Phonak M90-SP, M30-SP, M50-SP, M-sp Trial, M70-SP User Manual

Phonak Naída™ M

User Guide

Phonak Naída M-SP
Phonak Naída M-SP Trial

This user guide is valid for:

Models

Phonak Naída M90-SP
Phonak Naída M70-SP
Phonak Naída M50-SP
Phonak Naída M30-SP
Phonak Naída M-SP Trial

CE mark applied

2019
2019
2019
2019
2019

Your hearing aid details

If no box is checked and you do not know the

model of your hearing aid, please ask your hearing
care professional.

Your hearing aids operate between 2.4 GHz–2.48

GHz frequency range. When ying please check if
ight operator requires devices to be switched into
ight mode, see chapter 12.

Model

c

Naída M-SP (M90/M70/M50/M30)

c

Naída M-SP Trial

Earpiece

c

Classic earmold

c

Universal eartip

Battery size

13
13

3

4

Your hearing aids have been developed by
Phonak — the world leader in hearing solutions based
in Zurich, Switzerland.

These premium products are the result of decades of
research and expertise and are designed to keep you
connected to the beauty of sound! We thank you for
making such a great choice and wish you many years of
listening pleasure.

Please read the user guide carefully to make sure that
you understand and get the best out of your hearing
aids. For more information about features and benets,
simply contact your hearing care professional.

Phonak — life is on
www.phonak-us.com

5

Contents

Your hearing aid

1. Quick guide

2. Parts of the hearing aid

Using the hearing aid

3. Left & right hearing aid markings

4. On/O

5. Batteries

6. Putting on the hearing aid

7. Removing the hearing aid

8. Multi-function button

9. Connectivity overview

10. Initial pairing

11. Phone calls

12. Flight mode

Further information

13. Join our hearing loss community!

14. Care and maintenance

15. Exchanging the earpiece

16. Service and warranty

17. Compliance information

18. Information and description of symbols

19. Troubleshooting

8

10

12
13
14
16
18
20
21
22
25
29

31
32
35
38
40
46
50

6

20. Important safety information

21. For the US market only, complies
withtheFDA regulations

52
62

7

1. Quick guide

Left & right hearing aid markings

Blue marking for left hearing aid.
Red marking for right hearing aid.

Changing batteries

1.

Remove the
sticker from the
new battery and
wait two minutes.

8

2.

Open the
battery door.

3.

Place battery in
the battery door
with the “+”
symbol facing
upwards.

On/O

Multi-function button

The button has several functions. It
functions as a volume control and/or a
program change depending on the hearing
aid programming. This is indicated in your
individual instructions. If paired with a
Bluetooth®-enabled phone, a short press
will accept and a long press will reject an
incoming call.

Flight mode

To enter ight mode press the lower part
of the button for 7 seconds while closing
the battery door. To exit ight mode, simply
open and close the battery door again.

OOn

9

2. Parts of the hearing aid

The following pictures show the possible earpieces and
hearing aid model described in this user guide.

Possible earpieces

Classic
earmold

10

Naída M-SP / Naída M-SP Trial

Hook / sound output

Classic earmold (detachable)

Multi-function
button

Battery door

11

3. Left & right hearing aid markings

There is a red or blue marking to tell you if it is a left or a
right hearing aid.

Blue marking for left hearing aid.
Red marking for right hearing aid.

12

4. On/O

The battery door is also the on/o switch.

1.

Closed battery door =
hearing aid is on

2.

Open battery door =
hearing aid is o

When you switch on the hearing aid you may hear

a start-up melody.

13

5. Batteries

1.

Remove the
sticker from
the new battery
and wait two
minutes.

If it is dicult to close the battery door: Check that

the battery is inserted correctly and the “+” symbol
is facing upwards. If the battery is not inserted
correctly, the hearing aid will not work and the
battery door can be damaged.

14

2.

Open the
battery door.

3.

Place battery in
the battery door
with the “+”
symbol facing
upwards.

Low power: You will hear two beeps when the battery

is low. You will have approximately 30 minutes to
change the battery (this can vary, depending on the
hearing aid settings and battery). We recommend that
you always have a new battery on hand.

Replacement battery

This hearing aid requires a size 13 zinc-air battery.

