Starkey Hearing Technologies RIC User manual

RIC
(Receiver-In-Canal)
OPERATIONS MANUAL
RECHARGEABLE

Table of Contents
Overview
Rocker Switch RIC Overview 4
Synergy Charger Overview 6
Preparation
Charging Your Hearing Aids 8
Charger On-Board Battery LEDs 10
Insertion and Removal 11
Operations
Power On & Off 13
User Controls 14
Volume Control 15
Volume Control Indicators 16
Battery Indicators 16
Memory Change & Mute 17
BiCROS Balance Control 18
Multiflex Tinnitus Level Control 18
Directional Settings 18
Telephone Use 18
CROS/BiCROS Technology 21
Multiflex Tinnitus Technology 22
Accessories 23
Hearing Instrument Care
Hearing Aid Care 24
Synergy Charger Care 26
Service and Repair 27
Troubleshooting Guides 28
Tips for Better Communication 31
Regulatory Information
Safety Information 33
FDA Information 35
FCC Information 41
Synergy Charger
Hearing Aid

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42
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10
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Rocker Switch RIC Overview Rocker Switch RIC Overview
Features, Controls and Identification
Your hearing aid controls include:
1. Hearing Aid
2. Cable
3. Receiver
4. Microphones
5. Rocker Switch (user control)
6. Location of left/right side hearing aid indicator
RED is for right ear, BLUE is for left ear
7. Retention Lock
8. Location of manufacturer’s name and model name
9. Location of left/right side receiver indicator
10. Charging Contacts*
Comfort Fit Solutions:
11. Instant Fit Earbud
12. Custom Earmold (optional)
13. RIC Custom Power Earmold (optional)
* The hearing aid’s serial number is located under an access
panel that surrounds the charging contacts. Contact your
hearing professional for assistance.

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67
2
1
3
4
5
Synergy Charger Overview
Features, Controls and Identification
1. Desiccant puck holder
2. Cleaning brush
3. Earbud/earmold reservoir
4. Charging ports
5. Hearing Aid Charging LEDs
6. On-board battery LEDs
7. Micro USB port
Synergy Charger Overview

8 9
Charging Your Hearing Aids
• Place your hearing aids in the charger with
the earbud resting inside the case
• Your hearing aids will turn off automatically
and begin to charge
• Note: The LEDs corresponding to each
hearing aid:
- Glowing Green = Charging
- Solid Green = Fully Charged*
- Blinking Red = Fault State – Remove from charger,
wait until LED turns off and re-insert aids. If Fault
State continues, call your hearing professional.
• Charging occurs with the lid open or closed
• Your hearing aids will be completely charged in under
3 ½ hours
• It is safe to keep them in the charger after they are fully
charged and any time that you are not wearing them
• If you will not be wearing your hearing aids for an
extended period of time (i.e. weeks) remove the plug
from the charger and the hearing aids from the charging
ports. You will need to manually power the hearing aids
off by pressing the rocker switch for three seconds. You
may store them in the reservoir
• Your hearing aids will automatically power on when
removed from the charger
• When charging without the charger cord the
LEDs will turn off when the hearing aids are
fully charged
• To refresh LEDs when the charger is not plugged in,
remove a hearing aid from the charging port for three
seconds and then replace it in the charger (refresh lasts
10 seconds only – then LEDs will turn off again)
* If you are charging without cord, the LEDs will turn off when
charged, to save battery.
Preparation Preparation

