99-0173 EARGOLINK Hearing Aid System User Guide

99-0173 EARGOLINK Hearing Aid System

Product Information

Specifications

• Age Requirement: 18 years and older
• Possible Side Effects : Minor itchiness, redness, and irritation
• Compatibility : Use authentic Eargo accessories purchased from Eargo or Eargo authorized dealers
• Safety Precautions: Keep small parts out of reach of children, avoid using instruments to push the hearing device in the ear canal, use by intended person only, keep hearing device and charger away from active implants, do not place charger in clothing pocket while charging, avoid using hearing aid systems next to other electronic equipment, do not use in oxygen enriched or explosive areas
• Battery Warnings : Check for signs of leakage, discontinue use and contact Eargo immediately in case of leakage

Product Usage Instructions

1. Age Requirement
   This OTC hearing aid is designed for users who are 18 years and older. Individuals younger than 18 with hearing loss should consult a doctor, preferably an ear-nose-throat doctor (an ENT), for specialized care.

2. Insertion and Pain
   When inserting the hearing aid, it should not cause pain or discomfort. If you experience pain or discomfort, remove the device and try again by following the instructions carefully. If the pain
   or discomfort persists, contact the manufacturer or your hearing healthcare professional. In case of persistent pain or discomfort, you can also report it to the FDA as an adverse event.

3. Possible Side Effects
   As your ear becomes accustomed to having an object in it, minor itchiness, redness, and irritation may occur. If you experience any of these side effects or any other unusual conditions, such as allergic reactions, inflammation, discharge from the ear, or excessive wax, please contact Eargo or consult a physician.

General Warnings

• Use only authentic Eargo accessories purchased from Eargo or Eargo authorized dealers for optimal performance.
• Keep small parts of the hearing aid and accessories out of reach of children to prevent choking hazards.
• Avoid using instruments like cotton swabs to push the hearing device into the ear canal.
• The hearing device should only be used by the intended person to avoid potential damage to others’ hearing.
• If you have an active implant, such as a pacemaker, ensure that the hearing device and charger are kept away from the implant.
• Do not place the charger in your clothing pocket while charging with the USB cable to prevent overheating and malfunction.
• Avoid using the hearing aid system directly next to other electronic equipment as it may result in decreased performance. If such use is necessary, monitor the performance of both the hearing aid system and the other equipment to ensure they are operating normally.
• Do not use the hearing devices or charger in oxygen-enriched environments or other explosive areas unless those areas are certified for hearing device use.

Battery Warnings
Like many batteries, Eargo device batteries have a risk of leakage. Periodically check your Eargo devices for any signs of leakage, such as visible white residue. If you notice any residue or suspect battery leakage for any reason, immediately discontinue use and contact Eargo. If you have touched any battery fluid or residue, wash your hands thoroughly.

Frequently Asked Questions (FAQ)

• Q: What age group is this OTC hearing aid suitable for?
  A: This OTC hearing aid is suitable for users who are 18 years and older. Individuals younger than 18 with hearing loss should consult a doctor, preferably an ear-nose-throat doctor (an ENT), for specialized care.

• Q: What should I do if the hearing aid causes pain or discomfort?
  A: If the hearing aid causes pain or discomfort when inserting or placing it, remove the device and try again by following the instructions carefully. If the pain or discomfort persists, contact the manufacturer or your hearing healthcare professional. In case of persistent pain or discomfort, you can also report it to the FDA as an adverse event.

• Q: What side effects may occur with this hearing aid?
  A: As your ear becomes accustomed to having an object in it, minor itchiness, redness, and irritation may occur. If you experience any of these side effects or any other unusual conditions, such as allergic reactions, inflammation, discharge from the ear, or excessive wax, please contact Eargo or consult a physician.

• Q: Can I use accessories from other brands with this hearing aid?
  A: For optimal performance of your Eargo devices, we recommend using only authentic Eargo accessories purchased from Eargo or Eargo authorized dealers.

• Q: Can children use this hearing aid?
  A: No, the hearing aid and accessories contain small parts that pose a choking hazard. Keep them out of reach of children.

• Q: Can I use cotton swabs to insert the hearing device into the ear canal?
  A: No, using instruments such as cotton swabs to push the hearing device into the ear canal is not recommended. Follow the provided instructions for proper insertion.