Model

Phonak Naída
M-SP / M-SP Trial

Zinc-air
battery
size

13

Color
marking on
package

orange

IEC
code

PR48

Please ensure you use the correct type of battery in

your hearing aids (zinc-air). Please also read chapter

20.2 for further information on product safety.

ANSI
code

7000ZD

15

6. Putting on the hearing aid

6.1 Putting on the hearing aid with
classic earmold

1.

Take the earmold up to your ear
and place the ear canal part into
your ear canal.

2.

Place the hearing aid behind
your ear.

16

3.

Insert the upper part of the
earmold into the upper part
of the bowl of your ear.

17

7. Removing the hearing aid

7.1 Removing the hearing aid with
classic earmold

1.

Lift the hearing aid above
the upper part of your ear.

2.

Grasp the earmold with your
ngers and gently remove it.

18

Please try to avoid gripping the tube to remove the

hearing aid.

19

8. Multi-function button

The multi-function button has several functions.

It functions as a volume
control and/or a program
change depending on the
hearing aid programming.
This is indicated in your
individual “Hearing aid
instructions.” Please ask your
hearing care professional for
a printout.

If the hearing aid is paired with a Bluetooth-enabled
phone, a short press on the upper or lower part of the
button will accept an incoming call and a long press will
reject an incoming call — refer to chapter 11.

20

9. Connectivity overview

The illustration below shows the connectivity options
available for your hearing aid.

Cell phone

TV Connector connected to TV*

Roger**

* The T V Connector can b e connec ted to any au dio sourc e such as a T V, PC or hi- system.
** Roger wireles s microphones can be conne cted to your hearing aids as well.

21

10. Initial pairing

10.1 Initial pairing to Bluetooth-enabled device

It is only necessary to perform the pairing procedure

once with each device featuring Bluetooth wireless
technology. After the initial pairing, your hearing aids
will connect automatically to the device. This can take
up to 2 minutes.

1.

On your device (e.g. a phone), ensure that Bluetooth
wireless technology is enabled and search for Bluetooth­enabled devices in the connectivity setting menu.

2.

Switch on both hearing aids.
You now have 3 minutes to
pair your hearing aids with
your device.

22

3.

Select the hearing aid in the list of Bluetooth-enabled
devices. This will pair both hearing aids simultaneously.
A beep conrms successful pairing.

For more information about pairing instructions

for Bluetooth wireless technology, specic to some
of the most popular phone manufacturers, go to:
https://marvel-support.phonak.com

23

10.2 Connecting to the device

After your hearing aids have been paired to your device,
they will automatically connect again when switched on.

The connection will be maintained as long as the

device remains ON and within range.

Your hearing aids can be paired to up to two devices.

Your hearing aids can be connected to one device

at a time.

24

11. Phone calls

Your hearing aids connect directly with Bluetooth­enabled phones. When paired and connected to your
phone, you will hear the caller’s voice directly in your
hearing aids. Your hearing aids pick up your voice
through their own microphones.

Caller’s voice

Bluetooth® is a registered trademark owned by Bluetooth SIG, Inc.

Your voice

25

11.1 Making a call

Enter the phone number and press the dial button.
You will hear the ring tone through your hearing aids.
Your hearing aids pick up your voice through their own
microphones.

11.2 Accepting a call

When receiving a call, a calling notication will be heard
in the hearing aids.

The call can be accepted by a short press on the upper or
lower part of the multi-function button on the hearing
aid (less than 2 seconds) or directly on your phone.

short press
< 2 sec

26

11.3 Ending a call

A call can be ended by a long press on the upper or
lower part of the multi-function button on the hearing
aid (more than 2 seconds) or directly on your phone.

long press
> 2 sec

27

11.4 Rejecting a call

An incoming call can be rejected by a long press on
the upper or lower part of the multi-function button
on the hearing aid (more than 2 seconds) or directly
on your phone.

28

long press
> 2 sec

12. Flight mode

Your hearing aids operate between 2.4 GHz–2.48 GHz
frequency range. When ying some operators require all
devices to be switched into ight mode. Entering ight
mode will not disable normal hearing aid functionality,
only the Bluetooth connectivity functions.

12.1 Enter ight mode

To disable the wireless function and
enter ight mode in each hearing aid:

1.

