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Earlens Contact Hearing Solution User Manual

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Contact Hearing Solution User Manual

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Summary of Contents for Earlens Contact Hearing Solution

  • Page 1 Earlens ® Contact Hearing Solution User Manual...
  • Page 2 Earlens ® Contact Hearing Solution User Manual...
  • Page 3 • If you experience discomfort or pain in your ear, you should contact the ENT physician • Do not incinerate any component of the Earlens Hearing Solution or use near an open immediately. Only physicians trained in Ear, Nose & Throat procedures should place or...
  • Page 4 If you consistently need to • Earlens is custom designed and intended to be used only by a single patient. turn the volume down, you may need to further adjust your device.
  • Page 5 Ear Tip use. If the Earlens Processor fails to operate or if it appears damaged, including the presense of battery You should avoid getting the Processor wet, as it may damage the device. You must remove leakage or swelling, promptly remove the Processor, discontinue use and contact your hearing the Processor prior to showering, swimming, or bathing.
  • Page 6 Notices 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. 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.

  • Page 7: Table Of Contents

    Telephone and Cellphone Use ......24 Getting to Know Your Earlens Telephone and Cellphone Use to show you how to use and care for your new Earlens. We encourage you to carefully Charging and Battery Life ........26 The Lens ..............6 The Lens...

  • Page 8: The Lens

    Getting to Know Your Earlens The Earlens Hearing Solution uses a small Lens placed in your ear by a physician to Sound enters the microphone on the Processor, which processes the audio signal based on your hearing needs. and transfers it to the Ear Tip, which converts the sound signal into an energy signal.
  • Page 9 The Lens The Processor and Ear Tip The Lens is powered by pulses of energy that contain sound information. When the The Processor sits comfortably behind your ear. It collects and sends audio signals Lens detects the signal, it gently activates your natural hearing system, allowing you to through the Ear Tip.

  • Page 10: The Charger

    The Charger Charging Status Indicators Charging Status Indicators What It Means The Charger can hold one or two devices. It features a USB-based AC wall power Charger connecting to Processor, it may take light adapter as its power source. The Charger includes an LED indicator display to let you up to 20 seconds to connect.

  • Page 11: Mineral Oil

    Mineral Oil Using your Earlens Hearing Solution and properly working. Apply one pump of mineral oil to each ear When you remove your Processor from a plugged-in Charger, it will be ON. every other day, or as directed by your provider. If you forget to...

  • Page 12: Turning The Processor On

    Turning the Processor On Identifying Left or Right Device To turn the Processor ON, push and hold the top user control for 3 seconds. To identify a left or right device, look at the color of the indicator in the Ear Tip. Left Right Blue indicates a...

  • Page 13: 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 Slowly insert the Ear Tip into your ear Gently push the Ear Tip into your canal.

  • Page 14: Removing The Processor And Ear Tip Changing Volume And Program

    Changing Volume and Program Removing the Processor and Ear Tip To remove the Processor and Ear Tip, grasp the Cable between your thumb and Your hearing professional can customize your user Your hearing professional can customize your user controls based on your preferences and needs. Your user controls can controls based on your preferences and needs.
  • Page 15 User Control User Control Options Action/Press Options Action/Press Volume Volume = Short Press Up = Short Press Up Increase Increase Volume Short Volume Short Press Down Cycle Decrease Press Down Decrease Volume Volume Power to Next Increase Increase Volume & Volume Program Program...
  • Page 16 User Control User Control Options Action/Press Options Action/Press Cycle to = Short Press Up Disabled = Short Press Up Next Program Cycle to Short Short Previous Disabled = Cycle Press Down Press Down No Volume Program Power Power to Next Disabled Program or Program...

  • Page 17: Processor Alerts

    Processor Alerts 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. description of each alert. You are at the minimum or maximum Min/Max Volume 3 quick beeps limits of your volume control.

  • Page 18: Telephone And Cellphone Use

    Remove and re-insert the Ear T If available, use the speaker phone feature on your phone. There are a few ways you can try to use your phone with your Earlens. Hold the upper portion of the phone over the microphones on your Processor, with the mouthpiece pointed towards your mouth.

  • Page 19: Pairing And Connecting Your Apple Device

    With the Made for iPhone feature, you can connect your Earlens Hearing Solution to your Apple Tap on your name. device. This connection, along with the Earlens Control App, allows you to easily and discretely change your hearing aid programs and volume. You can also take phone calls and stream A pairing request window media from your iPhone, iPad, and iPod touch directly to your hearing aids.

