Starkey Laboratories 24HALO2R312 Halo 2 RIC 312 User Manual Synergy Made for iPhone RIC Operations Manual

Starkey Laboratories Inc Halo 2 RIC 312 Synergy Made for iPhone RIC Operations Manual

user manual

Made for iPhone® RIC
(Receiver-In-Canal)
OPERATIONS MANUAL
Table of Contents
Overview
RIC 13 Overview 4
Preparation
Batteries/Battery Indicators 6
Insertion and Removal 11
Operation
Power On & Off 14
User Controls 14
Volume Control 15
Volume Control Indicators 18
Memory Change 18
Mute 19
Multiflex Tinnitus Level Control 20
Directional Settings 20
Landline Telephone Use 21
Multiflex Tinnitus Technology 24
Adjustment
Adjusting Your Hearing Instrument 26
Pairing with an iOS Device 27
Cell Phone Use 31
Hearing Instrument Care
Instrument Care 33
Service and Repair 36
Troubleshooting Guide 37
Tips for Better Communication 38
Safety Information 41
FDA Information 44
FCC Information 53
Made for iPhone RIC and TruLink are compatible with
iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6,
iPhone 5s, iPhone 5c, iPhone 5, iPhone 4s, iPad Air
2, iPad Air, iPad (4th generation), iPad mini 3, iPad
mini with Retina display, iPad mini, iPod touch (5th
generation) and Apple Watch. Use of Apple Watch
requires iPhone 5 or later.
Hearing Instrument
Instrument Controls
Push Button Controls p. 14
Size 13 Battery - Orange
4 5
Made for iPhone RIC 13 OverviewMade for iPhone RIC 13 Overview
Features, Controls and Identification
Your hearing instrument controls include:
1. Hearing Instrument
2. Cable
3. Receiver
4. Microphones
5. Push Button (user control)
6. Battery Compartment (on/off control),
location of serial number
7. Retention Lock
8. Location of manufacturer’s name
and model name
9. Location of left/right side
receiver indicator
10. Instant Fit Earbud
11. Location of left/right side instrument
indicator
12. Custom Earmold (optional)
13. RIC Custom Power Earmold (optional)
12
13
42
1
3
7
10
5
8
6
9
11
6 7
PreparationPreparation
Batteries
Your hearing instrument uses a battery as
its power source. This battery size can be
identified by the orange (13) color code on
the packaging.
To insert or replace the battery:
1. Use the nail grip on the battery door.
2. Open the battery door gently and
remove the old battery.
3. Remove the colored tab from the new
battery.
4. Align the battery’s “+” sign (flat side
of the battery) with the “+” on the
battery door.
5. Close the battery door.
3
1 2
4
5
RIC 13
8 9
PreparationPreparation
Battery Indicators
An indicator will sound when the battery
voltage is low. You have approximately
30 minutes* to replace the battery. An
indicator may also sound just before the
battery stops working.
Helpful Hints
• NEVER FORCE THE BATTERY
DOOR SHUT. This could result in
serious damage. If the door will not
close securely, check that the battery
is inserted correctly.
• Do not open the battery door too
far or damage is likely to occur.
• Dispose of used batteries
immediately in the proper
waste or recycling container.
• Batteries vary in size and
performance. Your hearing
professional is your best source
for lifespan estimates and
verification that you are using the
proper size and type.
* Actual time between low battery indicator and shutdown will
vary depending on environmental noise levels and brand of
battery used.
10 11
PreparationPreparation
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 instrument 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 instrument 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 instrument case
as this may damage the connection.
WARNINGS
Batteries are dangerous if swallowed.
To help prevent the accidental ingestion
of batteries:
Keep out of reach of children and pets
Check your medications before taking
them – batteries have been mistaken
for pills
Never put batteries in your mouth,
as they can easily be swallowed
National Button Battery Ingestion
Hotline: 202-625-3333
12 13
PreparationPreparation
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.
1 2
3
14 15
OperationOperation
Power On & Off
To turn ON:
Insert a battery and completely close
the battery door. Your instrument has a
power-on delay which may require a few
seconds. You may hear a tone indicating that
your instrument is powered on.
To turn OFF:
Open the battery door until the battery is no
longer touching the battery contacts.
User Controls
Your hearing instrument’s user control
may have been customized by your hearing
professional. Ask your hearing professional
how the user control on your instrument
is set.
Available User Control Functionality
The user control on your hearing instrument
can respond differently depending on how
long you activate (press) the button.
Your instrument is 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 below indicate how
your particular user control is configured.
