Bose lexie B1 User Manual
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Bose lexie B1 User Manual

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LEXIE B1 HEARING AIDS
POWERED BY BOSE
User Manual

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  • Page 1 LEXIE B1 HEARING AIDS POWERED BY BOSE User Manual...
  • Page 2 Warnings WARNING: If you are younger than 18, do not use this. You should go to a doctor because your condition needs specialized evaluation and management. These hearing aids are only for users who are age 18 and older. These hearing aids are for users age 18 and older to compensate for perceived mild-to-moderate hearing impairment.
  • Page 3 You should familiarize yourself fully with the entire contents of this user manual before using the Lexie B1 powered by Bose hearing aid to ensure personal safety and correct use. Contact the Lexie Contact Center for support if you experience unexpected operations or performance.
  • Page 4 These WARNINGS point out situations which could cause serious injuries to the user or to the hearing aid. In some acoustic environments, overamplification can cause discomfort and damage to the wearer’s hearing. A hearing aid should only be used as directed by your physician or hearing healthcare provider.
  • Page 5 or accumulations of ear wax occur, please check with your hearing healthcare provider or physician. Hearing programs in the directional microphone mode reduce background noises. Please be aware that warning signals or noises coming from behind, e.g. cars, are partially or entirely suppressed. Your hearing aids have been adjusted for your hearing needs;...
  • Page 6 Note: Expectations about what a hearing aid can do. A hearing aid will not restore normal hearing and may not completely eliminate difficulty hearing over noise. Further, a hearing aid will not prevent or improve a hearing impairment resulting from a medical condition(s).
  • Page 7 This manual will provide you with all the information you need to set up, use and care for your new Lexie B1 Hearing Aids, Powered by Bose. For additional information on the use of these hearing aids after going through the contents of this guide, contact (779) 212-7334 or visit www.lexiehearing.com.

  • Page 8: Table Of Contents

    Safety and health information Intended use Indications for use Clinical data Hearing health care information Important safety instructions Warnings Cautions Set up the hearing aids What’s in the box Hearing aid overview Connect your phone Download the Lexie app Insert the batteries...
  • Page 9 How to wear Put on the hearing aids Check your fit Hearing aid and app controls Power on Power off World Volume Treble and bass Directionality Balance Environment settings Adjusting to the hearing aids What to expect...
  • Page 10 Battery management When to replace batteries Remove the batteries Battery life Purchase batteries Bluetooth® connections Connect your phone Connect a different phone Clear the hearing aid device lists Care and maintenance Store the hearing aids Maintain the hearing aids Consumables Limited warranty Returns and exchanges Update the hearing aids...
  • Page 11 Troubleshooting Try these solutions first Other solutions Dome troubleshooting Receiver wire troubleshooting 10. Regulatory and legal information Symbols and descriptions...

  • Page 12: Safety And Health Information

    Safety and health information Intended use Indications for use Clinical data Hearing health care information Important safety instructions Warnings Cautions...
  • Page 13 Indications for use The Lexie B1 Hearing Aids, Powered by Bose, are intended to amplify sound for individuals 18 years of age or older with a perceived mild to moderate hearing impairment.
  • Page 14 Safety and health information hearing impairment generally experienced similar hearing benefit, and were more satisfied, when using the Bose self-fitting technology compared with professional fitting of the same device. There were no adverse events encountered during this study. Hearing healthcare information This product may help you hear better if you: •...
  • Page 15 Safety and health information • Feel the hearing aid is not providing enough amplification even at the highest World Volume setting. A hearing healthcare professional may be able to help you select a different hearing aid solution to meet your needs. You should see a hearing healthcare professional if you: •...
  • Page 16 Safety and health information can include itching in your ear, a feeling of fullness in your ear, and/or reduced hearing. • Experience pain or discomfort in the ear. • Have a noticeable difference in hearing between ears. • Have sudden onset or rapid worsening of tinnitus (ringing in the ear) in one or both ears within the past 90 days.
  • Page 17 Safety and health information The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading. It is good health practice for a person with hearing loss to have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear).
  • Page 18 Safety and health information Please dispose of used batteries properly, following local regulations. When a replacement is needed, use only size 312 zinc-air batteries. Do NOT use the hearing aids without the supplied domes attached. This product contains magnetic material. Consult your physician on whether this might affect your implantable medical device.