  • Page 20: Daily Care

    Charging and Battery Life Cleaning and Maintenance Daily Care 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 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 wipe, or other To charge, place the Processor and Ear Tip into the Charger.
  • Page 21 Oiling Instructions If you notice wax on the Ear Tip, use a soft cloth to wipe the bowl If you notice wax on the Ear Tip, use a soft cloth to wipe of your ear. Never insert foreign objects into the ear canal, such the bowl of your ear.
  • Page 22 • Use only the mineral oil and container Before each use, prepare the 1 - 2 Minutes 1 Minute provided and/or recommended by your mineral oil dispenser by turning the hearing provider or Earlens. Note: into your ear. is dispensed.

  • Page 23: Avoiding Moisture & Heat

    Avoiding Moisture & Heat 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 online • Do not leave your devices in extreme heat.

  • Page 24: Troubleshooting

    It still require more volume, contact your may take the Processor up to 20 seconds to hearing professional. connect to the Charger. Repeat removal and insertion up to 5 times. If the lights continue call the Earlens Concierge at 1-844-234-5367.

  • Page 25: Technical Information

    • Technical Information Issue Possible Causes Possible Remedy Certain components of the Earlens® Contact Hearing Solution, including the Processor Whistling The Ear Tip is not Remove and re-insert the Ear Tip Earlens Hearing Aid FCC ID: 2AGDU-EL2PIN (feedback) properly inserted.
  • Page 26 700 – 1060 hPa verify normal operation in the configuration in which it will be used. The following accessories Limit* of 93% non-condensing. supplied with the Earlens® Contact Hearing Solution have been tested for electromagnetic Remove and r Avoid high temperatures Frequency range...
  • Page 27 Contact Hearing Solution, make s The Earlens® Contact Hearing Solution is intended for use in the electromagnetic environment specified below. The customer or the user of the Earlens® Contact Hearing Solution should assure that it is used in such an environment.
  • Page 28 Voltage Dips 30% reduction, Voltage Dips 30% reduction, Mains power quality should be that of a The customer or the user of the Earlens® Contact Hearing Solution should assure that it is used in such an 25/30 periods 25/30 periods...
  • Page 29 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Earlens® Contact where P is the maximum output power rating of the Hearing Solution is used exceeds the applicable RF compliance level above, the Earlens®...
  • Page 30 (V/m) The Earlens® Contact Hearing Solution is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Earlens® Contact Hearing Solution can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications Earlens®...
  • Page 31 Service Modulation Power TEST LEVEL (MHz) (MHz) (V/m) ® Earlens Contact Hearing Solution complies with part 15 of the FCC rules. Operation is subject to the GSM 1800; CDMA 1900; following two conditions: 1720 GSM 1900; Pulse modulation 1845 1700 –1990 DECT;...

  • Page 32: Clinical Study Information

    Before using the Earlens ® Contact Hearing Contact Hearing Solution in both ears in their daily lives for four months per study protocol. ® Earlens Contact Hearing Solution complies with part 18 of the FCC rules. Safety and effectiveness were assessed during the four months.
  • Page 33 ® Contact Hearing Solution, make s Before using the Earlens with the Earlens® Contact Hearing Solution at a speech level of 45 dB HL. The objective was to ® Contact Hearing Solution, make s not impacted and the subject continued device use throughout the study period of four months.
  • Page 34 2,000 to 10,000 Hz for aided thresholds measured at 30 days post placement 30% (standard deviation = 13%) with the subject’s own air conduction hearing aid, and for Earlens it when compared to unaided thresholds measured prior to placement. Mean functional gain was 30.5 was 29% (standard deviation = 14%).

  • Page 35: Device Labeling Symbols

    Ear Tip modification. One subject continues to report a sensation of fullness. Ingress Ingress Based on the results of the Definitive study, the Earlens® Contact Hearing Solution has been Before using the Earlens ® Contact Hearing Solution, make s...
  • Page 36 Humidity Non-Ionizing Product is a Type BF Applied Part Limitation Radiation Type BF Part the operation of this device or its compliance with safety and regulatory standards. Please Apple, the logo, AirPlay, iPhone, iPad, iPod are trademarks of Apple Inc., registered in the U.S. and other countries.
  • Page 37 Earlens ® Corporation, Inc. Earlens 4045A Campbell Ave. Earlens ® ® Corporation, Inc. Corporation, Inc. 4045A Campbell Ave. 4045A Campbell Ave. www.earlens.com...
  • Page 38 ©2023 Earlens Corp. All rights reserved. LBL00153vJ Patent Protected/Pending: www.earlens.com/patents Patent Protected/Pending: www.earlens.com/patents...

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