Oticon MiniRITE R Manual de usuario

Instructions for use miniRITE R

Oticon Opn S™

Oticon Opn Play™

Oticon Ruby

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 deter-

mine 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.

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 uncomfort-

ably 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 down-

load a form to mail 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 aect 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 individ-

ual needs. An audiologist can also provide

evaluation and rehabilitation since, for peo-

ple younger than 18, hearing loss may cause

problems in language development and

educational and social growth. An audiolo-

gist 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 Oticon Opn S™, Oticon Opn Play™ and

Oticon Ruby families in the following hearing aid models:

FW 8.0

Oticon Opn S 1 GTIN: (01) 05714464013166

Oticon Opn S 2 GTIN: (01) 05714464013173

Oticon Opn S 3 GTIN: (01) 05714464013180

Oticon Opn Play 1 GTIN: (01) 05707131374998

Oticon Opn Play 2 GTIN: (01) 05707131375001

FW 1.0

Oticon Ruby 1 GTIN: (01) 05714464013210

Oticon Ruby 2 GTIN: (01) 05714464013227

The following speakers are available for the above models:

Speaker 60

Speaker 85

Speaker 100 (Power Instrument)

Power receiver mold speaker 100

Power receiver mold speaker 105

Introduction to this booklet

This booklet gives you guidance on how to use and maintain your

new hearing aid. Please read the booklet carefully, including the

Warnings section. This will help you to get the most out of your

new hearing aid.

Your hearing care professional has adjusted the hearing aid to meet

your needs. If you have further questions, please 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 educated and has proven competency

in professionally assessing hearing, selecting, fitting, and

delivering hearing instruments and rehabilitation care to persons

with hearing loss.

The education of the hearing care professional is in accordance

with national or regional regulations.

About Start-up Handling Options Tinnitus Warnings More info

For your convenience, this booklet contains a navigation bar to help

you easily navigate through the different sections.

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.

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

(16dB HL*) to profound (95dB 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.

User environment Indoor and outdoor.

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