Miracle-Ear MEMINI RF10 MEMINI RF10 CROS Hearing Aid Device User Manual

MEMINI RF10 MEMINI RF10 CROS Hearing Aid Device

Product Information: Miracle-EarMINITM 5/4/3/2 RF 10 XP &

CROS RF 10 XP

The Miracle-EarMINITM 5/4/3/2 RF 10 XP & CROS RF 10 XP are
wireless hearing aids that are worn directly in the ear canal.
These hearing aids come with advanced audiological features and
synchronization between both the hearing aids. The CROS solution is
designed for people with normal hearing in one ear and profound
hearing loss in the other, while the BiCROS solution is for people
with profound hearing loss in one ear and less severe hearing loss
in the other.

Components:

• Ear piece (Click Sleeve)
• Microphone
• Battery compartment (on/off switch)
• Removal cord

Hearing Programs:

Your Hearing Care Professional can set custom programs for your
hearing aids. Discuss the programs that best meet your lifestyle
needs so they can create custom hearing programs for you.

Features:

• Power-on delay enables whistle-free insertion of hearing
  aids.

• The tinnitus control feature generates a sound to distract
  you.

Product Usage Instructions:

1. Read the Regulatory & Safety Information and User Manual
   thoroughly before using the hearing aids. Follow the safety
   information to avoid damage or injury.

2. Familiarize yourself with your new hearing aids.

3. If a smartphone app to control your hearing aids is available,
   ask your Hearing Care Specialist for it.

4. Your Hearing Care Professional will advise you on the
   compatible models if you are using a CROS transmitter.

5. CROS solutions are designed for people with profound hearing
   loss in one ear which cannot be aided with a hearing aid. A CROS
   transmitter worn on the non-aided ear captures sound from the
   applicable side and transmits it to the hearing aid on the ear with
   aidable loss when using a hearing aid. This allows the wearer of
   the hearing aid to hear sounds from both sides.

6. Your Hearing Care Professional can set custom programs for your
   hearing aids. Discuss the programs that best meet your lifestyle
   needs so they can create custom hearing programs for you.

7. The power-on delay feature enables whistle-free insertion of
   hearing aids.

8. The tinnitus control feature generates a sound to distract you
   if needed.

9. Refer to the Changing the hearing program section in the User
   Manual to change the hearing program.

10. Follow the Maintenance and care section in the User Manual to
    maintain and care for your hearing aids properly.

11. Refer to the Storage and transportation section in the User
    Manual to store and transport your hearing aids safely.

12. Refer to the Warranty and service section in the User Manual
    for warranty and service information.

Miracle-EarMINITM 5/4/3/2 RF 10 XP & CROS RF 10 XP
User Manual

www.miracle-ear.com
©2023 Miracle-Ear, Inc.

21025075 Rev 1 17164USRB

CONTENT
Welcome………………………………………………….. 3 Your hearing aids …………………………………….. 4 Daily use ………………………………………………….. 8 Telephone and streaming………………………. 16 Maintenance and care ……………………………. 17 Storage and transportation ……………………. 18 Warranty and service……………………………… 20

¿Necesita un manual de usuario en español?
Solicite uno a su audioprotesista o descárguelo de Miracle-Ear.com/manuals
Spanish and English User Manuals are available digitally at Miracle- Ear.com/manuals

Miracle-Ear® User Manuals

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WELCOME
Thank you for choosing Miracle-Ear® hearing aids to help you live life to the fullest. We’re excited to be on this journey with you. This manual, along with support from your Hearing Care Professional will help you learn to become familiar with your hearing aids and experience a greater quality of life.
Your hearing aid may not look exactly like the illustrations shown within this manual. CAUTION It is important to read the Regulatory & Safety Information and User Manual thoroughly and completely. Follow the safety information to avoid damage or injury. This manual describes all optional features that your hearing aids may or may not have. Confirm which options are valid for your hearing aids.
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YOUR HEARING AIDS
Instrument type
Miracle-EarMINITM RF 10 XP Hearing Aids Your hearing aids are worn directly in the ear canal. The wireless functionality enables advanced audiological features and synchronization between your two hearing aids.
Your hearing aids have no controls. Ask your Hearing Care Specialist if a smartphone app to control your hearing aids is available.

Getting to know your hearing aids We recommend you familiarize yourself with your new hearing aids.