10 11
Charger On-Board Battery LEDs
• When charger is plugged
in and fully charged = 4
solid LEDs
• When charging without the
cord the LEDs will turn off
after 10 seconds
• To refresh LEDs, remove a hearing aid from
the charging port for three seconds and then
replace it in the charger (refresh lasts 10
seconds only – then LEDs will turn off again)
- 4 Solid > 75%
- 3 Solid < 75%
- 2 Solid < 50%
- 1 Solid < 25%
- 1 Blinking = Charge Low
• While charging the on-board battery with
the provided cord, the 4 LEDs will be:
- Glowing while charging
- Solid when charged
1
2
3
Preparation Preparation
Insertion and Removal
To insert the earbud or earmold:
1. Hold the cable at the bend in front
of the receiver with your thumb and
forefinger. Gently insert the receiver
into your ear canal.
2. Wrap the hearing aid over the
top of your ear, carefully placing
it behind your ear.
3. Place the retention lock inside
the bowl of your ear.
To remove the earbud or earmold:
• Remove the retention lock from
the bowl of your ear.
• Remove the hearing aid from
behind your ear.
• Grasp the receiver with your thumb
and forefinger. Gently pull out of
your ear canal.
Do not pull with the hearing aid case
as this may damage the connection.

12 13
Operation
Preparation
Helpful Hints
• Minor irritation and/or inflammation may occur as
your ear becomes accustomed to having an object
in it; if so, please contact your hearing professional.
• If an actual allergic reaction occurs, alternative earmold
materials are available; contact your hearing professional.
• Severe swelling, discharge from the ear, excessive wax or
other unusual conditions warrant immediate consultation
with a physician.
Power On & Off
ON - The hearing aids will power on automatically after
removing them from the charger. There is a delay
that allows you time to insert your hearing aid into
your ear.
ON - If the hearing aid is manually powered off, pressing
the top of the rocker switch will power it on. The delay
still exists, to give you time to insert the hearing aid
into your ear.
OFF - The hearing aids will power off automatically when
placed in the charging port. Charging will proceed.
OFF - The hearing aids can be powered off manually by
pressing either the top or bottom rocker switch for
three seconds.

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Volume
Control
Memory
Change Mute Multiflex Tinnitus Level
Balance
Control On/Off
Short Press
(Press and Release)
Long Press
(Press and Hold)
Operation Operation
User Controls
Your hearing aid’s user control may have been customized by
your hearing professional.
Ask your hearing professional how the user
control on your hearing aid is set.
Available User Control Functionality
The user control on your hearing aids
can respond differently depending on how
long you activate (press) the button. Your
hearing aids are capable of having one
function assigned to a short press (press and
release) and one function assigned to a long
press (press and hold). The options selected
on the next page indicate how your
particular user control is configured.
Assigned User Control Settings
Volume Control
Power On Volume Level
Your hearing aids have been set to a specific volume
level by your hearing professional. If sounds are generally
too loud or too soft, please contact your hearing professional
for advice and adjustment. If your hearing aids have been set
up with a user adjustable volume control, temporary volume
adjustments can be made.
Your hearing aids will always power-on to the same
volume setting (Volume Home) determined by your
hearing professional.
Rocker Switch Volume Control
If your rocker switch is configured to control volume, pressing
the top part of the switch increases the volume while pressing
the lower portion of the switch decreases volume.

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 
Volume Level One*Two*
Volume Max 5 Beeps ••••• 5 Beeps •••••
Volume Step(s) Short Tone –4 Beeps ••••
Volume Home
(Power on volume level) 3 Beeps ••• 3 Beeps •••
Volume Step(s) Short Tone –2 Beeps ••
Volume Min Single Beep — 1 Beep •
Operation Operation
Volume Control Indicators
Your hearing professional may enable audible indicators,
which highlight the current volume position.
* Depending on your hearing aid model, you will have one of these indicator
options as the default. Additional options may be enabled by your hearing
professional depending on hearing aid model options.
Battery Indicators
An indicator will sound when the battery voltage is low. You
have approximately 30 minutes* of battery life remaining. An
indicator may also sound just before the battery stops working.
*Actual time between low battery indicator and shut down will vary depending
on environmental noise levels and your use of the process.
Memory Change
Your hearing professional may create multiple memories within
your hearing aid. These additional memories can be accessed
by activating the user control on your hearing aid.
If your user control is configured for memory changes, each time
you activate the user control, the memory of your hearing aid
will increment through the available memories.
Memory Indicators
Your hearing professional may enable an audible indicator, which is
presented while making a memory change. The indicator defaults
to a voice identifying which memory your hearing aid is in.
Mute
Long Press Mute
If your hearing aid is configured with
mute functionality, a long press and
hold of the user control will mute your
hearing aid. If enabled by your hearing
professional, you may hear an indicator
prior to the hearing aid muting. To unmute
your hearing aid, long press and hold the
user control until audio is restored.

