audicus The Icon 312 Battery An OTC Hearing Aid User Guide

: June 15, 2024
: AUDICUS

The Icon 312 Battery An OTC Hearing Aid

Product Information

Specifications

Product Name: Icon OTC Hearing Aid
Battery Type: 312 Battery
Age Requirement: 18 years and older

Product Usage Instructions

1. Age Requirement

This OTC hearing aid is specifically designed for users who are
18 years of age or older. Individuals under the age of 18 with
hearing loss should seek medical attention from a doctor,
preferably an ear-nose-throat doctor (ENT), as their condition may
require specialized care.

2. When to See a Doctor

If you experience any of the following problems, it is important
to consult a doctor, preferably an ENT:

Your ear has a birth defect or an unusual shape.
Your ear was injured or deformed in an accident.
You observed blood, pus, or fluid coming out of your ear in the
past 6 months.
Your ear feels painful or uncomfortable.
You have excessive ear wax or suspect that something is lodged
in your ear.
You experience dizziness, spinning, or swaying (vertigo).
Your hearing changed suddenly in the past 6 months.
Your hearing fluctuates, with periods of worsening followed by
improvement.
You have worse hearing in one ear.
You hear ringing or buzzing in only one ear.

3. Insertion and Comfort

It is important to ensure that the hearing aid does not cause
pain or discomfort when inserting it. If you experience any pain or
discomfort, follow these steps:

Remove the device from your ear.
Re-insert the device, making sure to carefully follow the
provided instructions.
If pain or discomfort persists, contact the manufacturer.
If pain or discomfort persists even after contacting the
manufacturer, consult your hearing healthcare professional.
If necessary, report the issue to the FDA as an adverse event
following the provided instructions.

4. Hearing Protection

The Icon hearing aid is not designed for hearing protection in
loud environments. If you are exposed to overly loud sounds,
whether short or long-lasting, it is recommended to remove the
device and use appropriate hearing protection such as ear plugs. If
you would normally use ear plugs in a loud place, remove the
hearing aid and use ear plugs instead.

5. Volume Control

The sound output of the hearing aid should not be uncomfortably
loud or painful. If you find the sound output to be too loud,
follow these steps:

Turn down the volume using the provided controls.
If volume adjustment is consistently needed, you may need to
further adjust the device settings.

6. Stuck Part in Ear

If any part of the hearing aid, such as the ear-tip, gets stuck
in your ear and cannot be easily removed with your fingers, it is
crucial to seek medical help immediately. Do not attempt to use
tweezers or cotton swabs, as they can potentially push the part
deeper into your ear and cause injury to your eardrum or ear
canal.

Frequently Asked Questions (FAQ)

Q: What should I do if I am under 18 years of age but have

hearing loss?

A: If you are younger than 18 and have hearing loss, it is
recommended to consult a doctor, preferably an ENT, as your
condition requires specialized care and medical testing.

Q: Can I use the Icon hearing aid if I have a birth defect or

an unusual shape in my ear?

A: If you have a birth defect or an unusual shape in your ear,
it is important to see a doctor, preferably an ENT, before using
the Icon hearing aid. They can assess your condition and provide
appropriate guidance.

Q: Is the Icon hearing aid suitable for hearing protection in

loud environments?

A: No, the Icon hearing aid is not designed for hearing
protection. In loud environments, it is recommended to remove the
device and use proper hearing protection such as ear plugs.

Q: What should I do if I experience discomfort or pain when

inserting the hearing aid?

A: If you experience discomfort or pain when inserting the
hearing aid, remove the device and carefully re-insert it following
the provided instructions. If the pain or discomfort persists,
contact the manufacturer. If the issue persists even after
contacting the manufacturer, consult your hearing healthcare
professional.

Q: What should I do if a part of the hearing aid gets stuck in

my ear?

A: If any part of the hearing aid gets stuck in your ear and
cannot be easily removed with your fingers, seek medical help as
soon as possible. Do not attempt to use tweezers or cotton swabs,
as they can potentially cause further injury.

Q: What should I do if I am still concerned about my hearing

even after using the Icon hearing aid?

A: If you remain concerned about your hearing or continue to
struggle with it, it is advisable to consult with a hearing
healthcare professional for further evaluation and assistance.