Components and names

Ear piece
(Click Sleeve)
Microphone Battery compartment
(on/off switch)
Removal cord

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CROS TRANSMITTER
Two Solutions are available:
CROS solution: For people with normal hearing in one ear and profound hearing loss in the other. Sounds from the side with hearing loss are captured and transmitted wirelessly to the good-hearing side.
BiCROS solution: For people with profound hearing loss in one ear and less severe hearing loss in the other. Sounds from the more severe hearing loss side are captured and transmitted wirelessly to the better-hearing side. The hearing aid processes and amplifies the sounds from both sides.
The CROS transmitter works with specific wireless hearing aids. Your Hearing Care Professional will advise you on the compatible models.

For individuals using a CROS transmitter
CROS solutions are designed for people with profound hearing loss in one ear which cannot be aided with a hearing aid. A CROS transmitter worn on the non- aided ear captures sound from the applicable side and transmits it to the hearing aid on the ear with aidable loss when using a hearing aid. This allows the wearer of the hearing aid to hear sounds from both sides.

CROS transmitter

hearing aid

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Hearing programs Your Hearing Care Professional can set custom programs for your hearing aids. Discuss the programs that best meet your lifestyle needs so they can create custom hearing programs for you.
1 2 3 4 5 6
Read more in section “Changing the hearing program.”

Features Power-on delay enables whistle-free insertion of hearing aids.
Read more in section “Turning on and off”. The tinnitus control feature generates a sound to distract you
from your tinnitus..
Signal tones Signal tones of the CROS transmitter -like a low battery beep are sent to the hearing instrument.
Ask your Hearing Care Professional to configure the signal tones.

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DAILY USE
Inserting and removing the hearing aids Your hearing aids have been programmed to your right and left ear. Colored markers indicate the correct side:
CAUTION Risk of injury! X Always wear the hearing aid with an ear piece. X Make sure that the ear piece is completely
attached.
Inserting a hearing aid: For sleeves, take care that the bend of the sleeve is in line with the bend of the receiver cable. Your hearing aids have been programmed to your right and left ear. Colored markers indicate the correct side: X “R” = right ear X “L” = left ear Take care that the flap of the Click Sleeve matches the line printed on the hearing aid.
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correct

incorrect

Hold the hearing aid correctly before inserting it: Pay special attention to the removal cord indicating the bottom. The arrow which is printed on the hearing aid must point upwards.

L

R

X Carefully push the hearing aid into the ear canal. X Twist it slightly until it sits well. Open and close your mouth to avoid accumulation of air in the ear canal.
CAUTION Risk of injury! Insert the ear piece carefully and not too deeply into the ear.
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X It may be helpful to insert the right hearing aid with the right hand and the left hearing aid with the left hand.
X If you have problems inserting the hearing aid, use the other hand to gently pull your earlobe downwards. This opens the ear canal and eases insertion of the hearing aid.
Removing a hearing aid:
NOTICE Never pull on the battery compartment door to remove the hearing aid. This could damage your hearing aid.
X Push lightly on the back of your ear to loosen the hearing aid. X Remove the hearing aid by pulling the removal cord forward.
CAUTION Risk of injury! X In very rare cases the ear piece could remain in your
ear when removing the hearing aid. If this happens, have the ear piece removed by a medical professional.
Clean and dry your hearing aids after usage. Read more in section “Maintenance and care”.
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Turning on and off The following options are available to turn your hearing aids on and off. Via battery compartment: Turn On: Close the battery compartment.
The default volume and hearing program are set. Turn Off: open the battery compartment fully. When wearing the hearing aids, an alert tone can indicate when an instrument is being turned on or off. When the power-on delay is activated, the hearing aids turn on after a delay of several seconds. During this time, you can insert the hearing aids into your ears without experiencing unpleasant feedback whistling. The “power-on delay” can be activated by your Hearing Care Specialist.
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Adjusting volume Your hearing aids automatically adjust the volume to your situation. If you prefer manual volume adjustment, use a remote control
option. An optional signal can indicate the volume change.
Changing hearing programs Your hearing aids automatically adjust their sound based on your listening situation.
However, your hearing aids may also have several hearing programs set up by your Hearing Care Professional which allow you to make adjustments based on specific situations such as at a restaurant.
To change the hearing program manually, use a remote control option.

