Cochlear Baha 6 Max Manuale utente

Cochlear™Baha®

6 Max

Sound Processor

User manual part A

ZONE EN-US

EN-US English

21 3

x 3

English

Warnings

WARNING: People

younger than 18 should go to

a doctor before using this.

People younger than 18 years old need

specialized care, and using this without a

medical evaluation may worsen impairment

or disability. A hearing aid user who is

younger than 18 should have a recent

medical evaluation from a doctor, preferably

an ear-nose-throat doctor (an ENT). Before

using this, a doctor should determine that

the use of a hearing aid is appropriate.

WARNING to Hearing

Aid Dispensers:

You should advise a prospective hearing

aid user to consult promptly with a doctor,

preferably an ear specialist such as an

ENT, before dispensing a hearing aid if

you determine 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:

• Visible deformity of the ear, either

congenital or traumatic

• Fluid, pus, or blood coming out of the ear

within the previous 6 months

• Pain or discomfort in the ear

• History of excessive ear wax or suspicion

that something is in the ear canal

• Dizziness, either recent or long-standing

• Sudden, quickly worsening, or fluctuating

hearing loss within the previous 6 months

• Hearing loss or ringing (tinnitus) only

in one ear or a noticeable difference in

hearing between ears

• Audiometric air-bone gap equal to or

greater than 15 dB at 500 Hz, 1000 Hz,

and 2000 Hz

WARNING to Hearing Aid

Dispenser, Outputs over 132 dB SPL:

You should exercise special care in selecting

and fitting a hearing aid with a maximum

output that exceeds 132 dB SPL because

it may impair the remaining hearing of the

hearing aid user.

WARNING

Batteries can be harmful if swallowed, put

in the nose or in the ear. Be sure to keep

your batteries out of reach of small children

and other recipients in need of supervision.

Before use, verify that the tamper-resistant

battery door is properly closed. In the event

a battery is accidentally swallowed, or stuck

in the nose or ear, seek immediate medical

attention at the nearest emergency center.

WARNING

The sound processor and removable parts

of the system (batteries, battery door, safety

line) can be lost or may be a choking or

strangulation hazard. Keep out of reach of

small children and other recipients in need

of supervision.

WARNING

Portable RF communications equipment

(including peripherals such as antenna

cables and external antennas) should be

used no closer than 30 cm (12 in.), to any

part of your sound processor, including

cables specified by the manufacturer.

Otherwise, degradation of the performance

of this equipment could result.

WARNING

Use of accessories, transducers and cables

other than those specified or provided by

Cochlear could result in electromagnetic

emissions or decreased electromagnetic

immunity of this equipment and result in

improper operation.

WARNING

Do not use damaged product.

Cautions

Caution: This is not

hearing protection.

You should remove this device if you

experience overly loud sounds, whether

short or long-lasting. If you’re in a loud

place, you should use the right kind of

hearing protection instead of wearing this

device. In general, if you would use ear

plugs in a loud place, you should remove

this device and use ear plugs.

Caution: The sound output should

not be uncomfortable or painful.

You should turn down the volume or

remove the device if the sound output

is uncomfortably loud or painful. If you

consistently need to turn the volume down,

you may need to further adjust your device.

Caution: You might need

medical help if a piece

gets stuck in your ear.

If any part of your hearing aid, like the

eartip, gets stuck in your ear, and you

can’t easily remove it with your fingers,

get medical help as soon as you can. You

should not try to use tweezers or cotton

swabs because they can push the part

farther into your ear, injuring your eardrum

or ear canal, possibly seriously.

English

Notes

Note: What you might

expect when you start

using a hearing aid.

A hearing aid can benefit many people with

hearing loss. However, you should know it

will not restore normal hearing, and you

may still have some difficulty hearing over

noise. Further, a hearing aid will not prevent

or improve a medical condition that causes

hearing loss.

People who start using hearing aids

sometimes need a few weeks to get used

to them. Similarly, many people find that

training or counseling can help them get

more out of their devices.

If you have hearing loss in both ears, you

might get more out of using hearing aids

in both, especially in situations that make

you tired from listening – for example, noisy

environments.

Note: Tell FDA about

injuries, malfunctions, or

other adverse events.

To report a problem involving your hearing

aid, you should submit information to FDA

as soon as possible after the problem. FDA

calls them “adverse events”, and they might

include: skin irritation in your ear, injury

from the device (like cuts or scratches, or

burns from an overheated battery), pieces

of the device getting stuck in your ear,

suddenly worsening hearing loss from

using the device, etc.

