Custom hearing aid operations manual

Custom
Products
ITE (In-The-Ear),
ITC (In-The-Canal),
CIC (Completely-In-Canal)
IIC (Invisible-In-The-Canal)
O P E R AT I O N S M A N U A L

Table of Contents
Overview
ITE Overview. 4
ITC Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
CIC Overview. 6
IIC Overview . 7
Preparation
Batteries . 8
Battery Indicators. 10
Insertion and Removal . 11
Operation
On & Off. 13
Volume Control. 14
Multimemory. 16
Directional Settings . 17
Telephone Use . 17
Accessories
Wireless Accessories . 20
Hearing System Care
Instrument Care . 21
Hear Clear . 22
Service and Repair . 25
Troubleshooting Guide. 25
Tips for Better Communication
For You . 26
For Your Family and Friends. 27
Safety Information. 28
FDA Information. 30
FCC Information. 32

Overview
My hearing instrument is a/an:
ITE (In-The-Ear) see page 4.
ITC (In-The-Canal) see page 5.
CIC (Completely-In-Canal) see page 6.
IIC (Invisible-In-The-Canal) see page 7.
My hearing instrument uses a:
13 battery (ITE) – Orange
312 battery (ITC) – Brown
10 battery (CIC) – Yellow
10 battery (IIC) – Yellow
3

ITE Overview
Features, Controls and Identification
Your hearing system controls include:
1. Microphone opening(s)
2. Battery compartment (on/off control)
3. Vent (optional)
4. Sound outlet (receiver) and wax protection system
Your hearing system can be identified by:
5. Location of serial number:
RED Right
BLUE Left
Multifunction
Button (Optional)
Volume Control
(Optional)
ITE Battery Size: 13
0 0- 0000 0 0 00
4
2
1
3
5
4

1. Microphone opening(s)
3. Vent (optional)
4. Sound outlet (receiver) and wax protection system
RED Right
BLUE Left
ITC Overview
0 0 - 0 0 00 0 0 0 0
Multifunction
Button (Optional)
Volume Control
(Optional)
ITC Battery Size: 312
4
2
1
3
5
5

CIC Overview
1. Multifunction button (optional)
2. Microphone opening
3. Sound outlet (receiver) and wax
protection system
5. Removal handle
6. Vent (optional)
RED Right
BLUE Left
00-00000000
CIC Battery Size: 10
2
4
1
3
5 6
7
6

IIC Overview
1. Microphone opening
2. Sound outlet (receiver)
4. Removal handle
5. Vent (optional)
Your hearing system can be identified by the white
R for the right ear and L for the left ear
and the serial number:
6. Location of serial number
1
IIC Battery Size: 10
4
2
3
5
6
7

Preparation
Batteries
Your hearing system uses a battery as its power
source. This battery size can be identified by the
orange (13), 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.
4. Line up the battery’s “+” sign (flat side of the
battery) with the “+” on the battery door.
5. Close the battery door.
8

Preparation
Battery Indicators
An indicator will sound when the battery voltage is
low. You have approximately 5 minutes* to replace the
battery. An indicator will 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.
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.
• Because of their size, it’s a good idea to change and
replace batteries above a table or desk to reduce
the risk of dropping the instrument or battery.
• Dispose of used batteries immediately in the proper
waste or recycling container.
• Because batteries can vary in size and performance,
your hearing care professional is your best source for
lifespan estimates and verification that you are using
the proper size and type.
10

Preparation
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
Insertion and Removal
To insert the hearing instrument:
1. Hold the instrument with your thumb and forefinger
on the outer edges of the case.
2. Tilt your hand slightly forward and gently insert the
canal tip of the instrument into your ear canal and
rotate the instrument backward. Softly press the
instrument into place with your fingertip.
1 2
11

Preparation
To remove the hearing instrument:
Grasp the instrument with your thumb and forefinger;
gently rotate it as you pull outward.
Devices with removal handle: grasp removal handle
and gently remove from ear.
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 care professional.
• If an actual allergic reaction occurs, alternative
materials are available; contact your hearing
care professional.
• Severe swelling, discharge from the ear, excessive
wax, or other unusual conditions warrant immediate
consultation with a physician.
12

