IHEAR MAX User Manual

Page 1
HIGH DEFINITION HEARING DEVICE
User Guide
iHear Loud & Clear
®
Page 2
2
3
Read the User Guide before using the iHEARMAX™.
Infrequent use of a hearing device does not permit a
user to attain full benet from it. Hearing device will not restore normal hearing and will not prevent or improve a hearing
impairment resulting from organic conditions.
This icon means a video is available online.
The iHEARMAX is a behind the ear hearing aid intended for adults
with mild to severe hearing loss who need hearing enhancement and is not to be worn by individuals under the age of 18. The Food and Drug Administration has determined that it is in your best health interest to have a medical evaluation by a physician (preferably a physician who specializes in diseases of the ear)
before purchasing a hearing aid. The purpose of a medical
evaluation is to assure that all medically treatable conditions that may aect hearing are identied and treated before a hearing aid is purchased. Following the medical evaluation, the physician can give you a written statement (medical clearance) that states that your hearing health has been evaluated and that you may be considered a candidate for a hearing aid. The physician may refer you to an audiologist or a hearing aid dispenser, for a hearing aid evaluation. You may also send (by mail, fax, or e-mail) the signed
medical clearance to iHear Medical for the purpose of purchasing
a hearing aid. Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a physician. Federal law also permits a fully informed adult to sign a medical waiver statement declining the medical evaluation. The exercise of such a waiver is not in your best health interest and its use is discouraged. iHear Medical will not sell a hearing device to you unless you either (1) obtain a signed medical clearance, or (2) review and accept the medical waiver statement.
IMPORTANT NOTICE
Page 3
3
CONTRAINDICATIONS FOR USE
The following conditions contraindicate the use of a hearing device. If you know or suspect you have the following conditions, you must consult with a physician who will
need to provide medical clearance before using a hearing device.
• 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 within the past 90 days
• History of conductive or mixed hearing loss or ear surgery
DISCLAIMERS
• The use of a hearing device will not restore normal hearing. All it can do is improve your existing hearing ability.
• The use of a hearing device will not cause further hearing loss, nor will it stop the progression of any further hearing loss.
• At rst you may notice sounds in your environment that you have not heard in a while which may be disturbing. Soon your brain will adapt to the sounds around you.
• For some, full adaptation to amplication can take up to 3 months of consistent wear.
• Optimal listening distance, even for someone who hears nor­mally, is about 3-10 feet. It’s especially important to remember this while adapting to amplication.
If you have any questions regarding the use of this product, please contact your hearing health professional, or iHear Medical customer support at 1-844-iHEAR-44 (1-844-443-2744).
Page 4
5
4
WHAT IS INCLUDED
Important Notice: Red marking refers to right ear device.
Blue marking refers to left ear device.

➀ iHEARMAX Device
➁ 1x iHEARMAX Battery Pack
(6 Batteries / 2 months supply)
➂ 1Pack Cleaning Wipe (2x)
➃ MAX Tip Set
➀
➁ ➂
STANDARD TIP SET (9mm Tip attached to device)
PETITE TIP SET (8mm Tip attached to device)
8Vmm 10Vmm 8mm 9mm 10mm 11mm
4mm 8Vmm 7mm 8mm 9mm 10mm
➃
Page 5
5
The iHEARMAX Programming Kit
(Purchased Separately)
Includes the iHearTest kit and the Programming Cable to program your iHEARMAX hearing device. It also includes a carrying case and travel bag.
IMPORTANT
The iHearUSB module and the Programming Cable are required to program your iHEARMAX
device(s).
A iHearTest
B iHearUSB
C Earphone & Eartips
D Travel Case
E Programming Cable
F Carrying Case
A
D E F
B C
Page 6
7
PAGE
Important Notice .......................................................2
Contraindications & Disclaimers ...............................3
What is Included ........................................................4
iHEARMAX Programming Kit ....................................5
Table of Contents ......................................................6
The iHEARMAX Device ............................................. 7
Preparing your iHEARMAX for use ........................... 8
Tip Sizing & Selection ................................................9
Removing the iHEARMAX from your ear ................ 10
iHEARMAX Tip Selection Guide ............................. 11
iHEARMAX Clear Wire ............................................ 12
Replacing the Clear Wire ......................................... 13
Attaching the Clear Wire .........................................13
Changing the Sound Prole ....................................14
Turning the iHEAR MAX O and On ........................15
Customizing Your iHEARMAX ................................16
Create an iHear Account or Sign in ......................... 17
Installing the iHTUNER Application ........................ 18
Launching the iHTUNER......................................... 19
Care & Maintenance ................................................ 20
Troubleshooting Guide ............................................22
Technical Specications .......................................... 23
Warranty ..................................................................26
Information & Explanation of Symbols ....................26
Table of Contents
Page 7
7
SIZING
The iHEARMAX Device
RIGHT DEVICELEFT DEVICE
Battery Door
➆
➈
2
➈
2
➇
1
1 RED DOT for Right device and BLUE DOT for Left Device 2 The Programming Slit is the input connection for the Programming Cable
➂
➁
➀
➃
➄
➅
iHEARMAX Device
➀Connector ➁ Socket ➂Battery Door ➃Clear Wire
(Speaker Assembly)
➄Speaker ➅Tip ➆Button ➇Dot ➈Programming Slit
Page 8
9
8
Preparing your iHEARMAX for Use
1) Remove the tab from the battery.