BATTERIES

When the battery is low the sound becomes weaker or you will hear an alert signal. The battery type will determine how long you have to replace the battery.

Battery size and handling tips Ask your Hearing Care Specialist for recommended batteries.

Battery size:

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· Always use the correct battery size for your hearing aids. · Remove the batteries if you do not intend to use the hearing
aids for several days. · Always carry spare batteries. · Remove empty batteries immediately and follow your local
recycling rules for battery disposal.

When the battery is low the sound becomes weaker or you will hear an alert signal. The battery type will determine how long you have to replace the battery.

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Replacing batteries Removing the battery: X Open the battery compartment. X Remove the battery by hand.
Inserting the battery: X If the battery has a protective film, remove it only
when you are ready to use the battery. X Insert the battery with the “+” symbol facing
upwards. X Carefully close the battery compartment.
If you feel resistance, the battery is not inserted correctly. Do not attempt to close the battery compartment by force. It can be damaged.
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Troubleshooting for hearing aid
Problem and possible solutions
Sound is weak.
X Gently close the battery compartment completely. X Clean the hearing aid. X Replace the empty battery. X Clean or exchange the ear piece.
Hearing aid emits whistling sounds.
X Reinsert the hearing aid until it fits securely. X Clean or exchange the ear piece.
Sound is distorted.
X Replace the empty battery. X Clean or exchange the ear piece.
Hearing aid emits signal tones.
X Replace the empty battery.
Hearing aid does not work.
X Turn the hearing aid on. X Gently close the battery compartment completely. X Replace the empty battery. X Make sure the battery is inserted correctly. X Power-on delay is active. Wait several seconds and check again.
Consult your Hearing Care Professional if you encounter further problems.
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TELEPHONE AND SMARTPHONE USE On the phone
When you are on the phone, turn the receiver slightly so that it does not completely cover your ear.
Telephone program You may prefer a certain volume when using the phone. Ask your Hearing Care Specialist to configure a telephone program. Switch to the telephone program whenever you are on the phone.

MAINTENANCE AND CARE
Follow these guidelines to care for your hearing aids.
Cleaning casing For hygiene reasons and to maintain functionality, clean your hearing aids daily. X Clean your hearing aids daily with a soft, dry cloth or tissue X Never use running water or immerse hearing aids in water X Never apply pressure while cleaning X Do not use alcohol solvent on the charging contacts
Cleaning earpieces Cerumen (ear wax) may accumulate on earpieces and affect sound. Clean all types of earpieces daily:
X Clean the earpiece right after removal with a soft and dry tissue. This prevents cerumen from becoming dry and hard.
X Squeeze the tip of the earpiece

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Drying and Storage Dry your hearing aids overnight.
X For longer periods of non-use, store your hearing aids in a dry environment with an open battery compartment and the batteries removed.
X Ask your Hearing Care Specialist for more information.

Operating, transport, and storage conditions

The hearing aids operate in the following environmental conditions:

Operating conditions Discharging

Temperature Relative humidity Atmospheric pressure

0-50°C (32-122°F) 5-93% 700-1060 hPa

During extended periods of transport and storage, please observe the following conditions

Storage

Temperature (recommended)

10-25°C (50-77°F)

Temperature (maximum range)

10-40°C (50-104°F)

Relative humidity (recommended) 20-80%

Relative humidity (maximum range) 10-80%

Transport
-20-60°C (-4-140°F) -20-60°C (-4-140°F)
5-90%
5-90%

Atmospheric pressure 20

700-1060 hPa

700-1060 hPa

Exchanging Click Sleeves Exchange standard earpieces approximately every three months. Replace them sooner if you notice cracks or other changes. The procedure for exchanging standard earpieces depends on the type of earpiece. Ask your Hearing Care Specialist which type of earpiece is appropriate for you.
X Grip the Click Sleeve with your fingers and pull it off. If you cannot grip it, turn it inside out and then pull it off.
click
X Take particular care that the new Click Sleeve clicks noticeably in place.
X When installing the new Click Sleeve, take care that the flap of the Click Sleeve matches the line printed on the device.
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Exchanging Click Domes
If you have problems removing the old Click Dome, follow the instructions on the packaging of the Click Domes.

