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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

Sign in or Create an iHear Account 

13

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

Содержание iHearTest

Страница 1: ...HOME HEARING SCREENER User Guide iHear Loud Clear R R R R R R L ...

Страница 2: ...tact 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 support ihearmedical com 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 iHearTes...

Страница 3: ...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 ...

Страница 4: ... 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...

Страница 5: ...e 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 rel...

Страница 6: ...2 Sign in or Create an iHear Account 13 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...

Страница 7: ...nt 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 Specifications 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 S...

Страница 8: ...phones 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 or...

Страница 9: ...evice 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 R 1 2 3 4 4 1 2 SMALL MEDIUM LARGE 3 ...

Страница 10: ...evel 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 wil...

Страница 11: ...her 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 our Customer 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 ...

Страница 12: ...ization 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 1 WorldHealthOrganization WHO http www who int pbd deafness hearing_impairment_grades en Sample Test Results and Test Scores ...

Страница 13: ...unt 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 ...

Страница 14: ... 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 ...

Страница 15: ...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 ...

Страница 16: ...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 ...

Страница 17: ...nstall 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 ...

Страница 18: ...al 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 A12345678 iHearUSB Serial Number Earphone Serial Number ...

Страница 19: ...ion 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 prompt...

Страница 20: ...ions 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 ...

Страница 21: ... 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 I...

Страница 22: ...22 S M L Connecting the Earphone iHearUSB device Follow the steps indicated onscreen then Click NEXT to continue ...

Страница 23: ... 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 detachme...

Страница 24: ...rly 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 LE...

Страница 25: ... 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 sound to enter Ear tip too small Gap present No blocking of ambient sounds You may requi...

Страница 26: ...ght 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 instructi...

Страница 27: ...mportant 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 ...

Страница 28: ...se 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 ...

Страница 29: ...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 ...

Страница 30: ...ulty 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 yo...

Страница 31: ...ar 41 60 dB better ear 61 80 dB better ear 81 dB or greater better ear Performance No or very slight hearing prob lems Able to hear whispers Able to hear and repeat words spoken in normal voice at 1 meter Able to hear and repeat words spoken in raised voice at 1 meter Able to hear some words when shouted into better ear Unable to hear and understand even a shouted voice Recommendations Counseling ...

Страница 32: ...uired 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 ...

Страница 33: ...eplyandnotvisibletoanyone seek assistancefromahearingprofessionaltoremovetheeartip ContactiHearMedical Inc CustomerSupport Makesureyoupushtheeartipfirmlyontotheearphonenozzle Tryaneweartip Discardtheoldone Donottryinsertingeartipintheearwhenitisnotsecurelyconnected totheearphones Turnoffanynearbyappliancesthatmaybecausingtheinterference ContactiHearMedical Inc CustomerSupport Repositiontheearphone...

Страница 34: ...rtthetest ContactiHearMedical Inc CustomerSupport ContactiHearMedical Inc CustomerSupport Makesurethatcalibrationcheckisperformedinaquietroomwiththe deviceplacedonasoftsurface Earphonenozzlemaynotbeproperlyinsertedintothecalibration cavity Re insertthenozzlefullyin refertothecorrectconnection diagramonpage28 I can t find the iHearTest launch icon for the downloaded software application I can t get...

Страница 35: ...e 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 ...

Страница 36: ...ose 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 ...

Страница 37: ...ohms at 1000 Hz Level Accuracy 3 dB Crosstalk 70 dB Seal attenuation 15 dB 250 4 000 Hz Ear tip material Medical Grade Silicone Rubber ELECTRICAL Power Source USB port 5V 2V 0 050A USB Compatibility 2 0 and higher Computer System Software Compatibility Internet Requirements Personal computer with USB 2 0 port Operating System Windows 7 or higher Mac 0S 10 10 or higher iHearTest Application Softwar...

Страница 38: ...ical 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 AUDIOMETRY ANSI ASA S3 6 2010 Specifications for Audiometers applicable sections CLASS II TYPE B MEDICAL DEVICE Thi...

Страница 39: ...oid 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 ...

Страница 40: ...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 USA Toll Free 1 844 IHEAR44 1...

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