IHEAR IHearTest Manual de usuario

HOME HEARING SCREENER

User Guide

iHear Loud & Clear®

Congratulations on the purchase of the iHearTest kit.

The test kit includes everything you need to accurately and rapidly proﬁle

your hearing ability from the comfort of your home. All you need is a personal

computer with an Internet connection.

The test is simple. No special training or knowledge is required to administer

the test to yourself or a family member. These instructions will guide you to test

your hearing ability.

Upon completion of your hearing screening, the results will be immediately

available on your computer screen. They will also be stored in our HIPAA-

compliant online server where you will have secure online access to view your

test results at any time.

Please don’t hesitate to contact us for questions by calling us or sending an

email. You may also check our website for the most updated information.

Toll Free 1 (844) iHEAR44 (1-844-443-2744) or email us at [email protected]

Introduction

Intended Use

The iHearTest is an air conduction over the counter hearing screener

for proling your hearing ability based on guidelines by the World Health

Organization (WHO)1. The iHearTest kit consists of the iHearUSB device

and calibrated earphones with assorted ear tips. The use of the iHearTest

requires a personal computer with an Internet browser and a standard

USB port. The iHearTest is intended for home use by adults of at least 18

years of age. Hearing test results are displayed on the computer screen

and stored in our HIPAA-compliant remote server for review anytime using

secure online access.

1 World Health Organization (WHO) | http://www.who.int/pbd/deafness/hearing_impairment_grades/en/

Congratulations on the purchase of the iHearTest kit.

The test kit includes everything you need to accurately and rapidly proﬁle

your hearing ability from the comfort of your home. All you need is a personal

computer with an Internet connection.

The test is simple. No special training or knowledge is required to administer

the test to yourself or a family member. These instructions will guide you to test

your hearing ability.

Upon completion of your hearing screening, the results will be immediately

available on your computer screen. They will also be stored in our HIPAA-

compliant online server where you will have secure online access to view your

test results at any time.

Please don’t hesitate to contact us for questions by calling us or sending an

email. You may also check our website for the most updated information.

Toll Free 1 (844) iHEAR44 (1-844-443-2744) or email us at suppor[email protected]

The following conditions contraindicate the use of the iHearTest. If you

know, or suspect, you have the following conditions, do not take the

iHearTest without consulting with your physician.

• Visible deformity of the ear

• Current ear infection

• History of active drainage from the ear within the past 90 days

• Sudden or rapid progression of hearing loss within the past 90

days in one or both ears

• Acute or chronic dizziness

• Visible evidence of signicant cerumen (ear wax) accumulation or

a foreign body in the ear canal

• Pain or discomfort in the ear

• Individuals with poor dexterity, poor vision, or signicant dementia

• Fluctuating hearing sensitivity

• Sudden onset or rapid worsening of tinnitus (ringing) within the

past 90 days

• History of conductive or mixed hearing loss or ear surgery

If you have any of the conditions listed, it is in your best interest to have

a medical evaluation performed by a physician. A medical clearance is

required in order to take the hearing test. The medical clearance form may

be downloaded from our website.

• Do not reuse earphone ear tips. They are intended for single use only.

• Use only the earphones provided with the iHearTest system. The

iHearTest system is individually calibrated to operate with the provided

earphones. No other earphones may be used with the iHearTest in

order to prevent erroneous hearing test results.

• Do not perform the hearing test in a noisy environment. Choose the

quietest room, or area away from street noise, TV and Audio sounds,

running machines, etc.

• Make sure the ear tip is rmly attached to the earphone. Do not insert

Medical Clearance

Contraindications

Important Precautions & Safety Information

the ear tip into your ear canal if not secured to the earphone.

• Stop using the earphones if they cause discomfort, irritation or

dizziness. Continued use may damage your ear skin and cause

rash or inflammation.

• If the ear tip becomes lodged in your ear, do not try to

remove it yourself. If visible, have someone other than

yourself remove it. If not visible, seek skilled medical assistance to

remove the ear tip from the ear canal.

• Store the earphone ear tips in a safe place where children or pets

cannot reach them to avoid the risk of a possible accident or hazard

such as swallowing them.

• When earphones are in use you may hear friction noise

caused by the cord rubbing against your clothing while

moving your body or head. This is not part of the test sound and

you should not respond to it.

• When replacing the ear tips, attach them rmly to prevent them

from getting lodged in your ear canal.

• Do not speak, chew gum, eat or drink during the test as this may

interfere with the hearing test.

The iHearTest is NOT a test to clinically diagnose your

hearing health, nor to treat, cure, or prevent any disease. For a

medical evaluation of your ears or auditory system, or for a

medical evaluation of your hearing health, you should consult with a

hearing health professional such as an Otolaryngologist (Ear, Nose,

and Throat) doctor, or an Audiologist. You may also contact your

primary care physician for consultation or referral to a hearing health

professional.

If the results of the iHearTest are “Good” (a score of 5) it means that

you hear the soft sounds that are necessary for hearing in everyday

situations. Good results do not rule out a medical condition that

may aect the health of your ears. If there are other symptoms of

ear problems such as pain, ringing, plugged feeling, or constant

or frequent dizziness, an evaluation by a medical professional is

recommended even if you have “Good” hearing results.