X Take particular care that the new

Click Dome attaches with a

noticeable “click”.

click

Professional maintenance X Your Hearing Care Specialist can perform a thorough
professional cleaning and maintenance. Ask your Hearing Care Specialist for recommended maintenance intervals and support.
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WARRANTY AND SERVICE
Your hearing aid, with the exception of the battery, is covered by a comprehensive warranty. All covered instrument parts received for warranty service at an authorized service center will be repaired or replaced with new or reconditioned components, without charge, to meet the performance specifications for that model.
This warranty does not cover malfunctions due to unusual wear and tear or mistreatment of the instrument such as physical shock, excessive wax build-up, or tampering with the instrument, any of which voids all warranties. Your Hearing Care Professional may charge a service fee for processing warranty service.
Warranty service must only be performed by an authorized service cent. Service performed by unauthorized service depots voids this warranty, and repairs so necessitated will be done on a parts and labor cost basis.
Please refer to the warranty card included with your hearing aids for warranty period effective dates.
Your hearing aids may have additional loss and damage coverage. Please consult your Hearing Care Professional to determine if this is applicable to your hearing aids.
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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.
For service and warranty support, please contact your local Miracle-Ear® Hearing Care Professional.
If your location is not available, or you need additional support, contact Miracle-Ear Customer Support 800-241-1372.

IDENTIFICATION INFORMATION
Your hearing aids have a serial number imprinted on them. The location of the serial number will vary according to the style of hearing aid. Record the serial number in your user guide for future reference.
The year of manufacture is incorporated in the serial number. For custom aids, the year of manufacture is derived from the first two digits.
Please note the warranty is based upon the date of purchase, not the date of manufacture.
Your Audiologist or Hearing Care Professional can answer any questions you may have about the identifying code on your hearing aid.

Manufacturer Year of Manufacture

Miracle-Ear 00 ######R
MEC

L=Left, R=Right Serial # Model

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Distributed By Miracle-Ear, Inc. 150 South Fifth Street, Suite 2300
Minneapolis, MN 55402 www.miracle-ear.com
Information in this manual subject to change without notice. Copyright ©2023 Miracle-Ear, Inc. Hearing aid made in Singapore
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FLIP BOOK FOR IMPORTANT SAFETY INFORMATION
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Distributed By Miracle-Ear, Inc. 150 South Fifth Street, Suite 2300
Minneapolis, MN 55402 www.miracle-ear.com
Information in this manual subject to change without notice. Copyright ©2023 Miracle-Ear, Inc.
Hearing aid made in Singapore

FLIP BOOK FOR PRODUCT USER MANUAL

For hearing aids with a magnet in the battery compartment
WARNING Risk of interference with active and non-active implants! There is a magnet in the battery compartment, therefore if you wear implants: Verify the electromagnetic compatibility prior to use Consult with the implant physician before using your hearing aids. Keep a safe distance of about 4 cm (1.6 inches) between the implant and
hearing aids.
Instant fit, customs, IIC, CIC and ITC models
The hearing aid is placed within the ear canal.
CAUTION Risk of injury! Insert the ear piece carefully and not too deeply into the ear. In very rare cases the ear piece could remain in your ear when removing
the hearing aid. If this happens, have the ear piece removed by a medical professional.

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A Hearing Care Professional should advise a prospective tinnitus feature user to consult promptly with a licensed physician (preferably an ear specialist) before using the tinnitus feature 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
NOTICE
Important Notice for Prospective Sound Generator Users Your hearing aids are designed to comply with international standards of electromagnetic compatibility but interference with nearby electronic devices could occur. In this case, move away from the source of the interference.
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.
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For hearing aids with AutoPhone magnet for Telecoil
WARNING Risk of affecting life support systems! Use a magnet only when it is a safe distance away from life support
systems such as pacemakers or magnetic valves. The safe distance between pacemaker and magnet should be at least 10 cm (4 inches). NOTICE Magnets can disturb electrical devices and delete stored data. Keep magnets away from computers, monitors, television sets, storage media and other electronic equipment/devices. NOTICE In close proximity, AutoPhone magnets can damage receiver units of RIC hearing aids. Keep a minimum distance of 2 cm (0.8 inches) between the RIC receiver and any magnet, including the AutoPhone magnet. Do not store your RIC hearing aids and a smartphone with attached AutoPhone magnet together in a small pocket or box. NOTICE Magnets can disturb electrical devices and delete stored data. Keep magnets away from computers, monitors, television sets, storage media and other electronic equipment/devices.
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When using remote control apps
When using an app for controlling hearing aids:
WARNING Risk of hearing damage!
The device with the app for controlling hearing aids generates short control signals which may be audible. If the device running the app has a very high audio output there is the risk of hearing damage.
While using the app: Do not hold the loudspeaker of the device to your ears or the ears of
others. Do not use the device with headphones, headsets or other audio playback
devices.

