AUDICUS SERIES 2 An OTC Hearing Aid Instruction Manual

: June 12, 2024
: AUDICUS

AUDICUS SERIES 2 An OTC Hearing Aid

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

Audicus is with you every step of the way.
Find more info and help at audicus.com/support And remember, you’re never on your own.
Reach out anytime, for anything at all.
917-999-0705 • help@audicus.com

What’s inside?

hearing aid(s) located in the carrying case
charging case
desiccant drying capsule
cleaning brush & audiowipes
dome variety pack – small, medium large (styles dependent on hearing loss)
earwax guard dispenser tool

Your hearing aid at a glance

multi-function button – changes volume, switches programs, answers/ends calls dual microphones – where sound enters your hearing aid
LED light – indicator of power status and charge level receiver wire – connects receiver (speaker) to hearing aid
receiver – amplifies sounds into the ear canal and contains the earwax guard in the tip
dome – grey hypoallergenic silicone cover on the receiver to hold in place comfortably
charging pins – short metal prongs to facilitate charging

Turning on / of

Your hearing aid will turn OFF while charging Depending on your settings, the hearing aid may remain OFF or turn ON when removed from the charging case / disconnected from power. A green flash on removal indicates the device is ON

To turn the device ON or OFF: Press and hold the DOWN button for 5 seconds

Green light and melody

Long red light and two long tones

Low battery warning

Charging your hearing aid

Your hearing aid contains an lithium-ion battery that is recharged with the charging case via micro-USB

Insert the desiccant capsule into the pocket to dry out hearing aids while charging

Gently insert your device into the charging case.
Match the colored marker on the device to the indicator on the charging case
Power the charging case via the included USB cable. The charging case will show a steady green light when powered and the LED light on the hearing aid will blink while the device charges
When the hearing aid light is solid green, the hearing aid is fully charged and ready for use
Hold the device by the plastic shell to remove Do not pull the hearing aid by the wire as this may damage the device.

Do not leave the hearing aids in the charger for longer than 48 hours. If you will not be using your devices remove them from the charger and turn off.

To keep your aids charged on the go, consider the Power Pack: an external battery for wire-free charging
The Power Pack holds 7 days of charge and simply connects into the bottom of the charging case audicus.com/power-pack

Putting on your hearing aid

Hearing aids are color-coded with a marking on the back of the device: blue = left red = rig

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
Trim retention guard to a comfortable length with scissors or remove altogether. Place the retention guard so it rests in the bowl of your ear.

Handle your hearing aid with care. Do not pull on or bend the wire as this may cause damage

Adding/Removing the Retention Guard

We recommend using the retention for a more stable positioning of the receiver in the ear canal To add

Hold the receiver firmly in one hand with the receiver text (e.g., 2M) facing upwards. In the other hand hold the retention guard at the base of the filament
Slide the retention over the receiver spout until you feel it click into place. The receiver text should still be clearly visible

To remove

Hold receiver firmly with one hand
Slide the retention guard forward over the receiver spout. The retention guard can be trimmed with scissors to a comfortable length

Volume & program

The toggle button controls volume and program settings. Both hearing aids are adjusted simultaneously. Turning off will reset the device to the default volume and program 1

Increase volume: short press the UP button
Decrease volume: short press DOWN button

From the default volume you can adjust 5 steps up or down. When you hear a double tone, that means you’ve reached the max / min volume Long press (>2sec) to change the the program. The number of ? beeps indicates the program choice

Standard Programs:

? Auto-adapt / universal 3??? Auditorium
?? Conversation in noise ???? Car/Plane

Adjusting to your new hearing aid

Your hearing aid is programmed to you individually Adjusting to hearing aids fully may take up to 6 weeks

You may hear sounds you haven’t heard in years
● Sounds will be amplified and more distinguished, e.g., leaves rustling, running water, your own voice
● Sensitivity to ‘new’ sounds is normal and will go away with regular use
Find the right dome for your ear
● Your hearing aid ships with a size medium dome attached, with an additional variety pack of domes
● Use the “Finding the right dome” guide if you have any discomfort or hear a whistling sound
It may take a few weeks to get used to the fit and feel of your hearing aid. Contact Audicus for guidance and tips on fit and comfort
Your aid is programmed to your specific hearing test; it may take some time to become accustomed. After a few weeks of daily use – if you’d like an adjustment – just contact us

