Starkey IIC NW Invisible-In-Canal Non-Wireless User Manual
- June 4, 2024
- Starkey
Table of Contents
IIC NW Invisible-In-Canal Non-Wireless
Custom Products
OPERATIONS MANUAL
IIC NW (Invisible-In-Canal Non-Wireless)
Table of Contents
Hearing Aid
IIC NW
Overview IIC NW Overview 3
Preparation Batteries/Battery Indicators 4 Insertion and Removal 7
Operation Power On & Off 9 Telephone Use 10 Adjustments Using T2 Remote 11
Troubleshooting Guide 12
Multiflex Tinnitus Technology 13 Hearing Aid Care
Hearing Aid Care 14 IIC NW Microphone Cleaning 16 Service and Repair 19
Troubleshooting Guide 20
Tips for Better Communication . . . . . . . . . . . . . . . . . . . . . . . 21
Regulatory Information
Safety Information 23 FDA Information 24 FCC Information 29
IIC NW Overview | 3
Features, Controls and Identification
Your hearing aid controls include: 1 Microphone 2 Battery compartment (on/off
control) 3 Vent (optional) 4 Sound outlet (receiver) 5 Removal handle
Your hearing aid can be identified by: 6 Location of serial number 7 Side
indicator R for Right, L for Left 8 White dot indicates the top of the
hearing aid
7
8
6 1
4
2
3
5
IIC NW Battery Size: 10
4 | Preparation
Batteries
Your hearing aid uses a battery as its power source The battery size can be
identified by the yellow (10) color code 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 35 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 | 5
1
2
3
4
5
6 | 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
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 | 7
Insertion and Removal
To insert the hearing aid:
1 Hold the hearing aid with your thumb and forefinger on the outer edges of the case
2 Tilt your hand slightly forward
1
and gently insert the canal tip
of the hearing aid into your
ear canal and rotate the
hearing aid backward Softly
press the hearing aid into
place with your fingertip
To remove the hearing aid:
2
Grasp the hearing aid with your
thumb and forefinger; gently rotate
it as you pull outward
For hearing aids with removal handle: grasp removal handle and gently remove from ear
8 | 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
Operation | 9
Power On & Off
To turn ON: Insert a battery and completely close the battery door Your
hearing aid has a poweron delay that allows you time to insert your hearing
aid into your ear You may hear a tone indicating that your hearing aid is
powering on
To turn OFF: Open the battery door until the battery is no longer touching the
battery contacts
10 | Operation
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
Operation | 11
Adjustments using T2 Remote
You may use a cell phone, cordless telephone, or corded telephone to adjust
your hearing system The telephone MUST “beep” when the keys are pressed for
this function to work
· Hold the phone approximately 3 inches from the ear
· Press ** to “wake” T² (a tone series indicates that it is ready for a
command)
· T² will “sleep” after 20 seconds
· Press the telephone key that corresponds to the desired function
Use the following keypad buttons to remotely adjust your hearing aid settings.
Volume
Memory Volume
Memory
Press 2 times to wake
Mute
12 | Operation
Troubleshooting Guide
SYMPTOM POSSIBLE CAUSES
SOLUTIONS
Telephone keys Consult telephone
not emitting beep operator’s manual to
tones
enable beep tones
Hearing system not responding to telephone command
T2 not unlocked Press ** and listen for prior to command unique T2 indicator
Telephone too far from hearing system
Bring telephone closer to hearing system microphone
Incorrect key command
Press ** to wake then press 2 or 8 to increase or decrease volume or 4 or 6 to change programs if device has multiple programs
Hearing system responded but won’t respond to later command
T2 automatically “sleeps” 20 seconds after last command
Press ** to wake then press key that corresponds to desired action
Multiflex Tinnitus Technology | 13
Multiflex Tinnitus Technology
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
14 | Accessories
Hearing Aid Care
Keep your hearing aid 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 hearing aid
Your hearing professional can provide further information on additional
maintenance procedures for your hearing aid, if needed
Hearing Aid Care | 15
Helpful Hints · When not wearing your hearing aids, 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 or heat to avoid extreme
temperatures Where you can easily find them Safely out of reach of
children and pets
16 | Hearing Aid Care
IIC NW Microphone Cleaning
Your hearing aid microphone is hidden alongside the battery door It is
important that the battery door be kept clean and free from wax and debris to
prevent damage to the microphone
Open the battery door and clean the acoustic recess on the battery door with a
small brush Be sure to brush away from the center of the battery door (toward
the outside)
Hearing Aid Care | 17
Hear Clear Receiver Wax Guards
The hearing aid integrates 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 empty end of the application stick straight into used wax guard in
hearing aid
2 Pull straight out (do not twist) on stick to remove used wax guard
3 Use opposite end of stick to firmly insert clean wax guard straight into
hearing aid
4 Pull straight out (do not twist) to remove stick and discard
18 | Hearing Aid Care
1
2
3
4
Hearing Aid Care | 19
Small Microphone Cover The custom microphone cover protects the microphone
from wax and debris Your hearing professional will instruct you on maintenance
of the microphone cover
Microphone Cover
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 in your hearing
professional’s office or clinic