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My hearing aids have the following telephone setting(s):
Automatic telephone memory and automatic
telecoil. See below.
Manual telephone memory and manual telecoil.
See below. (Memory # _________________ ).
None
Operation Operation
BiCROS Balance Control
Your user control on the transmitter can also adjust the
balance between your hearing aids and transmitter.
Please refer to the section labeled CROS/BiCROS
Technology (page 21) for further information.
Multiflex Tinnitus Level Control
Your user control can also adjust the level of your
Multiflex Tinnitus stimulus. Please refer to the section
labeled Multiflex Tinnitus Technology (page 22) for
further information.
Directional Settings
Your hearing aids may have a directional microphone
to help improve speech understanding in noisy situations.
Ask your hearing professional about your particular
directional settings.
Telephone Use
Some hearing aids can be customized with features to help
you effectively communicate on the telephone. Ask your
hearing professional about your telephone solution.
Automatic Telephone Memory and Automatic Telecoil
These options activate the telephone memory automatically
when used with a hearing aid compatible telephone. To use,
place the telephone receiver on your ear as you normally
would and the hearing aid will automatically select the
telephone memory. It might be necessary to move the
telephone receiver slightly to find the best reception. Once
the telephone is removed from the ear, the hearing aid will
switch back to the last used memory.
NOTE: Consult with your hearing professional if your hearing
aid does not switch to the telephone memory automatically,
if it is enabled.
Manual Telephone Memory and Manual Telecoil
Manual access allows you to switch the hearing aids into a
telephone or telecoil memory, as needed. Ask your hearing
professional which memory you should access for manual
telephone use.

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Introduction
A Contralateral Routing of Signals (CROS) hearing system is a
type of hearing aid that is used to treat unilateral hearing loss.
It takes sound from the ear with poorer hearing and transmits
it to the ear with better hearing. CROS only picks up sound
from the unaidable ear, while BiCROS picks up sound from
both ears. This helps the patient to receive sounds from both
sides of the head without the head-shadow effect.
Multifunction Button Balance Control
Your hearing system uses the button to adjust the balance
between the hearing aid and the transmitter. This control
adjusts the level of sound coming from the transmitter. Press
and release the button until the desired level is reached. Each
press and release changes the balance level one increment.
NOTE: Balance Control is only applicable for BiCROS
memories.
CROS Streaming
Your hearing system is equipped with a CROS transmitter.
When you enter a memory with either CROS or BiCROS
streaming enabled, audio from the transmitter is streamed
to your hearing aid. When CROS streaming begins you
may hear an alert tone. If for any reason the CROS stream
is unexpectedly interrupted you may also hear an alert tone.
Please ask your hearing professional about your particular
settings.
CROS/BiCROS TechnologyOperation
General Telephone Use
Some hearing aids work best by holding
the phone close to, but not fully covering
your ear. In some instances, if you
encounter whistling (feedback), tilt the
receiver at an angle until the whistling
stops. Additionally, the hearing aid in
the non-phone ear (ear opposite the
phone) may switch to a telephone
setting to reduce background sounds.
Your hearing professional can provide
instructions and techniques for your
specific needs.
Ear-to-Ear Phone Streaming
The telephone memory in your hearing aid may be equipped
with an ear-to-ear phone streaming option. When you enter
your telephone memory, the audio from your telephone will
be streamed from the phone ear’s hearing aid to the opposite
ear’s hearing aid. This allows you to hear the telephone
conversation in both ears. Ask your hearing professional about
your particular telephone settings.

