group B| Group B| The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

This hearing device is intended for use in the electromagnetic environment specified below. The user of the hearing device should assure that it is used in such an environment.
Immunity Test| IEC60601 Test Level| Compliance Level
Electrostatic discharge (ESD) IEC 61000-4-2| + i – 8 kV contact

+ i – 15 kV air

| + i – 8 kV contact

+ i – 15 kV air

Radiated RF EM Fields IEC 61000-4-3| 10Vim

80 MHz – 2.7 GHz

80% AM at 1 kHz

| 10 Vim

80 MHz – 2.7 GHz

80% AM at 1 kHz

MHz;Pulse modulation18 Hz

9 Vim; 5240, 5500,

5785MHz; Pulse modulation217 Hz 27 Vim; 385 MHz;

Pulse modulation 18 Hz

28 Vim; 450 MHz

FM

 | MHz; Pulse
Proximity fields from RF wireless communication equipment IEC 61000-4-3| modulation 18 Hz-

9 Vim; 5240, 5500,

5785 MHz;

Pulsemodulation 217 Hz

27 Vim; 385 MHz;

 | Pulse modulation 18
 | Hz
 | 28 Vim; 450 MHz FM

+ i – 5kHz deviation;

1 kHz sine

28 Vim; 810, 870,

930MHz;

Pulse modulation 18Hz

28Vim; 1720,1845,1970,

2450 MHz; Pulse

modulation 217 Hz

| + i – 5kHz deviation; 1kHz sine

28 Vim; 810, 870,

930MHz;

Pulse modultion18 Hz

28 Vim; 1720,

1845,

1970,2450 MHz;

Pulse

modulation 217 Hz

---|---|---

InnerScope Hearing Technologies
2151 Professional Dr., STE 200 Roseville, CA 95661 844-443-27 44
Email: support@iHEARdirect.com
08-00002 Rev B

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