Open battery door.

2.

Hold down the lower part of the
multi-function button on the hearing
aid for 7 seconds while closing the
battery door.

In ight mode, your hearing aid cannot connect directly
to your phone.

29

12.2 Exit ight mode

To enable the wireless function and exit ight mode in
each hearing aid:

1.

Open battery door.

2.

Close the battery door again.

30

13. Join our hearing loss
community!

On HearingLikeMe.com you will nd:

• Living with Hearing Loss

A set of interesting articles on how to live with
hearing loss.

• Forum

A forum to meet and engage with a growing number
of people who face the same challenges.

• Blog

A blog to keep up-to-date with the latest news on
anything hearing.

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14. Care and maintenance

Diligent and routine care of your hearing aid contributes
to outstanding performance and a long service life. To
ensure a long service life, Sonova AG provides a minimum
of a ve year service period after phase out of the
respective hearing aid.

Please use the following specications as a guideline.
For further information regarding product safety, see
chapter 20.2.

General information

Before using hair spray or applying cosmetics, you
should remove your hearing aid from your ear, because
these products may damage it.

When you are not using your hearing aid, leave the
battery door open so that any moisture can evaporate.
Make sure that you always completely dry your hearing
aid after use. Store the hearing aid in a safe, dry and
clean place.

32

Your hearing aids are resistant to water, sweat and dust
under the following conditions:

• The battery door is fully closed. Ensure that no foreign

object such as hair is caught in the battery door when
it is closed.

• After exposure to water, sweat or dust, the hearing aid

is cleaned and dried.

• The hearing aid is used and maintained as described in

this user guide.

Use of your hearing aid around water can restrict

air ow to the batteries causing it to stop working.
Should your hearing aid stop working after coming
into contact with water, refer to the troubleshooting
steps in chapter 19.

33

Daily

Inspect the earpiece and tube for earwax and moisture
deposits. Clean the surfaces with a lint-free cloth or use
the small brush provided in the hearing aid hard case.
Never use cleaning agents such as household detergents,
soap, etc. for cleaning your hearing aid. It is not
recommended to rinse these parts with water, risk for
lodging in the tube. If you need to clean your hearing aid
intensively, ask your hearing care professional for advice.

Weekly

Clean the earpiece with a soft, damp cloth or with a
special cleaning cloth for hearing aids. For further
maintenance or cleaning instructions, please see your
hearing care professional.

Monthly

Inspect your hearing tube for color changes, hardening, or
cracks. In the case of such changes, the hearing tube has
to be replaced. Please see your hearing care professional.

34

15. Exchanging the earpiece

If your hearing aid is tted with a SlimTube, you may
need to exchange or clean the earpiece.

Please check the earpiece regularly and exchange or
clean it if it looks dirty or if the hearing aid volume or
sound quality is reduced. If a dome is used, it should
be exchanged every 3 months.

35

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16. Service and warranty

Local warranty

Please ask the hearing care professional, where you
purchased your hearing aid, about the terms of the
local warranty.

International warranty

Sonova AG oers a one year limited international
warranty, valid starting from the date of purchase.
This limited warranty covers manufacturing and
material defects in the hearing aid itself, but not
accessories such as batteries, tubes, earmolds and
external receivers. The warranty only comes into
force if a proof of purchase is shown.

The international warranty does not aect any legal
rights that you might have under applicable national
legislation governing sale of consumer goods.

38

Warranty limitation

This warranty does not cover damage from improper
handling or care, exposure to chemicals or undue stress.
Damage caused by third parties or non-authorized service
centers renders the warranty null and void. This warranty
does not include any services performed by a hearing care
professional in their office.

Serial number (left side):

Serial number (right side):

Date of purchase:

Authorized hearing care professional (stamp/signature):

39

17. Compliance information

Europe:
Declaration of Conformity

Hereby Sonova AG declares that this product meets the
requirements of the Medical Devices Directive 93/42/EEC
as well as the Radio Equipment Directive 2014/53/EU. The
full text of the EU Declaration of Conformity can be
obtained from the manufacturer or the local Phonak
representative whose address can be taken from the list
on www.phonak.com/us/en/certicates (Phonak
worldwide locations).