Assigned User Control Settings
Volume Control
Power On Volume Level
Your hearing instrument has been set to
a specific volume level by your hearing
professional. If sounds are generally too
loud or too soft, please contact your hearing
Volume
Control
Memory
Change Mute Multiflex
Tinnitus Level
Short Press
(Press and Release)
Long Press
(Press and Hold)
16 17
OperationOperation
professional for advice and adjustment.
If your hearing instrument has been set
up with a user adjustable volume control,
temporary volume adjustments can be
made.
Your hearing instrument will always power-on
to the same volume setting (Volume Home)
determined by your hearing professional.
Sprinkler Volume Control
If your user control is configured as a
sprinkler volume control, each time you
activate the user control, the volume of your
hearing instrument changes.
Sprinkler volume control is configured by
default to automatically decrease in volume
before it increases. To make sounds louder,
activate the user control. Repeat this motion
until you are at the minimum setting. The
next time you activate the user control, the
volume will increase one step. Continue to
activate the user control until you reach the
desired loudness.
NOTE: If 10 minutes or more have passed
since the last volume change, the volume will
automatically decrease before it increases.
Up/Down Volume Control
If your user control is configured as a
dedicated up/down volume control, each
time you activate the user control, the
volume of your hearing instrument always
changes in a specific direction (either up
or down). For example, a short press and
release may increase the volume while a long
press and hold may decrease the volume in
your hearing instrument.
Some user controls can be set for the Right
instrument to increase volume and the Left
instrument to decrease volume. Ask your
hearing professional if this setting would
benefit you.
18 19
OperationOperation
Volume Control Indicators
Your hearing professional may enable
audible indicators, which highlight the
current volume position.
Memory Change
Your hearing professional may create
multiple memories within your hearing
instrument. These additional memories can
be accessed by activating the user control
on your hearing instrument.
If your user control is
configured for memory
changes, each time you
activate the user control,
the memory of your hearing
instrument 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 saying “One, Two, Three
or Four” to identify which memory your
instrument is in.
Mute
Long Press Mute
If your hearing instrument is configured with
mute functionality, a long press and hold
of the user control will mute your hearing
instrument. If enabled by your hearing
Volume Level Tone Length of Tone
Volume Max 5 Beeps .....
Volume Step(s) Click
–
Volume Home
(Power on volume level) 3 Beeps ...
Volume Step(s) Click
–
Volume Min Single Tone —
20 21
OperationOperation
professional, you may hear an
indicator prior to the hearing
instrument muting. To unmute
your hearing instrument, long
press and hold the user control
until audio is restored.
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 (on page 24) for further
information.
Directional Settings
Your hearing instrument may have a
directional microphone to help improve
speech understanding in noisy situations.
Ask your hearing professional about your
particular directional settings.
Landline Telephone Use
Some hearing instruments 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 instrument compatible telephone.
My hearing instruments have the following
landline telephone setting(s):
Automatic Telephone Memory and
Automatic Telecoil. See below.
Manual Telephone Memory and
Manual Telecoil. See next page.
(Memory # _________________ ).
None
22 23
OperationOperation
To use, place the telephone receiver on your
ear as you normally would and the hearing
instrument 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
instrument will switch back to the last used
memory.
NOTE: Consult with your hearing professional
if your instrument 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 instruments into a telephone or
telecoil memory, as needed. Ask your
hearing professional which memory you
should access for manual telephone use.
Landline Telephone Tips
Some hearing instruments
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 instrument 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.
24 25
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 instrument. 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.
Sprinkler Tinnitus Stimulus Control
If your user control is configured as a
sprinkler stimulus control, each time you
activate the user control, the stimulus level
in your hearing instrument changes.
Sprinkler stimulus control is configured by
default to automatically decrease in level
before it increases. To make the stimulus
level louder, activate the user control.
Repeat this motion until you are at the
minimum setting. The next time you activate
the user control, the level will increase one
step. Continue to activate the user control
until you reach the desired loudness.
NOTE: If 10 minutes or more have passed
since the last stimulus level change, the
level will automatically decrease before it
increases.
Up/Down Tinnitus Stimulus Control
If your user control is configured as a
dedicated up/down stimulus control,
each time you activate the user control,
the stimulus level in your hearing instrument
always changes in a specific direction (either
up or down). For example, a short press and
release may increase the stimulus level while
a long press and hold may decrease the
stimulus level in your hearing instrument.
Some user controls can be set for the Right
instrument to increase stimulus level and the
Left instrument to decrease stimulus level.
