User Guide - iHEAR Medical · 2018. 10. 16. · the ear tip into your ear canal if not secured to the earphone. • Stop using the earphones if they cause discomfort, irritation or

HOME HEARING SCREENER

User Guide

iHear Loud & Clear®

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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 profiling 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/

3

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]

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 significant 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 significant 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 firmly attached to the earphone. Do not insert

Medical Clearance

Contraindications

Important Precautions & Safety Information

4Important 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 firmly 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 affect 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

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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 efficacy 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) identification 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 specificity 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 effective as an over-the-counter hearing screening device.

Clinical Summary

6Table of Contents

Introduction 2Intended Use 2Contraindications 3Medical Clearance 3Important Precautions & Safety Information 3Disclaimers 4Clinical Summary 5Table of Contents 6What is the iHearTest? 8What’s in the iHearTest kit? 9Your iHearUSB Device & Earphones 10 System Requirements 11Sample Test Results and Test Scores 12Sign in or Create an iHear Account 13The iHear Dashboard (Windows) 14The iHear Dashboard (Mac) 15Install iHear Software (Windows) 16Install iHear Software (Mac) 17Labeling and Serial Numbers 18Launch iHearTest & iHearUSB Registration 19Taking the iHearTest 20iHear Device Contraindications & Disclaimers 21Medical Clearance Form 21Connecting the Earphone and iHearUSB Device 22Placement of Earphones in the Ear Canal 23Ear Tips & Selection 23Ear Tip Selection 24Proper Earphone Placement in the Ear 25 Initial Setup Before the Test 26

7 Table of Contents

Introduction 2Intended Use 2Contraindications 3Medical Clearance 3Important Precautions & Safety Information 3Disclaimers 4Clinical Summary 5Table of Contents 6What is the iHearTest? 8What’s in the iHearTest kit? 9Your iHearUSB Device & Earphones 10 System Requirements 11Sample Test Results and Test Scores 12Sign in or Create an iHear Account 13The iHear Dashboard (Windows) 14The iHear Dashboard (Mac) 15Install iHear Software (Windows) 16Install iHear Software (Mac) 17Labeling and Serial Numbers 18Launch iHearTest & iHearUSB Registration 19Taking the iHearTest 20iHear Device Contraindications & Disclaimers 21Medical Clearance Form 21Connecting the Earphone and iHearUSB Device 22Placement of Earphones in the Ear Canal 23Ear Tips & Selection 23Ear Tip Selection 24Proper Earphone Placement in the Ear 25 Initial Setup Before the Test 26

Before Taking the iHearTest 27Room Noise 28iHearTest is Complete - Show Results 28iHearTest Results 29iHearTest Scores and What it Means 30iHearTest Scores Compared to Hearing Impairment Grading by WHO 31Calibration Check 32Troubleshooting Guide 33How to Uninstall iHear Software (Windows) 35How to Uninstall iHear Software (Mac) 36Technical Specifications 37 Expiration Date 37 Audiometric 37 Earphones 37 Electrical 37Computer System Software Compatibility & Internet Requirements 37Mechanical 38Environmental 38 Standards 38Audiometry 38Warranty 39Information & Explanation of Symbols 39

8What 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.

A Calibrated earphonesB iHearUSB deviceC USB connectionD Personal ComputerE iHearTest Application

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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.

What’s in the iHearTest kit?

iHearUSB Device Earphones 2x Assortment Ear Tips Audio Jack

Use a clean, soft cloth or cleaning wipes to wipe down the iHearUSB and the Earphones. Make sure the input and output connectors are clean and free from debris.

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Please familiarize yourself with the iHearUSB device and earphones.

Use only the earphones and ear tips provided with the iHearTest kit to ensure proper fit in the ear canal and accurate test results. No other earphones or ear tips should be used with the iHearTest in order to prevent erroneous test results.