FOR HEARING AIDS WITH TINNITUS FEATURE
Your hearing aid may be equipped with tinnitus therapy, an 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. It is recommended that this tool be used with appropriate counseling and/or in a tinnitus management program to relieve patients suffering from tinnitus. As with any hearing aid, misuse of the tinnitus therapy instrument could present some potentially harmful effects.
TINNITUS THERAPY CONCEPTS AND BENEFITS
· May be used as a part of a tinnitus treatment program · Plays a white noise through the hearing aid · Programmed according to your hearing loss needs and preferences · May provide temporary relief of your tinnitus
WARNING Risk of exceeding noise exposure limits.
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 Miracle-Ear® Hearing Care Professional has set the hearing aid at levels that exceed your comfort level.

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SAFETY WARNINGS
WARNING Risk of impairing the residual hearing of the user. Use only hearing that have been fitted to your needs.
WARNING Your hearing aids may reduce some background sounds potentially traffic or warning signals.
WARNING This product can expose you to nickel which is known to the State of California to cause cancer. For more information, visit www.P65Warnings.ca.gov
WARNING Choking hazard! Your hearing aids contain small parts which can be swallowed. Keep hearing aids, batteries, and accessories out of reach of children and
mentally disabled persons. For some types of button batteries, severe or fatal injuries can occur in 2
hours or less, if it is swallowed or placed inside any part of the body. If parts have been swallowed, consult a physician or hospital immediately.
If a battery has been swallowed, call the 24-hour National Battery Ingestion Hotline immediately at 1-800-498-8666.
Contra-indications
WARNING In case of known contact allergy, consult the hearing aid manufacturer regarding the presence of allergens before using the hearing aid. If an allergic reaction develops after wearing the hearing aid, immediately discontinue use and consult a licensed physician. 22

