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Earlens Contact Hearing Solution User Manual

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Summary of Contents for Earlens Contact Hearing Solution

  • Page 1 Contact Hearing Solution User Manual ® Earlens Hearing Aid User Manual...
  • Page 3 Earlens(R) Contact Hearing Solution User Manual...
  • Page 4 Thank you for choosing the Earlens Hearing Solution. This user manual is designed to show you how to use and care for your new Earlens Hearing Aid. We encourage you to carefully read this entire booklet including the Warnings and Precautions sections to achieve the maximum benefit from your new hearing technology.

  • Page 5: Table Of Contents

    Contents Getting to Know Your Earlens Hearing Aid ..4 Telephone and Cellphone Use ......24 Charging and Battery Life ........26 The Lens ..............6 The Processor and Ear Tip ........7 Cleaning and Maintenance ........27 The Charger .............8 Daily Care...............27 Mineral Oil .............10 Oiling Instructions..........29...

  • Page 6: Getting To Know Your Earlens Hearing Aid

    Lens to vibrate and gently activate your natural hearing system. There are important components to your Earlens Hearing Aid that will be described in this section: the Lens, the Processor, the Ear Tip, the Charger and mineral oil. The components that you will interact with include the Processor, Ear Tip, Charger and mineral oil.
  • Page 7 Sound enters the microphone on the Processor, which processes the audio signal based on your hearing needs. The audio signal is then converted into pulses of energy that are transmitted by the Ear Tip. When the energy signal reaches the Lens, it vibrates the eardrum gently at different frequencies —...

  • Page 8: The Lens

    The Lens The Lens is powered by pulses of energy that contain sound information. When the Lens detects the signal, it gently activates your natural hearing system, allowing you to hear sound. To keep your Lens functioning properly, you must apply mineral oil once to twice daily, or as directed by your provider, and avoid placing foreign objects in your ear (such as Q-tips, bobby pins, and your fingernails).

  • Page 9: The Processor And Ear Tip

    The Processor and Ear Tip The Processor sits comfortably behind your ear. It collects and sends audio signals through the Ear Tip. Those signals are received by the Lens. Cable Microphones Ear Tip User Controls Transmitter Vent Processor...

  • Page 10: The Charger

    The Charger The Charger can hold one or two devices. It features a USB-based AC wall power adapter as its power source. The Charger includes an LED indicator display to let you know the charging status of your Processor(s). Charging Status Indicators Slot...
  • Page 11 Charging Status Indicators Charging Status Indicators What It Means One flashing light Charger connecting to Processor One solid light Battery charging and below 33% charged Two solid lights Battery charging and above 33% charged Three solid lights Battery charging and above 66% charged Four solid lights Battery fully charged Processor not charging;...

  • Page 12: Mineral Oil

    Mineral Oil Mineral oil plays an important role in keeping the Lens in position and properly working. Apply one pump of mineral daily, or as directed by your provider. If you forget to apply the mineral oil to your ear as advised, your Lens may stop working or fall out. In the event that you forget to oil as scheduled, apply oil as soon as possible and then resume as advised.

  • Page 13: Using Your Earlens Hearing Aid

    Using your Earlens Hearing Solution Turning the Processor Off When you remove your Processor from a plugged-in Charger, it will be ON. To turn the Processor OFF, push and hold the bottom user control for 3 seconds. 3 Seconds Bottom User Control...

  • Page 14: Turning The Processor On

    Turning the Processor On To turn the Processor ON, push and hold the top user control for 3 seconds. 3 Seconds Top User Control...

  • Page 15: Identifying Left Or Right Device

    Identifying Left or Right Device To identify a left or right device, look at the color of the indicator in the Ear Tip. Left Right Blue indicates a Red indicates a Left device Right device...

  • Page 16: Putting On The Processor And Ear Tip

    Putting on the Processor and Ear Tip It is important that the Ear Tip is placed properly in your ear. Place the Processor Hold the Ear Tip between your thumb behind your ear, where it and index finger with the colored dot should rest comfortably.
  • Page 17 Slowly insert the Ear Tip into your ear Gently push the Ear Tip into your canal. Gently pulling your outer ear up ear canal, pushing it as far as it will and back may help with insertion. comfortably go, to ensure it is seated in the correct position.

  • Page 18: Removing The Processor And Ear Tip

    Removing the Processor and Ear Tip To remove the Processor and Ear Tip, grasp the Cable between your thumb and index finger near the Ear Tip and gently pull it out of the ear canal.

