Miracle-Ear MINI 5/4 CIC 10 BL User manual

www.miracle-ear.com
Miracle-EarMINI™
5/4 CIC 10 BL
5/4 IIC 10 BL
Custom User Manual

32
WARNINGS, CAUTIONS, & NOTICESWARNINGS, 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
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.
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.
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.

54
WARNINGS, CAUTIONS, & NOTICES WARNINGS, CAUTIONS, & NOTICES
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.
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.
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.

76
WARNINGS, CAUTIONS, & NOTICESWARNINGS, CAUTIONS, & NOTICES
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.
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 asset 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.
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.

Regulatory Information
98
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)

1110
INTRODUCTION
Introducing your new hearing aids.
Great to have you hear.
Use this helpful manual to get to know your new hearing aids – and
get the most out of your hearing experience.
After all – when you hear better, you live better. Thanks to your new
hearing aids.
Congrats!
Your best life
begins with
better hearing.
Custom User Manual

1312
WHAT’S INCLUDED
Serial Number
Left:
Right:
Hearing aid style covered in this user manual:
CONTENT
Warnings, Cautions, & Notices ........................... 2
Get to know your hearing aids
Meet your hearing aids................................... 16
Use your hearing aids .....................................18
Care for your hearing aids..............................27
Troubleshooting guide ........................................29
Additional guidance
Intended use ....................................................34
FCC information...............................................40
Regulatory information................................... 41
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User Manuals
MEMINI™ CIC BL
MEMINI™ IIC BL
My hearing aid uses a:
10 battery (MEMINI™IIC 10 BL) – Yellow
10 battery (MEMINI™CIC 10 BL) – Yellow

1514
Get to know your
hearing aids
• Meet your hearing aids
• Use your hearing aids
• Care for your hearing aids

1716
MEET YOUR HEARING AIDS
Overview
1. Programming slot for hearing care professional
2. Microphone and cover
3. Battery compartment
4. Removal handle
5. Vent
6. Side indicator (location may vary)
RED is for right ear, BLUE is for left ear
7. Wax guard (included accessory) and sound outlet
8. White dot indicates top of hearing aid (MEMINI™IIC BL only)
9. Serial number
10. User control (MEMINI™CIC BL only, optional)
MEMINI™ CIC BL
2
3
7
5
4
6
9
5
18
3
4
MEMINI™IIC BL
6
9
5
7
2
1

1918
STEP 1: Insert hearing aid batteries
Your hearing aid is powered by a battery. Find your battery size
by looking at the color code on the packaging, yellow (10).
To insert or replace the battery:
1. Using the finger pick, gently open the battery door.
2. Remove the old battery.
3. Remove the colored tab from the new battery. Wait 3–5 minutes.
4. Insert the battery into the battery door, ensuring the “+” on the
flat side of the battery is even with the “+” on the battery door.
5. Close the battery door.
Helpful battery tips
• To avoid damage, try not to force the battery door shut or
open it too far.
• If the battery door won’t close securely, check that you’ve
inserted the battery correctly.
• Discard used batteries right away in the proper waste or
recycling container.
• Batteries vary. Ask your hearing care professional any
questions you may have on battery life, or the right battery
size and type for your hearing aids.
WARNINGS
Batteries can be harmful if swallowed. To help prevent this:
• Keep batteries out of reach of children and pets.
• Double-check your medications before taking them. Batteries
can be mistaken for pills.
• Do not put batteries in your mouth.
Use your hearing aids Use your hearing aids
NATIONAL BATTERY INGESTION HOTLINE: [phone]

2120
Use your hearing aids Use your hearing aids
STEP 2: Put on your hearing aids
1. Gripping the outer edge of your hearing aid, gently insert canal
tip into your ear canal and rotate the hearing aid backward.
2. Gently press the hearing aid into place. Done!
STEP 3: Remove your hearing aids
1. Grip the outer edges of your hearing aid.
2. Rotate the hearing aid forward and pull outward.
– OR -
If your hearing aid has a removal handle: Grip this and gently
remove the hearing aid from your ear. Done!

