(R) Contact Hearing Solution User Manual ® Earlens Hearing Aid User Manual
Earlens(R) Contact Hearing Solution User Manual 1
Welcome 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. If you have further questions that are not answered in this manual, please contact your hearing professional or call the Earlens Concierge at 1-844-730-5986.
Contents Getting to Know Your Earlens Hearing Aid..........4 The Lens....................................................................6 The Processor and Ear Tip.....................................7 The Charger..............................................................8 Mineral Oil..............................................................10 Using your Earlens Hearing Aid........................... 11 Turning the Processor Off....................................11 Turning the Processor On.........
Getting to Know Your Earlens Hearing Aid The Earlens Hearing Solution uses a small Lens placed in your ear by a physician to activate your natural hearing system. The behind-the-ear Processor collects sound and transfers it to the Ear Tip, which converts the sound signal into a rapidly pulsed energy pulses that power the Lens to vibrate and gently activate your natural hearing system.
1 Sound enters the microphone on the Processor, which processes the audio signal based on your hearing needs. 2 The audio signal is then converted into pulses of energy that are transmitted by the Ear Tip. 3 When the energy signal reaches the Lens, it vibrates the eardrum gently at different frequencies — resulting in rich, natural sound.
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).
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.
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 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 Four flashing lights No lights Processor not charging; remove from Charger, re-insert into charging slot and immediately press top user control Check that Charger is plugg
Mineral Oil Mineral oil plays an important role in keeping the Lens in position and properly working. Apply one pump of mineral oil 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. Detailed mineral oil use instructions are available in the Care and Maintenance section of this manual.
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.
Turning the Processor On To turn the Processor ON, push and hold the top user control for 3 seconds.
Identifying Left or Right Device To identify a left or right device, look at the color of the indicator in the Ear Tip.
Putting on the Processor and Ear Tip It is important that the Ear Tip is placed properly in your ear. 14 1 2 Place the Processor behind your ear, where it should rest comfortably. Hold the Ear Tip between your thumb and index finger with the colored dot pointing up and the Positioning Lip pointing toward the back of the head.
3 4 Slowly insert the Ear Tip into your ear canal. Gently pulling your outer ear up and back may help with insertion. Gently push the Ear Tip into your ear canal, pushing it as far as it will comfortably go, to ensure it is seated in the correct position.
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.
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 to your hearing professional how your user control settings have been customized. The tables on the next few pages can also serve as a helpful reference for instructions.
User Control Options Action/Press Volume = Short Press Up Increase Volume & Program Volume Short = Press Down Decrease Cycle to Next Long Press Up = Program (3 seconds) Power Off = 18 Long Press Down (3 seconds) Volume Increase Volume Decrease Cycle to Next Program Power Off
User Control Options Action/Press Volume = Short Press Up Increase Volume Short = Decrease Press Down Volume Only Power Off = Long Press Up (3 seconds) Power Off = Long Press Down (3 seconds) Volume Increase Volume Decrease Power Off Power Off 19
User Control Options Action/Press Cycle to = Short Press Up Next Program Program Only 20 Cycle to Short Previous = Press Down Program Power Off = Long Press Up (3 seconds) Power Off = Long Press Down (3 seconds) Cycle to Next Program Cycle to Previous Program Power Off Power Off
User Control Options Action/Press Disabled = Short Press Up No Volume or Program Control Enabled Disabled = Power Off = Power Off = Short Press Down Long Press Up (3 seconds) Disabled Power Off Disabled Power Off Long Press Down (3 seconds) 21
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. 22 Alert Type Description of Alert What it Means Power On 3 tone melody The Processor has powered on. Power Off 4 descending tone melody The Processor has powered off.
Alert Type Description of Alert What it Means Volume Change 1 quick beep The volume has increased/decreased. Default Volume Level 2 quick beeps The volume is at the default programmed level. Min/Max Volume 3 quick beeps You are at the minimum or maximum limits of your volume control. Program Change P1 = 1 beep P2 = 2 beeps P3 = 3 beeps P4 = 4 beeps The program has changed.
Telephone and Cellphone Use There are a few ways you can try to use your phone with your Earlens Hearing Aid. 1 24 Hold the upper portion of the phone over the microphones on your Processor, with the mouthpiece pointed towards your mouth.
2 3 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 to www.earlens.com/connectivity.
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. 26 1 To charge, place the Processor and Ear Tip into the Charger. 2 Wait until the indicator light turns solid to ensure the Processor is successfully charging. 3 If four indicator lights flash, the Processor is not charging.
