Starkey Laboratories 24LIVIOR312 Livio User Manual
Starkey Laboratories Inc Livio
user manual
Standard
Products
OPERATIONS MANUAL
Smartphone Compatible
RIC (Receiver-In-Canal)
Table of Contents
Hearing Aid
Hearing Aid Controls
Rocker Switch Controls p. 12
Size 312 Battery - Brown
Overview
RIC 312 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Preparation
Batteries/Battery Indicators . . . . . . . . . . . . . . . . . . . . . . . . 6
Insertion and Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Operation
Power On & Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
User Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Volume Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Volume Control Indicators . . . . . . . . . . . . . . . . . . . . . . . . 13
Memory Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Mute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Multiflex Tinnitus Level Control . . . . . . . . . . . . . . . . . . . . 14
Activity Tracking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Directional Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Telephone Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Multiflex Tinnitus Technology . . . . . . . . . . . . . . . . . . . . . . . . 17
Adjustment
Pairing with an iOS Device . . . . . . . . . . . . . . . . . . . . . . . 18
Mobile Phone Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Pairing with an Android Device . . . . . . . . . . . . . . . . . . . . 20
Hearing Aid Care
Hearing Aid Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Tips for Better Communication � � � � � � � � � � � � � � � � � � � � � � � 26
Regulatory Information
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
FDA Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
FCC Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
11
12
RIC 312 Overview | 5 4 | RIC 312 Overview
Features, Controls and Identification
Your hearing aid controls include:
1. Hearing aid
2. Cable
3. Receiver
4. Microphone
5. Rocker switch (user control)
6. Battery compartment (on/off control), location of
serial number
7. Location of manufacturer’s name and
model name
8. Location of left/right side receiver indicator
9. Instant fit earbud
10. Location of left/right side hearing aid indicator
11. Custom earmold (optional)
12. RIC custom power earmold (optional)
13. Retention lock
42
1
5
3
13
13
7
10
6
8
9
Preparation | 7 6 | Preparation
Batteries
Your hearing aid uses a battery as its power
source. The battery size can be identified by the
brown(312)colorcode on the packaging.
To insert or replace the battery:
1. Use the finger pick on the battery door.
2. Open the battery door gently and remove the
old battery.
3. Remove the colored tab from the new battery.
Wait 3-5 minutes after removing tab before
inserting battery.
4. Align the battery’s “+” sign (flat side of the
battery) with the “+” on the battery door.
5. Close the battery door.
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.
21
4
3
5
* Actual time between low battery indicator and shut down will vary depending on
environmental noise levels and brand of battery used.
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
Preparation | 9 8 | Preparation
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.
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.
1
2
3
Operation | 11 10 | 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
To turn ON:
Insert a battery and completely close the battery
door. Your hearing aid has a power-on delay which
may require a few seconds. You may hear a tone
indicating that your hearing aid is powered on.
To turn OFF:
Open the battery door until the battery is no longer
touching the battery contacts.
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 aid
can respond differently depending
on how long you activate (press) the
button. Your hearing aid is capable
of having one function assigned
to a short press (press and release)
and one function assigned to a long press
(pressandhold). The options selected on the next
page indicate how your particular user controls
areconfigured.
Tap Gesture
Your hearing aid may support an
additional user control. This
control can be configured by your
hearing professional to start/stop
streamed audio from a Starkey
Hearing Technologies accessory
by tapping your eartwice.
Operation | 13 12 | Operation
Volume
Control
Memory
Change Mute Multiflex
Tinnitus Level
Balance
Control
Short Press
(Press and Release)
Long Press
(Press and Hold)
Tap Gesture*
Assigned User Control Settings
*Hearing aid may support
Volume Control
Power On Volume Level
Your hearing aid has been set to a specific volume
level (VolumeHome) determined by your hearing
professional. If sounds are generally too loud or too
soft, please contact your hearing professional for
advice and adjustment.
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.
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 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.
Volume Level Tone
*
Volume Max 5 Beeps •••••
Volume Step(s) Short Tone –
Volume Home
(Power on volume level)
3 Beeps •••
Volume Step(s) Short Tone –
Volume Min Single Beep —
Operation | 15 14 | Operation
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.
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 (page22) for
further information.
Activity Tracking
Your hearing aid may support a sensor that is capable
of tracking daily physical activity and reporting it to
the Thrive Hearing Control app. This feature can be
used to view daily step count, minutes of activity and
to obtain reminders to get up and move throughout
the day. Physical activity is a component of your
Thrivescore.
Directional Settings
Your hearing aid 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
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.
My hearing aids have the following landline
telephone setting(s):
Automatic telephone memory. See next page.
Manual telephone memory. See page 20.
(Memory # _________________ ).
None
Multiflex Tinnitus Technology | 17 16 | Operation
Manual Telephone Memory
Manual access allows you to switch the hearing
aids into a telephone memory, as needed. Ask
your hearing professional which memory you
should access for manual telephone use.
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.
