Starkey Hearing Technologies RIC 10, Micro RIC 312, RIC 312 Operation Manual

Standard
Products

OPERATIONS MANUAL

RIC (Receiver-in-Canal)

Select Hearing Aid

Select Hearing Aid Controls

 Automatic Volume Control p. 14

 Adjustable Volume Control p. 14

 Multimemory p. 16

 Combined Volume and

Multimemory Control p. 17

Size 10 Battery - Yellow

Size 312 Battery - Brown

Size 312 Battery - Brown

Size 312 Battery - Brown

Size 312 Battery - Brown

 

 



Table of Contents

Overview

RIC 10 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Micro RIC 312 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . 5

RIC 312 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Preparation

Batteries/Battery Indicators . . . . . . . . . . . . . . . . . . . . . . . . .8

Tamper Resistant Battery Compartment . . . . . . . . . . . . . 10

Insertion and Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Operation

On & Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Volume Control/Volume Settings . . . . . . . . . . . . . . . . . . 14

Multimemory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Telephone Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Manual Switching . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Direct Audio Input (DAI) . . . . . . . . . . . . . . . . . . . . . . . . . 19

Multiflex Tinnitus Technology . . . . . . . . . . . . . . . . . . . . . . 21

Accessories

Wireless Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Hearing Aid Care

Hearing Aid Care/Hear Clear . . . . . . . . . . . . . . . . . . . . . 24

Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Tips for Better Communication

� � � � � � � � � � � � � � � � � � � � � � � 29

Regulatory Information

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

FDA Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

FCC Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

4 | RIC 10 Overview

Features, Controls and Identification

Your hearing aid controls include:

1. Hearing aid

2. Cable

3. Receiver

4. Microphones

5. Control Surface Switch

6. Battery Compartment
(on/off control), Location of
serial number, Location of
left/right side hearing aid indicator

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. Custom Earmold
(optional)

12. RIC Custom
Power
Earmold
(optional)

1

2

4

5

3

6

8

7

9

10

11

12

Micro RIC 312 Overview | 5

Features, Controls and Identification

Your hearing aid controls include:

1. Hearing Aid

2. Cable

3. Receiver

4. Microphones*

5. Push Button Switch or
Rotary Volume Control

6. Battery Compartment (on/off control),
Location of serial number, Location
of left/right side hearing aid indicator

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. Custom Earmold
(optional)

12. RIC Custom
Power
Earmold
(optional)

*Look may vary

IMPORTANT NOTE: The micro RIC 312 includes a Multiflex Tinnitus Technology feature that
can be enabled.

11

12

1

3

5

2

4

9

7

10

6

8

6 | RIC 312 Overview

Features, Controls and Identification

Your hearing aid controls include:

1. Hearing aid

2. Cable

3. Receiver

4. Microphones

5. Rocker Switch

6. Battery Compartment
(on/off control), Location of
serial number, Location of
left/right side hearing aid indicator

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. Custom Earmold
(optional)

12. RIC Custom
Power
Earmold
(optional)

11

12

10

8

6

7

9

3

2

4

1

5

RIC 312 Overview | 7

Features, Controls and Identification

Your hearing aid controls include:

1. Hearing Aid

2. Cable

3. Receiver

4. Microphones

5. Push Button Switch

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. Custom Earmold

12. RIC Custom
Power Earmold
(optional)

11

12

3

2

4

1

5

10

8

6

7

9

8 | Preparation

Batteries

Your hearing aid uses a battery as its power source.
This battery size can be identified by the brown (312)
or yellow (10) 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 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 five minutes

*

to replace
the battery. 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 brand of battery used.

Preparation | 9

21

4

3

5

10 | Preparation

Tamper Resistant Battery Compartment

To lock the battery door:

Use an appropriate tool to slide the recessed switch to
the left until it “clicks” and the colored mark is visible.

To unlock the battery door:

Slide the recessed switch to the right until it “clicks”
and the colored mark disappears.

Locking the door is not required for operation.

My hearing aid has a tamper resistant

battery compartment. See below.

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: [phone]

Preparation | 11

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.

12 | 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.

1

2

3

Preparation | 13

Helpful Hints

• Minor irritation and 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.

14 | Operation

On & Off

To turn ON: Insert a battery and completely close

the battery door.

To turn OFF: Open the battery door until the

battery is no longer touching the
battery contacts.

Your hearing aid has a Power-On delay and may
require a few seconds to power on. You may hear
a tone series indicating that your hearing aid is
fully powered on.

Volume Control

Automatic Volume Control

Your hearing aid 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 professional for advice and adjustment.

Adjustable Volume Control

Push Button/Control Surface Volume Control

Your hearing aid uses the control surface/push
button to control volume. To change volume,
press then release the control surface/push
button.

Operation | 15

Rocker Switch Volume Control

Your hearing aid uses the rocker
switch to control volume. To
increase volume, press then
release the top part of the
switch. To decrease volume,
press then release the bottom
part of the switch.

Rotary Volume Control

Your hearing aid uses a rotary volume
control to adjust volume. Turn the
wheel up (higher number) to increase
volume. Turn the wheel down (lower
number) to decrease volume.