The Icon
An OTC Hearing Aid Instruction Manual
312 Battery

WARNING: If you are younger than 18, do not use this. You should go to a doctor, preferably an ear-nose-throat doctor (an ENT), because your condition needs specialized care. Over-the-counter hearing aids are only for users who are age 18 or older.
This OTC hearing aid is for users who are 18 and older. People who are younger than 18 with hearing loss should see a doctor, preferably an ENT because they may need medical testing and management. Hearing loss can affect speech and learning, so professional fitting and continuing care are also important.
WARNING: When to See a Doctor If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor (an ENT). Your ear has a birth defect or an unusual shape. Your ear was injured or
deformed in an accident. You saw blood, pus, or fluid coming out of your ear in the past 6 months Your ear feels painful or uncomfortable You have a lot of ear wax, or you think something could be in your ear You get really dizzy or have a feeling of spinning or swaying (called vertigo) Your hearing changed suddenly in the past 6 months Your hearing changes: it gets worse then gets better again You have worse hearing in one ear You hear ringing or buzzing in only one ear
WARNING: This hearing aid should not cause pain when inserting it. Remove the device from your ear if it causes pain or discomfort when you insert or place it. To try again, make sure to follow the instructions. If you feel pain or discomfort again, contact the manufacturer. If your pain or discomfort doesn’t go away, contact your hearing healthcare professional. You can also report this to FDA as an adverse event according to the instructions that appear later.

Caution: This is not hearing protection. You should remove this device if you experience overly loud sounds, whether short or long-lasting. If you’re in a loud place, you should use the right kind of hearing protection instead of wearing this device. In general, if you would use ear plugs in a loud place, you should remove this device and use ear plugs.
Caution: The sound output should not be uncomfortable or painful. You should turn down the volume or remove the device if the sound output is uncomfortably loud or painful. If you consistently need to turn the volume down, you may need to further adjust your device.
Caution: You might need medical help if a piece gets stuck in your ear. If any part of your hearing aid, like the ear-tip, gets stuck in your ear, and you can’t easily remove it with your fingers, get medical help as soon as you can. You should not try to use tweezers or cotton swabs because they can push the part farther into your ear, injuring your eardrum or ear canal, possibly seriously.
Note: If you remain concerned, consult a professional If you try this device and continue to struggle with or remain concerned about your hearing, you should consult with a hearing healthcare professional.
Note: What you might expect when you start using a hearing aid A hearing aid can benefit many people with hearing loss. However, you should know it will not restore normal hearing, and you may still have some difficulty hearing over noise. Further, a hearing aid will not prevent or improve a medical condition that causes hearing loss. People who start using hearing aids sometimes need a few weeks to get used to them. Similarly, many people find that training or counseling can help them get more out of their devices. If you have hearing loss in both ears, you might get more out of using hearing aids in both, especially in situations that make you tired from listening–for example, noisy environments.
Note: Tell FDA about injuries, malfunctions, or other adverse events. To report a problem involving your hearing aid, you should submit information to FDA as soon as possible after the problem. FDA calls them “adverse events,” and they might include: skin irritation in your ear, injury from the device (like cuts or scratches, or burns from an overheated battery), pieces of the device getting stuck in your ear, suddenly worsening hearing loss from using the device, etc. Instructions for reporting are available at https://www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088. You can also download a form to mail to FDA.

Welcome!
Congratulations on your Icon hearing aid purchase!
This guide is an important resource. Please review and keep this handy to get the most out of your Icon hearing aid

And for any questions or needed assistance reach out to
[email protected] · 917-999-0705

What’s inside?

hearing aid(s) located in the case

carrying case

312

cleaning brush & audio wipes

size 312 batteries

Contents

Getting Started Using The Icon Tuned Hearing App Device Information Troubleshooting

page 8 page 16 page 22 page 26 page 30

dome variety pack
6

Extra slim tubes & cleaning wire

Your hearing aid at a glance
mic program control

volume control
UP DOWN
battery door

slim tube dome

volume control changes volume up and down program control adjust the environmental programs
microphone where sound enters your hearing aid battery door on/off switch and battery access point
slim tube connects device (and speaker) to allow amplification of sound into the ear canal
dome clear tulip dome transmits sound into canal
retention guard keeps the dome/tubing securely in place
8

Turning on / off
The battery door acts as the on & off switch.