Instructions for reporting are available at

https://www.fda.gov/Safety/MedWatch, or

call 1-800-FDA-1088. You can also download

a form to email to FDA.

Note: Hearing loss in

people younger than 18.

• People younger than 18 should see a

doctor first, preferably an ear-nose-throat

doctor (an ENT), because they may have

different needs than adults.

• The doctor will identify and treat medical

conditions as appropriate.

• The doctor may refer the person to an

audiologist for a separate test, a hearing

aid evaluation.

• The hearing aid evaluation will help the

audiologist select and fit the appropriate

hearing aid.

A person who is younger than 18 years old

with hearing loss should have a medical

evaluation by a doctor, preferably an ENT,

before buying a hearing aid. The purpose of

a medical evaluation is to identify and treat

medical conditions that may affect hearing

but that a hearing aid won’t treat on its own.

Following the medical evaluation and

if appropriate, the doctor will provide a

written statement that the hearing loss has

been medically evaluated and the person

is a candidate for a hearing aid. The doctor

may refer the person to an audiologist for

a hearing aid evaluation, which is different

from the medical evaluation and is intended

to identify the appropriate hearing aid.

The audiologist will conduct a hearing aid

evaluation to assess the person’s ability to

hear with and without a hearing aid. This

will enable the audiologist to select and fit

a hearing aid for the person’s individual

needs. An audiologist can also provide

evaluation and rehabilitation since, for

people younger than 18, hearing loss may

cause problems in language development

and educational and social growth. An

audiologist is qualified by training and

experience to assist in the evaluation and

rehabilitation of hearing loss in people

younger than 18.