Australia/New Zealand:

Indicates a device’s compliance with applicable

Radio Spectrum Management’s (RSM) and

Australian Communications and Media Authority

(ACMA) regulatory arrangements for the legal
sale in New Zealand and Australia.

The compliance label R-NZ is for radio products

supplied in the New Zealand market under
conformity level A1.

40

The models listed on page 2 are certied under:

Phonak Naída M-SP (M90/M70/M50/M30)
Phonak Naída M-SP Trial

USA FCC ID: KWC-BSP
Canada IC: 2262A-BSP

41

Notice 1:

This device complies with Part 15 of the FCC Rules and
with RSS-210 of Industry Canada. 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.

Notice 2:

Changes or modications made to this device not
expressly approved by Sonova AG may void the FCC
authorization to operate this device.

Notice 3:

This device has been tested and found to comply with
the limits for a Class B digital device, pursuant to Part 15
of the FCC Rules and ICES-003 of Industry Canada.
These limits are designed to provide reasonable
protection against harmful interference in a residential
installation. This device generates, uses and can radiate
radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful
interference to radio communications. However, there is

42

no guarantee that interference will not occur in a
particular installation. If this device does cause harmful
interference to radio or television reception, which can
be determined by turning the equipment o and on, the
user is encouraged to try to correct the interference by
one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the device
and receiver.

• Connect the device into an outlet on a circuit
dierent from that to which the receiver is connected.

• Consult the dealer or an experienced radio/TV
technician for help.

43

Radio information of your hearing aid

Antenna type
Operation frequency
Modulation
Radiated power

Resonant loop antenna

2.4 GHz – 2.48 GHz
GFSK, Pi/4 DPSK, GMSK
< 1 mW

Bluetooth®

Range
Bluetooth
Proles supported

~1m

4.2 Dual-Mode
HFP (Hands-free prole), A2DP

Compliance with emission and immunity standards

Emission standards EN 60601–1-2:2015

IEC 606 01–1-2:2014
EN 55011:2009+A1
CISPR11:2009/AMD1:2010
CISPR22:1997
CISPR32:2012
ISO 7637-2:2011
CISPR25:2016
EN 55025:2017

44

Immunity standards EN 60601-1-2: 2015

IEC 606 01-1-2:2014
EN 61000-4-2:2009
IEC 61000-4-2:2008
EN 61000-4-3:2006+A1+A2
IEC 61000-4-3:2006+A1+A2
EN 61000-4-4:2012
IEC 61000-4-4:2012
EN 61000-4-5:2014
IEC 61000-4-5:2014
EN 61000-4-6:2014
IEC 61000-4-6:2013
EN 61000-4-8:2010
IEC 61000-4-8:2009
EN 61000-4-11:2004
IEC 61000-4-11:2004
IEC 60601-1 (§ 4.10.2):2005
ISO 7637-2:2011

45

18. Information and description
of symbols

With the CE symbol, Sonova AG conrms that
this product — including accessories — meets the
requirements of the Medical Devices Directive
93/42/EEC as well as the Radio Equipment
Directive 2014/53/EU. The numbers after the
CE symbol correspond to the code of certied
institutions that were consulted under the
above-mentioned directives.

This symbol indicates that the products
described in these user instructions adhere to
the requirements for an applied part of Type B
of EN 60601-1. The surface of the hearing aid
is specied as an applied part of Type B.

Indicates the medical device manufacturer, as
dened in EU Directive 93/42/EEC.

46

This symbol indicates that it is important
for the user to read and take into account the
relevant information in these user guides.

This symbol indicates that it is important
for the user to pay attention to the relevant
warning notices in these user guides.

Important information for handling and
product safety.

During transportation keep dry.

The Bluetooth® word mark and logos are
registered trademarks owned by Bluetooth SIG,
Inc. and any use of such marks by Sonova AG
is under license. Other trademarks and trade
names are those of their respective owners.

Japanese symbol for certified radio devices.

47

Operating

The product is designed such that it functions

conditions

without problems or restrictions if used as
intended, unless otherwise noted in this user
guide. The hearing aids are classied IP68 (depth
of 1 meter for 60 minutes) and designed to be
used in all daily life situations. Therefore you do
not have to worry about exposing the hearing
aids to rain shower or sweat. However, the
hearing aid is not intended to be used in
water activities that includes chlorinated water,
soap, salt water or other liquids with a
chemical content.

