AUDICUS 312 Icon OTC Hearing Aid Instruction Manual

: June 12, 2024
: AUDICUS

AUDICUS 312 Icon OTC Hearing Aid

WARNING

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 eartip, 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 icon@audicus.com • 917-999-0705

What’s inside?

hearing aid(s) located in the case
carrying case
cleaning brush & audiowipes
size 312 batteries
dome variety pack
Extra slim tubes & cleaning wire

Your hearing aid at a glance

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

Turning on / off

The battery door acts as the on & off switch.

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

Inserting a new battery

To insert or replace the battery:

Gently swing open the battery door with your fingernail and push out the old battery.
Remove the plastic tab from the new battery, wait 1 minute for battery to reach full power before using (or testing) battery.
Line up the battery’s plus “+” sign so that it is facing up inside the battery door.
Close the battery door gently.

Putting on your hearing aid

Clean your ear and hearing aid before every use
We recommend using a mirror to practice. First, place the hearing aid body over the top of your ear
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
Rest the retention guard in the bowl of your ear. 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

Volume control & Program Control

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

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’, or ‘program 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

Airplane Mode

To enable/disable Airplane Mode:

To enable airplane mode, close the battery door while holding the volume up control for six seconds
To disable airplane mode, open and close the battery door

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:

Grasp the base of the slim tube near the top of the hearing aid
Twist the base of the tubing 90° to the left
Pull the base away from the hearing aid

How to attach the slim tube:

Line up the top of the aid and the tubing base
Gently push the base of the tubing onto the aid until it snaps into position

How to clean the slim tube

Remove the slim tube from the hearing aid
Remove the dome from the tube
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
Wipe off any debris on the end of the cleaning tool before pulling it back through the tube

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

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

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 missized 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

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 2–3 months
Always ensure that a new dome is firmly attached to the receiver before inserting into your ear

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+

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Android
version 7.0+

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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 icon@audicus.com

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:

Disconnect from Tuned App Settings › Delete devices
Uninstall the Tuned app
Check for and install any updates
Disable/enable or turn off/on Bluetooth
Restart your phone
Restart hearing aids – open/close battery door

For additional support visit audicus.com/support

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 icon@audicus.com or 917-999-0705

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.

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:

This device may not cause harmful interference and
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.

IEC 60118-7 / ANSI S3.22-2003 (2cc)	Nominal Specification
Peak OSPL90 (dB SPL)	117
HFA OSPL90 (dB SPL)	109
Peak FOG (dB)	40
HFA FOG (dB)	33
HFA Reference Test Gain (dB)	33
Frequency Range (Hz): f1 – f2	200 – 6700
Total Harmonic Distortion 500 Hz	< 2
Total Harmonic Distortion 800 Hz (%)	< 1
Total Harmonic Distortion 1600 Hz (%)	<1
Equivalent Input Noise (db SPL) (%)	<18
Attack Time (msec)	10
Release Time (msec)	200
Supply Voltage (V) – STD 312	1.3
Induction Coil Sensitivity (dB)*	80
Battery Life (h)	125

Troubleshooting

Cause	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| Insert battery according to battery symbol. See page “Inserting a new battery”
Dirty battery contact| Wipe battery compartment or reach out to Audicus
Poor quality sound

Dome blocked with debris / earwax| Replace dome. See “Replacing the dome”
Plugged microphone| Clean device with cleaning brush. If issue persists, contact Audicus
General sound quality| Access the Tuned app
Voice prompt says “low battery”

Low battery| Replace battery
Feedback / whistling
Hand or clothing near device| Move hand / clothing away from device
Dome not inserted properly| See “Putting on your hearing aid”
Poorly fitted dome| See “Finding the right dome”

For more help please visit audicus.com/support