  • Page 19: Warnings

    Safety and health information WARNINGS • Do NOT store or replace batteries near to where you store medication or children. Battery ingestion can cause serious harm. If you think that you or someone else has swallowed a battery or placed a battery inside any part of the body, seek immediate medical attention.
  • Page 20 Safety and health information WARNINGS • Check before using the hearing aids in areas where electronics or wireless devices are restricted. This may cause interference. • Do NOT resell the hearing aids or share them with others. They are intended for use by a single user.

  • Page 21: Cautions

    Safety and health information CAUTIONS • Be aware that some sounds may sound different when you’re using the hearing aids. Keep this in mind when you need to be aware of your surroundings. You should adjust to this over time. •...
  • Page 22 Safety and health information • Do NOT make unauthorized alterations to this product. • If the battery leaks, do NOT allow the liquid to come in contact with the skin or eyes. If contact is made, seek medical advice. • Sleeping with your hearing aids in is not recommended.

  • Page 23: Set Up The Hearing Aids

    Set up the hearing aids What’s in the box Hearing aid overview Connect your phone Download the Lexie app Insert the batteries...

  • Page 24: What's In The Box

    Set up the hearing aids What’s in the box Lexie B1 hearing aids, Carrying case Size 312 powered by Bose batteries (1 pair) Open domes Closed domes Hearing aid (3 pairs) Sizes 1 and 3* : Sizes 1, 2, and 3...

  • Page 25: Hearing Aid Overview

    Set up the hearing aids Hearing aid overview Dome Microphones Receiver Hearing aid body Receiver wire World Volume up button Battery door World Volume down button...

  • Page 26: Connect Your Phone

    Set up the hearing aids Connect your phone To control the hearing aids using the Lexie app, you must connect your phone with the hearing aids. To connect your phone, follow the steps below. Step 1: Download the Lexie app (see page 27). Step 2: Insert the batteries and fully close the battery doors to power on the hearing aids (see page 28).

  • Page 27: Download The Lexie App

    Set up the hearing aids Download the Lexie app The Lexie app lets you set up the hearing aids, adjust them to fit your hearing needs, and manage settings. Step 1: On your smartphone, use your web browser to visit lexiehearing.com/us/the-lexie-app-and-lexie-care- promise and download the Lexie app.

  • Page 28: Insert The Batteries

    Set up the hearing aids Insert the batteries Note: Wash and dry your hands before handling the batteries. Grease and dirt can reduce battery life and damage the hearing aids. Step 1: Gently pull the tab on the bottom of the hearing aid until the battery door fully opens.
  • Page 29 Set up the hearing aids Step 3: Peel the sticker off the battery, securing it with your other hand. This activates the battery. TIP: To extend battery life, leave the battery in the open battery door for 5 minutes. This exposes it to air and gives it time to fully activate.
  • Page 30 Set up the hearing aids Step 5: Repeat steps 1 – 4 for the other hearing aid. Step 6: Follow the app instructions to connect the hearing aids and learn how to wear and use them with video tutorials. Note: After completing the app tutorials, if you’d like more information about wearing or using the hearing aids, see “How to wear”...

  • Page 31: How To Wear

    How to wear Put on the hearing aids Check your fit...

  • Page 32: Put On The Hearing Aids

    How to wear Put on the hearing aids TIPS: • If you have long hair, put your hair up. • If you wear glasses, keep your glasses on. • Consider using a mirror to check your fit. Step 1: Compare the left and right hearing aids.
  • Page 33 How to wear TIP: If you wear glasses, place hearing aid between your glasses and your ear. Step 3: Hold the hearing aid by the bend in the receiver wire close to the dome. Step 4: Fully insert the dome into your ear canal until the receiver wire is flat against your ear and the dome...
  • Page 34 How to wear Step 5: Check to make sure that all parts of the receiver wire run close to the side of your head. Step 6: Repeat steps 2 – 5 for the left hearing aid. Step 7: Check your fit (see page 35). To remove the hearing aids Hold the receiver wire close to the dome and gently remove the dome from your ear canal.