Indicates the manufacturer’s serial number so
that a specic medical device can be identied.

Indicates the manufacturer’s catalogue number
so that the medical device can be identied.

48

Temperature during transportation and storage:
–20° to +60° Celsius (–4° to +140° Fahrenheit).

Humidity during transportation: Up to 90%
(non condensing).
Humidity during storage: 0% to 70%, if not in
use. See instruction in chapter 20.2 regarding
drying the hearing aid after use.

Atmospheric pressure: 500 hPa to 1060 hPa

The symbol with the crossed-out garbage
bin is to make you aware that this hearing
aid may not be thrown away as normal household
waste. Please dispose of old or unused hearing
aids, at waste disposal sites intended for
electronic waste, or give your hearing aid to your
hearing care professional for disposal. Proper
disposal protects the environment and health.

49

19. Troubleshooting

Problem

Hearing aid not functioning

Hearing aid whistles

Hearing aid too loud
Hearing aid not loud enough

or distorted

Hearing aid plays two beeps
Hearing aid switches on and o

(intermittent)

Phone call function does
not work

Causes

Dead battery
Earpiece blocked
Battery not inserted correctly
Hearing aid switched o
Hearing aid not inserted correctly
Earwax in ear canal
Volume too loud
Low battery
Earpiece blocked
Volume too low
Hearing has changed
Indication for low battery
Moisture on battery or

hearing aid

Hearing aid is in ight mode
Hearing aid not paired to the phone

If the problem persists, contact your hearing care

professional for assistance.

Please check https://marvel-support.phonak.com for
further information.

50

What to do

Change battery (chapter 5)
Clean earpiece (chapter 14)
Insert battery correctly (chapter 5)
Switch hearing aid on by completely closing battery door (chapter 4)
Insert hearing aid correctly (chapter 6)
Contact your hearing care professional
Decrease volume if volume control available (chapter 8)
Change battery (chapter 5)
Clean earpiece (chapter 14)
Turn volume up if volume control available (chapter 8)
Contact your hearing care professional
Change battery within the next 30 minutes (chapter 5)
Wipe battery and hearing aid with dry cloth

Open and close battery door (chapter 12.2)
Pair it to the phone (chapter 10)

51

20. Important safety information

Please read the information on the following pages before
using your hearing aid.

A hearing aid will not restore normal hearing and will not
prevent or improve a hearing impairment resulting from
organic conditions. Infrequent use of a hearing aid does
not permit a user to attain full benet from it. The use of
a hearing aid is only part of hearing habilitation and may
need to be supplemented by auditory training and
instruction in lipreading.

Hearing aids are suitable for the home healthcare
environment and due to their portability it may happen
that they are used in professional healthcare facility
environments like physician oces, dental oces, etc.

52

20.1 Hazard warnings

Your hearing aids operate between 2.4 GHz–2.48 GHz

frequency range. When ying please check if ight operator
requires devices to be switched into ight mode, see
chapter 12.

The intended use of hearing aids is to amplify and transmit

sound to the ears and hereby compensate for impaired
hearing. The hearing aids (specially programmed for each
hearing loss) must only be used by the intended person.
They should not be used by any other person as they could
damage hearing.

Changes or modications to the hearing aid that were not

explicitly approved by Sonova AG are not permitted. Such
changes may damage your ear or the hearing aid.

Do not use the hearing aids in explosive areas (mines

or industrial areas with danger of explosions, oxygen rich
environments or areas where ammable anesthetics
are handled) or where electronic equipment is prohibited.

53

Hearing aid batteries are toxic if they are swallowed! Keep

out of the reach of children, individuals with cognitive
impairment, and pets. If batteries are swallowed, consult
your physician immediately!

If you feel pain in or behind your ear, if it is inamed or if

skin irritation and accelerated accumulations of earwax occur,
please check with your hearing care professional or physician.

In very rare cases, the dome can remain in your ear canal

when removing the hearing tube from the ear. In the unlikely
case that the dome does get stuck in your ear canal, it is
strongly recommended to see a physician for safe removal.
To prevent pushing the dome towards the eardrum, never try
to re-insert the tube into the ear canal.