2) Open the battery door by gently swinging it into the
open position.
3) Insert the new battery with the positive (+) side up.
4) Close the battery door.
Inserting the Battery
Battery door
You will hear the startup melody when the iHEARMAX is turned ON and placed in your ear within a few seconds.
Page 9
9
SIZING
Tip Sizing & Selection
Inserting the Tip into your ear(s)
1) Gently INSERT the Tip (attached to the speaker) into your ear.
2) TUCK the device behind your ear.
3) PUSH the Tip gently into your ear to ensure snug and comfortable t.
Selecting the correct MAX Tip size for your ear(s)
Correct Tip size should feel snug but comfortable in the ear and no whistling (feedback).
u Start with the Tip that's already attached to the device. u Too tight? Go down a size. Too loose? Go up a size. u Your left and right ears may require dierent Tip sizes.
Tip should be securely attached to the speaker.
CLICK
Speaker
Page 10
10
11
7mm 8mm 9mm 10mm 11mm 4mm 8Vmm 10Vmm
Best for Moderate or Severe Hearing Losses (up to 70dB, iHearTest Scores of 2 and 3).
1) GRAB the Clear Wire
2) PULL AWAY from your ear
Make sure that the Tip comes out with the device.
Connecting the Tip to the Speaker
You will feel a light click as the Tip locks in.
Removing the Tip from the Speaker
PINCH the Tip and PULL
Removing the iHEARMAX from yourt ear
CLICK
Speaker
Page 11
11
SIZING
iHEARMAX Tip Selection Guide
7mm 8mm 9mm 10mm 11mm 4mm 8Vmm 10Vmm
STANDARD TIPS VENTED TIPS
Best for Moderate or Severe Hearing Losses (up to 70dB, iHearTest Scores of 2 and 3).
For Mild to Moderate Hearing Losses (up to 50dB, iHear Test Score 4). Eliminates feeling plugged up (occlusion effect) by open style venting
u With Standard Tips, you may feel a little plugged up
but should feel comfortable.
u With Vented Tips, it should feel secure and
comfortable.
u Dampening the outside of the Tips with water may
facilitate insertion into the ear.
u Your Left and right ear may require dierent Tip
sizes.
u Feeling too plugged up? Try a vented Tip for mild to
moderate loss.*
*Determine your size rst using Standard Tips before switching to a Vented Tip.
Replace Tips once a month for optimum
performance and hygiene.
Page 12
13
12
TOO SHORT TOO LONG CORRECT
Verify the correct length of the Clear Wire by checking your ear. First insert the Tip in your ear, then tuck the device behind your ear.
iHEARMAX Clear Wire
up & visible loose &
too low
1) TOO SHORT Clear Wire feels tight and the device is
pulled up and visible over the ear.
2)
TOO LONG Clear Wire feels loose and the device
dangles behind the ear.
3)
CORRECT Clear Wire is ush to the side of the ear and
the device is securely hidden behind the ear.
If the Clear Wire is too long or too short, please contact iHear Customer Support with a photo of the device in your ear for evaluation by our Professional Support. If the size is incorrect for your ear, Customer Support will arrange to exchange for the correct size.
Page 13
13
Replacing the Clear Wire
Removing the Clear Wire
HOLD the Clear Wire and PULL
away from the device.
Attaching the Clear Wire
u PUSH the Clear Wire
connector rmly into the device socket.
v Make sure the Speaker
color matches the Dot color on the device. Attach the Right/Left connectors to the corresponding Right/Left
sockets.
Clear Wire should curve down as shown.
NO GAP
Logo Up
Tip Facing Down
GAP
R
Q
v
u
Page 14
14
15
Changing the Sound Prole
Use the button on the back of
the device to adjust volume
and cycle through four (4) sound proles for dierent
environments.
Each push cycles to the next sound prole.