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AccessoriesMultiflex Tinnitus Technology
NOTE: CROS and BiCROS systems will have considerably
shorter battery life. Your rechargeable CROS/BiCROS system
will need to be recharged after approximately 15 hours.
Introduction
Multiflex Tinnitus Technology can be used as a part of a
tinnitus treatment program. Multiflex Tinnitus Technology
plays a tinnitus stimulus through the hearing aids.
The tinnitus stimulus is programmed according to your
hearing loss, and your hearing professional can adjust
the settings of the tinnitus stimulus to meet your needs.
Rocker Switch Tinnitus Stimulus Control
If your rocker switch is configured for Tinnitus Stimulus
Control, pressing the top part of the switch increases the
stimulus level while pressing the bottom part of the switch
decreases the stimulus level.
My hearing aid is configured with the
following control:
Press and Release Tinnitus Stimulus Control.
Press and Hold Tinnitus Stimulus Control.
Wireless Accessories
There are several wireless accessories that allow you to control
and maximize the full potential of your hearing aids. Available
functionality includes:
• Ability to adjust your hearing device settings and
memories using a remote control.
• Ability to transmit television/media device audio directly
to your hearing aids.
• Ability to transmit remote microphone audio directly
to your hearing aids.
• Ability to transmit your cell phone conversation directly
to your hearing aids.
Consult with your hearing professional to determine if your
hearing aids have wireless capabilities and which accessories
may be best for you.

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Hearing Instrument Care Hearing Instrument Care
Hearing Aid Care
Keep your hearing aids clean. Heat, moisture and
foreign substances can result in poor performance.
• Use a cleaning brush or soft cloth to clean debris
from around the user control, microphone and
charging contacts; inspect the receiver, earbud
or eartip and wax guard regularly.
• Never use water, solvents, cleaning fluids or oil
to clean your hearing aids.
• Charging contacts should always be kept clean and dry.
Your hearing professional can provide further information
on additional maintenance procedures for your hearing
aids, if needed.
Hear Clear™Receiver Wax Guards
RIC hearing aids integrate disposable Hear Clear earwax
protection. The innovative wax guards prevent earwax
accumulation in the hearing aid receiver. When you need to
replace your wax guards, please follow the instructions below.
1. Insert yellow end of the application stick into used wax
guard in hearing aid.
2. Pull outward on stick to remove used wax guard.
3. Use opposite end of stick to firmly insert clean wax
guard into hearing aid.
4. Pull outward to remove stick and discard.
2
1
3
4

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Hearing Instrument Care Hearing Instrument Care
Helpful Hints
• Do not take apart your hearing aids or insert
the cleaning tools inside them.
• When not in use, place your hearing aids
in the charger and store:
– In a dry, safe place
– Away from direct sunlight or heat to
avoid extreme temperatures
– Where you can easily find them
– Safely out of reach from children and pets
Synergy Charger Care
• Keep your charger clean. Heat, moisture and foreign
materials can result in poor performance.
– Using the provided cleaning brush keep the
charging ports clear of debris.
– Do not use water, solvents or cleaning fluids
to clean the charging ports.
– Keep lid closed as much as possible to avoid
dust and debris build up.
– Store your charger in a clean and dry location,
i.e. a dresser or shelf rather than the bathroom
or kitchen.
• To ensure the longest life of you rechargeable hearing
aid batteries and the batteries in the charger:
– Unplug charger when not in use.
– Fully charge hearing aid batteries every night.
– Do not expose to excess heat, i.e. do not store
on a window sill or in a hot car.
Service and Repair
If, for any reason, your hearing aids and charger do 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 aids and charger fail or perform poorly,
check the guide on the next page for possible solutions. If
problems continue, contact your hearing professional for
advice and assistance. Many common problems may be
solved right in your hearing professional’s office or clinic.