English

Contents

Warnings � � � � � � � � � � � � � � � � � � � � � � � � � 3

Cautions � � � � � � � � � � � � � � � � � � � � � � � � � 4

Notes � � � � � � � � � � � � � � � � � � � � � � � � � � � � 5

1� Introduction � � � � � � � � � � � � � � � � � � � � 9

1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . 9

1.2 Intended use . . . . . . . . . . . . . . . . . . . . 9

1.3 Indications. . . . . . . . . . . . . . . . . . . . . . . 9

1.4 Clinical benefit . . . . . . . . . . . . . . . . . . . 9

1.5 Warranty . . . . . . . . . . . . . . . . . . . . . . . . 9

2� Use � � � � � � � � � � � � � � � � � � � � � � � � � � � 10

2.1 Turn on and off . . . . . . . . . . . . . . . . . 10

2.2 Sound processor indicators. . . . . . . 10

2.3 Change programs . . . . . . . . . . . . . . . 10

2.4 Adjust volume . . . . . . . . . . . . . . . . . . 11

2.5 Share the experience . . . . . . . . . . . . 11

3� Power � � � � � � � � � � � � � � � � � � � � � � � � � 11

3.1 Battery type. . . . . . . . . . . . . . . . . . . . . 11

3.2 Low battery indication. . . . . . . . . . . . 11

3.3 Change the battery . . . . . . . . . . . . . . 12

3.4 Tamper-resistant battery door . . . . 12

4� Wear � � � � � � � � � � � � � � � � � � � � � � � � � � 13

4.1 Safety line . . . . . . . . . . . . . . . . . . . . . . 13

4.2 Flight mode. . . . . . . . . . . . . . . . . . . . . 13

4.3 For users with two sound

processors . . . . . . . . . . . . . . . . . . . . . 13

4.4 Wireless devices . . . . . . . . . . . . . . . . . 13

4.5 Baha Smart App . . . . . . . . . . . . . . . . 14

4.6 Made for iPhone (MFi) . . . . . . . . . . . 14

4.7 Android streaming. . . . . . . . . . . . . . . 14

5� Audio and visual indicators � � � � � � 15

5.1 General audio and visual signals. . . 15

5.2 Wireless audio and visual signals . . 16

5.3 Paediatric mode . . . . . . . . . . . . . . . . 16

6� Care� � � � � � � � � � � � � � � � � � � � � � � � � � � 17

6.1 Care and maintenance . . . . . . . . . . . 17

6.2 IP classification. . . . . . . . . . . . . . . . . . 17

7� Troubleshooting � � � � � � � � � � � � � � � � 18

7.1 Processor will not turn on . . . . . . . . 18

7.2 Sound is too quiet or muffled . . . . . 18

7.3 Sound is too loud or

uncomfortable . . . . . . . . . . . . . . . . . . 18

7.4 You experience feedback

(whistling) . . . . . . . . . . . . . . . . . . . . . . 18

8� Other information � � � � � � � � � � � � � � 19

8.1 Sound processor and parts . . . . . . .19

8.2 Serious incidents . . . . . . . . . . . . . . . . 19

8.3 Performance characteristics . . . . . . 20

8.4 Environmental conditions. . . . . . . . .23

8.5 Environmental protection. . . . . . . . . 23

8.6 Magnetic Resonance Imaging

(MRI) . . . . . . . . . . . . . . . . . . . . . . . . . . 23

8.7 Electromagnetic compatibility

(EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . 23

9� Regulatory information� � � � � � � � � � 24

9.1 Equipment classification and

compliance . . . . . . . . . . . . . . . . . . . . . 24

9.2 Certification and applied

standards . . . . . . . . . . . . . . . . . . . . . . 25

10� Information� � � � � � � � � � � � � � � � � � � 25

10.1 Service and repair . . . . . . . . . . . . . . 25

10.2 Clinical and non-clinical

performance . . . . . . . . . . . . . . . . . . . 25

11� Key to symbols � � � � � � � � � � � � � � � � 26

English

1. Introduction

Congratulations on your choice of the Cochlear™ Baha®6 Max Sound Processor.

This manual is full of tips and advice on how to best use and care for your Baha

sound processor. Be sure to discuss any questions or concerns that you may have

regarding your hearing or use of this system with your hearing care professional.

1.1 Overview

NOTE

Additional illustrations, figures 1-9, can be found on the inside

of the cover of this user manual.

1.2 Intended use

The Cochlear Baha System uses bone

conduction to transmit sounds to the

cochlea (inner ear) with the purpose

of enhancing hearing. The Baha 6 Max

Sound Processor is intended to be used

as part of the Cochlear Baha System to

pick up surrounding sound and transfer

it to the skull bone via a Baha Implant,

Baha Softband or Baha SoundArc™ and

can be used unilaterally or bilaterally.

1.3 Indications

The Cochlear Baha System is indicated

for patients with conductive hearing loss,

mixed hearing loss and SSD (single-sided

sensorineural deafness). The Baha 6 Max

Sound Processor is indicated for patients

with up to 55 dB SNHL (sensorineural

hearing loss).

1.4 Clinical benefit

Most recipients of a bone conduction

hearing solution will experience improved

hearing performance and quality of life

compared to unaided listening.

1.5 Warranty

The warranty does not cover defects or

damage arising from, associated with,

or related to the use of this product with

any non-Cochlear processing unit and/

or any non-Cochlear implant. See the

“Cochlear Baha Global Limited Warranty card”

for more details.

Battery door

Snap coupling

Indicator light

Control button

Microphone ports

Attachment hole

for safety line

2. Use

2.1 Turn on and off

See figure 1

The battery door is used to turn the sound

processor on and off.

1. To turn on your sound processor, close

the battery door completely.

2. To turn off your sound processor, gently

open the battery door until you feel the

first “click”.

When your sound processor is turned off

and back on again, it will return to Program

1 and default volume level. If enabled, audio

and/or visual signals will let you know that

the device is starting up. See chapter 5,

“Audio and visual indicators”.

2.2 Sound processor indicators

See figure 2

Audio signals and the visual indicator

will alert you of changes to your sound

processor. For a complete overview see

chapter 5, “Audio and visual indicators”.

2.3 Change programs

See figure 3

You can choose between programs to

change the way your sound processor deals

with sound. You and your hearing care

professional will have selected up to four

pre-set programs for your sound processor.

Program 1 __________________________________

Program 2 __________________________________

Program 3 __________________________________

Program 4 __________________________________

These programs are suitable for different

listening situations. Ask your hearing care

professional to fill in your specific programs

on the lines in the previous page.

1. To change the program, press and

release the control button located on

the top of your sound processor once.

2. If enabled, audio and visual signals will

let you know which program you have

changed to. See chapter 5, “Audio and

visual indicators”.

3. To change to any of the other programs

pre-set by your clinician, repeat above

steps until you get confirmation that

you are in the desired program.

NOTE

If you are a bilateral recipient,

program changes you make to one

device will automatically apply to the

second device. This function can be

enabled or disabled by your hearing

care professional.

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