2322
Battery indicators
• Low battery: An indicator will sound when battery voltage is
low. From there, you’ll have about 5 minutes*of battery life left.
• Battery shutdown: An indicator may also sound just before the
battery stops working.
Expected battery operating time
Battery life varies based on usage.
• MEMINI™IIC BL (10 battery): 5-7 days
• MEMINI™CIC BL (10 battery): 5-7 days
Use your hearing aids Use your hearing aids
Turning ON Turning OFF
Battery
door
Insert your battery and
close the battery door
securely.
A 3-second delay occurs
before your hearing aid
turns ON. This allows time
to place it in your ear.
Each hearing aid will
turn OFF when you
open the battery door
(and the battery is no
longer touching the
battery contacts).
User control (optional, MEMINI™CIC BL only)
Your hearing aid user control lets you control your hearing aids by
hand. This is set up by your hearing care professional.
Your user control operates in 2 ways:
• Short press: Press the user control for 1 second and then
release.
• Long press: Press and hold the user control for 3 seconds
or more.
User control Hearing aid function
Short press (1 second)
Long press (3 seconds)
Questions? Your hearing care professional can help.

2524
Keep your hearing aid clean at all times. Heat, moisture and foreign
substances can result in poor performance.
Using the included cleaning tool:
1. Do not clean using water, solvents, cleaning fluids or oils.
Do not take your hearing aid apart or insert a cleaning tool
inside of them.
2. Wipe hearing aids daily over a soft cloth to prevent damage
should they drop to a hard surface. If the hearing aid falls/drops
onto a hard surface, it could cause the shell or casing to break
and/or become damaged. This includes mechanical stress or
shock of the device.
See your hearing care professional for more care and
maintenance tips.
Use your hearing aids Use your hearing aids
Storage tips
When you’re not wearing your hearing aids, protect them from
damage using these storage tips:
• Choose a cool, dry location away from heat and moisture.
Avoid direct sunlight if you can.
• Ensure you can easily find your hearing aids – and your kids
and pets cannot. A nightstand or dresser spot is ideal.
See your hearing care professional for more storage tips.
Cleaning microphone cover
The custom microphone cover on your hearing aids protects
the microphone from earwax and debris. Ask your hearing care
professional for instructions on cleaning and maintaining it.

2726
Use your hearing aids Care for your hearing aids
Replacing wax guards
The wax guards prevent earwax from building up in your hearing
aid. It’s best to replace this if you notice built-up debris or poor
sound from your hearing aids.
To replace your wax guards:
1. Insert the empty end of the application stick straight into the
used wax guard of your hearing aid. Push firmly.
2. Pull the application stick straight out to remove the used wax
guard. Do not twist.
3. Use the opposite end of the application stick to insert the
new wax guard straight into the hearing aid. Push firmly.
4. Pull straight out to remove the application stick. Do not twist.
Discard the application stick. Done!

2928
Troubleshooting
guide

3130
Troubleshooting guide Troubleshooting guide
If, for any reason, your hearing aid does not operate properly, do
NOT attempt to fix it yourself. Not only are you likely to violate any
applicable warranties or insurance, you could easily cause further
damage.
Should your hearing aid fail or perform poorly, check this
troubleshooting guide for possible solutions. If problems continue,
contact your hearing care professional for advice and assistance.
Many common problems may be solved in your hearing care
professional’s office or clinic.
Symptom Possible causes Solutions
Hearing aids
are not loud
enough.
Blocked microphone or wax
guard and sound outlet.
1. Clean your hearing aids.
2. Replace the wax guards as
needed.
Buildup of debris.
Clean the microphone, as well
as the wax guard and sound
outlet with your cleaning tool.
Change in your hearing. Contact your hearing care
professional.
Low battery. Replace the battery.
Symptom Possible causes Solutions
Inconsistent
hearing aid
performance.
Blocked microphone or wax
guard and sound outlet.
1. Clean your hearing aids.
2. Replace the wax guards as
needed.
A restart is needed.
1. Open the battery door
until the battery is no
longer touching the battery
contacts.
2. Close the battery door
securely.
Low battery. Replace the battery.
Unclear and
distorted
hearing aid
performance.
Blocked microphone or wax
guard and sound outlet.
1. Clean your hearing aids.
2. Replace the wax guards as
needed.
Blocked vent. Clean the vent.
Defective
hearing aids.
Contact your hearing care
professional.