Disclaimers

The iHearTest is not intended for use by individuals with dementia or other

cognitive impairment.

If you have any questions regarding the use of this product, please contact

iHear Medical, Inc. Customer Support Toll Free at 1 (844) iHEAR44 (1-844-

443-2744), or [email protected].

An Institutional Review Board (IRB)-approved clinical study was conducted

to assess the safety and ecacy of the iHearTest (home hearing screener)

in normal use settings. 77 subjects (154 ears), including 47 males and 30

females, ages 22-90 years, median age of 51 years, were enrolled for the

clinical study. The iHearTest scoring results were compared to the World

Health Organization (WHO) method for grading of hearing impairment

using standard practice audiometry methods. The study targeted adult

subjects who suspected or knew they had hearing loss.

The primary objective of the iHearTest clinical study was to determine a

binary (yes/no) identication of disabling hearing impairment (correspond-

ing to WHO levels 2-4), and the extent to which the iHearTest agreed with

the WHO method for determining disabling hearing impairment. The clinical

study results showed 95% agreement with the WHO method using standard

practice instruments for the assessment of disabling hearing impairment,

with high sensitivity and specicity of 89% and 97%, respectively. For the

ordinal assessment of hearing ability the iHearTest showed 86% agreement

level-by-level, relative to the WHO method using standard practice audi-

ometry, and showed 100% agreement with the WHO method using stan-

dard practice audiometry within ±1 level of WHO grading. The variability of

scoring between the iHearTest with respect to the primary standard practice

method was consistent with – and nearly identical to – the variability across

two alternate standard practice audiometry methods.

In addition to the primary objectives of determining agreement with the WHO

method using standard practice audiometry, the usability of the iHearTest

system was also evaluated in a subset of 25 subjects as an exploratory

endeavor to obtain comments on the subjective experience with the device,

packaging and setup. The iHearTest was found to be safe and eective as

an over-the-counter hearing screening device.

Clinical Summary

Table of Contents

Introduction 2

Intended Use 2

Contraindications 3

Medical Clearance 3

Important Precautions & Safety Information 3

Disclaimers 4

Clinical Summary 5

Table of Contents 6

What is the iHearTest? 8

What’s in the iHearTest kit? 9

Your iHearUSB Device & Earphones 10

System Requirements 11

Sample Test Results and Test Scores 12

The iHear Dashboard (Windows) 14

The iHear Dashboard (Mac) 15

Install iHear Software (Windows) 16

Install iHear Software (Mac) 17

Labeling and Serial Numbers 18

Launch iHearTest & iHearUSB Registration 19

Taking the iHearTest 20

iHear Device Contraindications & Disclaimers 21

Medical Clearance Form 21

Connecting the Earphone and iHearUSB Device 22

Placement of Earphones in the Ear Canal 23

Ear Tips & Selection 23

Ear Tip Selection 24

Proper Earphone Placement in the Ear 25

Initial Setup Before the Test 26

7Table of Contents

Introduction 2

Intended Use 2

Contraindications 3

Medical Clearance 3

Important Precautions & Safety Information 3

Disclaimers 4

Clinical Summary 5

Table of Contents 6

What is the iHearTest? 8

What’s in the iHearTest kit? 9

Your iHearUSB Device & Earphones 10

System Requirements 11

Sample Test Results and Test Scores 12

The iHear Dashboard (Windows) 14

The iHear Dashboard (Mac) 15

Install iHear Software (Windows) 16

Install iHear Software (Mac) 17

Labeling and Serial Numbers 18

Launch iHearTest & iHearUSB Registration 19

Taking the iHearTest 20

iHear Device Contraindications & Disclaimers 21

Medical Clearance Form 21

Connecting the Earphone and iHearUSB Device 22

Placement of Earphones in the Ear Canal 23

Ear Tips & Selection 23

Ear Tip Selection 24

Proper Earphone Placement in the Ear 25

Initial Setup Before the Test 26

Before Taking the iHearTest 27

Room Noise 28

iHearTest is Complete - Show Results 28

iHearTest Results 29

iHearTest Scores and What it Means 30

iHearTest Scores Compared to Hearing Impairment

Grading by WHO 31

Calibration Check 32

Troubleshooting Guide 33

How to Uninstall iHear Software (Windows) 35

How to Uninstall iHear Software (Mac) 36

Technical Specications 37

Expiration Date 37

Audiometric 37

Earphones 37

Electrical 37

Computer System

Software Compatibility & Internet Requirements 37

Mechanical 38

Environmental 38

Standards 38

Audiometry 38

Warranty 39

Information & Explanation of Symbols 39

What is the iHearTest?

The iHearTest is an over the counter home hearing screener that allows you

to test and proﬁle your hearing ability at home. The iHearTest kit consists of

the iHearUSB device and calibrated earphones to ensure accurate hearing test

results. An assortment of ear tip sizes are also included to ensure proper ﬁt of the

earphones in your ear for best results. You will need a personal computer with

online connection, Internet Browser and a USB port to connect the iHearUSB

device to your personal computer. You will also need to download the iHearTest

software application before you can administer the iHearTest.

The iHearTest system is illustrated below. Please familiarize yourself with the

iHearTest system components in order to better understand this User Guide.

ACalibrated earphones

BiHearUSB device

CUSB connection

DPersonal Computer

EiHearTest Application

8 9