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RIC Troubleshooting Guide Charger Troubleshooting Guide
SYMPTOM POSSIBLE CAUSES SOLUTIONS
Not Loud
Enough
Blocked earmold/
tubing/earbud Clean or replace wax guard as needed
Hearing change Contact your hearing professional
Debris buildup Clean both microphone and receiver
with brush
Inconsistent
Performance
Restart required
Place in charger until charging begins and
then remove-this will power cycle your
hearing aids
Blocked earmold/
tubing/earbud Clean or replace wax guard as needed
Unclear,
Distorted
Performance
Restart required
Place in charger until charging begins and
then remove-this will power cycle your
hearing aids
Blocked earmold/
tubing/earbud Clean or replace wax guard as needed
Defective hearing
aids Contact your hearing professional
Dead
Hearing Aid
Charge required Place in your charger until the LEDs stop
blinking and become solid
Blocked
earmold/tubing Clean or replace wax guard as needed
Crimped tubing Contact your hearing professional
SYMPTOM POSSIBLE CAUSES SOLUTIONS
No LED
indicator
when hearing
aids are
inserted into
the charging
port
Incorrect
orientation
Connect the micro USB to your
charger and plug it into the wall.
The on-board battery LEDs will
turn on for a few seconds to
indicate connection to the power
source. If they do not, contact your
hearing professional.
Dead battery
Reposition your hearing aids in
the port with the earbud resting
in charger reservoir. There is not a
right and left port, your hearing aid
will charge in either port.
Red blinking
LED by
charging port
Fault occurred
Remove the hearing aids from
the charging port, wait until the
LED turns off, reinsert. If the red
blinking LED persists, contact your
hearing professional.
While
charging
cordless, no
LEDs are
illuminated
Power save mode
To refresh LEDs, remove a hearing
aid from the charging port for
3 seconds and then reinsert it
into the charging port. Both the
charging port LEDs and the on-
board battery LEDs will illuminate
for 10 seconds.
Hearing Instrument Care Hearing Instrument Care

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Tips for Better CommunicationHearing Instrument Care
Charger Troubleshooting Guide (Cont.)
SYMPTOM POSSIBLE CAUSES SOLUTIONS
Hearing aids
whistling in the
charger
Incorrect orientation
Reposition your hearing
aids in the port with the
earbud resting in the
charger reservoir. Confirm
that the charging LED
begins to glow.
Dead battery
Your charger’s on board
battery has died. Plug your
charger in. If you do not
have the cord with you,
push and hold the hearing
aid’s rocker switch for 3
seconds to turn it off. This
will conserve the charge in
your hearing aid.
Your hearing professional will recommend an appropriate
schedule to help you adapt to your new hearing aids. It will
take practice, time and patience for your brain to adapt to the
new sounds that your hearing aids provide. Hearing is only
part of how we share thoughts, ideas and feelings. Reading
lips, facial expressions and gestures can help the learning
process and add to what amplification alone may miss.
Please review the following simple communication tips:
For You
• Move closer to and look at the speaker
• Sit face-to-face in a quiet room
• Try different locations to find the best place to listen
• Minimize distractions
• Background noises may be frustrating at first; remember,
you have not heard them for a while
• Let others know what you need; keep in mind that
people cannot “see” your hearing loss
• Develop realistic expectations of what your hearing
aids can and cannot do
• Better hearing with hearing aids is a learned skill
combining desire, practice and patience

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Regulatory InformationTips for Better Communication
For Your Family and Friends
Your family and friends are also affected by your hearing loss.
Request that they:
• Get your full attention before beginning to speak
• Look at you or sit face-to-face in a quiet room
• Speak clearly and at a normal rate and level; shouting
can actually make understanding more difficult
• Rephrase rather than repeat the same words; different
words may be easier to understand
• Minimize distractions while speaking
Safety Information
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.
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.
Your hearing aids and charger should be stored within the temperature and
humidity ranges of -10°C (14°F) to +45°C (113°F) and 10%-95% rH.
The charging temperature range is between 0°C (32°F) and 40°C (104°F).
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from very cold up to 40°C (104°F).
At the maximum operating temperature of 40°C (104°F), the hearing aid case
temperature may reach 42°C (108°F).
• Charge both the hearing aids and charger for 3.5 hours before use.
• If the charger 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.