Hearing programs in the directional microphone mode

reduce background noises. Please be aware that warning
signals or noises coming from behind, e.g. cars, are
partially or entirely suppressed.

54

This hearing aid is not for children below 36 months. The

usage of this device by children and individuals with cognitive
impairment should be supervised at all times to ensure their
safety. The hearing aid is a small device and contains small
parts. Do not leave children and individuals with cognitive
impairment unsupervised with this hearing aid. If swallowed,
consult a physician or hospital immediately as the hearing aid
or its parts can cause choking!

The following is only applicable for persons with active

implantable medical devices (i.e. pacemakers, debrillators, etc.):

Keep the hearing aid at least 15 cm (6 inches) away from

the active implant. If you experience any interference, do
not use the hearing aids and contact the manufacturer of
the active implant. Please, note that interference can also be
caused by power lines, electrostatic discharge, airport metal
detectors, etc.

Keep magnets (i.e. battery handling tool, EasyPhone magnet,

etc.) at least 15 cm (6 inches) away from the active implant.

If using a Phonak wireless accessory, consult the chapter

“Important safety information” in your wireless accessory
user guide.

55

Use of accessories, transducers and cables other than those

specied or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.

Portable RF communications equipment (including

peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part
of the hearing aids, including cables specied by the
manufacturer. Otherwise, degradation of the performance
of this equipment could result.

Hearing aids should not be tted with domes /universal

eartip when used by clients with perforated eardrums,
inamed ear canals or otherwise exposed middle ear
cavities. In these cases, we recommend the use of a custom
earpiece. In the unlikely case that any part of this product
should remain in the ear canal, it is strongly recommended
to see a medical specialist for safe removal.

56

Avoid strong physical impacts to the ear when wearing

a hearing aid with customized earpiece. The stability of
customized earpieces is designed for normal use. A strong
physical impact to the ear (e.g. during sports) may cause the
customized earpiece to break. This may lead to perforation
of the ear canal or eardrum.

After mechanical stress or shock to the customized earpiece,

please ensure that it is intact before placing it in the ear.

Use of this equipment adjacent to or stacked with other

equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that
they are operating normally.

57

20.2 Information on product safety

These hearing aids are water resistant and not waterproof.

They are designed to withstand normal activities and
occasional accidental exposure to extreme conditions. Never
immerse your hearing aid in water! These hearing aids are
not specically designed for extended periods of water
submersion on a continual basis, that is worn in activities
such as swimming or bathing. Always remove your hearing
aid before these activities, as the hearing aid contains
sensitive electronic parts.

Never wash the microphone inputs. Doing so could cause it

to lose its special acoustic features.

Protect your hearing aid from heat (never leave near a

window or in the car). Never use a microwave or other
heating devices to dry your hearing aid. Ask your hearing
care professional about suitable drying methods.

58

When you are not using your hearing aid, leave the battery

door open so that any moisture can evaporate. Make sure
that you always completely dry your hearing aid after use.
Store the hearing aid in a safe, dry and clean place.

The dome should be changed every three months or when

it becomes sti or brittle. This is to prevent the dome from
detaching from the tube spout during insertion into or
removal from the ear.

Do not drop your hearing aid! Dropping onto a hard surface

can damage your hearing aid.

If you are not using your hearing aid for a long period

of time, store it in a box with a drying capsule or in a well
ventilated location. This allows moisture to evaporate
from your hearing aid and prevents a potential impact on
its performance.

59

Always use new batteries for your hearing aid. In case a

battery is leaking, replace it immediately with a new one to
avoid any skin irritation. You can return used batteries
to your hearing care professional.

The batteries used in these hearing aids should not exceed

1.5 Volts. Please do not use silver-zinc or Li-ion (lithium-ion)
rechargeable batteries as these may cause severe damage
to your hearing aids. The table in chapter 5 explains exactly
which type of battery your particular hearing aids require.

Remove the battery if you are not using your hearing aid for

a long period of time.

Special medical or dental examination including radiation

described below, may adversely aect the correct
functioning of your hearing aids. Remove and keep them
outside the examination room/area before undergoing:

Medical or dental examination with X-ray (also CT scan).
Medical examinations with MRI/NMRI scans, generating

magnetic elds.