Introduction
Multiflex Tinnitus Technology can be used as part
of a tinnitus treatment program. Multiflex Tinnitus
Technology plays a tinnitus stimulus through the
hearing aid. 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
Adjustment | 19 18 | Adjustment
Pairing Your Hearing Aid with an iOS Device
To adjust your hearing aid 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 aid.
1. Ensure Bluetooth® is enabled on your iOS
device. Within the Settings menu go to
Bluetooth and toggle to On.
2. Locate, then tap the Settings icon on your
iOS device.
3. Within the Settings menu go to General >
Accessibility > MFi Hearing Devices.
4. While the iOS device searches for the hearing
aids, open and close the battery door on your
hearing aids. This puts the hearing aids in
pairing mode.
• You will see your hearing aid name (e.g. “Chris
Hearing Aids”) when the iOS device first
discovers your hearing aids.
• If your name does not appear in the “Devices”
list within 5-7 seconds, tap Accessibility in the
upper left corner, then tap MFi Hearing Devices.
You are now ready to use your iOS device to adjust
your hearing aid. You can adjust either with the native
iOS controls or withThrive Hearing Control.
To access the native iOS hearing aid 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 aid. 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 aid individually.
Turn off Adjust Independently to make changes to
both hearing aids simultaneously.
Normal indicates the name of a memory setting in
the
hearing aid. You can select from any memories
shown in
the list to change the hearing aid to that
memory setting.
Adjustment | 21 20 | Adjustment
Mobile Phone Use
Your hearing aid is designed to work with a
smartphone. When the hearing aid is paired and
powered on, incoming phone calls will route
automatically to your hearing aid. When your hearing
aid is not powered on, incoming calls route only to
your smartphone.
iOS allows you to select a preference for how audio
(call audio and media audio) is routed from your
smartphone to your hearing aids.
Pairing Your Hearing Aid with an
Android Device
To adjust your hearing aid with your Android
device, you must pair the two together so they
can communicate. Please follow the hearing aids
to pair your device and your hearing aid.
1. Locate, then tap the Settings icon on
your device.
2. Select Bluetooth.
3. In this screen, if Bluetooth appears Off, change
the settings to On. Then, open and close the
battery door on your hearing aids (this puts your
hearing aids into pairing mode).
4. Under Paired devices you will see your first name
followed by hearing aid (e.g. Michelle H/As) when
the device first discovers the hearing aids. If your
name does not appear in the “Devices” list within
5-7 seconds, tap Accessibility in the upper left
corner, then tap Hearing Devices.
5. Tap the hearing aid name to connect each
hearing aid to the device.
6. Pairing is complete.
Hearing Aid Care | 23 22 | Accessories
Accessories
There are several accessories that allow you to control
and maximize the full potential of your hearing aids.
Available functionality includes:
• Ability to adjust your hearing aids using a remote
control
• Ability to transmit television audio directly to your
hearing aids
• Ability to transmit remote microphone audio
directly to your hearing aids
Consult with your hearing professional to determine
which accessories may be best for you.
Hearing Aid Care
Keep your hearing aid 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 and wax guard regularly.
• Never use water, solvents, cleaning fluids or
oil to clean your hearing aid.
Your hearing professional can provide further
information on additional maintenance procedures
for your hearing aid, 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 these instructions:
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
Hearing Aid Care | 25 24 | Hearing Aid Care
1 2
3
4
Helpful Hints
• When not wearing your hearing aid, open the
battery door to allow any moisture to evaporate.
• Do not take apart your hearing aids or insert
the cleaning tools inside them.
• When not in use, remove the batteries
completely; place your hearing aid in the storage
container and store:
– In a dry, safe place
– Away from direct sunlight and heat
to avoid extreme temperatures
– Where you can easily find them
– Safely out of reach from children
and pets
Service and Repair
If, for any reason, your hearing aid does not operate
properly, do NOT attempt to fix it yourself. Not only
are you likely to violate any applicable warranties or
insurance, you could easily cause further damage.
Should your hearing aid fail or perform poorly, check
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.
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
Hearing aid
needs repair/
maintenance
Contact your hearing
professional
Dead
Low battery Replace battery
Blocked
earmold/earbud
Clean or replace wax
guard as needed
Tips for Better Communication | 27 26 | Hearing Aid Care
Your hearing professional will recommend an
appropriate schedule to help you adapt to your
new hearing aid. It will take practice, time and
patience for your brain to adapt to the new sounds
that your hearing aid 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 aids can and cannot do
• Better hearing with hearing aids is a learned skill
combining desire, practice and patience
Regulatory Information | 29 28 | Tips 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 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 aids 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 aids can be
used on an aircraft as hearing aids are exempt from the rules applied to other
personal electronic devices on an aircraft. Your smartphone device should be
put into Airplane Mode or turned off.
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.
Regulatory Information | 31 30 | Regulatory Information
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.
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
HEARINGAIDUSERS
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 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.
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.
Special care should be exercised in selecting and fitting a hearing aid whose
maximum sound pressure level exceeds 132 decibels because there may be risk in
impairing the remaining hearing of the hearing aid user.