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 instrument has a Power‑On delay and may require
a few seconds to power on. You may hear a tone series
indicating that your device is fully powered on.
13

Operation
Volume Control
My hearing instrument volume is set automatically.
See below.
My hearing instrument uses the multifunction
button for volume control. See below.
My hearing instrument has a rotary volume
control. See page 15.
Automatic Volume Control
Your hearing system has been set to a specific volume
level by your hearing care professional. If sounds are
generally too loud or too soft, please contact your
hearing care professional for advice and adjustment.
Multifunction Button – Volume Control
Your hearing system uses the button to control
volume. Press then release the button until the
desired volume level is reached. Each press/release
changes the volume one increment.
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
14

Operation
INCREASE VOLUME
decrease Volume
Volume Level Tone
(Maximum) Five beeps plus tone
Level 3 (Power on volume level) Three beeps
(Minimum) One beep plus tone
15
Volume Settings
Rotary Volume Control
Use your fingertip to rotate
the volume control.
1. To make sounds louder, continue
to rotate the control forward,
toward your face.
2. To make sounds softer, use your
fingertip to rotate the control
toward the back of your head.
Some hearing systems can be set for the Right device
to increase the volume and the Left device to decrease
the volume. Ask your hearing care professional if this
setting would benefit you.

Operation
Multimemory
My multifunction button is set for multimemory.
Please read the section below.
Your hearing care professional can
set up to four hearing programs
for you. These additional programs
are accessed by pressing the
multifunction button inward.
When you press the multifunction
button, you may hear an indicator
or a tone series indicating the device
has changed to the next program.
Ask your hearing care professional about your specific
hearing programs.
16

Operation
Directional Settings
Your hearing system may have a directional
microphone to help improve speech understanding
in noisy situations. Ask your hearing care professional
about your particular directional settings.
My hearing instruments have the following
telephone setting(s):
Automatic Telephone. See below.
Automatic Telecoil. See below.
Telecoil and Manual Switching. See page 18.
(Program # _____________________________).
17
Telephone Use
Your hearing instruments are equipped with
tools to help you effectively communicate on the
telephone. Ask your hearing professional about
your telephone solution.
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 instrument 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 instrument will
switch back to the normal listening mode.

Operation
Note: Consult with your hearing professional if your
device does not seem to switch to the telephone
setting automatically.
Telecoil and Manual Switching
Hearing instruments with a
manual telecoil allow you to
switch the devices to telephone
mode when needed.
Manually switched telecoils
are activated by choosing
the telecoil setting using the
Multifunction button.
General Telephone Use
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.
18

Operation
DISCLAIMER – Some hearing aid users have reported
a buzzing sound in their hearing aids when they are
using cell phones, indicating that the cell phone and
hearing aid may not be compatible. According to the
ANSI C63.19 standard (ANSI C63.19-2006 American
National Standard Methods of Measurement of
Compatibility Between Wireless Communications
Devices and Hearing Aids), the compatibility of
a particular hearing aid and cell phone can be
predicted by adding the rating for the hearing aid
immunity to the rating for the cell 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 of 5. Any combined rating
that equals at least 5 would provide “normal use”;
a combined rating of 6 or greater would indicate
“excellent performance.”
The immunity of this hearing aid is at least M2/T2.
The equipment performance measurements,
categories and system classifications are based upon
the best information available but cannot guarantee
that all users will be satisfied.
NOTE: The performance of individual hearing aids
may vary with individual cell phones. Therefore,
please try this hearing aid with your cell phone or,
if you are purchasing a new phone, be sure to try it
with your hearing aid prior to purchase. For additional
guidance, please ask your cell phone provider for
the booklet entitled “Hearing Aid Compatibility with
Digital Wireless Cell Phones.”
19