3332
Troubleshooting guide
Symptom Possible causes Solutions
No sound
coming
from your
hearing aids.
Blocked microphone or
wax guard.
1. Clean the microphone with
your cleaning tool brush.
2. Replace the wax guard as
needed.
Dead battery. Replace the battery.
Defective
hearing aids.
Contact your hearing care
professional.
Additional
guidance
• Intended use
• FCC information
• Regulatory information

3534
Intended use Intended use
Intended Use:
An air conduction hearing aid is a wearable sound-amplifying device intended to
compensate for impaired hearing. Hearing aids are available in multiple gain/output
levels appropriate to treat hearing losses ranging from mild to profound.
Your hearing aids are designed to operate in public and residential environments
and are designed to comply with international Electromagnetic Compatibility
emissions and immunity standards for medical devices. However, it is still possible
that you may experience interference caused by power line disturbances, airport
metal detectors, electromagnetic fields from other medical devices, radio signals
and electrostatic discharges.
If you use other medical devices or wear implantable medical devices such as
defibrillators or pacemakers and are concerned that your hearing aids might
cause interference with your medical device, please contact your physician or the
manufacturer of your medical device for information about the risk of disturbance.
Your hearing aids should not be worn during an MRI procedure or in a hyperbaric
chamber or other oxygen-rich environments.
Your hearing aids are classified as a Type B applied part under the IEC 60601-1
medical device standard.
Your hearing aids are not formally certified to operate in explosive atmospheres such
as may be found in coal mines or certain chemical factories.
10% r H
95% rH
-10˚C
45˚C
Your hearing aids should be stored and transported within
the temperature, humidity, and pressure ranges of -40°C
(-40°F) to +60°C (140°F), 10%-95% rH, and 70 kPa–106 kPa
(equivalent to altitudes from 1,200 ft (380 m) below sea
level to 10,000 ft (3,000 m).
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from -20°C (-4°F) to +50°C (122°F).
The expected service life is 3 years.
CAUTIONS:
• If the product is hot, do not touch it until cool.
• If the product is not working, do not disassemble. Due to a shock hazard, please
send in for repair.
• Keep out of reach from children. Do not ingest anything in the package, including
desiccant, cleaning tool, etc.
Clinical benefit
The hearing aid is designed to provide better speech understanding to help ease
communication with the aim of improving quality of life.
Clinical Study Summary
A clinical study, including adults aged 18 years and over with hearing losses ranging
from mild to profound, assessed hearing aid performance and benefit. Over the
course of 2-6 weeks of device wear, users completed various laboratory and field
assessments to determine if the devices met clinical expectations. The results of
the study confirm that the devices provide amplification appropriate for the users’
hearing losses, and that users perceive benefit from amplification consistent with
normative data. There were no serious or lasting adverse events encountered during
the study.
DO NOT OPEN HEARING AID, NO USER-SERVICEABLE PARTS INSIDE
Required Hearing Aid Information
The following additional information is provided in compliance with U.S. Food and
Drug Administration (FDA) regulations:
IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID USERS:
Good health practice requires that a person with a hearing loss have a medical
evaluation by a licensed physician (preferably a physician who specializes in diseases
of the ear) before purchasing a hearing aid. Licensed physicians who specialize in

