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50 | Regulatory

Information

Regulatory Information | 51

As with any device,

misuse

of the

tinnitus therapy

device could present some

potentially harmful effects

Care

should

be taken to prevent the

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

TINNITUS TECHNICAL

Multiflex Tinnitus

Technology

Maximum

Output = 87 dB SPL

(typical)

when

measured in a 2cc coupler per ANSI S3

22 or IEC

60118-7

WIRELESS

TECHNICAL DESCRIPTION

Your

hearing

aids

contain

a radio transceiver

utilizing

Bluetooth Low Ener

wireless technology operating in the 2

4-2

4835 GHz frequency band with

maximum

effective radiated power of

dBm using GFSK transmission

modulation

The receiver section of the radio has a

bandwidth

of 1

MHz

This

hearing

aid model has been tested to, and has passed, the following

emissions

and

immunity

tests:

• IEC

60601-1-2

radiated

emissions requirements

for a Group 1 Class

device as stated in CISPR 11

• RF radiated

immunity

at a field level of 10

V/m

between 80

MHz

and 2

GHz as well as

higher

field levels

from communications

devices as stated

in Table 9 of IEC 60601-1-2.

•

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 60601-1-2.

•

Immunity

to ESD levels of

+/-

8 kV conducted discharge and

+/-

15 kV

air discharge.

REGULATORY

NOTICES

FCC ID: EOA-24LIVIOCIC

IC: 6903A-24LIVIOCIC (Evolv AI CIC, Arc AI CIC, Envy AI CIC, Savant AI CIC, AGXs evolv AI CIC)

FCC

NOTICE

This device complies with part 15 of the FCC rules and with ISED Canada’

license-exempt

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

this equipment

Such modifications

could void the user’s

authority

to operate the

equipment

Cet appareil est conforme à la partie 15 des règlements de la FCC ainsi qu’aux cahiers des

charges sur les normes radioélectriques relativement aux appareils exempts de licence

d’ISDE Canada. Son fonctionnement est assujetti aux deux conditions suivant es : (1) cet

appareil ne doit pas causer d’interférence nuisible, et (2) cet appareil doit accepter toute

interférence reçue, y compris celles pouvant générer un fonctionnement indésirable.

Remarque : Le fabricant n’est responsable d’aucune interférence radiophonique ou

télévisuelle qui pourrait se produire si des modifications non autorisées sont effectuées sur

cet équipement. De telles modifications risquent d’annuler le droit de l’utilisateur à se

servir de cet équipement.

Hereby,

Starkey

Hearing Technologies declares that the Custom hearing aid

is in compliance with the essential

requirements

and other relevant

provisions

of Directive 2014/53/EU. A copy of the Declaration of Conformity

can be obtained

from

the addresses on the

following

page or

from

docs

starkeyhearingtechnologies

com