The iHearUSB device has a built in microphone to monitor the ambient noise level in your room. If the noise level exceeds the maximum allowed level, testing will be paused and a message will be displayed on your computer screen to alert you of the excessive noise condition. After you reduce the noise level to an acceptable level, you can proceed with the hearing test.

After you complete the hearing testing for both ears, the results will be displayed on the screen of your computing device. The test results will also be stored on our HIPAA-compliant online server and you will have secure online access to the test results for review at any time. You can also print the results.

The iHearUSB Device & Earphones

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Browser Compatibility, Computer & Internet Requirements

COMPUTER & INTERNET REQUIREMENTS

• Personal computer with USB 2.0+ port• Operating System: Windows 7 or higher Mac 0S 10.10 or higher• iHearTest Application Software (Available for download online)• Most high-speed connections will work. Minimum speed of 512 Kbps is required.

For installation assistance or compatibility questions, please contact ourCustomer Support at Toll Free 1-844-iHEAR44 (1-844-443-2744) or visit:

www.ihearmedical.com/faq for the most up-to-date compatibily information.

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Please familiarize yourself with the iHearUSB device and earphones.

Use only the earphones and ear tips provided with the iHearTest kit to ensure proper fit in the ear canal and accurate test results. No other earphones or ear tips should be used with the iHearTest in order to prevent erroneous test results.

The iHearUSB device has a built in microphone to monitor the ambient noise level in your room. If the noise level exceeds the maximum allowed level, testing will be paused and a message will be displayed on your computer screen to alert you of the excessive noise condition. After you reduce the noise level to an acceptable level, you can proceed with the hearing test.

After you complete the hearing testing for both ears, the results will be displayed on the screen of your computing device. The test results will also be stored on our HIPAA-compliant online server and you will have secure online access to the test results for review at any time. You can also print the results.

System Requirements

Browser Compatibility, Computer & Internet Requirements

COMPUTER & INTERNET REQUIREMENTS


For installation assistance or compatibility questions, please contact ourCustomer Support at Toll Free 1-844-iHEAR44 (1-844-443-2744) or visit:

www.ihearmedical.com/faq for the most up-to-date compatibily information.

iHearTest User Guide

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The iHearTest scores your hearing ability in each ear on a scale from 1 to 5. The hearing ability grading is based on World Health Organization (WHO)1 guidelines.

At the end of the hearing test, the iHearTest automatically generates a report of your hearing ability that you may review or print. Shown below is a sample of the test results and scores page.


Sample Test Results and Test Scores

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The iHearTest scores your hearing ability in each ear on a scale from 1 to 5. The hearing ability grading is based on World Health Organization (WHO)1 guidelines.

At the end of the hearing test, the iHearTest automatically generates a report of your hearing ability that you may review or print. Shown below is a sample of the test results and scores page.


Sign in or Create an iHear Account

In order to use or register iHear Medical products or services, please create an account. (Skip if you already have an iHear account and proceed to Sign in.)

Go to: www.ihearmedical.com

Click on My iHear Account.

To set up a new account Click on �Create an Account fill in the required information then Click Sign Up.

Once you’ve created your iHear account you will receive notification by email to activate your account.

�Sign In to your account.

Go to: www.ihearmedical.com/ signin and Sign in to your account.

� �

http://app.ihearmedical.com/#/signin

14The iHear Dashboard (Windows)

You may launch the iHearTest from the iHear Dashboard. The Dashboard is the launch site for all iHear software programs.

Go to iHearTest and Click on LAUNCH APPLICATION. This launches the iHearTest application if it is already installed, if not you will be prompted to download and install the software.

14 15 The iHear Dashboard (Mac)

The Dashboard on the Mac has a LAUNCH and INSTALL button. If the iHearTest is not yet installed on your computer, you will need to install the application first.

Click to INSTALL APPLICATION.

Click DOWNLOAD then follow the step-by-step procedures to complete the iHear application installation and product activation.

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Click SAVE FILE

Follow the iHearTest installer setup wizard. Agree to the license agreement, then follow the step-by-step procedures to complete the iHear software installation.