  • Page 35: Check Your Fit

    How to wear Check your fit Use a mirror to make sure that the hearing aids are on correctly and that they fit your ears prop- erly. Are the hearing aids on correctly? Correct: • The hearing aid body is behind your ear.
  • Page 36 How to wear Is the dome size correct for each ear? The size of the dome affects comfort and stability. Correct size: • The dome feels secure, though it may feel strange at first (see “Adjusting to the hearing aids” on page 48).
  • Page 37 How to wear Is the receiver wire size correct for each ear? The size of the receiver wire determines the position and angle of the hearing aid behind your ear. This affects audio performance, comfort, and stability. The provided receiver wires will fit most ears. Howev- er, you might need longer or shorter receiver wires or a different size for each ear.

  • Page 38: Hearing Aid And App Controls

    Hearing aid and app controls Power on Power off World Volume Treble and bass Directionality Balance Environment settings...

  • Page 39: Power On

    Hearing aid and app controls Power on To power on, fully close the battery door on each hearing aid. You should feel two clicks as each door closes. If you’re wearing the hearing aids, after 3 seconds, you hear a tone; 6 seconds later, the hearing aids power on.

  • Page 40: World Volume

    Hearing aid and app controls World Volume You can make sounds louder or quieter by adjusting World Volume. Adjust World Volume using the hearing aid controls The World Volume buttons are located on the back of each hearing aid. Increase World Volume (make sounds louder) Decrease World Volume (make sounds softer)
  • Page 41 Hearing aid and app controls Notes: • Pressing the World Volume buttons on either hearing aid adjusts World Volume in both ears. • To quickly adjust World Volume, press and release either World Volume button multiple times. Adjust World Volume using the Lexie app In the Lexie app, from the home screen, do one of the following: •...

  • Page 42: Treble And Bass

    Hearing aid and app controls Treble and bass You can make voices sound clearer using the treble and bass controls in the Lexie app. Adjust treble and bass In the Lexie app, from the home screen, do one of the following: •...

  • Page 43: Directionality

    Hearing aid and app controls Directionality You can adjust Directionality settings so that the microphones focus on sounds coming from different areas around you. When to use each Directionality setting Each Directionality setting is best for different situations. Directionality setting Description When to use Helps you hear...
  • Page 44 Hearing aid and app controls Select a Directionality setting Step 1: BOSE HEARI NG AID In the Lexie app, from the home screen, tap the Directionality button. The Directionality menu appears. Step 2: Tap your preferred Directionality setting.

  • Page 45: Balance

    Balance controls in the Lexie app. Adjust Balance Step 1: BOSE H E AR ING AI D In the Lexie app, from the home screen, tap the Balance button.
  • Page 46 Hearing aid and app controls Step 2: Do one of the following: • To make sounds louder in your left ear: Drag your finger to the left along the semicircle. • To make sounds louder in your right ear: Drag your finger to the right along the semicircle.

  • Page 47: Environment Settings

    Environment setting, adjust the setting according to your preference, then save your changes. Access Environment settings In the Lexie app, once you have selected ‘Bose’ from the home screen as the hearing aids you’re wearing, tap the Environment settings button.

  • Page 48: Adjusting To The Hearing Aids

    Adjusting to the hearing aids What to expect...

  • Page 49: What To Expect

    Adjusting to the hearing aids What to expect Adjusting to a new hearing aid can feel overwhelm- ing at first, and it can take time to feel fully comfort- able. With patience, though, you’ll soon be enjoying better hearing. Here’s what you can expect during the first few days and weeks of using the hearing aids.
  • Page 50 Adjusting to the hearing aids Adjusting to new sounds • Sounds may seem loud or different. You may also notice background noises that you haven’t heard before. As your brain learns to recognize and filter out these sounds, they’ll become less apparent over time.

  • Page 51: Battery Management

    Battery management When to replace batteries Remove the batteries Battery life Purchase batteries...

  • Page 52: When To Replace Batteries

    Battery management When to replace batteries When you hear “Low battery,” from one of the hearing aids, replace the battery in that hearing aid. Remove the batteries Step 1: Gently pull the tab on the bottom of the hearing aid until the battery door fully opens.