SOUND PROFILE BEEPS
OTHER BEEPS
1
2
3
4
MAIN PROFILE
CLEAR SPEECH
VOLUME UP
PUSH BUTTON
PUSH BUTTON
PUSH BUTTON
PUSH BUTTON
ACTION PROFILES DESCRIPTION
# OF
BEEPS
LOW BAT INDICATOR
4 LOW-PITCH BEEPS WHEN BATTERY IS LOW
You will hear dierent beeps to help you identify the changes in our settings
STARTUP MELODY WHEN YOU INSERT THE BATTERY
DEVICE START UP
#1
#2
#3
#4
Beeps & Push Button Control
VOLUME DOWN / TELEPHONE USE
Button
Page 15
15
Turning the iHEARMAX OFF & ON
When the battery door is open, the device is OFF.
iHEARMAX is OFF
When the battery door is closed the device is ON.
iHEARMAX is ON
Turning the device OFF when not in use is important to prolong battery life.
Page 16
17
16
Customizing Your iHEARMAX
At this point you should be familiar with:
1) Inserting or removing the Battery
2) Inserting or removing the Tips
3) Inserting and Removing iHEARMAX from your ear
4) Turning your iHEARMAX ON and OFF
So far you have just been using the device with the factory settings. Selecting the correct Tip size is important. Before you start programming your device ensure that it ts in your ear comfortably - not too loose
or too tight, and does not produce whistling (feedback) sound.
Programming your iHEARMAX for best results
To optimize your hearing experience you will need to customize the iHEAR MAX device based on your preference. The next few pages will guide you through the download, installation and launch of the iHTUNER software application. The iHTUNER allows you to program your iHEARMAX device(s).
Page 17
17
SOFTWARE SETUP
Create an iHear Account or Sign in
In order to use 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 an account you will receive notication by email to activate your account.
Go to: www.ihearmedical.com/signin
Sign In to your
account.
Page 18
18
19
To Install the iH TUNER Application
Click DOWNLOAD then complete the installer setup wizard. Follow the step-by-step procedures to complete
the iHTUNER installation and product activation.
Installing the iHTUNER Application
The iHTUNER application allows you to program your
iHEARMAX device(s) based on your personal preference.
You may launch the iH TUNER from the iHear Dashboard. The dashboard is the launch site for all iHear software
application.
Go to iHTUNER and Click on LAUNCH APPLICATION. If iH TUNER is not yet
installed on your computer, you will be prompted to download and install the
application.
Page 19
19
SOFTWARE SETUP
Launching the iHTUNER Application
LEFT EAR ONLY LEFT & RIGHT RIGHT EAR ONLY
If you have just nished installing the software,
The iH TUNER application should launch
automatically. If you need to re-launch the application, follow these instructions:
1. Sign in to your account at www.ihearmedical.com/signin
2. Click on the
LAUNCH APPLICATION button for iHTUNER
-OR-
Locate the iH TUNER application on your computer by searching for the application by name and CLICK on the iHTUNER.
Click on either the LEFT EAR ONLY, LEFT & RIGHT or
RIGHT EAR ONLY
Follow the iH TUNER's step-by-step instructions to complete your device programming.
Page 20
20
21
Care and Maintenance
Use the Carrying Case to store your device and supplies.
Replace Tips once a month for optimum
performance and hygiene.
Clean the iHEARMAX daily using the Cleaning Wipe.
IMPORTANT
DO NOT USE isopropyl alcohol or alcohol-based products to clean
the iHEARMAX. This may damage the device and void the warranty.
Carrying Case
Page 21
21
DO NOT wash the iHEARMAX
with soap and water.
u The iHear Cleaning Wipes are available in a pack of
20 pairs (40 wipes total)
u Tips need to be replaced once a month for optimum
performance and best hygiene practices.
u Cleaning Wipes and Tip replacements are available
through our on-line store at www.ihearmedical.com or through our customer support at 1 (844) IHEAR44 (1-844-443-2744).
u Visually check your Tips to ensure they are not soiled
or damaged. If damaged, replace immediately.
u Earwax build up on the Tip may obstruct sound
delivery and reduce the volume, or degrade the sound quality. Clean the device daily, and replace the Tip periodically to avoid earwax contamination.
u The iHEARMAX is designed to withstand limited
water exposure such as surface swimming and showering.
NO USER SERVICEABLE OR REPAIRABLE PARTS INSIDE.
Page 22
23
22
Troubleshooting Guide
Feeling too plugged up? Try a Vented Tip.