Install iHear Software (Windows)

16 17 Install iHear Software (Mac)

Click OK to save file

Follow the iHearTest installer setup wizard. Agree to the license agreement, then follow the step-by-step procedures to complete the iHear software installation.

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If you have just finished installing the software, iHearTest should launch auto-matically. If you need to re-launch the application, follow these instructions:

1. Sign in to you account at www.ihearmedical.com/signin2. Click on the LAUNCH APPLICATION button for iHearTest

-OR-

Locate the iHearTest application by searching for the application by name and CLICK on iHearTest.

iHearUSB Device Registration

After installing the iHear software, you need to register your iHearUSB device and then activate it before you can take the iHearTest. You will be prompted with the following screen. Click on PROCEED TO REGISTRATION to register your iHearUSB device. Once your iHearUSB device is connected you will be prompted to register your device. Click on PROCEED TO REGISTRATION.

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Labeling and Serial Numbers

There is an 8 digit serial number on the back of the iHearUSB device and an 8 digit serial number for the earphones located near the plug.

You may need the serial number of the iHearUSB device when you contact iHear Medical for technical support.

A 1 2 3 4 5 6 7 8

iHearUSBSerial Number

EarphoneSerial Number

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If you have just finished installing the software, iHearTest should launch auto-matically. If you need to re-launch the application, follow these instructions:

1. Sign in to you account at www.ihearmedical.com/signin2. Click on the LAUNCH APPLICATION button for iHearTest

-OR-

Locate the iHearTest application by searching for the application by name and CLICK on iHearTest.

iHearUSB Device Registration

After installing the iHear software, you need to register your iHearUSB device and then activate it before you can take the iHearTest. You will be prompted with the following screen. Click on PROCEED TO REGISTRATION to register your iHearUSB device. Once your iHearUSB device is connected you will be prompted to register your device. Click on PROCEED TO REGISTRATION.

Launch iHearTest & iHearUSB Registration

There is an 8 digit serial number on the back of the iHearUSB device and an 8 digit serial number for the earphones located near the plug.

You may need the serial number of the iHearUSB device when you contact iHear Medical for technical support.

20Taking the iHearTest

jRead the contraindications and disclaimers (medical waiver)kBy clicking on the appropriate boxes (1 & 2) you acknowledge that you do not have any of the conditions (Contraindications) listed therein and that you have read and un-derstood the statements.

Once you agree to the Terms and Conditions, lPROCEED TO IHEARTEST and follow the onscreen procedures. A medical clearance is required in order to take the hearing test and may be downloaded by following the mclick here link.

After a successful registration the Congratulations! screen comes up and prompts you to PROCEED TO IHEARTEST.

The total number of available credits is shown below. Extra credits for additional hearing tests may be ordered online. You may select the name of the person who will take the test or ADD NEW USER then Click PROCEED TO IHEARTEST.

2120

jRead the contraindications and disclaimers (medical waiver)kBy clicking on the appropriate boxes (1 & 2) you acknowledge that you do not have any of the conditions (Contraindications) listed therein and that you have read and un-derstood the statements.

Once you agree to the Terms and Conditions, lPROCEED TO IHEARTEST and follow the onscreen procedures. A medical clearance is required in order to take the hearing test and may be downloaded by following the mclick here link.

iHear Device Contraindications & Disclaimers

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I. Contraindications (Medical Waiver)

The following conditions contraindicate the use of the iHearTest. If you know, or suspect you have the following conditions, do not use the iHearTest without consulting 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 significant 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 significant 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

II. Disclaimers

The iHearTest is not a test to clinically diagnose your hearing health, nor to treat, cure or prevent

By checking this box you acknowledge that you are an adult age 18 or older, have read and understood the above Disclaimers statement and the Precautions and Safety Information Statement.

By checking this box and clicking on the "PROCEED TO IHEARTEST" button below, you certify that you do not have any of the conditions (Contraindications) listed above. You also acknowledge that you have been advised by iHear Medical, Inc. that your best health interest would be served by having a medical evaluation by a physician.