OFF (fully open)

OFF (partly open)

ON (fully closed)

Low battery warning You will hear “low battery” voice prompt. Hearing aid will shut down after “replace battery” voice prompt.
Battery size 312 zinc-air brown tab
IEC: PR41 | ANSI: 7002ZD

Do not dispose of batteries in household trash Do not recharge batteries as this could result in injury Keep batteries away from high temperature Keep batteries away from children and pets Do not carry batteries loose in your pocket or purse Do not place batteries in your mouth; if swallowed,
consult a physician

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Inserting a new battery

Putting on your hearing aid

To insert or replace the battery:
1. Gently swing open the battery door with your fingernail and push out the old battery.
2. Remove the plastic tab from the new battery, wait 1 minute for battery to reach full power before using (or testing) battery.
3. Line up the battery’s plus “+” sign so that it is facing up inside the battery door.
4. Close the battery door gently.
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retention guard
1. Clean your ear and hearing aid before every use 2. We recommend using a mirror to practice. First, place
the hearing aid body over the top of your ear 3. Hold the wire near the dome and gently push the
dome into your ear canal. Pull up and back on the cartilage of the ear to ease insertion 4. Resttheretentionguardinthebowlofyourear.You can trim the retention guard to a comfortable length or remove it altogether
Handle your hearing aid with care. Do not pull on or bend the tube as this may cause damage
Note: The outer shell of the hearing aid is laser marked with Left or Right
11

Volume & Program Control
Program Control Volume Up Volume Down
Adjust the volume with the volume up/down buttons. Your device has 10 volume levels. You will hear a confirmation when you reach the min/max volume settings See “Tuned Hearing App” for how to adjust volume, environment, and equalizer using your smartphone
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The program control is located above the volume controls. Choose between four program settings by pressing the program button. When you press the program button you will hear a voice prompt say: program 1′,program 2′, program 3′, orprogram 4′
1 Everyday: Daily setting use in most listening situations
2 Meeting: Talk setting use when having conversation
3 Music: Music setting use when listening to music
4 Noise: Noise setting reduces the low frequency amplification. Often helpful in noisy situations
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Airplane Mode
To enable/disable Airplane Mode: 1. To enable airplane mode, close the battery
door while holding the volume up control for six seconds 2. To disable airplane mode, open and close the battery door
Hold volume up control

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15

Slim Tubes
The slim tube should rest against the side of your head and allow the dome to remain comfortably in your ear canal.
A Size 2 slim tube will already be attached to your hearing aid. Also included are 2 additional sizes: 1, and 3. Size 1 is the shortest in length and size 3 is the longest

Removing & attaching the slim tube
For optimal performance, replace slim tubes every three months.
How to remove the slim tube: 1. Grasp the base of the slim tube near the top of
the hearing aid 2. Twist the base of the tubing 90° to the left 3. Pull the base away from the hearing aid
How to attach the slim tube: 1. Line up the top of the aid and the tubing base 2. Gently push the base of the tubing onto the
aid until it snaps into position

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How to clean the slim tube
1. Remove the slim tube from the hearing aid 2. Remove the dome from the tube 3. Insert the cleaning tool into the base at the end
of the slim tube and thread it all the way through so it comes out the other end 4. Wipe off any debris on the end of the cleaning tool before pulling it back through the tube
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Protecting your aid
Open the battery door when not in use. Remove the battery when storing for extended periods
Always store your hearing aid in its case, in a clean and dry environment. The UV Dry Box can also be used for safe storage
Never wear your hearing aid in the shower, bath, sauna or swimming. Keep protected from rain
If the hearing aid becomes wet, remove battery and ensure the aid is dry before using. Do not dry in an oven or microwave
We recommend regularly drying your hearing aid. You can purchase a sanitizing UV Dry Box from audicus.com/accessories Remove battery before placing in the UV Dry Box
Keep your hearing aid away from high temperatures. Do not leave your hearing aid in direct sunlight or wear while using a hair dryer
Keep hearing aids away from children and pets
19

Finding the right dome
The dome is the small, clear hypoallergenic silicone tip on the end of the hearing aid that is inserted into your ear
Domes come in a variety of shapes and sizes. The proper choice of dome style and size can help with comfort and sound quality
New devices come pre-fit with a medium dome
Dome styles and sizes

Take some time to find which size dome is right for you. The dome should fit snugly in your ear canal and inserted far enough to not be visible
If mis-sized or the wrong style, you may hear feedback: a squealing or whistling sound that can be resolved with a different dome size or style
Order new domes at audicus.com/supplies