  • Page 53: Battery Life

    Battery management Battery life Each battery can provide up to 4 days of use, assuming that you use both hearing aids for 14 hours per day. Note: Battery life may vary by battery brand, age, chemistry, and frequency of use, or if you use a single hearing aid.

  • Page 54: Bluetooth® Connections

    Bluetooth connections ® Connect your phone Connect a different phone Clear the hearing aid device lists...

  • Page 55: Connect Your Phone

    Bluetooth® connections Bluetooth Low Energy wireless technology lets you ® control the hearing aids using the Lexie app. Before you can control the hearing aids, you must download the app and connect your phone with the hearing aids. Note: Although connecting your phone lets you control the hearing aids using the app, it doesn’t let you wirelessly stream music or phone calls from your phone.

  • Page 56: Connect A Different Phone

    Bluetooth® connections • For the best experience, connect the hearing aids to your phone using the Lexie app instead of the Bluetooth menu on your phone. ® Connect a different phone You can store up to 20 phones in the hearing aid device lists.
  • Page 57 Bluetooth® connections Step 2: On one of the hearing aids, press and hold the World Volume down button for 15 seconds until you hear “Bluetooth device list ® cleared.” Step 3: Repeat step 2 for the other hearing aid. Step 4: Delete the hearing aids from the Bluetooth list on ®...

  • Page 58: Care And Maintenance

    Care and maintenance Store the hearing aids Maintain the hearing aids Replacement components Limited warranty Returns and exchanges Update the hearing aids...

  • Page 59: Store The Hearing Aids

    Care and maintenance Store the hearing aids To protect the hearing aids, store them in the case with the battery doors partially open when you’re not using them. WARNINGS • Do NOT store or replace batteries near where you store medication or near children.

  • Page 60: Maintain The Hearing Aids

    Care and maintenance Maintain the hearing aids To prevent damage and preserve sound quality, it’s important to regularly maintain the hearing aids and replace components. Keep the hearing aids dry • Moisture can damage the hearing aids or cause them to fail. •...
  • Page 61 Care and maintenance Daily maintenance Maintain the domes Dome and microphones: Receiver wire After removing the hearing aids, remove Microphones earwax and debris from the domes and microphones using the provided hearing aid brush or a soft, lint-free cloth. Weekly maintenance Maintain the receiver wire and hearing aid body: Wipe the outside of the receiver wire and hearing aid body with a soft, lint-free cloth.
  • Page 62 Care and maintenance Replace the wax guards: Wax guard Replace the white plastic screens at the ends of each receiver every 3 months. To order replacement wax guards, call the Lexie Contact Center. For contact information, visit: lexiehearing.com/us/contact. If the wax guards get blocked by earwax buildup or you notice that the hearing aids sound quieter than usual, replace the wax guards and the domes immediately.

  • Page 63: Consumables

    Care and maintenance Consumables Consumables can be ordered through the Lexie Contact Center. Visit: lexiehearing.com/us/contact Open or closed domes (sizes 1, 2, or 3) Carrying case Batteries (size 312) Receiver wire (sizes 1, 2, or 3) Hearing aid brush Limited warranty The hearing aids are covered by a limited warranty.

  • Page 64: Returns And Exchanges

    Care and maintenance Returns and exchanges Satisfaction is guaranteed on all Lexie products. We want you to be thrilled, so if you’re not satisfied with your purchase for any reason, simply return it within the trial period for a full refund. Please see the Lexie Returns Policy at lexiehearing.com/returns-refunds- policy for details.

  • Page 65: Troubleshooting

    Troubleshooting Try these solutions first Other solutions Dome troubleshooting Receiver wire size troubleshooting...

  • Page 66: Try These Solutions First

    Troubleshooting Try these solutions first If you experience problems with the hearing aids, try these general solutions first: • Open and fully close the battery doors (see page 39). • Replace the batteries (see page 28). • Download the Lexie app and run available software updates (see page 27).