Volume Settings

Some hearing aids can be set for the right hearingaid
to increase the volume and the left hearingaid to
decrease the volume. Ask your hearing professional if
this setting would benefit you.

16 | Operation

Push Button/Rocker Switch/Control Surface
Volume Control

Rotary Volume Control

Multimemory

Your hearing professional may be able to set up to
four hearing programs for you. These additional
programs are accessed by pressing the control
surface/push button/rocker switch.

When you press the control surface/push button/rocker
switch, you may hear an alert indicating the hearing aid
has changed to the next program. Ask your hearing
professional about your specific hearing programs.

Volume Level Tone

Optimal volume setting One beep

Volume Level Tone

Level 5 (More volume)

Five beeps
plus tone

Level 4 Four beeps

Level 3 (Power on volume level) Three beeps

Level 2 Two beeps

Level 1 (Less volume)

One beep
plus tone

Operation | 17

Combined Volume and Multimemory
Control

Your hearing aid is set up to adjust volume and
programs. To adjust volume, press then release
the switch. To change programs, press and hold
the switch. The hearing aid will cycle through the
programs and present indicators. Release the switch
when you are at the desired program.

Telephone Use

Some hearing aids are equipped with
tools to help you effectively communicate on the
telephone. Ask your hearing professional about your
telephone solution.

My hearing aids have the following
telephone setting(s):

Automatic Telephone. See next page.

Automatic Telecoil. See next page.

Telecoil and Manual Switching.

(Program # ____________________ ).

None

18 | Operation

Automatic Telephone and
Automatic Telecoil

These options activate the telephone response
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 select the telephone setting. 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 normal listening
mode.

NOTE: Consult with your hearing professional if your

hearing aid does not seem to switch to the telephone
setting automatically.

Manual Switching

Manual switching allows you
to switch the hearing aids to
telephone mode when needed.

Ask your hearing professional
which program you should access
for manual telephone use.

General Telephone Use

Some hearing aids work best
by holding the phone close to,

Operation | 19

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.

Direct Audio Input (DAI)

Your hearing aid has full direct audio input (DAI)
capability. This allows you to connect your hearing
aid to an electronic sound source such as a wireless
FM system, computer audio or an MP3 player. DAI
can improve communication and sound quality
when reverberation, distance and background noise
compete with what you want to hear.

My hearing aid is set up for DAI use.

My hearing aid is not set up for DAI use.

See page 23.

20 | Operation

To attach the DAI shoe:

Snap the DAI shoe on the bottom
of the RIC.

To access the battery with
the DAI shoe attached:

Hold the RIC and DAI shoe and
press the lower part of the DAI
shoe, then open the battery door.

To remove the
DAI shoe:

Turn the RIC on the side. Grasp
the RIC in one hand and the DAI shoe in the other.
Gently bend at the seam between the DAI shoe and
the hearing aid.

There are many FM systems available to help improve
communication in challenging environments. Ask your
hearing professional about personal FM systems.

Multiflex Tinnitus Technology | 21

Introduction

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. 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.

Multifunction Switch

Your switch can be set to perform different functions.
Ask your hearing professional how your hearing aid is
set.

Tinnitus Stimulus Control

Your hearing aid uses the multifunction switch to
control the tinnitus stimulus. Press then release the
switch until the desired level is reached. Each press/
release changes the volume one increment.

My hearing aid uses the switch for

tinnitus stimulus control. See below.

My hearing aid has combined volume

and tinnitus stimulus control. See next page.

My hearing aid has combined

multimemory and tinnitus stimulus control.
See next page.

22 | Multiflex Tinnitus Technology

Combined Volume or Multimemory
and Tinnitus Stimulus Control

If your hearing aid is set up to adjust volume
and tinnitus stimulus, adjust volume by pressing
then releasing the switch until the desired volume
level is reached.

If your hearing aid is set up to adjust multimemory
and tinnitus stimulus, adjust memory by pressing then
releasing the switch until the desired memory
is reached.

To adjust the tinnitus stimulus, press and hold the
switch. The hearing aid will cycle through the tinnitus
stimulus levels. Release the switch when you are at
the desired level.

Accessories | 23

Wireless Accessories

*

There are several wireless accessories that allow
you to control and maximize the full potential of
your hearing aid. These include a remote control as
well as wireless connection to your cell phone and
entertainment system. Consult with your hearing
professional to determine if your hearing aids have
wireless capabilities and which accessories may be
best for you.

* Wireless accessories are only compatible with hearing aids that have wireless

technology.

24 | Hearing Aid Care

Hearing Aid Care

Do your best to keep your hearing aid clean at all
times. Heat, moisture and foreign substances can
result in poor performance.

• Use a cleaning brush or soft cloth to clean debris
from around the switches, microphone and
battery compartment; inspect the receiver or
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 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.

Hearing Aid Care | 25

1 2

3

4

26 | Hearing Aid Care

Helpful Hints

• When not wearing your hearing aid, open the
battery door to allow any moisture to evaporate.