• Q: Can someone else use my hearing device?
  A: The hearing device must only be used by the intended person. Using it by another person may damage their hearing.

• Q: Can I use the hearing device and charger near my pacemaker?
  A: No, if you have an active implant such as a pacemaker, keep the hearing device and charger away from the active implant to prevent any interference.

• Q: Can I charge the hearing device with the charger in my clothing pocket?
  A: No, do not place the charger in your clothing pocket while charging with the USB cable as it may overheat and malfunction.

• Q: Can I use the hearing aid system next to other electronic equipment?
  A: It is generally recommended to avoid using the hearing aid system directly next to other electronic equipment as it could result in decreased performance. If such use is necessary, monitor the performance of both the hearing aid system and the other equipment to ensure they are operating normally.

• Q: Can I use the hearing devices or charger in oxygen-enriched environments?
  A: No, electrical equipment like hearing devices and chargers are potential ignition sources. Do not use them in oxygen-enriched environments or other explosive areas unless those areas are certified for hearing device use.

• Q: What should I do if I suspect battery leakage?
  A: If you notice any signs of battery leakage, such as visible white residue, immediately discontinue use of the device and contact Eargo for further assistance.

• Q: What should I do if I have touched battery fluid or residue?
  A: If you have touched any battery fluid or residue, wash your hands thoroughly.

TECHNICAL & REGULATORY INFORMATION

USER GUIDE PART 1

WARNING : If 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.

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

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.

Possible Side Effects
Minor itchiness, redness, and irritation may occur as your ear becomes accustomed to having an object in it. If this or anything related may arise, please contact Eargo. If an actual allergic reaction occurs or you experience inflammation, discharge from the ear, excessive wax or other unusual conditions, contact a physician.

GENERAL WARNINGS

• For best performance of your Eargo devices we recommend only using authentic Eargo accessories purchased from Eargo or Eargo authorized dealers.
• The hearing aid and accessories contain small parts which should be kept out of reach of children due to choking hazard.
• Do not use an instrument, such as a cotton swab, to push the hearing device in the ear canal.
• Hearing device must only be used by intended person. Use by another person may damage their hearing.
• Users with active implants such as a pacemaker should keep hearing device and charger away from the active implant.
• Do not place charger in clothing pocket while charging with the USB cable. The charger may overheat and malfunction.
• Avoid use of hearing aid systems directly next to other electronic equipment, which could result in decreased performance. If such use is necessary, monitor the performance of your hearing aid system and the other equipment to ensure they are operating normally.
• Electrical equipment are an ignition source. Do NOT use your hearing devices or charger in an oxygen enriched environment or other explosive areas, unless those areas are certified for hearing device use.

BATTERY WARNINGS
Eargo devices contain batteries which are dangerous if swallowed. To help prevent accidental ingestion of batteries

• Keep out of reach of children and pets.
• Check your medications before taking them–hearing devices have been mistaken for pills.
• Never put hearing devices in your mouth, as they can easily be swallowed.
• Do not replace battery.

National Button Battery Ingestion Hotline:800-498-8666
As with many batteries, Eargo device batteries have a risk of leakage. Periodically check Eargo devices for any signs of leakage (visible white residue). If you see such residue or suspect battery leakage for any other reason, immediately discontinue use and contact Eargo immediately. If you suspect you have touched any battery fluid or residue, wash your hands thoroughly.

• 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.

• 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 our device.

• 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 it 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.

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.

• 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 not prevent or improve 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.

• 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 fda.gov/Safety/MedWatch or call (800) FDA-1088. You can also download a form to mail to FDA.

Link by Eargo Indications For Use
Link by Eargo OTC Hearing Aids are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment in individuals 18 years of age or older. No pre-programming or hearing test is necessary. The product is to be used without the assistance of a hearing care professional.