  • Page 67: Other Solutions

    Troubleshooting • If your hearing aids do not operate as intended, including with the Lexie app, please ensure that they are paired with the appropriate phone. Other solutions If you could not resolve your issue, see the table below to identify symptoms and solutions to common problems.
  • Page 68 Troubleshooting Problem Solutions Make sure both battery doors are fully closed. You should feel two clicks. While wearing the hearing aids, close the battery doors and wait 3 seconds. If you hear a tone, the hearing aids are Hearing powering on (see page 39). aids don’t Make sure both batteries are inserted power on (no...
  • Page 69 Troubleshooting Problem Solutions On your phone, open the App Store or Google Play Store and search for “Lexie app” Unable to Type lexiehearing.com/us/the-lexie-app- locate the and-lexie-care-promise into the address Lexie app bar of your phone’s web browser, not a search bar or separate search application.
  • Page 70 Troubleshooting Problem Solutions On your phone: • Turn the Bluetooth feature off and ® then on. • Delete the hearing aids from the Bluetooth list on your phone. ® Connect again. Open and fully close both battery doors (see page 39). This causes the Hearing aids hearing aids to enter Bluetooth pairing...
  • Page 71 Troubleshooting Problem Solutions (continued from previous page) If another previously-connected phone is within range, turn the Bluetooth ® feature off on that phone. Hearing aids don’t connect Clear the hearing aid device lists to phone (see page 56). Connect the hearing aids to a different phone (see page 26).
  • Page 72 Troubleshooting Problem Solutions Restart your phone. Make sure the Lexie app is compatible with your phone. Visit the Lexie page on Lexie app the App Store or Google Play Store for doesn’t work compatibility information. on phone Uninstall the Lexie app on your phone, then reinstall the app (see page 27).
  • Page 73 Troubleshooting Problem Solutions Clear any debris or wax buildup from the domes and microphones (see page 61). Dry the hearing aids: Open both battery doors, remove the batteries, and leave the hearing aids and batteries in the case overnight with the lid open (see page 52). Replace the batteries (see page 28).
  • Page 74 Troubleshooting Problem Solutions Increase World Volume (see page 40). Clear any debris or wax buildup from the domes and microphones Hearing (see page 61). aids aren’t loud enough If you’re using open domes, try (not enough replacing them with the same size amplification) closed domes (see page 85).
  • Page 75 Troubleshooting Problem Solutions Make sure that you’re putting the hearing aids on correctly (see page 32). Choose another dome size (see page 3). You may need a different size for each ear. Hearing aids are Check whether you need a different size uncomfortable receiver wire (see page 37).
  • Page 76 Troubleshooting Problem Solutions Make sure that you’re placing the domes in your ears correctly. Remember to insert each dome deep into your ear canal until the receiver Hearing aids wire is flat against your ear and the falling out dome feels secure (see page 32). of ears Choose another dome size (see page 83).
  • Page 77 Troubleshooting Problem Solutions Dome stuck Contact a hearing healthcare in ear professional for removal. Contact the Lexie Contact Center for Lost domes replacement domes (see page 63).
  • Page 78 Troubleshooting Problem Solutions Make sure that you’re placing the domes in your ears correctly. Remember to insert each dome deep into your ear canal until the receiver wire is flat against your ear and the dome feels secure (see page 32). Choose another dome size (see page 83).
  • Page 79 Troubleshooting Problem Solutions On your phone, increase the volume. If you’re in private, turn on receiver phone and hold your phone in front of you. Make sure you’re not pressing your phone too hard against your ear. This can block the hearing aid microphones and cause the call to sound muffled.
  • Page 80 Troubleshooting Problem Solutions Hearing aids Tilt your phone receiver slightly away whistle when from the hearing aid on that ear. on the phone Hearing Adjust World Volume (see page 40). aids sound This syncs audio settings between the different from hearing aids.
  • Page 81 Troubleshooting Problem Solutions Practice listening to new sounds and talking with a friend in a familiar environment before you use the hearing aids for conversation (see page 50). Sound of own voice is If you’re using closed domes, try too loud replacing them with the same size open domes (see page 83).