• 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 or heat to

avoid extreme temperatures

– Where you can easily find them

– Safely out of reach from children and pets

• Do not take apart your hearing aids or insert the
cleaning tools inside them.

Hearing Aid Care | 27

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/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

Low battery Replace battery

Blocked
earmold/tubing/
earbud

Clean or replace wax
guard as needed

Unclear,
Distorted
Performance

Low battery Replace battery

Blocked
earmold/tubing/
earbud

Clean or replace wax
guard as needed

Defective
hearing aid

Contact your hearing
professional

Dead

Low battery Replace battery

Blocked
earmold/tubing

Clean or replace wax
guard as needed

Crimped tubing

Contact your hearing
professional

28 | Hearing Aid Care

Tips for Better Communication | 29

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

30 | 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

*Applies to wireless hearing aids only.

Regulatory Information | 31

Safety Information

INTENDED USE: An air conduction hearing aid is a wearable sound-

amplifying device that is 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 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 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 not formally certified to operate in explosive
atmospheres such as may be found in coal mines or certain chemical factories.
Your hearing aids are classified as a Type B applied part under the IEC 60601-1
medical device standard.

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% rH.

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 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.

32 | 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.

Regulatory Information | 33

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.

34 | 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 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.

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 C63.19­2007 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 rating of 6 or greater would indicate
“excellent performance”. See the Product Card included with your hearing aid
for the exact M/T rating of your hearing aid.

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.

Regulatory Information | 35

For hearing care 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.

DEVICE 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 device, or as a
hearing aid and tinnitus treatment device.

When enabled, the Multiflex Tinnitus Technology generates the sound and allows
a patient’s hearing care professional to design and program appropriate settings
for an individually prescribed sound treatment plan. The treatment plan should
be used in a tinnitus management program for relief of tinnitus.

Multiflex Tinnitus Technology generates a broadband white noise signal that
varies in frequency and amplitude. These characteristics are adjustable by the
hearing care professional and are specific to the prescribed therapy designed by
the professional for the patient’s needs and comfort.

The patient may have some control of the level or volume of the signal and the
patient should discuss this adjustment as well as his or her comfort level and
sound of the signal with their hearing care professional.

WARNING 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.

36 | Regulatory Information

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 device 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 device is an electronic device 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 care 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 aids
in your state.

The use of any sound generating tinnitus therapy device should be only on the
advice and in consultation with your audiologist or hearing care practitioner.
Your hearing care professional will properly diagnose and fit the device to your
personal needs and requirements. This should include its use in a prescribed
tinnitus treatment program.

Your hearing care professional will also be able to offer the appropriate follow-up
care. It is important that you follow your hearing care professional’s advice and
direction regarding such care.

WARNING: There are some potential concerns associated with the use of

any sound generating tinnitus therapy device. 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 device.

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 device and seek a consultation with a medical, audiology,
or other hearing care professional.

Regulatory Information | 37

As with any device, misuse of the tinnitus therapy device could present some
potentially harmful effects. Care should be taken to prevent the unauthorized
use and to keep the device 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 aid
for more than sixteen (16) hours a day if your hearing aid is set at the maximum
output level, nor should you use your hearing aid if your hearing care professional
has set the hearing aid at levels that exceed your comfort level.

Important notice for prospective sound
generator users

Good health practice requires that a person with tinnitus have a medical
evaluation by a licensed physician (preferably a physician who specializes in
diseases of the ear) before using a sound generator. Licensed physicians who
specialize in diseases of the ear are often referred to as otolaryngologists,
otologists, or otorhinolaryngologists.

The purpose of a medical evaluation is to assure that all medically treatable
conditions that may affect tinnitus are identified and treated before the sound
generator instrument is used.

TECHNICAL DATA

Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when
measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7.

38 | Regulatory Information

WIRELESS TECHNICAL DESCRIPTION

Your hearing aids may contain a radio transceiver operating in the 902-928 MHz
(North America) or 863-865 MHz (EU) frequency band with a maximum effective
radiated power of -20 dBm with transmission modulation type of 342KFXD. The
receiver section of the radio has a bandwidth of 300 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 3 V/m between 80 MHz and 2.7 GHz.

• Immunity to power frequency magnetic fields at a field level of 3 A/m.

• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV
air discharge.

REGULATORY NOTICES

FCC ID: EOA-ZSERIES-HI IC: 6903A-ZSERIESHI

FCC ID: EOA-3SER312 IC: 6903A-3SER312

FCC ID: EOA-IRIS-HA IC: 6903A-3SER312

Regulatory Information | 39

Waste from electronic equipment
must be handled according to
local regulations

Consult Operations Manual

FCC Notice

This device complies with part 15 of the FCC rules and with ISED Canada
license-exempt RSS standard(s). 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 of the device.

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.

Hereby, Starkey Hearing Technologies declares that the products listed at
docs.starkeyhearingtechnologies.com are 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 below addresses or
from docs.starkeyhearingtechnologies.com.

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

© 2018 Starkey Hearing Technologies. All Rights Reserved.

86141-007 4/18 BKLT2993-00-EE-XX