Accessories
Wireless Accessories*
There are several wireless accessories that allow you
to control and maximize the full potential of your
hearing system. These include a remote control as well
as wireless connection to your entertainment system.
Consult with your hearing professional to determine
which accessories may be best for you.
*Wireless accessories are only compatible with hearing aids that have wireless technology.
20

Hearing System Care
Instrument Care
Do your best to keep your hearing instrument clean at
all times. Heat, moisture and foreign substances can
result in poor performance.
• Clean daily over a soft cloth to prevent damage from
a fall to a hard surface.
• Use a cleaning brush to clean debris from around
the microphone, receiver and battery compartment.
• Never use water, solvents, cleaning fluids or oil to
clean your instrument.
Your hearing care professional can provide further
information on additional maintenance procedures
for your hearing system if needed.
Helpful Hints
• When not wearing your hearing instruments, open
the battery door to allow any moisture to evaporate.
• When not in use, remove the batteries completely;
place your hearing system 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 of pets and children
• Do not take apart your hearing instruments or insert
the cleaning tools inside them.
21

Hearing System Care
Wax Guard
Hear Clear™
The Hear Clear exclusive
earwax protection system
uses disposable wax
guards. The innovative
wax guards prevent
earwax accumulation in
the hearing aid receiver.
Hear Clear Plus
The Hear Clear Plus microphone cover protects the
microphone from wax and debris. Your hearing care
professional will instruct you on maintenance of the
microphone cover.
There are two sizes of microphone cover: one is small
and one is large. The size of the microphone cover
determines the method for removing and replacing.
22

Hearing System Care
Small
Microphone Cover – Small
Guard
PKGS2603-01-EE-XX 81060-007 2/13 Rev. B
© 2013 All Rights Reserved.
23

Hearing System Care
Service and Repair
If, for any reason, your hearing system 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 system fail or perform poorly,
check the guide below for possible solutions. If
problems continue, contact your hearing care
professional for advice and assistance.
Troubleshooting Guide
Symptom Possible
Causes
Solutions
Not Loud
Enough
Low battery Replace battery
Wax or debris in
the microphone
or receiver
Clean both microphone
and receiver with brush
Change wax prevention
system
Hearing change Contact your hearing
care professional
Inconsistent
Performance
Unclear,
Distorted
Performance
Defective hearing
instrument
Contact your hearing
care professional
Dead
Wax or debris in
the microphone
or receiver
Clean both microphone
and receiver with brush.
Change wax prevention
system.
25

Your hearing care professional will recommend an
appropriate schedule to help you adapt to your new
hearing system. It will take practice, time and patience
for your brain to adapt to the new sounds that your
hearing system 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
26

27
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
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 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 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 fully certified to
operate in explosive atmospheres that may be found
in coal mines or certain chemical factories.
28

Safety Information
Your hearing instruments should be stored
within the temperature and humidity ranges of
-40oC (-40oF) to +60oC (140oF) and 10%-95% rH.
Your hearing instruments are designed to operate
beyond the range of temperatures comfortable to you,
from very cold up to 50oC (122oF).
Use on Aircraft*
The optional wireless capabilities that may be featured
in your hearing instruments should not be used on
an aircraft unless specifically permitted by the flight
personnel. Your hearing care professional can enable
a special program that allows your hearing aids to work
without wireless functionality.
International Use*
The optional wireless capabilities that may be featured
in your hearing instruments 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 devices, or other electronic devices may
cause interference to your hearing instruments.
*Applies to wireless hearing instruments only.
29

FDA 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 otorhynolaryngologists.
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.
30

FDA 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.
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.
31

FCC Information
Regulatory Notices
FCC ID: EOA-IRIS-HA
IC: 6903A-IRISHA
FCC Notice
This device complies with part 15 of the FCC rules and with RSS-210.
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 wireless
custom product family is in compliance with the essential requirements
and other relevant provisions of Directive 1999/5/EC. A copy of the
Declaration of Conformity can be obtained from the below addresses.
Starkey Hearing Technologies
6600 Washington Ave. South
Eden Prairie, MN 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
320086

Custom hearing aid operations manual

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