If you have any of these conditions please click here.

BACK PRINT FOR YOUR RECORDSPROCEED TO iHEARTEST

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Connecting the Earphone & iHearUSB device

Follow the steps indicated onscreen then Click NEXT to continue.

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Placement of Earphones in the Ear Canal

Attach the ear tips to the earphone nozzles ensuring that they are attached securely. For optimal accuracy of the hearing test, the earphones must be placed properly into the ear. This requires proper selection of the correct tip size and proper insertion into the ear opening for best test results.

Ear Tips and Selection

Two sets of three pairs of ear tips are included with your iHearTest kit - Small, Medium and Large. For the most accurate test result, it is important to select the ear tip size that fits most securely and comfortably inside your ear canal. The tip should be securely attached to the earphone nozzle and must fit inside your ear for best test results.

The ear tip must be attached securely to the earphones to prevent accidental detachment of the ear tip inside your ear. Test the attachment by tugging on it.

Opening

Attach ear tip to the nozzle. Tug on the tip to ensure that it’s secured.

Insert ear tip past the ear opening.

Earphone Nozzle

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• If the fit feels loose in the ear canal (no blocking of ambient sounds), replace the ear tip with a larger size.

• If the fit feels too tight or uncomfortable, replace with a smaller ear tip size.• Once the fit feels tight, but comfortable and background sounds are blocked,

this is your correct ear tip size.• Make sure you insert well into the ear opening.

Ear Tip Selection

For best fit and the most accurate test results we recommend that you carefully follow these instructions:

• Start with the MEDIUM tips, which have already been securely attached to the right and left earphones. If MEDIUM’s too tight, then try SMALL or if loose then try LARGE.

• A properly sized tip should effectively block ambient sounds, similar to plugging your ear with an ear plug

For proper placement of the earphones in the ear canal, pulling the external ear, up or back, may help facilitate insertion of the earphone into the ear.

Please ensure that you have selected a new tip that is most comfortable and secure. You should hear individual ear specific instructions through the LEFT and RIGHT earphones.

Do not reuse ear tips, they are disposable and are intended for single use only.

24 25 Proper Earphone Placement in the Ear

• If the fit feels loose in the ear canal (no blocking of ambient sounds), replace the ear tip with a larger size.

• If the fit feels too tight or uncomfortable, replace with a smaller ear tip size.• Once the fit feels tight, but comfortable and background sounds are blocked,

this is your correct ear tip size.• Make sure you insert well into the ear opening.

Ambient sounds blocked

Opening of the ear

• Proper sizing and proper placement of the ear tip

• No gap to block ambient sounds

• Placement into the ear opening

• Cable pointing down• The fit should feel snug but

comfortable

Air gap allows ambient soundto enter

• Ear tip too small• Gap present• No blocking of ambient

sounds

You may require a different size ear tip for each ear.

Loose fit in the ear canal.

Correct fit in the ear canal - no gaps.

For best fit and the most accurate test results we recommend that you carefully follow these instructions:

• Start with the MEDIUM tips, which have already been securely attached to the right and left earphones. If MEDIUM’s too tight, then try SMALL or if loose then try LARGE.

• A properly sized tip should effectively block ambient sounds, similar to plugging your ear with an ear plug

For proper placement of the earphones in the ear canal, pulling the external ear, up or back, may help facilitate insertion of the earphone into the ear.

Do not reuse ear tips, they are disposable and are intended for single use only.

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Follow the online instructions.

Voice recording will play through your right earphones only. If you do not hear the re-cording, check the earphones’ plug connection, and make sure the earphone is properly inserted into the right ear. If you hear the “right” instructions from the left ear, make sure you swap the placement of the earphones in your ears.

Click the NEXT button to proceed only when you hear the instructions play in the right ear only! Instruction will now play through your left earphone. If you do not hear the re-cording, make sure the left earphone is properly inserted in the left ear. Click the NEXT button only when you hear the instructions in the left ear.