FOR HEARING AIDS WITH WIRELESS FUNCTIONALITY
WARNING Risk of affecting electronic equipment! In areas where the use of electronics or wireless devices are restricted,
verify if your device must be turned off.
WARNING Interference with implantable devices The device can be used with all electronic implants that comply with the
ANSI/AAMI/ISO 14117:2012 Electromagnetic compatibility standard for human implants. In case your implant does not comply with the ANSI/AAMI/ISO 14117:2012 standard, consult the manufacturer of your implantable device for information about the risk of disturbance.
NOTICE Your hearing aids are designed to comply with international standards of electromagnetic compatibility but interference with nearby electronic devices could occur. In this case, move away from the source of the interference. In some countries restrictions for the usage of wireless equipment exist.
Refer to local authorities for further information.
Devices with the FCC marking comply with the standards of the FCC regarding electromagnetic interference (only for products with wireless functionality).
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International standards NOTICE
Your devices comply with international standards However, it cannot be guaranteed that all products on the market work interference-free, for example some induction cookers, electromagnetic security systems (e.g. anti-theft systems and metal detectors) cellular telephones, RFID, room surveillance systems may cause audible interference. If you encounter unwanted noise in the vicinity of such device, you should increase the distance between the hearing aid and that device.
Use on Aircrafts The optional wireless capabilities that may be featured in your hearing aids can be used on an aircraft as hearing aids are exempt from the rules applied to other personal electronic instruments on an aircraft. Expected service lifetime The hearing aids are designed for an expected service life of 5 years. They are expected to remain safe for use for this duration.
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SAFETY WARNINGS
WARNING A lithium-ion rechargeable battery may be built into your hearing aid. Incorrect use of the hearing aid can cause lithium-ion rechargeable battery to burst.
If relevant, follow safety instructions for lithium-ion rechargeable battery.
WARNING Risk of electric shock!
Connect the charger only with a USB power supply which complies with IEC60950-1 and/or IEC62368-1.
WARNING Observe the operating conditions appropriate for your hearing aid model: Pay special attention to protect your hearing aid from extreme heat and
sunlight (e.g. fire, microwave, induction oven or other high induction fields) Protect your hearing aids from high humidity. Do not wear in the shower or
when applying make-up, perfume, aftershave, hairspray, or suntan lotion. Charge your hearing aids only in approved charger. Do not modify this product without authorization from the manufacturer. Do not use the hearing aid in explosive atmospheres (e.g. mining areas). Do not use hearing aids that are deformed or obviously damaged. Do not use hearing aids when its performance after charging reduces
considerably. Return the hearing aid to your hearing care professional. Do not dry hearings aids in the microwave oven. Do not dispose of the hearing aid in fire or water. Replacements and repair must be performed by a professional. Do not repair or replace the lithium-ion rechargeable battery yourself. In the unlikely event of a lithium-ion rechargeable battery bursting or
exploding, keep all combustible materials away.
In any of the above cases, contact your Hearing Care Professional. In case of a serious incident, report the occurrence to the manufacturer of the device.
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INSTRUCTIONS FOR DISPOSAL OF OLD ELECTRONICS
Miracle-Ear® encourages, the EU requires, and your local community laws may require, that your hearing aids and charger be disposed of via your local electronics recycling/disposal process.
The instructions below are provided for the benefit of disposal/recycling personnel. Please include this manual when disposing of your hearing aids and/or charger.
FOR DISPOSAL/RECYCLING PERSONNEL ONLY To remove the Lithium-ion Polymer battery from the chargers, follow one of two options:
Option 1 · Insert pry bars between the plastic and the USB metal housing
(top and bottom) · Pry apart to break the seam. · Clip battery wires and dispose battery.
Option 2 Using the style groove as a guide, sever the plastic case on all 4 sides with a blade, ultrasonic knife, hot wire, or band saw blade In each case, establish a limit guide so entrance over 3/32 inch beyond the outer shell is prevented.
Clip battery wires and dispose battery.
Applies to rechargeable hearing aids
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SAFETY INFORMATION
Intended use Hearing aids are intended to improve the hearing of hearing impaired persons. Diagnosis and prescription of a hearing aid must be performed by hearing health specialists, e.g. acousticians, audiologists or ENT doctors. Use the hearing aids and accessories only as described in the respective user guides.
Classification Your hearing aids are classified as a Type B applied part under the IEC 60601-1 medical devices standard. They are not certified to operate in explosive atmospheres that may be found in coal mines or certain chemical factories.
Medical device interference Different types of strong radiation, e.g. during X-ray or MRI head examinations, may damage hearing aids. Do not wear the hearing aids during these or similar procedures like electrosurgery (diathermy, electrocautery, HF-surgery). Weaker radiation, e.g. from radio equipment or airport security, does not damage the hearing aids.
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Standard ANSI/AAMI PC69 ISO 14117
EN 45502-2-1

Test Type RF radiation
RF radiation
RF radiation

Note
Implantable medical device EMC immunity, American National Standard.
Implantable medical device EMC immunity, International Standard
Particular requirements for pacemakers.

Cybersecurity
Proper set-up and operation of your hearing aids requires a safe, private and secure operating environment.
The U.S. Federal Trade Commission’s guidance for online security https://consumer.ftc.gov/online-security provides examples of best practices for securing your home network and mobile device to ensure your security.

Emissions

CISPR 11, Group 1, Class B

Immunity

ESD, Conducted up to +/-8 kV, Air discharge up to +/-15 kV Power frequency magnetic fields: 30 A/m, 50/60 Hz

Immunity to RF fields

80 MHz-2.7 GHz 10 V/m, 2.7 GHz-6 GHz 3 V/m

Proximity to wireless Up to 28 V/m ­

communication

See IEC 60601-1-2:2014/AMD1:2020, Table 9

devices

Proximity to magnetic fields

8 A/m@30 kHz, 65 A/m@134.2 kHz, 7.5 A/m@50 kHz

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Data is stored inside the hearing aid. This contains: · The audiogram · The average daily wearing · The frequency distribution of acoustic environments (i.e., what
percentage of the wearing time you were in a quiet environment, in a noisy environment, in an environment with speech, in a car and how often you listened to music) · The different noise levels (including wind noise) within the last 24 hours · The average frequency of changes to user controls · The average frequency that algorithms in hearing aids are actively in operation · An identification number. · Part of the information inside your hearing aids is additionally stored in separate databases in anonymized form (meaning, it cannot be connected to you) in order to improve the quality of future hearing devices. This information may help your acoustician provide the optimal fitting for you. However, he/she will not read out this information without your consent. Also, when you send in your device for service, this information will not be read out without your consent.
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Bluetooth® low energy*