Troubleshooting

Cause	Remedy

No sound or weak sound
Not turned on| See page “Turning on / off”
Low / dead battery| Place device in charging case
Dome blocked with debris / earwax| Clean dome and replace earwax guard. See page “Replacing the dome and earwax guard”
Clogged microphone| Clean device with cleaning brush. If issue persists, contact Audicus
Feedback / whistling
Object or clothing near device| Move any objects or clothing away from device
Dome not inserted properly| See “Putting on your hearing aid”
Poorly fitted dome| See “Finding the right dome”
Bluetooth
Bluetooth| See “Bluetooth Troubleshooting” Not all phones work well with Bluetooth devices
Hearing Aid won’t turn on
Device needs to be reset| ● Hold DOWN button for 20 seconds
● Put the device in the charging base for 30 seconds
● Remove and device is now reset
Two long beeps
Low battery| Charge device in charging case
LED light off while in charging case
Charger not connected to power source| Ensure the USB cable is plugged into the back of the charging case and into a powered outlet
Hearing aid not inserted correctly| See “Charging your hearing aid”
Dirty charging pins| Clean aid and charger with a dry clo
LED light fast blinking while charging
Temperature issue or faulty battery| Ensure device is between 50-100°F (10-40°C). Contact if issue persists

Finding the right dome

The dome is the small, grey 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 hearing aids come pre-fit with a medium size dome in your recommended dome style

New orders include a variety of dome sizes and styles. Depending on your specific hearing loss, your order may not include all dome styles 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 /omni-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

Caring for your hearing aid

With regular maintenance your devices will sound great for years to come

Daily: Clean with a lint-free cloth or nonalcoholic Audiowipe. Allow earwax to dry and harden before brushing off. Charge in charging case overnight
Weekly: Remove earwax and debris from device and dome using supplied cleaning brush

Quarterly: Domes, earwax guards and desiccant drying capsules should be replaced at least every 2–3 months

Everybody’s ears are different: you may need to clean your devices more frequently
Never use cleaning agents such as detergent, soap, alcohol or bleach to clean your hearing aid
Do not submerge your hearing aid or rinse your hearing aid under water

Audicus Care

All the products to care and maintain your device are available at audicus.com/omni-supplies
Audicus Care is the easiest way to get everything you need to maintain your Omni. Sign up and you’ll receive an unlimited supply of domes, earwax guards, wipes, desiccant drying capsules and cleaning brushes conveniently delivered every 3 months or when requested. Never worry about running out of hearing aid supplies again. Find out more at audicus.com/care

Sign up at : audicus.com/care

Replacing the dome and earwax guard

A. To remove the dome: hold the receiver with one hand and gently pull off the dome with the other hand

B. You now have access to change the earwax guard The earwax guard is a very small, white plastic filter inserted into the receiver tip. The earwax guard collects and prevents earwax from entering the receiver, which may impair or damage the device Replace the earwax guard at least every 2-3 months or any time the sound quality is diminished Your order comes with a grey circular accessory which contains eight new earwax guards and is also the earwax guard removal tool

C. To dispose of the used earwax guard: first ensure chamber 1 is empty. Then press the receiver in until it “clicks” – this will remove the used earwax guard

D. Ensure the receiver is empty and a new earwax guard is visible in chamber 2. Press the empty receiver into chamber 2 and the earwax guard should be inserted into the receiver

E. Reattach the silicone dome onto the receiver to finish.
Order replacement earwax guards at audicus.com/omni- supplies

Protecting your aid

Store your device in the charging case when not in use. If storing for an extended period simply turn off and store in a clean and dry environment. Do not store in an unplugged charging case
Never wear your hearing aid in the shower, bath, sauna or while swimming. Keep protected from rain
If the hearing aid becomes wet, ensure the aid is dry before using. Do not dry in an oven or microwave
Replace the desiccant drying capsule in the charging case every 2–3 months
Keep your hearing aid away from sources of high temperature. Do not leave your hearing aid in direct sunlight or wear while using a hair dryer
Keep hearing aids away from children and pets