  • Page 19: Changing Volume And Program

    Changing Volume and Program Your hearing professional can customize your user controls based on your preferences and needs. Your user controls can be set up to change volume, change programs or to change both the volume and programs. Please speak your hearing professional how your user control settings have been customized.
  • Page 20 User Control Options Action/Press Volume = Short Press Up Increase Volume Short Press Down Decrease Cycle Volume to Next Increase Volume & Program Program Cycle to Next Long Press Up Power Program (3 seconds) Volume Decrease Long Press Down Power Off = (3 seconds)
  • Page 21 User Control Options Action/Press Volume = Short Press Up Increase Volume Short Decrease Press Down Volume Power Increase Volume Only Long Press Up Power Off = Power (3 seconds) Volume Decrease Long Press Down Power Off = (3 seconds)
  • Page 22 User Control Options Action/Press Cycle to = Short Press Up Next Program Cycle to Short Previous Cycle Press Down Program Power to Next Program Program Only Long Press Up Power Off = Cycle to Power (3 seconds) Previous Program Long Press Down Power Off = (3 seconds)
  • Page 23 User Control Options Action/Press Disabled = Short Press Up Short Disabled = Press Down No Volume Power Disabled or Program Control Long Press Up Power Off = Enabled Power (3 seconds) Disabled Long Press Down Power Off = (3 seconds)

  • Page 24: Processor Alerts

    Processor Alerts Your hearing professional can program your Processor(s) to have a number of sound alerts that indicate a specific function. The following table provides a description of each alert. Alert Type Description of Alert What it Means Power On 3 tone melody The Processor has powered on.
  • Page 25 Alert Type Description of Alert What it Means Volume Change 1 quick beep The volume has increased/decreased. Default The volume is at the default 2 quick beeps Volume Level programmed level. You are at the minimum or maximum Min/Max Volume 3 quick beeps limits of your volume control.

  • Page 26: Telephone And Cellphone Use

    Telephone and Cellphone Use There are a few ways you can try to use your phone with your Earlens Hearing Aid. Hold the upper portion of the phone over the microphones on your Processor, with the mouthpiece pointed towards your mouth.
  • Page 27 If available, use the speaker phone feature on your phone. The Earlens Hearing Aid features Made for iPhone compatibility. This feature allows you to take phone calls and stream media from your Apple device directly to your Processor(s). For the latest iOS and Apple device compatibility information, please go...

  • Page 28: Charging And Battery Life

    Charging and Battery Life The Processor battery will last an average of 20 hours. It takes 4 hours in the Charger to completely recharge a fully depleted Processor battery. We highly recommend charging your Processor(s) in a dry and low-humidity location. To charge, place the Processor and Ear Tip into the Charger.

  • Page 29: Cleaning And Maintenance

    Cleaning and Maintenance Daily Care Check that there is no wax or debris on the Ear Tip. If wax or debris is present, use a soft cloth, a baby wipe or other Isopropyl Alcohol (IPA) based wipes to remove. If there is wax or debris in the Ear Tip vent or covering the emitter, use a soft-bristle toothbrush, a pipe-cleaner or a hearing aid cleaning tool to gently clear the debris.
  • Page 30 If you notice wax on the Ear Tip, use a soft cloth to wipe the bowl of your ear. Never insert foreign objects into the ear, such as Q-tips, bobby pins or your fingernails. Insertion of foreign objects could result in pain, may damage your ear and may cause damage to the Lens.

  • Page 31: Oiling Instructions

    Oiling Instructions Oiling is required to keep the Lens in place and functioning properly. Apply pump of mineral oil daily, or as directed by your provider, to your ear canal. Follow the instructions provided by your physician if he or she asks you to oil on a different schedule.
  • Page 32 • Use only the mineral oil and container Before each use, prepare the provided and/or recommended by your mineral oil by depressing the pump hearing provider or Earlens. until a constant stream is observed.
  • Page 33 1 - 2x With your head in an upright position, place the cone tip of the dispenser fully into the ear canal opening. Dispense one pump of oil into the ear canal by depressing the pump. Update image to new oiler Remove the dispenser from the ear and tilt your head to the side.

  • Page 34: Avoiding Moisture & Heat

    Avoiding Moisture & Heat Moisture and heat can damage your Earlens Hearing Aid. You can avoid this by taking these steps: • Do not leave your devices in extreme heat. • Do not wear your processor(s) in heavy rain, steam baths or showers.

