Miracle-Ear MINI 5/4 CIC 312 BL Manuale utente

www.miracle-ear.com

Miracle-EarMINI™

5/4 CIC 312 BL

Custom User Manual

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

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.

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.

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.

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.

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

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)

Congrats!

Your best life

begins with

better hearing.

Custom User Manual

Indice

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