Oticon Real miniBTE R Manual de usuario

miniBTE R

miniBTE T

Oticon Real™

Instructions for use

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 d8 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.

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.

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 mail to FDA.

Note: Hearing loss in people younger

than 18

• People younger than 18 should see a

doctor rst, preferably an ear-nose-throat

doctor (an ENT), because they may have

dierent 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.

Model overview

This booklet is valid for the following hearing aid models:

miniBTE R

miniBTE T

FW 1.0

Oticon Real 1 miniBTE R GTIN: (01) 05714464097302

Oticon Real 2 miniBTE R GTIN: (01) 05714464097296

Oticon Real 3 miniBTE R GTIN: (01) 05714464097289

Oticon Real 1 miniBTE T GTIN: (01) 05714464097302

Oticon Real 2 miniBTE T GTIN: (01) 05714464097296

Oticon Real 3 miniBTE T GTIN: (01) 05714464097289

Introduction to this booklet

This booklet guides you on how to use and maintain your new hearing

aids. Ensure you read this booklet carefully, including the Warnings

section. This will help you get the most benefit from your hearing aids.

Your hearing care professional has adjusted the hearing aids to meet

your needs. If you have additional questions, contact your hearing care

professional.

A hearing care professional* (hearing aid professional, audiologist,

ENT (ear, nose and throat) doctor, and hearing aid dispenser) is a

person who is appropriately trained and has proven competency in

professionally assessing hearing, selecting, fitting, and delivering

hearing instruments and rehabilitation care to persons with hearing

loss. The hearing care professional has been trained in accordance

with national or regional regulations.

*The job title may vary from country to country.

Intended use

Intended use The hearing aid is intended to amplify and transmit sound

to the ear.

Indications for use Bilateral or unilateral impaired hearing of sensorineural,

conductive or mixed type ranging from a slight (16 dBHL*)

to severe (75dBHL*) degree of hearing loss, with an

individual frequency configuration.

Intended user Person with hearing loss using a hearing aid and their

caregivers. Hearing care professional responsible for

adjusting the hearing aid.

Intended user group Adults and children older than 36months.

Use environment Indoor and outdoor

Contraindications Not suitable for infants below 36months. Users of active

implants must pay special attention when using the hearing

aid. For more information read the Warnings section.

Clinical benefits The hearing aid is designed to provide better speech

understanding to help ease communication with the

aim of improving quality of life.

* As specified by the American Speech-Language-Hearing Association, asha.org, using pure-tone average of

0.5, 1 and 2kHz

IMPORTANT NOTICE

The hearing aid amplification is uniquely adjusted and optimized to your

personal hearing capabilities during the hearing aid fitting performed by

your hearing care professional.

Table of contents

About

Your hearing aid and earpiece 14

Getting started

Charging time 18

Battery performance 19

Identify left and right hearing aids 20

Turn hearing aids ON/OFF 22

Low battery indication 26

Replace disposable battery (size 312) 28

Daily Use

Put on hearing aid with sound hook 30

Put on hearing aid with thin tube 31

Cleaning 32

Clean the hearing aid 33

Clean the thin tube 34

Clean customized earpiece 35

Replace standard earpiece 38

Replace ProWax filter 40

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