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Hearing aids don’t need to be removed when passing
security gates (airports, etc.). If X-ray is used at all, it will be
in very low doses, and will not aect the hearing aids.

Do not use your hearing aid in areas where electronic

equipment is prohibited.

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21. For the US market only, complies
with the FDA regulations

Important information: Cell phones

Some hearing aid users have reported a buzzing sound
intheir hearing aids when they are using cell phones.
According to the ANSI 63.19 (American National
Standard Methods of Measurement of Compatibility
between Wireless Communications Devices and Hearing
Instruments) standard, 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. The sum of the hearing
aid rating (e.g. M2/T2=2) and the telephone rating (e.g.
M3/T3=3) is5, and any combination that equals 5will
provide “normal use”; a sum of 6 or greater would indicate
“excellent performance.” The equipment performance
measurements, categories and system classications are
based upon the best information available but cannot
guarantee that all users will be satised. The immunity of
this hearing aid is at least M2/T2.

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Note: the performance of individual hearing aids may
vary with individual cell phones. Therefore, please try the
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
hearing care professional for the booklet entitled “hearing
aid compatibility with digital wireless cell phones.”

Important information in case of battery ingestion

If a battery is swallowed, call the 24-hour National
Battery Ingestion Hotline at 202-625-3333 or consult
your physician immediately.

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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.

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(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 signicant cerumen

accumulation or a foreign body in the ear canal.

(viii) Pain or discomfort in the ear. Special care should

beexercised in selecting and tting a hearing aid
whose maximum sound pressure level exceeds
132decibels because there may be risk of impairing
the remaining hearing of the hearing aid user. (This
provision isrequired only for those hearing aids with
a maximum sound pressure capability greater than
132 decibels (dB).)

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Important Notice for Prospective Hearing Aid Users

Good health practice requires that a person with a
hearing loss have a medical evaluation by a licensed
physician (preferably a physician who specializes in
diseases of the ear) before purchasing a hearing aid.
Licensed physicians who specialize in diseases of the ear
are often referred to as otolaryngologists, otologists or
otorhinolaryngologists. The purpose of medical
evaluation is to assure that all medically treatable
conditions that may aect hearing are identied 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 a 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

66

evaluation will enable the audiologist or dispenser to
select and t ahearing aid to your individual needs.

If you have reservations about your ability to adapt to
amplication, you should inquire about the availability of
a trial-rental or purchase-option program. Many hearing
aid dispensers now oer 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.

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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 qualied
by training and experience to assist in the evaluation
and rehabilitation of a child with a hearing loss.

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Important notice for Prospective Noise Generator users

The Tinnitus Balance noise generator is a broadband
sound Generator which may have been enabled in your
hearing aid. It provides a means of sound enrichment
that can beused as part of a personalized tinnitus
management program to provide temporary relief from
tinnitus. It should always be used as prescribed by your
audiologist. The underlying principle of sound enrichment
is to provide supplementary noise stimulation which can
help defocus your attention from your tinnitus and avoid
negative reactions. Sound enrichment, coupled with
instructional counseling, is an established approach to
managing tinnitus.

Good health practice requires that a person reporting
tinnitus have a medical evaluation by a licensed ear
physician before using a sound generator. The purpose
of such an evaluation is to ensure medically treatable
conditions that may be causing tinnitus are identied
and treated prior to using a sound generator.

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Should you develop any side eects whilst using the
noise generator such as headaches, nausea, dizziness or
heart palpitations or experience a decrease in auditory
function, you should discontinue use and seek a medical
evaluation.

According to OSHA (Occupational Safety & Health
Administration, U.S. Department of Labor) regulations,
thevolume of the noise generator can be set to a level
which could lead to permanent hearing damage when
used for a prolonged period of time. Should the noise
generator be set to such a level in your hearing aid, your
audiologist will advise you of the maximum amount of
time per day you should use the noise generator. The noise
generator should never be used at uncomfortable levels.

For more information visit www.phonak-us.com

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Your hearing care professional:

Manufacturer:

Sonova AG
Laubisrütistrasse 28
CH-8712 Stäfa
Switzerland
www.phonak.com

029- 0829-03 / 2 020- 01 / © 2020 Son ova AG All rights res erved