3736
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.
Federal law restricts the sale of hearing aids to those individuals who have obtained
a medical evaluation from a licensed physician. Federal law permits a fully informed
adult to sign a waiver statement declining the medical evaluation for religious or
personal beliefs that preclude consultation with a physician. The exercise of such a
waiver is not in your best health interest and its use is strongly discouraged.
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.
CHILDREN WITH HEARING LOSS
In addition to seeing a physician for a medical evaluation, a child with a hearing loss
should be directed to an audiologist for evaluation and rehabilitation since hearing
loss may cause problems in language development and the educational and social
growth of a child. An audiologist is qualified by training and experience to assist in the
evaluation and rehabilitation of a child with a hearing loss.
Required Custom Tinnitus+™Information for Hearing Care Professionals
INDICATIONS FOR USE
The Custom Tinnitus+™Technology is a tool to generate sounds to be used in a
Tinnitus Management Program to relieve patients suffering from tinnitus. The target
population is primarily the adult population over 18 years of age.
The Custom Tinnitus+™Technology is targeted for hearing care professionals, which
are treating patients suffering from tinnitus, as well as conventional hearing disorders.
The fitting of the Custom Tinnitus+™Technology must be done by a hearing care
professional participating in a Tinnitus Management Program.
INSTRUMENT DESCRIPTION
Custom Tinnitus+™Technology is a software function that generates sound which is
programmed into a hearing aid. The hearing aid may be used in one of three modes of
operation: as a hearing aid, as a tinnitus treatment instrument or as a hearing aid and
tinnitus treatment instrument.
When enabled, the Custom Tinnitus+™Technology generates the sound and allows a
patient’s hearing care professional to design and program appropriate settings for an
individually prescribed sound treatment plan. The treatment plan should be used in a
tinnitus management program for relief of tinnitus.
Custom Tinnitus+™Technology generates a broadband white noise signal that varies
in frequency and amplitude. These characteristics are adjustable by the hearing care
professional and are specific to the prescribed therapy designed by the professional
for the patient’s needs and comfort.
Intended use Intended use

3938
The patient may have some control of the level or volume of the signal and the
patient should discuss this adjustment as well as his or her comfort level and sound of
the signal with their hearing care professional.
CAUTION: If set to the maximum output level and worn for periods of time
exceeding the recommendations below, the patient’s exposure to sound energy has
the potential to exceed noise exposure limits. This hearing aid is intended for use for
a maximum of sixteen (16) hours a day when set at the maximum output level.
For the Patient
A tinnitus therapy instrument is an electronic instrument intended to generate noise
of sufficient intensity and bandwidth to treat ringing in the ears. It can also be used as
an aid in hearing external sounds and speech.
Custom Tinnitus+™Technology is a tool to generate sounds. It is recommended
that this tool be used with appropriate counseling and/or in a tinnitus management
program to relieve patients suffering from tinnitus.
TINNITUS THERAPY CONCEPTS AND BENEFITS
Custom Tinnitus+™Technology can be used as a part of a tinnitus treatment program.
Custom Tinnitus+™Technology plays a white noise through the hearing aid.
Custom Tinnitus+™Technology is programmed according to your hearing loss
and preference, and your hearing care professional can adjust the settings of
Custom Tinnitus+™Technology to meet your needs.
Custom Tinnitus+™Technology may provide temporary relief of your tinnitus.
PRESCRIPTION USE ONLY
CAUTION: Federal law restricts this hearing aid to sale by or on the order of a
doctor, audiologist or other hearing care professional licensed to dispense hearing
aids in your state.
The use of any sound generating tinnitus therapy instrument should be only on
the advice and in consultation with your audiologist or hearing care professional.
Your hearing care professional will properly diagnose and fit the hearing aid to your
personal needs and requirements. This should include its use in a prescribed tinnitus
treatment program.
Your hearing care professional will also be able to offer the appropriate follow-up
care. It is important that you follow your hearing care professional’s advice and
direction regarding such care.
CAUTION: If set to the maximum output level and worn for periods of time
exceeding the recommendations below, your exposure to sound energy has the
potential to exceed noise exposure limits.
You should not use your hearing aid for more than sixteen (16) hours a day if your
hearing aid is set at the maximum output level, nor should you use your hearing aid
if your hearing care professional has set the hearing aid at levels that exceed your
comfort level.
Important Notice for Prospective Sound Generator Users
Good health practice requires that a person with tinnitus have a medical evaluation
by a licensed physician (preferably a physician who specializes in diseases of the ear)
before using a sound generator. 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 assure that all medically treatable conditions
that may affect tinnitus are identified and treated before the sound generator
instrument is used.
TINNITUS TECHNICAL DATA
Custom Tinnitus+™Technology Maximum Output = 87 dB SPL (typical) when
measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7.
Intended use Intended use