Miracle-Ear MINI 5/4 CIC 312 BL User manual

www.miracle-ear.com
Miracle-EarMINI™
5/4 CIC 312 BL
Custom User Manual

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WARNINGS, CAUTIONS, & NOTICES
REQUIRED HEARING AID INFORMATION
The following additional information is provided in compliance with U.S. Food and
Drug Administration (FDA) regulations:
WARNING: People younger than 18 should go to a doctor before using this.
People younger than 18 years old need specialized care, and using this without a
medical evaluation may worsen impairment or disability. A hearing aid user who is
younger than 18 should have a recent medical evaluation from a doctor, preferably
an ear-nose-throat doctor (an ENT). Before using this, a doctor should determine
that the use of a hearing aid is appropriate.
WARNING to Hearing Aid Dispensers:
You should advise a prospective hearing aid user to consult promptly with a doctor,
preferably an ear specialist such as an ENT, before dispensing a hearing aid if you
determine through inquiry, actual observation, or review of any other available
information concerning the prospective user, that the prospective user has any of the
following conditions:
•Visible deformity of the ear, either congenital or traumatic
•Fluid, pus, or blood coming out of the ear within the previous 6 months
•Pain or discomfort in the ear
•History of excessive ear wax or suspicion that something is in the ear canal
•Dizziness, either recent or long-standing
•Sudden, quickly worsening, or fluctuating hearing loss within the previous 6
months
•Hearing loss or ringing (tinnitus) only in one ear or a noticeable difference in hearing
between ears
•Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and
2000 Hz

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WARNINGS, CAUTIONS, & NOTICES
WARNING to Hearing Aid Dispenser, Outputs over 132 dB SPL:
You should exercise special care in selecting and fitting a hearing aid with a maximum
output that exceeds 132 dB SPL because it may impair the remaining hearing of the
hearing aid user.
International Use
Your hearing aids are approved to operate at a radio frequency that is specific to your
country or region and might not be approved for use outside your country or region.
Be aware that operation during international travel may cause interference to other
electronic instruments, or other electronic instruments may cause interference to your
hearing aids.
We are required by regulations to provide the following warnings:
WARNING: Use of wireless hearing aids directly next to other electronic
equipment should be avoided because it could result in improper performance. If such
use is necessary, note as to whether your hearing aids and the other equipment are
operating normally.
WARNING: Use of accessories, components or replacement parts other than
those provided by the manufacturer of your hearing aids could result in increased
electromagnetic emissions and decreased electromagnetic immunity and could result
in degradation of performance.
WARNING: If Portable Radio Frequency communications equipment is used
closer than 30 cm (12 inches) from your hearing aid, degradation of the performance
of your hearing aid could result. If this occurs, move away from the communications
equipment.
WARNING: The stability of the hearing aid is designed for normal use. Avoid
physical impacts to the ear when wearing a hearing aid that may cause the device to
break or component of the device to become detached. This may lead to lacerations of
the ear canal or perforation of the ear drum. If this occurs, it is strongly recommended
to see a physician for evaluation and safe removal.

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WARNINGS, CAUTIONS, & NOTICES
WARNING: If the hearing aid drops onto a hard surface, it could cause the
hearing aid to break or become damaged. This includes mechanical stress or shock
of the device. Ensure the hearing aid is intact before placing it in the ear. If you find
the device is damaged, discontinue use and see your hearing professional.
WARNING: Repeated stress to the removal handle may cause it to break. If
the removal handle breaks and you’re unable to remove the device carefully, it is
recommended to see a physician for safe removal.
WARNING TO HEARING CARE PROFESSIONAL
A hearing care professional should advise a prospective sound generator
(tinnitus masker) user to consult promptly with a licensed physician (preferably
an ear specialist) before using a sound generator if the hearing care professional
determines through inquiry, actual observation or review or any other available
information concerning the prospective user that the prospective user has any of the
following conditions:
•Visible congenital or traumatic deformity of the ear
•History of active drainage from the ear within the previous 90 days
•History of sudden or rapidly progressive hearing loss within the previous 90 days
•Acute or chronic dizziness
•Unilateral hearing loss of sudden or recent onset within the previous 90 days
WARNING: There are some potential concerns associated with the use of any
sound generating tinnitus therapy instrument. Among them are the potential for
worsening of tinnitus, a possible change in hearing thresholds, and possible skin
irritation at the point of contact with the hearing aid.
Custom Tinnitus+™Technology has been designed to minimize these concerns.
However, should you experience or notice any of the above conditions or any
dizziness, nausea, headaches or heart palpitations, you should immediately
discontinue use of the hearing aid and seek a consultation with a medical, audiology
or other hearing care professional.