Cleaning and Maintenance Daily Care 1 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. Only perform cleaning when the device is off of the ear and do not use a sharp brush or tool when cleaning the Ear Tip.
28 3 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. 4 Wipe the Processor with a soft cloth if you notice any moisture or debris. 5 Never use chemicals on the Processor or Ear Tip. 6 Use a soft cloth to wipe the Charger when necessary.
Oiling Instructions Oiling is required to keep the Lens in place and functioning properly. Apply one 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. If you have difficulty applying the mineral oil, consider having another person assist you. Instructions for Oiling: We recommend you oil your ears at bedtime, after you have removed your devices for the day.
• After oiling, your ears may feel a little stuffy. This feeling should subside on its own as the oil is absorbed. • It is recommended that you reapply mineral oil after you go swimming, take a bath or enjoy any other activity that causes your ear canals to fill with water. • Use only the mineral oil and container provided and/or recommended by your hearing provider or Earlens.
1-2x Update image to new oiler 1-2 Minutes 2 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. 3 Remove the dispenser from the ear and tilt your head to the side. Allow oil to run down to the eardrum by keeping your head tilted for one to two minutes. You may hear or feel the oil when it reaches the eardrum. 4 Repeat on the opposite ear.
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. • Do not dry your devices in a microwave or with any other heat source. • Take off your processor(s) when applying hairspray, perfume, aftershave, insect repellent or any other harsh chemical as it can damage your device.
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.
Troubleshooting 34 Issue Possible Causes Possible Remedy No sound Battery is not charged. Charge the Processor until at least 2 solid 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 improperly inserted. Remove and re-insert the Ear Tip and check the position in a mirror if possible. Volume is set too low. If your device features volume user control functionality, increase the volume.
Issue Possible Causes Possible Remedy Damage to Ear Tip or Cable Wear and tear. Contact your hearing professional. Sound distorted/ not clear Battery is low. Charge the Processor until at least 2 solid lights appear. Hearing aid is damaged. Contact your hearing professional. Hearing aid setting is not optimal. Contact your hearing professional. Something is wrong with the Charger or Processor.
36 Issue Possible Causes Possible Remedy Whistling (feedback) The Ear Tip is not properly inserted. Remove and re-insert the Ear Tip and check the position in a mirror if possible. If the issue persists, contact your hearing professional.
Warnings Before using the Earlens(R) Contact Hearing 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.
• Do not insert foreign objects into your ear, such as Q-tips, bobby pins or fingernails. Insertion of foreign objects could result in pain and damage to the ear, damage to the Lens or cause it to operate improperly. • Contact your hearing professional if you experience discharge from the ear or persistent discomfort or any other problems. • Should the Processor become unusually warm or hot, promptly remove it, discontinue use and contact your hearing healthcare professional.
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.
• 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. • Earplugs or headphones can be used with the Lens in place as long as they are not overinserted and do not protrude deeply into the ear canal.
• You may experience a reduction in your hearing levels when the Lens is in place but the Processor is not activated. • Do not direct streams of liquid (i.e. isopropyl alcohol, hydrogen peroxide, DeBrox) into your ears, as this may cause the Lens to become dislodged or cause damage to the device. • Failure to oil your ear canal twice a week may result in Lens displacement. • Do not place any component of the Earlens Hearing Solution into a microwave, or near a significant source of static electricity.
• 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. • Keep Charger cord out of reach of individuals who may be at risk of strangulation.
Technical Information Earlens Hearing Aid FCC ID: 2AGDU-EL2PIN.
Device Labeling Symbols 44 Refer to Instruction Manual Date of Manufacture MR Unsafe Product is a Type BF Part By Prescription Only Serial Number Ingress Protection Code Batch Code Catalog Code
Humidity Limitation Non-Ionizing Radiation Atmospheric Pressure Limitation FCC Approved Equipment Storage Temperature Limit Dispose Electronic Waste Properly Caution Keep Dry 45
“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. Please note that the use of this accessory with iPod, iPhone, or iPad may affect wireless performance.
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 product does not contain any user serviceable components.
Manufactured by: Earlens(R) Corporation, Inc. 4045A Campbell Ave. Menlo Park, CA 94025 USA +1 (844) 234-LENS www.earlens.com 48 European Authorized Representative: Medimark® Europe SARL 11, Rue Emile Zola, B.P.
www.earlens.
(R) LBL00153vC March 2019 ©2019 Earlens, Inc. All rights reserved. LBL00153vB January 2019 Patent Protected/Pending: www.earlens.