The following table shows the main information on BLE, some parameters are different from product to product, so the worst case is indicated:

Wireless technology

Radio frequency Bluetooth low energy (BLE)

Output power (EIRP)

3.9 mW

Range

< 10 m between smartphone/accessory and hearing aids

Frequency

2,400 ­ 2,480 MHz

Channel

40 channels

Bandwidth

2 MHz per channel, 2 MHz spacing

Modulation type

Gaussian Frequency Shift Keying

• Applies only to hearing aids with Bluetooth capabilities.
  The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc., and any use of such marks by the legal manufacturer of this product is under licenses. Other trademarks and trade names are those of their respective owners.
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EMI/EMC COMPLIANCE

Wireless hearing aids comply with the following EMC/EMI standards. Applies only to hearing aids with wireless capabilities:

Standard
47 CFR Part 15, Subpart C
EN 300 330

Test Type

Note

RF emissions U.S. FCC requirements for intentional radiators.

RF emissions including spurious emission

EMC and radio spectrum matters for short range devices in the frequency range 9 kHz – 25 MHz.

EN 301 489-1/3 Immunity, Standard for low power transmitters in RF and ESD the frequency range 9 kHz – 40 GHz.

EN 300 328

Signal integrity and emissions

Wideband transmission systems; data transmission equipment operating in the 2.4 GHz ISM band and using wide band modulation techniques.

IEC 60118-13

RF immunity

International product standard for hearing aids to ensure adequate immunity to radio interference from mobile telephones.

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NOTICE Changes or modifications made to this equipment not expressly approved by the legal manufacturer may void the FCC authorization to operate this equipment. This device complies with Part 15 of the FCC Rules and with ISED’s license-exempt RSSs.
Operation is subject to the following conditions:
· This device may not cause harmful interference, and · This device must accept any interference received, including interference
that may cause undesired operation
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 design 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 interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following: · Reorient or relocate the receiving antenna · Increase the separation between the equipment and receiver · Connect the equipment to an outlet on the circuit different from that to
which the receiver is connected · Consult the dealer or an experienced radio/TV technician for help
For body worn operation, this device has been tested and meets the FCC RF exposure guidelines when used with the legal manufacturer’s accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. 12

Wireless functionality
USA and CANADA Certification information for hearing aids with wireless functionality:

MEMINITM RF 10 · NFMI Module 2 · Contains FCC ID: SGI-MIM002

The following table shows the main information on NFMI connectivity, some parameters are different from product to product, so the worst case is indicated:

Wireless technology

Nearfield magnetic induction (NFMI)

Magnetic field strength 0.14 A/m

Output power (EIRP)

53 W

Range

< 20 cm between hearing aids

Center frequency

3.27 MHz

Channel

Single Channel Radio

Bandwidth

330 kHz (-15 dB)

Modulation type

PSK (Phase Shift Keying)