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WARNINGS, CAUTIONS, & NOTICES
As with any hearing aid, misuse of the tinnitus therapy instrument could present
some potentially harmful effects. Care should be taken to prevent the unauthorized
use and to keep the hearing aid out of the reach of children and pets.
CAUTION: This is not hearing protection.
You should remove this device if you experience overly loud sounds, whether short
or long-lasting. If you’re in a loud place, you should use the right kind of hearing
protection instead of wearing this device. In general, if you would use ear plugs in a
loud place, you should remove this device and use ear plugs.
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. If you consistently need to turn the volume down, you
may need to further adjust your device.
CAUTION: You might need medical help if a piece gets stuck in your ear.
If any part of your hearing aid, like the eartip, gets stuck in your ear, and you can’t
easily remove it with your fingers, get medical help as soon as you can. You should
not try to use tweezers or cotton swabs because they can push the part farther into
your ear, injuring your eardrum or ear canal, possibly seriously.
NOTE: 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. Further, a hearing aid will not prevent or improve a medical condition that
causes hearing loss.
People who start using hearing aids sometimes need a few weeks to get used to
them. Similarly, many people find that training or counseling can help them get more
out of their devices.
If you have hearing loss in both ears, you might get more out of using hearing aids in
both, especially in situations that make you tired from listening—for example, noisy
environments.

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WARNINGS, CAUTIONS, & NOTICES
NOTE: Tell FDA about injuries, malfunctions, or other adverse events.
To report a problem involving your hearing aid, you should submit information to
FDA as soon as possible after the problem. FDA calls them “adverse events,” and they
might include: skin irritation in your ear, injury from the device (like cuts or scratches,
or burns from an overheated battery), pieces of the device getting stuck in your ear,
suddenly worsening hearing loss from using the devices, etc.
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.
NOTE: Hearing loss in people younger than 18.
• People younger than 18 should see a doctor first, preferably an ear-nose-throat
doctor (an ENT), because they may have different needs than adults
• The doctor will identify and treat medical conditions as appropriate
• The doctor may refer the person to an audiologist for a separate test, a hearing aid
evaluation
• The hearing aid evaluation will help the audiologist select and fit the appropriate
hearing aid
A person who is younger than 18 years old with hearing loss should have a medical
evaluation by a doctor, preferably an ENT, before buying a hearing aid. The purpose
of a medical evaluation is to identify and treat medical conditions that may affect
hearing but that a hearing aid won’t treat on its own.
Following the medical evaluation and if appropriate, the doctor will provide a written
statement that the hearing loss has been medically evaluated and the person is a
candidate for a hearing aid. The doctor may refer the person to an audiologist for a
hearing aid evaluation, which is different from the medical evaluation and is intended
to identify the appropriate hearing aid.

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WARNINGS, CAUTIONS, & NOTICES
The audiologist will conduct a hearing aid evaluation to assess the person’s ability
to hear with and without a hearing aid. This will enable the audiologist to select and
fit a hearing aid for the person’s individual needs. An audiologist can also provide
evaluation and rehabilitation since, for people younger than 18, hearing loss may
cause problems in language development and educational and social growth. An
audiologist is qualified by training and experience to assist in the evaluation and
rehabilitation of hearing loss in people younger than 18.
IMPORTANT NOTICE FOR PROSPECTIVE Rx HEARING AID USERS:
It is good health practice for a person with a hearing loss to have a medical
evaluation by a licensed physician (preferably a physician who specializes in diseases
of the ear) before purchasing a prescription hearing aid. Licensed physicians who
specialize in diseases of the ear are often referred to as otolaryngologists, otologists
or otorhinolaryngologists. The purpose of the medical evaluation is to assure that
all medically treatable conditions that may affect hearing are identified and treated
before the hearing aid is purchased.
Following the medical evaluation, the physician will give you a written statement
that states that your hearing loss has been medically evaluated and that you may
be considered a candidate for a hearing aid. The physician will refer you to an
audiologist or hearing aid dispenser, as appropriate, for a hearing aid evaluation.
The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to
assess your ability to hear with and without a hearing aid. The hearing aid evaluation
will enable the audiologist or dispenser to select and fit a hearing aid to your
individual needs.
If you have reservations about your ability to adapt to amplification, you should
inquire about the availability of a trial-rental or purchase option program. Many
hearing aid dispensers now offer programs that permit you to wear a hearing aid for
a period of time for a nominal fee after which you may decide if you want to purchase
the hearing aid.

Regulatory Information
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In some geographies, you must have a medical evaluation before purchasing a
prescription hearing aid. Some States allow an adult to waive the medical evaluation.
A hearing aid will not restore normal hearing and will not prevent or improve a
hearing impairment resulting from organic conditions. Use of a hearing aid is only
part of hearing habilitation and may need to be supplemented by auditory training
and instruction in lip reading. In most cases infrequent use of a hearing aid does not
permit a user to attain full benefit from it.
Some hearing instrument users have reported a buzzing sound in their hearing
instrument when they are using mobile phones, indicating that the mobile phone
and hearing instrument may not be compatible. It is well-known that mobile phones
are potential sources of noise for hearing aids. Your Miracle-Ear®Hearing Aids have
been tested for compliance to two standards that define hearing aid immunity to
digital wireless devices and meet the requirements of ANSI C63.19- 2019 as well as
the criteria for user compatibility as defined by IEC 60118-13:2019.
CAUTION: The following are potential physiological side effects from use of
hearing aids. Consult a physician
if the following occur:
• Worsening of Hearing Loss or Tinnitus
• Pain or Discomfort from heat (burns), abrasion (cuts and scratches), infection,
shock
• Dermal Allergic Reaction (inflammation, irritation, swelling, discharge)
• Excessive production of cerumen (Earwax)

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Congrats!
Your best life
begins with
better hearing.
Custom User Manual

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