Initial Setup Before the Test

Listen to the instructions and Press the SPACEBAR on your keyboard to begin the test.

It’s important to reduce all sources of ambient noise when you take this test. For example turn off the television, stereo, radio, and request others to refrain from making noise if in the same room with you while taking this test.

Press the SPACEBAR every time you hear a sound.

26 27

Follow the online instructions.

Voice recording will play through your right earphones only. If you do not hear the re-cording, check the earphones’ plug connection, and make sure the earphone is properly inserted into the right ear. If you hear the “right” instructions from the left ear, make sure you swap the placement of the earphones in your ears.

Click the NEXT button to proceed only when you hear the instructions play in the right ear only! Instruction will now play through your left earphone. If you do not hear the re-cording, make sure the left earphone is properly inserted in the left ear. Click the NEXT button only when you hear the instructions in the left ear.

Listen to the instructions and Press the SPACEBAR on your keyboard to begin the test.

It’s important to reduce all sources of ambient noise when you take this test. For example turn off the television, stereo, radio, and request others to refrain from making noise if in the same room with you while taking this test.

Press the SPACEBAR every time you hear a sound.

Before Taking the iHearTest

28

During the test, if the ambient sound levels are excessive, the test will automatically pause and NOISE message will appear on your screen. After the sound disturbance is reduced or eliminated, Click CONTINUE to proceed.

Once the testing is complete, you see the Congratulations! screen. Click on SHOW RESULTS to display your test results score.

Room Noise

iHearTest is Complete - Show Results

28 29

During the test, if the ambient sound levels are excessive, the test will automatically pause and NOISE message will appear on your screen. After the sound disturbance is reduced or eliminated, Click CONTINUE to proceed.

Once the testing is complete, you see the Congratulations! screen. Click on SHOW RESULTS to display your test results score.

iHearTest is Complete - Show Results

The hearing ability for each ear is presented as a score from 1-5. A description of the score and indication for hearing aid use is also presented.

A maximum score of 5 represents “Normal” hearing ability, or insignificant hearing loss. A score of 1 represents the lowest score indicating a potentially serious hearing impairment that is best evaluated by a hearing health professional. Your test score may be identical or different for each ear.

iHearTest Results

30iHearTest Scores and What it Means

SCORE HEARING ABILITY

5 Good Hearing Ability

4 Slight Impairment

3 Moderate Impairment

2 Severe Impairment

1 Profound Impairment

WHAT IT MEANS

No or very slight hearing impairment. You are not likely to benefit from a hearing aid. Test score of 5 does not rule out a medical condition.

Able to hear well at normal conversation levels, but may have difficulty hearing conversations in noisy conditions. A hearing device may improve your hearing in challenging situations.

Difficulty hearing speech unless it is shouted. A hearing device is recommended to improve your hearing in almost every listening situation.

Words must be shouted into your better ear to be heard correctly. Learning to lip-read can be helpful. A hearing device is recommended to improve your hearing in many but not all listening situations.

For this degree of impairment, we recommend you see a hearing professional for further evaluation and recommendation for a hearing solution.

3130

WHAT IT MEANS

No or very slight hearing impairment. You are not likely to benefit from a hearing aid. Test score of 5 does not rule out a medical condition.

Able to hear well at normal conversation levels, but may have difficulty hearing conversations in noisy conditions. A hearing device may improve your hearing in challenging situations.

Difficulty hearing speech unless it is shouted. A hearing device is recommended to improve your hearing in almost every listening situation.

Words must be shouted into your better ear to be heard correctly. Learning to lip-read can be helpful. A hearing device is recommended to improve your hearing in many but not all listening situations.

For this degree of impairment, we recommend you see a hearing professional for further evaluation and recommendation for a hearing solution.

iHearTest Scores Compared to Hearing Impairment Grading by WHO*

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32If you have any questions regarding the use of this product, please contact iHear Medical, Inc. Customer Support at

Toll Free at 1 (844) iHEAR44 (1-844-443-2744), or send an email to [email protected].