20 | Hearing Aid Care
Troubleshooting Guide
SYMPTOM POSSIBLE CAUSES
Not Loud Enough
Low battery
Blocked microphone or receiver
Hearing change
Inconsistent Performance
Unclear, Distorted Performance
Dead
Debris buildup
Low battery Blocked microphone or receiver
Low battery
Blocked microphone or receiver
Blocked vent
Defective hearing aid
Low battery Blocked microphone or receiver
SOLUTIONS
Replace battery
Clean or replace wax guard as needed
Contact your hearing professional Clean both microphone and receiver with
brush Replace battery
Clean or replace wax guard as needed
Replace battery
Clean or replace wax guard as needed
Clean vent
Contact your hearing professional Replace battery
Clean or replace wax guard as needed
Tips for Better Communication | 21
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 facetoface 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
22 | 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
facetoface 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
Regulatory Information | 23
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 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 classified as a Type B applied part under the IEC 606011 medical device standard
Your hearing aids are not formally certified to operate in explosive atmospheres that may be found in coal mines or certain chemical factories
10% rH
95% rH -40 C
60 C Your hearing aids should be stored within the temperature and humidity ranges of 40oC (40oF) to +60oC (140oF) and 10 to 95 percent rH
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from very cold up to 50oC (122oF)
Any serious incident that has occurred in relation to your Starkey device
should be reported to your local Starkey representative and the Competent
Authority of the Member State in which you are established A serious incident
is defined as any malfunction, deterioration in the characteristics and/or
performance of the device, or inadequacy in the device Operations Manual/
labeling which could lead to the death or serious deterioration in the state
of health of the user, OR could do so upon recurrence
We are required by regulations to provide the following warnings:
24 | Regulatory Information
WARNING: Use of 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 US 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 airbone 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
Regulatory Information | 25
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
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 trialrental or purchaseoption
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 C6319 standard (ANSI C63192007
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
26 | Regulatory Information
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 or Quick Start Guide
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
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
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 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
Regulatory Information | 27
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 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 professional can adjust the settings of Multiflex
Tinnitus Technology to meet your needs
Multiflex Tinnitus Technology may provide temporary relief of your tinnitus
28 | Regulatory Information
PRESCRIPTION USE ONLY
CAUTION: Federal law restricts this device 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 device 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 device 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 followup
care It is important that you follow your hearing professional’s advice and
direction regarding such care
WARNING: There are some potential concerns associated with the use
of any sound generating tinnitus therapy 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 professional
As with any device, misuse of the tinnitus therapy device could present some
potentially harmful effects Care should be taken to prevent 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 following recommendations, your exposure to sound energy
has the potential to exceed noise exposure limits You should not use your
hearing device for more than sixteen (16) hours a day if your device is set at
the maximum output level, nor should you use your device if your hearing
professional has set the device 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
Regulatory Information | 29
TINNITUS TECHNICAL DATA
Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when
measured in a 2cc coupler per ANSI S322 or IEC 601187
EMC COMPLIANCE
This hearing aid model has been tested to, and has passed, the following
emissions and immunity tests:
· IEC 6060112 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 27 GHz as
well as higher field levels from communications devices as stated in Table 9
of IEC 6060112
· Immunity to power frequency magnetic fields at a field level of 30 A/m and
proximity magnetic fields as stated in Table 11 of IEC 6060112
· Immunity to ESD levels of +/ 8 kV conducted discharge and +/ 15 kV air
discharge
FCC NOTICE This device complies with part 15 of the FCC rules and with ISED
Canada’s licenseexempt 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
30 | Regulatory Information
Starkey Hearing Technologies 6700 Washington Ave South Eden Prairie, MN 55344
USA
Starkey Laboratories (Germany) GmbH Weg beim Jäger 218222 22335 Hamburg
Germany
Waste from electronic equipment must be handled according to local regulations
Consult Operations Manual
Keep dry
Notes
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