Feedback Control
u Always start by checking the physical t of the Tip
u Often the easiest way to stop feedback is to increase
the size of the Tip or switch from vented to standard Tip
Soreness in the ear
u Decrease the size of the Tip. If it still persists, check the
size of the Clear Wire. It may be too long, or too short.
u You may dampen the outside rim of the Tips with a
small amount of water for easier insertion.
7mm 8mm 9mm 10mm 11mm 4mm 8Vmm 10Vmm
STANDARD TIP VENTED TIP
7mm 8mm 9mm 10mm 11mm 4mm 8Vmm 10Vmm
IF USING STANDARD TIP
Increase size of the MAX TIP
IF USING VENTED TIP
Try Standard MAX TIP
Page 23
23
TECHNICAL SPECIFICATIONS
RECOMMENDED HEARING ABILITY RANGE
Storing or shipping the device outside of the specied temperature range may cause the device to fail.
312 Zinc Air | 1.35 V, 180 mAhr 170 Hours (12 days of typical 14 hrs/day use) 30 days (typical use) 60°F - 85°F (16°C - 29°C) 32°F - 122°F (0°C - 50°C)
Battery Type
Battery Life
MAX Tip Life
Storage Temperature
Shipping Temperature
The iHEARMAX is not suitable for profound hearing loss.
HEARING LEVEL (dB)
FREQUENCY (Hz)
þ Mild Loss þ Moderate Loss þ Severe Loss
250 500 750 1000 1500 2000 3000 4000 6000 8000
0
10
20
30
40
50
60
70
80
90
100
Page 24
24
25
Model: iHEAR MAX Ear: 2cc Coupler
Model: iHEAR MAX Ear: 2cc Coupler
TECHNICAL SPECIFICATIONS
MAXIMUM OUTPUT (OSPL 90)
RTG GAIN
Telecoil mode for telephone and audio loop systems.
Available in Sound Prole #2.
Page 25
25
ANSI S3.22 - 2003
Output
Maximum Output
HF Average OSPL90
AmplificAtiOn
Max. Peak Gain
HF Average FOG
Minimum Frequency Range
HArmOnic DistOrtiOn
500 Hz 800 Hz
1600 Hz
EquivAlEnt input nOisE
ADAptivE AttAck timE
ADAptivE rElEAsE timE
116 dB
110 dB
46 dB
40 dB
200 Hz - 5 kHz
1.0%
1.0%
1.0%
13 dBSPL 50 ms 950 ms
Computer and Software Requirements*
u Personal computer with USB 2.0+ port u iHear Software (Available for download online) u Operating System: Windows 7 or higher
Mac OS 10.10 or higher
u Internet connection 512 Kbps or higher
*Visit www.ihearmedical.com/faq for the most up-to-date compatibility information.
Class I, Type B Medical Device
This 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.
TECHNICAL SPECIFICATIONS
Page 26
26
Warranty
Information & Explanation of Symbols
iHear Medical, Inc.
Limited One Year Warranty
This warranty is extended to the original purchaser of the hearing device and covers defects in material and workmanship for a period of one year from the
date of shipment of the device.
If the device 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 modication. 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.
Batteries and hearing aids may not be thrown away as normal household waste. Please
dispose of batteries and old or unused hearing aids 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.
Page 27
Right iHEARMAX Serial Number
Left iHEARMAX Serial Number
Right MAX Tip Size
Left MAX Tip Size
NOTES
DEVICE & SIZING INFORMATION
For reference purposes please be sure to record
pertinent information below for professional support
or for reordering purposes.
4 7 8 9 10 11 8V 10V
Page 28
Int. Eriat etur sam velendel experes alibus nitectatur re
dellaborunt quaeror antemod ut laboriae
IMPORTANT: Use requires acceptance of the software license terms presented electronically during setup.
Keep the iHEARMAX device and parts out of reach of pets and children. Pets have been known to chew on them. Hearing aids and parts can be dangerous if they are swallowed by children or pets. Contact your doctor or veterinarian if the iHEARMAX, or any part of, is accidentally swallowed.
Made by iHear Medical in California, USA
U.S. and international patents issued and pending.
©2016 iHear Medical, Inc. All rights reserved. iHEAR, iHEARMAX, iHear Loud & Clear, iHearTest and iHearUSB are trademarks of iHear Medical, Inc.
CUSTOMER SUPPORT
iHear Medical, Inc.
15250 Hesperian Blvd. San Leandro, CA 94578 USA Toll Free 1 (844) IHEAR44 (1-844-443-2744)
www.ihearmedical.com
MODEL: IHEAR MAX 01-00089-001-E One year limited warranty
An electronic version of this user guide is available online.
To view, SIGN IN to your account and CLICK on SUPPORT.
Loading...