Calibration Check

The iHearUSB has been calibrated to accurately test your hearing ability for up to one year from the original calibration date (as indicated on the back of the package), or after 10 tests; whichever comes first. The software auto-detects the iHearUSB if calibration is required and the Time to Recheck Calibration screen will come up. When this screen appears, Click on Proceed to Calibration Check then follow the step-by-step online instructions.

When prompted to insert the earphone to the iHearUSB, remove the ear tip and push the earphone nozzle all the way down until it’s flushed against the iHearUSB, and until a “clicking” sound is heard indicating that the earphone is secured for accurate calibration.

RR

Incorrect Connection

LOOSE NO GAP

Correct Connection

32 33

I cannot hear sounds or the instruction recording from the earphones during setup or test.

The Noise Screen keeps popping up.

None of the ear tips fit in my ear canal comfortably and securely.

The earphones ear tip came off in my ear.

The earphones ear tip does not stay securely to the earphone nozzle.

I hear static through the earphones.

The sound through the earphones is intermittent.

One earphone seems louder than the other.

My computer does not recognize/find my iHearUSB device.

My computer does not recognize that my earphones are plugged in.

• Check connection of the audio jack• Make sure the correct earphones (Left & Right) are inserted in each ear

• Turn down/off all noisy sources in the room. • Remain still while taking the test.

• Contact iHear Medical, Inc. Customer Support

• Be careful not to push the tip in the ear deeper.• If the ear tip is visible, have someone other than yourself remove it. • Do not use any sharp object to remove an ear tip from the ear canal• If the ear tip is lodged deeply and not visible to anyone, seek

assistance from a hearing professional to remove the ear tip. • Contact iHear Medical, Inc. Customer Support.

• Make sure you push the ear tip firmly on to the earphone nozzle. • Try a new ear tip. Discard the old one.• Do not try inserting ear tip in the ear when it is not securely connected

to the earphones.

• Turn off any nearby appliances that may be causing the interference.• Contact iHear Medical, Inc. Customer Support

• Reposition the earphones in the ear canal. • Make sure the earphones audio plug is inserted fully into the audio

jack of iHearUSB device.• Contact iHear Medical, Inc. Customer Support

• You may have different hearing ability in each ear. • Contact iHear Medical, Inc. if you are certain that you have equal

hearing in both ears.

• Try a different USB port• Restart your computer• Try a different personal computer if available.

• Make sure the USB plug of the iHearUSB device is completely inserted into the USB port of the computer and the earphone plug is completely inserted into the audio jack of the iHearUSB device.

Troubleshooting GuideIf you have any questions regarding the use of this product, please contact iHear Medical, Inc. Customer Support at

Toll Free at 1 (844) iHEAR44 (1-844-443-2744), or send an email to [email protected].

The iHearUSB has been calibrated to accurately test your hearing ability for up to one year from the original calibration date (as indicated on the back of the package), or after 10 tests; whichever comes first. The software auto-detects the iHearUSB if calibration is required and the Time to Recheck Calibration screen will come up. When this screen appears, Click on Proceed to Calibration Check then follow the step-by-step online instructions.

34

• Search your computer for the iHearTest application by name• Check in your Downloads Folder.

• Make sure that you have an online connection on your computer.

• Unplug the iHearUSB device from your computer• Contact iHear Medical, Inc. Customer Support



• Order new ear tips by visiting our website at www.ihearmedical.com• Contact iHear Medical, Inc. Customer Support

• Remove and reinsert the earphones • Reposition the earphones in the ear canal• Try a different ear tip size• Contact iHear Medical, Inc. Customer Support

• Pause the test• Make sure that you have the right (Red) earphone (labeled R) in your

right ear and the left one (L) in your left ear and that they are securely inserted into your ear canal.

• Restart the test.



• Make sure that calibration check is performed in a quiet room with the device placed on a soft surface.

• Earphone nozzle may not be properly inserted into the calibration cavity. Re-insert the nozzle fully in (refer to the correct connection diagram on page 28).