Clean & Care, Repairs and Audicus Protect

Your hearing aids come with a 24 month manufacturer’s warranty. Additional repairs may incur costs depending on the severity Accidents happen. The Audicus Protect plan has you covered. With Audicus Protect you have complete coverage of your hearing aids for 36 months, including low-cost repairs, free Clean & Care service and reduced-price loss replacement. Audicus Protect must be purchased within 60 days of delivery

Sign up at: audicus.com/protect

Audicus offers a Clean & Care service to have your instruments professionally checked and cleaned, find out more at audicus.com/clean If you return your aids to Audicus dirty, you may be billed for the Clean & Care service

Remote Adjustment

The hearing aids have remote adjustment capabilities that allow Audicus specialists to provide modifications to the sound quality and clarity from the comfort of your home
The adjustment occurs through your smart phone while connected to the Hearing Remote app. You can download the app from audicus.com/app To enable this service, make sure to click activate during the app install process. To request a remote adjustment, please submit your information at audicus.com/adjust Remote adjustment requests may take up to 72 hours to process Any significant changes in your hearing loss, or requests to modify your programs, may require the device to be sent to Audicus for a full reprogramming

Ensure push notifications are enabled for the app.
When the remote adjustment is ready you will.
receive a notification on your phone
Open the Hearing Remote app and you will see a list of the available adjustments for your devices

Select an adjustment to view the details and apply You can return to this menu to apply other adjustments or restore to the original settings. Only one adjustment can be applied at a time

Accessories

TV Connector The TV Connector allows you to wirelessly connect your hearing aids to your TV/stereo/laptop, etc. The TV Connector sends wireless audio signals up to 15m (50ft). Accepts audio signals via either a 3.5mm audio cable or a digital optical TOSLINK and is powered via USB

Remote Control

Control the volume and programs with this small and discreet device. The Remote Control uses a nonchargeable CR2032 battery

Partner Mic

This small device can be worn by a conversation partner to stream their voice directly to your hearing aids wirelessly

Small and discreet with a convenient clip, the Partner Mic is ideal for busy environments – such as restaurants – to focus on one person’s voice The Partner Mic is rechargeable with the included USB-C charging cable Order your Omni accessories ataudicus.com/omni-supplies

Bluetooth – Pairing your hearing aid

Your hearing aid has built-in Bluetooth® connectivity, allowing you to connect with up to two devices seamlessly that support Bluetooth 4.2 or higher, including most modern Apple iOS or Android smartphones When connected to a smartphone your hearing aid is able to play music and answer calls hands-free In your phone’s settings menu:

Turn on Bluetooth
Search for new devices

Hearing aid pairing starts automatically on start-up

The device enters Bluetooth pairing mode for3 minutes after being turned on
From the list of available devices, select your hearing aid to simultaneously pair both devices Only connect to the Right (“R-”) hearing ai
A melody is played when successfully paired

Once paired, your hearing aids will automatically reconnect when in range of your phone. This reconnection can take up to 2 minutes

Hands free calls

When paired, phone calls are automatically transferred to your hearing aids. Your voice is picked up by the hearing aid’s microphones
To accept an incoming call, you will first hear a notification through the hearing aids
The call can be accepted by a short press on the multi-function button (either UP or DOWN) or rejected with a long press (over 2 seconds)
Alternatively, accepting the phone call on your phone will transfer the call to your hearing aids
End a call with a long press on your multifunction button (either UP or DOWN)
Pairing is only necessary once per phone
Bluetooth connection will extend to 30ft / 10m but can be reduced by obstructions in a purse or pocket
Bluetooth connection will cause extra battery drain. If hearing aids are not connected via Bluetooth there will be no extra battery loss
See audicus.com/support for help with Bluetooth