Ask your hearing professional if this setting
would benefit you.
Multiflex Tinnitus TechnologyMultiflex Tinnitus Technology
26 27
Adjusting Your Hearing Instrument
Your Made for iPhone hearing instrument and
TruLink
™
are compatible with iPhone 6s Plus,
iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone 5s,
iPhone 5c, iPhone 5, iPhone 4s, iPad Air 2, iPad
Air, iPad (4th generation), iPad mini 3, iPad mini
with Retina display, iPad mini, iPod touch (5th
generation) and Apple Watch. Use of Apple
Watch requires iPhone 5 or later.
To adjust your hearing instrument with
your iOS device:
• For best performance, ensure that the
iOS device is running iOS 9 or higher.
• Download the TruLink Hearing Control
app from the App Store® or use the
native iOS on your device (see Pairing
Your Hearing Instrument to the iOS
Device section on the next page).
For more detailed information on hearing
instrument functionality with the app,
open the app and touch the i icon.
Detailed instructions are located there.
Pairing Your Hearing Instrument
to the iOS Device
To adjust your hearing instrument with your
iOS device, you must ‘pair’ the two together
so they can communicate. Please follow the
instructions to ‘pair’ your iOS device and
your hearing instrument.
IMPORTANT: Before completing the following
steps, ensure Bluetooth® is enabled on your iOS
device. Within the Settings menu, go to Bluetooth
and toggle to On.
1. Locate then tap the
Settings icon
on your iOS device.
2. Within the Settings menu go to
General > Accessibility > Hearing Aids.
3. While the iOS device searches for the
hearing instrument, open and close the
battery door on your hearing instrument
(this puts the hearing instrument into
‘pairing’ mode).
Adjustment Adjustment
28 29
Adjustment Adjustment
4a. If your name does not appear in the
“Devices List” within 5-7 seconds, tap
Accessibility
in the upper left corner,
then tap
Hearing Aids.
4b. You will see your first name and
hearing aid (e.g. “Matt Hearing Aids”
or “Matthew H/As” depending on
the length of the first name) when the
iOS device first discovers the hearing
instrument.
5. Tap on the
Hearing Aid Name
to
connect the hearing instrument to the
iOS device.
6. You will see two pairing requests
(one for each hearing instrument).
Select
Pair
for each request. These
requests may be several seconds apart.
7. Pairing is complete.
30 31
Turn off
Adjust Independently
to make
changes to both hearing instruments
simultaneously.
Normal
indicates the name of a memory
setting in the
hearing instrument. You can
select from any memories shown in
the list
to change the hearing instrument to that
memory setting.
Cell Phone Use
Your hearing instrument is designed to work
with iPhone. When the hearing instrument
is paired and powered on, incoming phone
calls will route automatically to your hearing
instrument. When your hearing instrument
is not powered on, incoming calls route only
to iPhone.
Adjustment Adjustment
You are now ready to use your iOS device
to adjust your hearing instrument. You can
adjust either with the native iOS controls or
with the TruLink app.
To access the native iOS hearing instrument
controls, triple-click the
Home button
on
your iOS device. From this screen you can
adjust the volume, select memory or use
your iOS device as a remote microphone.
Select
Start Live Listen
to stream the iOS
device microphone input directly into your
hearing instrument. Point the iOS device
microphone toward the audio source. To
minimize background noise and provide the
best signal, place the iOS device as close to
the source as possible.
Right Volume/Left Volume
allows you to
increase and decrease volume for each
hearing instrument individually.
32 33
Hearing Instrument CareAdjustment
iOS allows you to select a preference for
how audio (call audio and media audio)
is routed from iPhone to your hearing
instruments.
Instrument Care
Keep your hearing instrument 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 battery
compartment; inspect the receiver,
earbud or eartip, and wax guard
regularly.
• Never use water, solvents, cleaning
fluids or oil to clean your instrument.
Your hearing professional can provide further
information on additional maintenance
procedures for your hearing instrument,
if needed.
34 35
Hearing Instrument CareHearing Instrument Care
Hear Clear™ Receiver Wax Guards
The hearing instrument integrates
disposable Hear Clear earwax protection.
The innovative wax guards prevent earwax
accumulation in the hearing instrument
receiver.
Helpful Hints
• When not wearing your hearing
instrument, open the battery door to
allow any moisture to evaporate.
• Do not take apart your hearing
instruments or insert the cleaning tools
inside them.