I can’t find the iHearTest launch icon for the downloaded software application.

I can’t get to the iHear or iHearTest Website.

My iHearUSB device feels too hot.

I lost or damaged my iHearUSB device.

I lost or damaged my earphones.

I lost or damaged my earphone ear tips.I need new ear tips.

The earphones hurt my ears or feel uncomfortable.

I hear sounds from the opposite ear during instructions or the test.

The iHear software application freezes up.

The iHear software application download did not complete or install properly.

Calibration Check Fails

Troubleshooting Guide

Close or exit the iHearTest by going to File on the menu bar then Exit.

Open Programs and Features from the Start button, Click CONTROL PANEL ð PROGRAMS ð PROGRAMS AND FEATURES.

34 35

• Search your computer for the iHearTest application by name• Check in your Downloads Folder.

• Make sure that you have an online connection on your computer.

• Unplug the iHearUSB device from your computer• Contact iHear Medical, Inc. Customer Support



• Order new ear tips by visiting our website at www.ihearmedical.com• Contact iHear Medical, Inc. Customer Support

• Remove and reinsert the earphones • Reposition the earphones in the ear canal• Try a different ear tip size• Contact iHear Medical, Inc. Customer Support

• Pause the test• Make sure that you have the right (Red) earphone (labeled R) in your

right ear and the left one (L) in your left ear and that they are securely inserted into your ear canal.

• Restart the test.



• Make sure that calibration check is performed in a quiet room with the device placed on a soft surface.

• Earphone nozzle may not be properly inserted into the calibration cavity. Re-insert the nozzle fully in (refer to the correct connection diagram on page 28).

Close or exit the iHearTest by going to File on the menu bar then Exit.

Open Programs and Features from the Start button, Click CONTROL PANEL ð PROGRAMS ð PROGRAMS AND FEATURES.

How to Uninstall iHear Software [Windows]

36How to Uninstall iHear Software (Mac)

Close or exit the iHearTest by selecting Quit from the menu bar.

Open maintenancetool from the folder where the iHearTest software is installed (default location for iHearTest is at <username>/iHear/iheartest/maintenancetool) ð Remove all components.

36 37

Model No: IHTK-OTC

Expiration Date: 3 years from date of calibration (as marked on the box)

AUDIOMETRIC*Test Frequencies 500, 1000, 2000, 4000 HzTest Step Range 10-20 dB Rise/fall time 35 ms TypicalStimulus Type Warble Tone, Narrow-Band natural soundDistortion <1% THD Typical, 2.5% THD Maximum*ANSI/ASA S3.6-2010

EARPHONESCalibrated In-Ear Type with assorted ear tips

Sensitivity 115 ± 3 (dB SPL/mW) at 1000 Hz Impedance 18 ± 3 ohms at 1000 HzLevel Accuracy ± 3 dBCrosstalk < 70 dBSeal attenuation ≥ 15 dB 250-4,000 HzEar tip material Medical Grade Silicone Rubber

ELECTRICALPower Source USB port, 5V ±.2V @0.050AUSB Compatibility 2.0 and higher

Computer System, Software Compatibility & Internet Requirements*


*Please visit www.ihearmedical.com/faq for the most up-to-date compatibility information.

Technical Specifications

38Technical Specifications

MECHANICAL (iHearUSB)

Dimensions Length=72 mm, Width=41 mm, Thickness=11 mm (approximately)Case Injection molded plastic Weight ≈2 ounces (48 grams) including USB cable

ENVIRONMENTAL

Storage Temperature Range 0° to 40° CShipping Temperature Range -20° to 45° COperating Temperature Range 15° to +40° COperating Humidity Range 30% to 90% RH

STANDARDSSafety & Electromagnetic Compatibility

EN/IEC 60601-1: Medical electrical equipment: Part 1: General requirements for basic safety and essential performance.EN/IEC 60601-1-2 : Medical electrical equipment: Part 1-2: General requirements for safety and essential performance; Section 1.2 Collateral standard: Electromagnetic com-patibility - Requirements and tests.