Bluetooth 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 aids from remote app, if installed Settings › My Hearing Aids › My Devices › Forget Devices
Uninstall the Hearing Remote app, if installed
Delete/forget hearing aids from Bluetooth menu
Check for and install any updates on your phone
Disable/enable or turn off/on Bluetooth
Restart your phone
Restart the hearing aids (hold the DOWN button)
Reconnect one hearing aid via Bluetooth menu If desired, install the Hearing Remote app and connect devices in the app. The Hearing Remote app is not required for basic Bluetooth usage and is not supported on all phones
For additional support visit audicus.com/support

Hearing Remote App

Your device works without an app with any compatible Bluetooth devices For additional functionality, control, and remote adjustment, you can use the optional smartphone app. Note: this app may not be compatible with all smartphones The free Hearing Remote app can be downloaded from the App Store (iOS) or Play Store (Android). Find links at audicus.com/app

Requirements for the Hearing Remote app:

iOS Android version 12.0+

|

Android version 7.0+

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Tap Control

Your devices can be controlled with a tap gesture. Tap on the side of your ear to control device function

Left ear double tap Right ear double tap
Pause / resume streamin g Start / stop voice assistant\ Accept / end call (either ear) These settings and tap sensitivity can be customized using the Hearing Remote app. See the app for detail

Returns and warranty

The Audicus 100% happiness guarantee
If for any reason you are not satisfied with your Audicus hearing aids, you may return them 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 Audicus hearing aids come with a 24 month guarantee that covers manufacturing defects. This guarantee will not be valid if the hearing aid has been modified, tampered with, damaged or repaired by the user. Hearing aids must be cleaned prior to any repairs, otherwise a cleaning fee will apply If your device stops functioning correctly reach out to contact@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 Omni Series 2 is manufactured by Unitron Hearing, Canada and distributed by Audicus.
FCC ID: KWC-MRP IC: 2262A-MRP
Hereby, Unitron 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.

Operating conditions:
This device is designed such that it functions without problems or
restrictions if used as intended, unless otherwise noted in these user guides.
Transport conditions:
Temperature Limits: –20° C (–4° F) to +60° C (+140°F)
Humidity: Lower Limit = 0%, Upper Limit = 70%
Pressure: Lower Limit = 50kPA, Upper Limit =106kPA
Radio information of your wireless hearing aid:
Antenna type: Resonant loop antenna
Operation frequency : 2.4 – 2.48 GHz
Radiated Power: <2.5mW
Bluetooth: 4.2 Dual-Mode
Profiles supported: HFP (Hands-free profile), A2D

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by the manufacturer is under license. Other trademarks and trade names are those of their respective owners.

Keep dry

The symbol with the crossed-out garbage bin is to make you aware that this device may not be thrown away as normal household waste. Please dispose of old or unused devices at waste disposal sites intended for electronic waste, or give your device to your hearing care professional for disposal. Proper disposal protects the environment and health.

Warning to hearing aid dispensers (to comply with the U.S. Food and Drug Administration (FDA) regulations)

Hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review or any other available information concerning the prospective user, that the prospective user has any of the following conditions:

i. Visible congenital or traumatic deformity of the ear.
ii. History of active drainage from the ear within the previous 90 days.
iii. History of sudden or rapidly progressive hearing loss within the previous 90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
vi. Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1000 Hz and 2000 Hz.
vii. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
viii. Pain or discomfort in the ear.

Important notice for prospective hearing aid users
Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists, or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased.

Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a hearing aid dispenser, as appropriate, for a hearing aid evaluation. The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs. If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial-rental or purchase-option program. Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee after which you may decide if you want to purchase the hearing aid. Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged.

Children with hearing loss
In addition to seeing a physician for a medical evaluation, a child with hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.

Technical specifications

| Standard Receiver| Medium Receiver
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Output Sound Pressure Level 90 (OSPL90) (dB SPL)| 111| 114
Full on gain (input 50 dB SPL)| 46| 50
Total harmonic distortion at 500Hz/800Hz/1600Hz/3200Hz (%)| 1.5/2.0/2.0/1.0
Equivalent input noise at Reference Test Setting (dB SPL)| 19
Latency (ms)| <8
Frequency range (Hz)| <100-8000
Typical battery life (h)| 18