  • Page 35: Warranty

    Warranty Your Earlens Hearing Solution is covered by a warranty. Please talk to your hearing provider about the details of your warranty. You can register your Earlens Hearing Aid online at: www.earlens.com/register Warranty Period Start Date: _____________________________________________________________________________________ End Date: ______________________________________________________________________________________...

  • Page 36: Troubleshooting

    Troubleshooting Issue Possible Causes Possible Remedy No sound Battery is Charge the Processor until at least 2 solid not charged. lights appear. If 2 or more solid lights appear, the battery is not the issue. Contact your hearing professional. Not loud enough The Ear Tip is Remove and re-insert the Ear Tip and check the improperly inserted.
  • Page 37 4 lights with the Charger and immediately short press the top user or Processor. control. Repeat removal and insertion up to 5 times. If the lights continue to flash, contact your hearing professional or call the Earlens Concierge at 1-844-730-5986.
  • Page 38 Issue Possible Causes Possible Remedy Whistling The Ear Tip is not Remove and re-insert the Ear Tip (feedback) properly inserted. and check the position in a mirror if possible. If the issue persists, contact your hearing professional.

  • Page 39: Warnings

    Solution, make sure you read and understand each of the following safety warnings: • The Earlens Hearing Aid is considered MR unsafe. The Lens should be removed prior to an MRI exam or MRI exposure. Only physicians trained in Ear, Nose & Throat procedures should place or remove the Lens.
  • Page 40 • Should the Processor become unusually warm or hot, promptly remove it, discontinue use and contact your hearing healthcare professional. • Do not crush, short circuit, modify or disassemble any component of the Earlens Hearing Solution. Keep all components of the Earlens Hearing...

  • Page 41: Precautions

    Precautions Before using the Earlens Hearing Solution, make sure you read and understand each of the following safety precautions. • If you have known nickel sensitivity/allergy, please be aware that the Lens and Ear Tip components contain nickel that is coated with a parylene barrier. If you develop an allergic reaction, the Lens and Ear Tip should be promptly removed.
  • Page 42 • The Earlens Hearing Aid is custom designed and intended to be used only by a single patient. • The Ear Tip is designed to sit a set distance from the Lens. Sound output may deviate if the Ear Tip is not inserted to the proper depth. If the sound output does deviate, you can reposition the Ear Tip until optimal sound output is achieved.
  • Page 43 • Use only the Earlens Charger and AC wall adaptor provided. Although other adapters may look similar, they may cause damage to the Earlens Hearing Solution. • Handle the components carefully and prevent hard knocks. Do not drop them as it may...
  • Page 44 • If the Earlens Processor fails to operate or if it appears damaged, including the presence of battery leakage or swelling, promptly remove the Processor, discontinue use and contact your hearing professional. • Only clean the Processor with a soft cloth. Do not use chemicals (i.e. hairspray) in close proximity or to clean the Processor.

  • Page 45: Technical Information

    Technical Information Earlens Hearing Aid FCC ID: 2AGDU-EL2PIN. IC ID: 20825-EL2PIN...

  • Page 46: Device Labeling Symbols

    Device Labeling Symbols Refer to Date of Instruction MR Unsafe Manufacture Manual Product is a By Prescription Serial Number Type BF Part Only Ingress Protection Batch Code Catalog Code Code...
  • Page 47 Non-Ionizing Humidity Radiation Caution Limitation Atmospheric FCC Approved Pressure Keep Dry Equipment Limitation Storage Dispose Temperature Electronic Limit Waste Properly...
  • Page 48 “Made for iPod,” “Made for iPhone,” and “Made for iPad” mean that an electronic accessory has been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards.
  • Page 49 FCC Part 15 Digital Emissions Compliance We, Earlens® ., declare under our sole responsibility that this product 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.
  • Page 50 European Authorized Representative: Manufactured by: Medimark Europe SARL ® Earlens(R) Corporation, 11, Rue Emile Zola, B.P. 2332 Inc. 4045A Campbell Ave. F-38033 Grenoble Cedex 2 – France Menlo Park, CA 94025 USA +1 (844) 234-LENS www.earlens.com...
  • Page 51 www.earlens.com...
  • Page 52 LBL00153vC March 2019 ©2019 Earlens, Inc. All rights reserved. LBL00153vB January 2019 Patent Protected/Pending: www.earlens.com/patents...

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