Bose B1 User manual

LEXIE B1 HEARING AIDS
POWERED BY BOSE
User Manual

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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. A younger person
with hearing loss should see a licensed physician, preferably an ear
specialist, for diagnosis of potential associated medical conditions.
Furthermore, children should receive a formal hearing evaluation
and rehabilitation since hearing loss may cause problems in
language development, and educational and social growth of a child.
WARNING: Conditions that require medical care.
Prior to purchasing this device, you should promptly consult with a
licensed physician, preferably an ear specialist, if you have any of the
following:
Visible deformity of the ear, either present since birth or from trauma.
Fluid, pus, or blood coming out of the ear in the past 6 months.
Pain or discomfort in the ear.
History of excessive ear wax or suspicion that something is in the ear
canal.

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Episodes of vertigo (a sensation of spinning or swaying) or severe
dizziness.
Sudden, quickly worsening, or uctuating hearing loss in the past 6
months.
Hearing loss or ringing (tinnitus) only in one ear or a noticeable
difference in hearing between ears.
WARNING: This hearing aid should not cause pain when inserting it.
Remove this device from your ear if it causes pain or discomfort
when inserting or placing it. To try again, make sure to follow
the instructions. If you feel pain or discomfort again, contact the
manufacturer. You may also report this to FDA as an adverse event
according to the instructions that appear later.
These PRECAUTIONS point out situations which could cause minor
or moderate injuries to the user or to the hearing aid.
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.
Do not attempt to modify the shape of the hearing aid or receiver
wire yourself.
For best results, use hearing aid accessories, i.e. receiver wires and
domes, provided by Lexie.

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These WARNINGS point out situations which could cause serious
injuries to the user or to the hearing aid.
In some acoustic environments, overamplication 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.
Do not use your hearing aid in explosive or oxygen-enriched areas.
Allergic reactions to hearing aids are unlikely. However, if you
experience itching, redness, soreness, inammation, or a burning
sensation in or around your ears, inform your hearing healthcare
provider and contact your physician.
You may notice accelerated accumulation of earwax when using your
hearing aid. This is normal, but see your hearing healthcare provider
if you continue to have difculty.
In the unlikely case that any parts remain in the ear canal after the
removal of the hearing aid, contact a physician immediately. Report
the event to your hearing healthcare provider as soon as possible.
Remove your aids for CT and MRI scans or for other electromagnetic
procedures.
Never leave your hearing aids or batteries where small children and
pets can reach them. If batteries are swallowed or inhaled, contact
the local poison control center immediately.
If you feel pain in or behind your ear, if it is inamed, if skin irritation

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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; please
do not share your hearing device with other people.
Caution and notices for users
Caution: This is not hearing protection.
You should remove this device if you experience overly loud sounds,
either of short or long duration. You should use appropriate hearing
protection in loud environments. As a general rule, if you would use
ear plugs in a loud environment, you should remove this device and
use ear plugs in that environment.
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.
Note: If you remain concerned, consult with 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.

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Note: Expectations about what a hearing aid can do.
A hearing aid will not restore normal hearing and may not completely
eliminate difculty hearing over noise. Further, a hearing aid will not
prevent or improve a hearing impairment resulting from a medical
condition(s). For many people, the use of a hearing aid may be more
satisfactory with training or counselling because the device is only
one part of hearing habilitation. Also, if you have hearing loss in
both ears, use of hearing aids for both ears (bilateral hearing aids)
may provide more benet than just one hearing aid, especially in
demanding listening situations - for example, noisy environments.
Note: Tell FDA about injuries, malfunctions, or other adverse
events.
To report an adverse event, you should submit the information to the
FDA as soon as possible after the event. Adverse events can include:
ear canal or outer ear skin irritation, injury from the device (like cuts or
scratches, or burns from an overheated battery), pieces of the device
lodged in your ear canal, sudden increased severity in hearing loss
with device use, etc.
Instructions for reporting are available at https://www.fda.gov/Safety/
MedWatch, or call 1-800-FDA-1088.

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Congratulations
We are thrilled that you have taken the rst step
towards better hearing. We look forward to being part
of this new journey. 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 [phone] or visit www.lexiehearing.com.