Small Medium Large

Open
20

Closed

Double

Clean your domes regularly Replace old, brittle, discolored or damaged domes
or if they pull off the hearing aid easily Earwax production is different for each person.
Replace domes as needed, at least every 23 months Always ensure that a new dome is firmly attached to
the receiver before inserting into your ear
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Tuned Hearing App
For additional functionality, control, and customization please use the Tuned Hearing App. Note: this app may not be compatible with all smartphones.
The free Tuned Hearing App can be downloaded from audicus.com/app

Requirements for the Hearing Remote app:

iOS
Version 13.0+

Android
version 7.0+

Customizing your device
The Tuned app will take you on a step by step guide to customize the hearing aids to your needs
You will complete a short hearing test to setup the devices to your individual profile
Running into issues? Reach out to our team at [email protected]

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App Troubleshooting
Not all phones work well with Bluetooth devices Follow these steps if you are having trouble connecting or experiencing poor audio with Bluetooth: 1. Disconnect from Tuned App
Settings > Delete devices
2. Uninstall the Tuned app 3. Check for and install any updates 4. Disable/enable or turn off/on Bluetooth 5. Restart your phone 6. Restart hearing aids open/close battery door

For additional support visit audicus.com/support

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Returns and warranty
The Audicus guarantee If for any reason you are not satisfied with your Audicus hearing aids, you may return it within 45 days after delivery date for a full refund of the original purchase price
This guarantee is only possible if the hearing aid has not been modified, tampered with, damaged or repaired by the user. Please see return instructions at audicus.com/returns
Manufacturer warranty All Icon hearing aids come with a 12 month guarantee that will cover manufacturing defects. This guarantee will not be valid if the hearing aid has been modified, tampered with, damaged or repaired by the user.
If your device stops functioning correctly reach out to [email protected] or 917-999-0705
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FDA information
Use your hearing aid all day long The best way to ensure better hearing is to practice listening with your hearing aid until you are able to wear it comfortably all day. Generally, infrequent use of the hearing aid does not provide you with the full benefit of amplification. Your hearing aid will not restore normal hearing. Hearing aids will not prevent or improve hearing impairment resulting from a physiological condition. Hearing aids will help you to make better use of your residual hearing. The use of hearing aids is only part of hearing rehabilitation; auditory training and lip reading instruction may be required as well.
Possible side effects If you are experiencing discomfort, contact Audicus or your hearing care professional for modification of the hearing aid at the point of irritation. A hearing aid may cause an accelerated accumulation of cerumen (earwax). Also in rare cases, the otherwise nonallergenic material may cause a discharge from the ear, allergic reaction, or any other unusual condition. Please seek immediate consultation with a physician if these conditions occur.
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Technical information
The Audicus Icon is manufactured by Intricon and distributed by Audicus.
FCC ID: POMIINHBC1B0 Hereby, Intricon Hearing declares that this product meets the requirements of the Medical Device Directive 93/42/EEC and complies with Radio Equipment Directive 2014/53/EU.
Changes or modifications not expressly approved by Audicus may void the FCC authorization to operate this device.
This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) This device may not cause harmful interference and (2) this device must accept any interference received, including interference
that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules and ICES-003 of Industry Canada. These limits are designed to provide reasonable protection against harmful interference in a residential installation. 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.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the device into an outlet on a circuit different from that to which
the receiver is connected. Consult the dealer or an experienced radio/TV technician for help.
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IEC 60118-7 / ANSI S3.22-2003 (2cc)
Peak OSPL90 (dB SPL) HFA OSPL90 (dB SPL) Peak FOG (dB) HFA FOG (dB) HFA Reference Test Gain (dB) Frequency Range (Hz): f1 f2 Total Harmonic Distortion 500 Hz Total Harmonic Distortion 800 Hz (%) Total Harmonic Distortion 1600 Hz (%) Equivalent Input Noise (db SPL) (%) Attack Time (msec) Release Time (msec) Supply Voltage (V) STD 312 Induction Coil Sensitivity (dB)* Battery Life (h)

Nominal Specification
117 109 40 33 33 200 6700 < 2 < 1 <1 <18 10 200 1.3 80 125
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Troubleshooting

Cause

Remedy

No sound or intermittent sound

Not turned on

Ensure battery is inserted and battery door is fully closed, see page “Turning on / off”

Low / dead battery

Replace battery

Battery upside down Dirty battery contact

Insert battery according to battery symbol. See page “Inserting a new battery”
Wipe battery compartment or reach out to Audicus

Poor quality sound