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INFORMATION FOR USERS OF TINNITUS TECHNOLOGY Your hearing aid may be equipped with a tinnitus feature. Many hearing aids may be used alone or in combination with the tinnitus feature which is fixed to a broadband noise that can be adjusted by your Hearing Care Professional for your tinnitus therapy.
The feature may provide temporary relief of your tinnitus.
TINNITUS TECHNOLOGY – INDICATIONS FOR USE The tinnitus feature 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 21 years of age. The tinnitus feature is targeted for healthcare professionals treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the tinnitus feature should be done by a Hearing Care Professional participating in a tinnitus management program.
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.
WARNING Risk of further impairment to user’s hearing health The volume of the tinnitus feature can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. Should the tinnitus feature be set to such a level in the hearing aid, advise
the user of the maximum amount of time per day to use the tinnitus feature. For example, occupational safety guidelines restrict continuous noise exposure of 80 dBA SPL to 8 hours per day. The tinnitus feature should never be used at uncomfortable levels.
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Prescription use only
U.S. federal law restricts this device to sale by or on the order of a doctor or Hearing Care Professional licensed to dispense hearing aids in your state. The use of any sound generating tinnitus therapy device should be only on the advice and in consultation with your Hearing Care Professional who will properly diagnose and fit the device to your personal needs and requirements. This includes 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 to follow the advice and direction regarding such care.
Potential concerns associated with the use of any sound generating tinnitus therapy device. Discontinue use and seek medical evaluation if any of the following conditions occur: · Chronic skin irritation on, near, or around the site of the device · Unusual side effects (e.g., dizziness, nausea, headaches, heart palpitations · Perceived decrease in auditory function (e.g.,decreased loudness, speak
not as clear)
Device Description
The tinnitus feature is a software function that generates sound which is programmed into a hearing aid.
Depending on the type of hearing aid, the hearing aid may be used in up to three modes of operation: as a hearing aid, as a tinnitus treatment device, or as a hearing aid and tinnitus treatment device.
When enabled, the tinnitus feature 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.
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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 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 Hearing Aid Professional 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 Hearing Care Professional 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 Care Professionals 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.
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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.
INFORMATION FOR HEARING AID USERS Hearing aids will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. In most cases, infrequent use of hearing aids prohibits the wearer from attaining the full benefit. The use of hearing aids is only part of hearing rehabilitation and may need to be supplemented by auditory training and instruction in lip reading.
Some hearing aid users have reported a buzzing sound in their hearing aid when they are using mobile phones indicating that the mobile phone and hearing aid may not be compatible. According to the ANSI C63.19 standard (ANSI C63.19-2007 American National Standard Methods of Measurement of Compatibility Between Wireless Communications).
HEALTH CONSIDERATION If soreness or skin irritation develops, discontinue wearing your hearing aids and bring the aids and earmolds to your Hearing Care Professional. Minor fit adjustments or earmold modifications can often correct this condition. If soreness persists, discontinue wearing the hearing aid and see your physician.
Consult a Hearing Care Professional if you experience any unusual side effects like skin irritation, excessive accumulation of ear wax, dizziness, change in your hearing, or if you think there may be a foreign object in your ear canal.
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WARNING Keep batteries out of reach of children. For some types of button batteries, severe or fatal injuries can occur in 2
hours or less, if it is swallowed or placed inside any part of the body. If you suspect your child has swallowed or inserted a button battery, call the
24-hour National Battery Ingestion Hotline immediately at 1-800-498-8666 for fast, expert advice. Examine devices and make sure the battery compartment is correctly secured, e.g. that the screw or other mechanical fastener is tightened. Do not use if compartment is not secure. Dispose of used button batteries immediately and safely. Used/discharged batteries can still be dangerous. Tell others about the risk associated with button batteries and how to keep their children safe. For Canada: If battery is swallowed contact the local Poisons Information Hotline for your province, which can be found at https://infopoison.ca
If you have hearing aids that are intended for the fitting of children under the age of 3 years or persons with a developmental age of under 3 years, refer also to section “For children under the age of 3 years”.
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For children under the age of 3 years There are special hearing aids for the fitting of children under the age of 3 years or persons with a developmental age of under 3 years. Ask your Hearing Care Professional for further information.
WARNING Choking hazard! Your hearing aids contain small parts which can be swallowed. Ensure adequate supervision if infants, small children or mentally disabled
persons need to wear hearing aids. Check the completeness of the hearing aids regularly. Ensure that your child or the mentally disabled person does not detach the
hearing aid from the earmold. Consult your Hearing Care Professional if the housing is deformed. Keep the battery compartment locked. Verify the proper function of the
locking mechanism. Keep batteries and accessories out of children’s or mentally disabled
person’s reach. If swallowed consult a physician or a hospital immediately.
For 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.
7

REGULATORY NOTES FOR USERS
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 a 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, malfunction, 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 may 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 device, 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.
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REGULATORY CAUTIONS FOR USERS
NOTE: Hearing loss in people younger than 18
· People younger than 18 should see a doctor first, preferably an ear- nosethroat 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 the 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 a 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 assist in the evaluation and rehabilitation of hearing loss in people younger than 18.
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REGULATORY WARNINGS
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 15dB 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.
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REGULATORY CAUTIONS FOR USERS
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.
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Miracle-EarMINITM 5/4/3/2 RF 10 XP & CROS RF 10 XP
Regulations & Safety Information

www.miracle-ear.com
©2023 Miracle-Ear, Inc.

21025075 Rev 1 17164USRB

References

• P65Warnings.ca.gov
• Canadian Association for Poison Centres and Clinical Toxicology
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA

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