  • Page 82: Dome Troubleshooting

    Troubleshooting Dome troubleshooting Check if the domes are too big or too small If one or both domes match the descriptions below, try a different dome size (see page 83). Too big: • The dome feels painful or uncomfortable. • It’s difficult to insert the dome into your ear canal. •...
  • Page 83 Troubleshooting Dome sizes The dome size is marked on the dome packaging as size 1, size 2, or size 3. Size 2 open domes come attached to the hearing aids. Note: Dome size doesn’t relate to receiver wire length. You might have a different dome size and receiver wire size for the same hearing aid.
  • Page 84 Troubleshooting Try another dome size If the domes don’t feel comfortable or secure, choose another dome size. Note: You may need to try all three dome sizes or use a different size dome for each ear. Step 1: Based on the sizing information on page 82, if the default size 2 domes are too big, try size 1.
  • Page 85 Troubleshooting Dome types Within each dome size, there are two types of domes: open and closed. Open domes (attached to the hearing aids) help your voice sound more natural. They have holes around the center of the dome. Closed domes provide more bass and allow you to comfortably use a higher World Volume...
  • Page 86 Troubleshooting Change the domes Step 1: Hold the receiver and firmly pull the current dome off. Step 2: Choose a new dome size (see page 83) and/or dome type (see page 85). Note: Each dome can work with either the left or right hearing aid.
  • Page 87 Troubleshooting Step 4: Gently tug the dome to make sure that it’s securely fastened on the receiver. Note: Don’t wear the hearing aid if the dome isn’t secure. Otherwise, the dome could become stuck in your ear canal (see page 77). Step 5: Repeat steps 1 –...

  • Page 88: Receiver Wire Troubleshooting

    Troubleshooting Receiver wire size troubleshooting Check if the receiver wires are too long or too short If one or both receiver wires match the descriptions below, use the provided receiver wire sizing tool to measure your exact size (see page 90). If you need a different size, you can order a free replacement.
  • Page 89 Troubleshooting The receiver wire feels tight • or pulls the dome partially out of your ear canal. If you look straight in a mirror, • you see the hearing aid body over the top of your ear. Correct size: • If you shake your head, the hearing aid body feels secure.
  • Page 90 Troubleshooting Measure your receiver wire size Step 1: Ask a friend or family member to help (recommended). They can make things easier by checking that the receiver wire sizing tool is on your ear correctly and taking a photo for you. Note: If nobody’s around to help, you can use a mirror to check the receiver wire sizing tool and use your...
  • Page 91 Troubleshooting Step 3: Compare the red and blue sides of the tool. Use the red side to measure your right ear and the blue side to measure your left ear. Step 4: Place the tool on Dotted your right ear. line It should hook around the front...
  • Page 92 Troubleshooting Step 5: Ask a friend or family member to take a photo of your ear. Make sure that you can see your ear canal in the photo. Note: If you’re taking the canal photo yourself, rest your elbow on a surface and hold your phone facing you.
  • Page 93 Troubleshooting Step 6: Look at the photo and see which colored band aligns with the top of your ear canal. The number in the band is the Size 1 receiver wire size you need. Size 2 Size 3...
  • Page 94 Troubleshooting Step 7: Repeat steps 4 – 6 for your left ear. Note: You may need a different receiver wire size for each ear. Step 8: Compare your measurements for each ear. • If you need size 2: Size 2 receiver wires come attached to the hearing aids, so you already have the correct size for that ear.