AUDIOMETRYANSI/ASA S3.6-2010: Specifications for Audiometers, applicable sections.

CLASS II, TYPE B MEDICAL DEVICEThis device generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.

NO USER SERVICEABLE OR REPAIRABLE PARTS INSIDE.

38 39 Warranty

MECHANICAL (iHearUSB)

Dimensions Length=72 mm, Width=41 mm, Thickness=11 mm (approximately)Case Injection molded plastic Weight ≈2 ounces (48 grams) including USB cable

ENVIRONMENTAL

Storage Temperature Range 0° to 40° CShipping Temperature Range -20° to 45° COperating Temperature Range 15° to +40° COperating Humidity Range 30% to 90% RH

STANDARDSSafety & Electromagnetic Compatibility

EN/IEC 60601-1: Medical electrical equipment: Part 1: General requirements for basic safety and essential performance.EN/IEC 60601-1-2 : Medical electrical equipment: Part 1-2: General requirements for safety and essential performance; Section 1.2 Collateral standard: Electromagnetic com-patibility - Requirements and tests.

AUDIOMETRYANSI/ASA S3.6-2010: Specifications for Audiometers, applicable sections.

CLASS II, TYPE B MEDICAL DEVICEThis device generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.

NO USER SERVICEABLE OR REPAIRABLE PARTS INSIDE.

Information & Explanation of Symbols

iHear Medical, Inc. Limited One Year Warranty

This warranty is extended to the original purchaser of the iHearTest and covers defects in material and workmanship for a period of one year from the date of shipment of the device.If the iHearTest contains a defect in material or workmanship, iHear Medical, Inc., at its option will repair or replace the device at no charge except for transportation to and from the point of service. It is the purchaser’s responsibility to return the device directly to iHear Medical, Inc. after receiving authorization to return.This warranty does not cover breakage or failure due to tampering, misuse, carelessness, improper maintenance, excessive wax build-up, accidents, liquid exposure or modification. The warranty is void if the device is repaired by anyone other than iHear Medical, Inc.

This symbol indicates that the products described in

this user instruction are generally non-conductive, can be immediately removed from the user and adheres to the requirements of EN 60601-1 Type B applied part.

This symbol indicates that it is important for the user to read

and take into account the relevant information in these user guides.

Important information for handling and product safety.

This symbol indicates that it is important for the user to pay

attention to the relevant warning notices in these user guides.

Components of the iHearTest may not be thrown away as normal household waste.

Please dispose of based on local regulations and at your local waste disposal sites intended for electronic waste. Proper disposal protects the environment and health.

Complies with PB lead-free restrictions.

Complies with restriction of the use of certain hazardous substances in electrical and electronic equipment.

Informational tip.

40

The iHearTest is an air conduction over the counter hearing screener for home use by adults of at least 18 years of age. The iHearTest is not a diagnostic test to clinically diagnose your hearing health, nor to treat, cure, or prevent any disease. For a medical evaluation of your ears or your hearing health, you should consult with a hearing health professional.

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

Designed by iHear Medical in California, USA

U.S. and international patents issued and pending.

©2016 iHear Medical, Inc. All rights reserved. iHEAR, iHearTest and iHearUSB are trademarks of iHear Medical, Inc.All other trademarks are the property of the respective owners.

CUSTOMER SUPPORT

iHear Medical, Inc.15250 Hesperian Blvd.San Leandro, CA 94578 USAToll Free 1 (844) IHEAR44 (1-844-443-2744)[email protected]

MODEL: IHTK-OTC01-00035-001-EOne year limited warranty

An electronic version of this user guide is available online.To view, SIGN IN to your account and CLICK on SUPPORT.

Documents

User Guide - iHEAR Medical · 2018. 10. 16. · the ear tip into your ear canal if not secured to the earphone. • Stop using the earphones if they cause discomfort, irritation or