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Regulatory Information Regulatory Information
• There is nothing edible in the package, including the desiccant,
cleaning tool, etc.
• Any cords and wall warts must be approved or listed by a Nationally
Recognized Testing Laboratory.
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.
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.
DO NOT OPEN HEARING AID OR CHARGER,
NO USER-SERVICEABLE PARTS INSIDE
The Synergy Charger has a rating of IP 5X per IEC 60529. This means that the Synergy
Charger is protected from dust.
The service life of the Synergy Charger is 3 years.
Required Hearing Aid Information
The following additional information is provided in compliance with U.S. Food and Drug
Administration (FDA) regulations:
WARNING TO HEARING AID DISPENSERS
A hearing aid dispenser should advise a prospective hearing aid user to consult
promptly with a licensed physician (preferably an ear specialist) before dispensing a
hearing aid if the hearing aid dispenser determines 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:
i. Visible congenital or traumatic deformity of the ear.
ii. History of active drainage from the ear within the previous 90 days.
iii. History of sudden or rapidly progressive hearing
loss within the previous 90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent onset within the previous
90 days.
vi. Audiometric air-bone gap equal to or greater than
15 decibels at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz.
vii. Visible evidence of significant cerumen accumulation or a foreign
body in the ear canal.
viii. Pain or discomfort in the ear.
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 otorhynolaringologists.
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.

36 37
Regulatory Information Regulatory Information
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 instruments 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 Multiflex Tinnitus Information for
Hearing Professionals
INDICATIONS FOR USE
The Multiflex 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 Multiflex Tinnitus Technology is targeted for healthcare professionals, which are
treating patients suffering from tinnitus, as well as conventional hearing disorders. The
fitting of the Multiflex Tinnitus Technology must be done by a hearing professional
participating in a Tinnitus Management Program.
INSTRUMENT DESCRIPTION
Multiflex 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 Multiflex Tinnitus Technology generates the sound and allows
a patient’s hearing 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.
Multiflex Tinnitus Technology generates a broadband white noise signal that varies
in frequency and amplitude. These characteristics are adjustable by the hearing
professional and are specific to the prescribed therapy designed by the professional for
the patient’s needs and comfort.
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 professional.

38 39
Regulatory Information Regulatory Information
WARNING TO HEARING CARE PRACTITIONER
A hearing care practitioner should advise a prospective sound generator user to consult
promptly with a licensed physician (preferably an ear specialist) before using a sound
generator if the hearing care practitioner 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:
i. Visible congenital or traumatic deformity of the ear.
ii. History of active drainage from the ear within the previous 90 days.
iii. History of sudden or rapidly progressive hearing loss within the previous
90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
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 instrument 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.
Multiflex 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
Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program.
Multiflex Tinnitus Technology plays a white noise through the hearing aid.
Multiflex Tinnitus Technology is programmed according to your hearing loss and
preference, and your hearing professional can adjust the settings of Multiflex Tinnitus
Technology to meet your needs.
Multiflex Tinnitus Technology may provide temporary relief of your tinnitus.
PRESCRIPTION USE ONLY
CAUTION: Federal law restricts this instrument to sale by or on the order of a
doctor, audiologist or other hearing care practitioner licensed to dispense hearing
instruments 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 practitioner. Your
hearing professional will properly diagnose and fit the instrument to your personal
needs and requirements. This should include its use in a prescribed tinnitus treatment
program.
Your hearing professional will also be able to offer the appropriate follow-up care. It is
important that you follow your hearing professional’s advice and direction regarding
such care.
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 instrument.
Multiflex 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 instrument and seek a consultation with a medical, audiology or other hearing
professional.
As with any instrument, 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 instrument out of the reach of children and pets.
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 instrument
for more than sixteen (16) hours a day if your instrument is set at the maximum output
level, nor should you use your instrument if your hearing professional has set the
instrument at levels that exceed your comfort level.