  • Page 95: Regulatory And Legal Information

    Regulatory and legal information Symbols and descriptions...
  • Page 96 Regulatory and legal information 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...
  • Page 97 Regulatory and legal information technician for help. Changes or modifications not expressly approved by Lexie Hearing 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...
  • Page 98 Regulatory and legal information Modulation Type: 1 Mb/s and 2 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. This symbol means the product must not be discarded as household waste, and should be delivered to an appropriate collection facility for recycling.
  • Page 99 Regulatory and legal information Storage/Transport Conditions: Temperature Range: -13°F – 158°F (-25°C – 70°C) Humidity Range: 0 – 90% RH Pressure Range: 70 – 110 kPa Time to warm from minimum storage temperature before use: 1 hour (ambient temperature 68°F or 20°C) Time to cool from maximum storage temperature before use: 1 hour (ambient temperature 68°F or...
  • Page 100 This product does not contain natural rubber latex. This product is provided non-sterile. Do NOT use if package is damaged. The Lexie B1 hearing aids, powered by Bose, comply with the following domestic and international regulations for medical devices: IEC 60601-1...
  • Page 101 Regulatory and legal information Features per ANSI/CTA-2051 The Lexie B1 hearing aids, Feature Category powered by Bose Fixed or have level-dependent frequency Level-Dependent equalization that is adjusted via Frequency user controls. Equalization utilize 12-channel wide dynamic Level- Dependent range compression to make...
  • Page 102 Regulatory and legal information The Lexie B1 hearing aids, Feature Category powered by Bose are self-tuned by the user either via an app on a smart device (phone or tablet) or by using the Personalization on-device controls. Individual hearing thresholds are not required to personalize the amplification settings.
  • Page 103 Regulatory and legal information Electromagnetic Emissions IEC60601 Compliance Environment Test Test Level Level Guidance The hearing aid uses RF energy only for its- internal function. Therefore, its RF emissions are emissions Group 1 Group 1 very low and CISPR 11 are not likely to cause any interference in...
  • Page 104 Regulatory and legal information The hearing aid is suitable for use in all establishments, including domestic establishments and those emissions Class B Class B directly connected to CISPR 11 the public low- voltage power supply network that supplies buildings used for domestic purposes.
  • Page 105 Regulatory and legal information Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The hearing aid is intended for use in the electromagnetic environment specified below. The user of the hearing aid should ensure that it is used in such an environment. Compliance Immunity Test IEC60601 Test Level...
  • Page 106 Regulatory and legal information IEC60601 Test Immunity Test Compliance Level Level 9 V/m; 710, 745, 780 9 V/m; 710, 745, 780 MHz; MHz; Pulse modulation Pulse modulation 18 Hz 18 Hz 9 V/m; 5240, 5500, 9 V/m; 5240, 5500, 5785 MHz; Pulse 5785 MHz;...
  • Page 107 Regulatory and legal information Measurements per ANSI S3.22:2014 (or per ANSI/CTA-2051:2017 where Result denoted with *) Maximum output (OSPL90) curve See Figure 1 Maximum output (OSPL90) 113 dB SPL Fitted OSPL90 Up to 108 dB SPL High-frequency average (HFA) 106 dB SPL OSPL90 High-frequency average full-on gain 30 dB...
  • Page 108 Regulatory and legal information Maximum Output (OSPL90) Figure 1: Nominal OSPL90 curve as measured in a 2 cc coupler. 1000 10000 Frequency (Hz) Full-On Gain (FOG50) Figure 2: Nominal frequency response curve as measured in a 2 cc coupler. 1000 10000 Frequency (Hz) 1 0 8...
  • Page 109 Regulatory and legal information Please complete and retain for your records The serial numbers are located on the bottom of each hearing aid. Serial number: __________________________________ Model number: LB1001 Please keep your receipt with this document. Proper operation of your Lexie Hearing product requires a safe, private, and secure operating environment.
  • Page 110 Regulatory and legal information The Lexie Hearing Privacy Policy is available at lexiehearing.com/us/privacy-policy Apple and the Apple logo are trademarks of Apple ® Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. The Bluetooth word mark and logos are registered ®...
  • Page 111 Symbols and descriptions Symbol Description Symbol Description Does not Batch code contain latex Do not use ® Bluetooth if package is damaged Catalogue number Downloads Caution Forum Choking hazard Keep the device dry Consult instructions Manufacturer for use Customer Magnetic support material Date of...
  • Page 112 Symbol Description Symbol Description Type B Non-sterile applied part Phone Videos Waste Electrical and Electronic Serial number Equipment Directive symbol Size 312 Humidity Range zinc-air battery Temperature MRI unsafe range Pressure range 1 1 2...
  • Page 113 lexiehearing.com/us/support o s W lexiehearing.com/us/terms-conditions Copyright © 2016-2022 hearX IP (Pty) Ltd. Copyright in this work including its layout and the design contained herein is reserved and the making of copies is prohibited. 44-0006-04, REV1 1 1 3...

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