• When not in use, remove the batteries
completely; place your hearing
instrument in the storage container
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 pets
and children
36 37
Hearing Instrument CareHearing Instrument Care
Troubleshooting Guide
SYMPTOM POSSIBLE
CAUSES
SOLUTIONS
Not Loud
Enough
Low battery Replace battery
Blocked
earmold/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
Low battery Replace battery
Blocked
earmold/earbud
Clean or replace wax
guard as needed
Unclear,
Distorted
Performance
Low battery Replace battery
Blocked
earmold/earbud
Clean or replace wax
guard as needed
Defective hearing
instrument
Contact your hearing
professional
Dead
Low battery Replace battery
Blocked
earmold/earbud
Clean or replace wax
guard as needed
Service and Repair
If, for any reason, your hearing instrument
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 instrument 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.
38 39
Tips for Better CommunicationTips for Better Communication
Your hearing professional will recommend
an appropriate schedule to help you adapt
to your new hearing instrument. It will take
practice, time and patience for your brain to
adapt to the new sounds that your hearing
instrument provides. 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 instruments can and
cannot do
• Better hearing with hearing
instruments is a learned skill combining
desire, practice and patience
40 41
Safety 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
instrument is a wearable sound-amplifying
device intended to compensate for impaired
hearing. Hearing instruments are available
in multiple gain/output levels appropriate
to treat hearing losses ranging from
mild-to-profound.
Your hearing instruments are designed to
comply with the most stringent Standards of
International Electromagnetic Compatibility.
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 instruments
might cause interference with your medical
42 43
Safety InformationSafety Information
device, please contact your physician or the
manufacturer of your medical device for
information about the risk of disturbance.
Your hearing instruments should not be worn
during an MRI procedure or in a hyperbaric
chamber.
Your hearing instruments are classified as a
Type B applied part under the IEC 60601-1
medical device standard.
Your hearing instruments are not
formally certified to operate in explosive
atmospheres such as may be found in coal
mines or certain chemical factories.
Your hearing instruments should be
stored within the temperature and humidity
ranges of -40°C (-40°F) to +60°C (140°F)
and 10%-95% relative humidity.
Your hearing instruments are designed to
operate beyond the range of temperatures
comfortable to you, from very cold up to
50°C (122°F).
Use on Aircrafts
The wireless capabilities that may be
featured in your hearing instruments can be
used on an aircraft as hearing instruments
are exempt from the rules applied to other
personal electronic instruments on an
aircraft. Your iOS device should be put into
Airplane Mode or turned off.
International Use
Be aware that operation during international
travel may cause interference to other
electronic devices, or other electronic
devices may cause interference to your
hearing instruments.
44 45
FDA InformationFDA Information
Required 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 otorhinolaryngologists. The purpose of the medical
evaluation is to assure that all medically treatable
conditions which 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 affirming 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.
46 47
FDA InformationFDA Information
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.
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.
48 49
FDA InformationFDA Information
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.
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 following
recommendations, 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.
50 51
FDA InformationFDA Information
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 following
recommendations, 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.
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.
FDA
Inform
ation
FCC
Information
TECHNICAL DATA
Multiflex
Tinnitus Technology
Maximum Output = 87 dB
SPL
(typical)
when
m
easured
in a 2cc coupler per ANSI
S3.22
or
IEC
60118-7.
REGULATORY
NOTICES
RIC 13
FCC
ID: EOA-24HALO2R13
IC: 6903A-24HALO2R13
RIC 312
FCC
ID: EOA-24HALO2R312
IC: 6903A-24HALO2R312
FCC
Notice
52
53
54 55
NotesFCC Information
Starkey Hearing Technologies
6700 Washington Ave. South
Eden Prairie, MN 55344 USA
Wm. F. Austin House, Bramhall Technology Park
Pepper Road, Hazel Grove, Stockport SK7 5BX
United Kingdom
Waste from electronic equipment must be
handled according to local regulations.
0086
“Made for iPod,” “Made for iPhone,” and “Made for iPad”
mean that an electronic accessory has been designed to connect
specifically to iPod, iPhone, or iPad, respectively, and has
been certified by the developer to meet Apple performance
standards. Apple is not responsible for the operation of this
device or its compliance with safety and regulatory standards.
Please note that the use of this accessory with iPod, iPhone, or
iPad may affect wireless performance.
© 2016 Starkey Hearing Technologies. All Rights Reserved.
81960-007 1/16 BKLT2839-00-EE-XX
Apple, the Apple logo, iPhone, iPad, iPod touch, Apple Watch
and App Store are trademarks of Apple Inc., registered in the
U.S. and other countries.

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