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1. Safety and health information
Intended use 13
Indications for use 13
Clinical data 13
Hearing health care information 14
Important safety instructions 17
Warnings 19
Cautions 21
2. Set up the hearing aids
What’s in the box 24
Hearing aid overview 25
Connect your phone 26
Download the Lexie app 27
Insert the batteries 28

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3. How to wear
Put on the hearing aids 32
Check your t 35
4. Hearing aid and app controls
Power on 39
Power off 39
World Volume 40
Treble and bass 42
Directionality 43
Balance 45
Environment settings 47
5. Adjusting to the hearing aids
What to expect 49

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6. Battery management
When to replace batteries 52
Remove the batteries 52
Battery life 53
Purchase batteries 53
7. Bluetooth® connections
Connect your phone 55
Connect a different phone 56
Clear the hearing aid device lists 56
8. Care and maintenance
Store the hearing aids 59
Maintain the hearing aids 60
Consumables 64
Limited warranty 64
Returns and exchanges 65
Update the hearing aids 65

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9. Troubleshooting
Try these solutions rst 67
Other solutions 68
Dome troubleshooting 83
Receiver wire troubleshooting 89
10. Regulatory and legal information
Symbols and descriptions 107

1
Safety and health information
Intended use
Indications for use
Clinical data
Hearing health care information
Important safety instructions
Warnings
Cautions

Safety and health information 1
13
Intended use
The Lexie B1 Hearing Aids, Powered by Bose,
are a pair of user-tted air conduction hearing
aids intended for use by individuals 18 years and
older with a perceived mild to moderate hearing
impairment. This allows the user to set up and
control their hearing aids through wireless
connection with an app on their mobile phone.
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. They are adjusted by the
user to meet the user’s hearing needs. No pre-
programming or hearing test is necessary. The
device is intended for direct-to-consumer sale
and use without the assistance of a hearing care
professional.
Clinical data
In a clinical study, people with mild to moderate

Safety and health information
14
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hearing impairment generally experienced similar
hearing benet, and were more satised, when
using the Bose self-tting technology compared
with professional tting 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:
•Strain to follow conversations when others don’t,
especially in noisy places.
•Have trouble understanding the TV.
This product may not be right for you if you:
•Consistently experience feedback (whistling)
of the hearing aid when you turn up World
Volume to a level that is comfortable for you, even
after you have followed the suggestions in this
User Manual to make sure your hearing aid ts
properly.

Safety and health information
15
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•Feel the hearing aid is not providing enough
amplication 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:
•Have a visible deformity of the ear.
•Have a current ear infection or a history of active
discharge from one or both ears within the past
90 days.
•Have sudden or rapid progression of hearing loss
within the past 90 days in one or both ears.
•Have acute or chronic dizziness, poor dexterity,
poor vision, or signicant dementia.
•Suspect that you have signicant ear wax
accumulation or a foreign object in the ear canal.
Symptoms of signicant ear wax accumulation

Safety and health information
16
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•Have sudden onset or rapid worsening of tinnitus
(ringing in the ear) in one or both ears within the
past 90 days.
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.
This product will not restore normal hearing and
will not prevent or improve a hearing impairment
resulting from organic conditions. This product
is designed to help you make greater use of your
remaining hearing ability. Keep in mind that it
can take time to become accustomed to hearing
sounds you have not heard for a long time.
For best results, practice using the hearing aids as
much as possible. In most cases, infrequent use of
the hearing aids doesn’t permit you to attain full
benet from them.

Safety and health information
17
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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). Licensed physicians
who specialize in diseases of the ear are often
referred to as otolaryngologists, otologists, or
otorhinolaryngologists. The purpose of a medical
evaluation is to ensure that all medically treatable
conditions that may affect hearing are identied
and treated.
Important safety instructions
Only use attachments/components specied by
the manufacturer.
The battery provided with this product may present
a risk of chemical burn if mishandled.
Please read and keep all safety and
use instructions.

Safety and health information
18
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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.

Safety and health information
19
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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.
Keep and store device and components out
of reach of children. Contains small parts
which may be a choking hazard.
•To prevent hearing damage:
–Use appropriate hearing protection in loud
environments. The hearing aids are NOT
hearing protection devices.
–Remove the hearing aids if you encounter any
overly loud sounds.
•Do NOT use the hearing aids in explosive or
oxygen-enriched atmospheres. Otherwise, a re
or explosion could occur.

Safety and health information
20
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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. Using resold or shared hearing aids may lead
to infection.
•Keep the product away from re and excessive
heat (e.g., from storage in direct sunlight, near
candles, or in a hot car) to avoid burns or damage
to product.
•Do NOT submerge in water, wear in the shower,
or wear while participating in water sports, e.g.,
swimming, waterskiing, surng, etc. Prolonged
exposure to water may damage the hearing aids.