Cautions

• Do not expose hearing device to contaminants such as hair spray, mousse, gel, lotions, etc. to prevent damage to the hearing device.
• Keep Eargos Dry: Long-term exposure to moisture can harm your devices. Store and charge your Eargo system in a dry location. Bathrooms and kitchens can be moist/humid.
• Eargo devices and charger are not waterproof. Please do not immerse or submerge your devices in water, alcohol, or any liquid. Don’t wear them while swimming or showering, and
• leave them behind when visiting a hot tub or steam room.
• Do not dry hearing device with a hairdryer or other heat source. Heat may damage hearing device.
• Only clean hearing device with acceptable materials as stated in your Eargo Use & Care User Guide. Be careful to prevent any damage to the hearing device.
• To prevent damage and/or malfunction, do not modify hearing device, charger, or accessories.

Information And Explanation Of Symbols

• Warning/Cautio n: Important information for injury prevention, handling and product safety.
• Consult instructions for use.
• Contains electronics, dispose according to local regulations, or return to Eargo.
• Do not use if package is damaged.
• Manufacturer.
• Date of manufacture.
• Catalogue number.
• Serial number.
• Relative humidity : Store between 0% to 90% relative humidity.

Link by Eargo Wireless Technical Description

• Your Eargo hearing aid system is classified as Class II Exempt per 21 CFR 874 and Class II Type BF per IEC 60601-1 Medical Electrical Equipment.
• Your Eargo hearing aid system, specifically the charger, contains a radio transceiver operating in the frequency range of 2.4 GHz to 2.48 GHz.
• This hearing aid model has been tested to, and has passed, the following EMC, emissions, and immunity tests
• IEC 60601-1-2 radiated emissions requirements for a Class II Type BF device as stated in CISPR 11.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV air discharge.

Charger Specification

Charger uses 5V, 1.2A. Ensure power outlet does not exceed 5V.

Repair & Warranty Policy

• To initiate a repair or exchange of a damaged device and/or charger under warranty, call us at 800-615-9000. For eligible warranty repairs or exchanges, we will provide you with a return label to send the damaged device and/or charger to Eargo.
• At the time of original purchase, Eargo provides an original warranty on all hearing devices and chargers. Go to eargo.com/warranty or call us at 800-615-9000 for details on your Link by Eargo warranty.

ANSI/CTA-2051:2017 Technical Specifications

Waste Disposal
Waste from electronic equipment must be handled according to local regulations.

Power Supply Specification

• One USB-C to USB-A power cable, with length 1 meter (~ 3 feet) is supplied in the system box.
  • Input : 100-240V ~ 50/60 Hz, 200mA max current – Output: 5.0V 1000mA
• Do not puncture the charger.
• You can expect reliable operation for up to 2 years, beyond this decreased battery life may occur.

Environment

• Your Link By Eargo system is designed to operate in public and residential environments and to comply with International Electromagnetic Compatibility emissions and immunity standards for medical devices.
• However, it is still possible that you may experience interference caused by power line disturbances, metal detectors (e.g. at airports), electromagnetic fields from othermedical devices, radio signals, and electrostatic discharges.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Do not use hearing device during X-rays, MRls, CT scans or other similar medical treatment to prevent damage to the hearing device. Check for electronic or wireless restrictions prior to using hearing devices or charger to prevent electrical interference to nearby equipment.

Storage
Your hearing aid system is designed to be stored within the temperature ranges of -4°F ( -20°C) to 113°F (45°C).

Operating Conditions
Your hearing aid system is designed to operate within the temperature ranges of 32°F (0°C) to 113°F (45°C).

Compliance Information

• This device complies with FCC 47 CFR Part 15 Left Hearing Aid
• FCC ID : 2BDFPEARGOLINK

Right Hearing Aid FCC ID: 2BDFPEARGOLINK

• 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.

Link By Eargo Serial Number Location

• Original component Serial Numbers are located on the base of the charger and on the sound outlet of the earbud, as well as listed on the original packaging. This information and other labeling, including the user instructional brochure, are available on the internet at www.eargo.com.
• You may also call 800-615-9000 to request a paper copy of this information and other labeling.

• Model Number: 99-0173

(800) 61 5-9000

• eargo.com
• Eargo and the Eargo wordmark are registered trademarks of Eargo, Inc.
• ©2024 Eargo, Inc.
• LBL 0333-001-REV A

References

• Eargo | A Revolutionary New Hearing Aid
• Learn About Our Original Warranty | Eargo
• FDA Error
• Eargo | A Revolutionary New Hearing Aid

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