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 Devices and Hearing Aids), the compatibility of a particular
hearing aid and mobile phone can be predicted by adding the rating for the hearing
aid immunity to the rating for the mobile phone emissions. For example, the sum of
a hearing aid rating of 2 (M2/T2) and a telephone rating of 3 (M3/T3) would result in
a combined rating that equals at least 5 would provide “normal use;” a combined
Regulatory Information | 33 32 | Regulatory Information
rating of 6 or greater would indicate “excellent performance”. See the Quick
Start Guide included with your hearing aid for the exact M/T rating of your
hearingaid.
CAUTION:
If set to the maximum output level and worn for periods of time
exceeding the recommendations below, your exposure to sound energy has the
potential to exceed noise exposure limits. You should not use your hearing aid for
more than sixteen (16) hours a day if your hearing aid is set at the maximum output
level, nor should you use your hearing aid if your hearing professional has set the
hearing aid at levels that exceed your comfort level.
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.
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.
34 | Regulatory Information
Regulatory Information |
35
PRESCRIPTION USE
ONL
Y
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 aids in your state.
The use of any sound generating tinnitus therapy instrument should be only on
the advice and in consultation with your audiologist or hearing care 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 o
any sound generating tinnitus therapy instrument. Among them are the potentia
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.
TINNITUS TECHNICAL
DA
T
A
Multiflex Tinnitus Technology Maximum Output = 87 dB
SPL (typical)
when
measured in a 2cc coupler per ANSI
S3.22
or
IEC
60118-7.
WIRELESS
TECHNICAL DESCRIPTION
Your hearing aids contain a radio transceiver utilizing Bluetooth® Low
Energy wireless technology operating in the 2.4-2.4835 GHz frequency
band with a maximum effective radiated power of 2 dBm using GFSK
transmission modulation. The receiver section of the radio has a bandwidth
of 1.5 MHz. They also contain a radio transceiver utilizing Near Field
Magnetic Induction operating on 10.281 MHz with maximum induced
magnetic field strength of -5 dBuA/m at a measurement distance of 10
meters with 8-DPSK transmission modulation. The receiver section of the
NFMI radio has a bandwidth of 400 kHz.
This hearing aid model
has
been tested to, and
has passed,
the following
emissions
and immunity tests:
•
IEC
60601-1-2 radiated
emissions
requirements for a Group 1
Class
B device as
stated in
CISPR
11.
•
RF
radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz
as well as higher field levels from communication devices as stated in Table 9
of
IEC
60601-1-2.
•
Immunity to power frequency magnetic fields at a field level of 30 A/m.
•
Immunity to
ESD
levels of +/- 8 kV conducted discharge and +/- 15 kV
air discharge.
Hereby,
Starkey
Hearing Technologies
declares
that the products listed above
ar
e in
compliance with the
essential
requirements and other relevant provisions of
Directive 2014/53/EU. A copy of the Declaration of Conformity can be obtained
from the
addresses
on the following page or docs.starkeyhearingtechnologies.com
WIRELESS
NOTICES
FCC ID: EOA-24LIVIOR312
IC: 6903A-24LIVIOR312 (Livio RIC 312, Via RIC 312, AGXsliv RIC 312, Circa
RIC 312, Livio AI RIC 312, Via AI RIC 312, AGXsliv AI RIC 312, Circa AI
RIC 312)
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.
FCC
NOTICE
This device complies with part 15 of the FCC rules and with
ISED
Canada
license-exempt
RSS standards.
Operation is subject to the following two
conditions:
(1) This
device may not
cause
harmful interference, and
(2)
this device
must accept any interference received, including interference that
may
cause
undesired operation.
NOTE: The manufacturer is not responsible for any radio or TV interference
caused by unauthorized modifications to this equipment.
Such
modifications
could void the
user’s
authority to operate the equipment.
36 | Regulatory
Information
Notes
Note FCC/IC
Cet
appareil est conforme
à la partie 15
des règles
de la
FCC
et
avec les
normes
RSS
de
licence d’Industrie Canada.
Le
fonctionnement est soumis
à
deux conditions: (1)
Cet
appareil
ne doit
pas causer d’interférences
nuisibles
et
(2)
cet
appareil
doit
accepter
toute
interference reçue,
y
compris les interférences
qui
peuvent causer des fonctionnements
du
dispositif.
NOTE: Le
manufacturier n’est pas responsable
de l’interférence
créée
par la
modification
de cet
équipement lors
de l’écoute
du
téléviseur
ou de la radio. De
telles modifications
pourraient
entrainer
la
révocation
de l’autorité de
l’utilisateur
à opérer cet
équipement.
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
r
egulations
Consult Operations Manual
NotesNotes
© 2018 Starkey Hearing Technologies. All Rights Reserved.
86158-007 4/18 BKLT3005-00-EE-XX
Use of the Made for Apple badge means that an accessory has been designed
to connect specifically to the Apple product(s) identified in the badge, 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.
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. App Store is
a registered service mark of Apple Inc.