OTC Audien Ion User Manual

Precautions

WARNING: If you are younger than 18, do not use this. You should go to the 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 18 or 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 earwax, or 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 this 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 the FDA as an adverse event according to the instructions that appear later.

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.

These precautions point out situations which could cause minor or moderate injuries to the user or to the hearing aid:

• Your should familiarize yourself fully with the entire contents of the user manual before using the hearing aid to ensure personal safety and correct use.
• Contact the manufacturer for support if you experience unexpected operations or performance.
• Do not attempt to modify the shape of the hearing aid or slim tube yourself.
• In some acoustic environments, over amplification can cause discomfort and damage to the patient's hearing.
• A hearing aid should only be used as directed by your physician or hearing healthcare provider.
• Do not use your hearing aid in explosive or oxygen-enriched areas. Allergic reactions to hearing aids are unlikely. However, if you experience itching, redness, soreness, inflammation, or a burning sensation in or around your ears, inform your hearing healthcare provider and contact your physician.
• You may notice accelerated accumulation of earwax when using your hearing aid. This is normal, but see your hearing healthcare provider if you continue to have difficulties.
• In the unlikely case that any parts remain in the ear canal after the removal of the hearing aid, contact a physician immediately. Report the event to your hearing healthcare provider as soon as possible.
• Remove your aids for CT and MRI scans or other electromagnetic procedures.
• Never leave your hearing aids or batteries where small children and pets can reach them.
• If batteries are swallowed or inhaled, contact the local poison control center immediately.
• If you feel pain in or behind your ear, if it is inflamed, if skin irritation or accumulations of ear wax occur, please check with your hearing healthcare provider or physician.
• Your hearing aids have been adjusted for your hearing needs, please do not share your hearing device with other people.

Caution: This is not hearing protection You should remove this device if you are experiencing 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 out 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 the FDA as soon as possible after the problem. The 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 www.fda.gov/safety/MedWatch or call 1-800-FDA-1088. You can also download a form to mail to FDA.

Table of Contents

• Device Diagram: 1-2
• Package Contents: 3
• Setting Up Your Device: 4-10
• Choosing The Right Ear Dome: 4
• Fitting The Ear Dome: 5
• Powering ON/OFF: 6
• Switching Between Modes: 7
• Wearing The Audien Ion: 8
• Adjusting Volume: 9
• Charging Indicator Key: 10
• Charging Your Device: 11-12
• Charging The Units: 12
• Cleaning Your Device: 13-18
• Dome & Product Cleaning: 13
• Replace Ear Domes: 15
• Replacing The Wax Guards: 17-18
• Troubleshooting: 19
• Technical Specifications: 20

Device Diagram

Package Contents

• Audien Ion Hearing Aids
• Ear Domes
• Cleaning Brush
• Wax Guard Replacement Kit
• Wall Adapter & USB-C Cable
• Charging Case

Setting Up Your Device

Choosing The Right Ear Dome

Choosing the dome type & size most suitable for your ear canal will ensure minimal feedback during insertion & a better experience using the Audien Ion. Take the time to find your optimal fit.

There are 2 types of Ears Domes that come in small, medium & large sizes:

• Rounded: [image of rounded ear domes]
• Coned: [image of coned ear domes]

The smallest size of the rounded Ear Dome comes pre-installed on your Audien Ion.

Fitting The Ear Domes

Remove Ear Domes: Pinch the Ear Dome with your thumb, index and middle finger to separate the Ear Dome from the connector.

Fit Ear Domes: Select an appropriate Ear Dome according to the size of your ear canal, hold the Ear Dome and fit it into the connector of the hearing aid.

Powering ON/OFF

! Device will turn on in 10 seconds, giving you time to insert the hearing aid. You will hear a musical chime once the device powers on.

Switching between Modes

Volume Control/Mode Switch Button

Switch Modes: Cycle through modes by using the multi-function button. Press & hold the volume up or volume down button until you hear a chime.

Wearing the Audien Ion

1. Insert the Ear Dome into your ear canal.
2. Gently wrap the Audien Ion over your ear until it rests securely behind your ear.
3. Push the ear tube into your ear canal until it is snug and comfortable.

Adjusting Volume

To adjust volume, tap (volume up) or (volume down) for 1 second. Each volume level is denoted by a quick double beep. Max volume or lowest volume are denoted by a single beep. There are 9 volume levels.

Charging Indicator Key

Middle light = Case charge indicator

Charging Your Device

Charging the Charging Case

CHARGE TIME: 2 HOURS

Step 1 Plug the USB-C cable into the charging port and connect the Wall Adapter to an outlet. For first time use, it is recommended to charge for 3 hours until the charging indicators turn on.

! Be sure the hearing aids are turned off before charging.

Charging The Audien Ion

Step 2 Insert the Audien Ion units into the Charging Ports. The left ear unit (blue tip) should be in the charging port marked L. The right ear unit (red tip) should be in the charging port marked R.

LEFT

RIGHT

Charging Case contains 20 hours of charge time when fully charged. The Charging Case can charge the hearing aids up to 3 times after being fully charged.

Cleaning Your Device

Cleaning The Device

Remove the Ear Domes from the hearing aid, use the Cleaning Brush to remove any earwax or debris from the device's components and the Charging Case.

Cleaning Your Audien Ion

Use a soft cloth or tissue to clean the body of the Audien Ion. This includes the push buttons, charging contacts and ear pieces. Do not use alcohol, water or other cleaning solvents to clean the Audien Ion as it may damage them.

Regular cleaning is necessary. You may visit audienhearing.com to order new domes and other accessories.

Replace Ear Domes

Hold the Ear Dome and Sound Connector with your left and right hands respectively to separate the Ear Dome from the Connector. You may contact us by email at: support@audienhearing.com to order new domes and other accessories.

Take the Ear Dome off & make sure to clean any ear-wax buildup under the ear dome.

Product Care Continued:

• Change your wax guards every 2-4 weeks.
• Keep your Audien Ion and charging case clean. Extreme temperatures (hot or cold), moisture, and foreign substances may damage the product.
• Regular cleaning is necessary.
• Charging contact points should always be kept clean and dry.
• Use the provided cleaning brush to keep the charging ports clear of dust or dirt.

Replacing The Wax Guards

Change your Wax Guards every 2-4 weeks.

Remove the Ear Domes & locate the Wax Guard Replacement Kit.

Troubleshooting

Feedback/Whistling

• To resolve this, lower the volume and increase it slowly.
• Ensure the earbuds on your device snuggly fit your ear canal.
• You may be accidentally putting pressure or obstructing the microphone when fitting the device. Do not worry. Once the device is secure in your ear, remove your hands and the whistling will stop.

No Sound/Not Working

• Change your wax guards.
• Clean all charging connectors, ensure there is nothing obstructing the charging port.
• Fully charge the device, then try using them again. Be sure that both devices are secure in their Charging Case, making a firm connection.
• Remember that it's expected for your device to NOT feel normal for the first few weeks. Focus on using your devices every day for a few weeks, and you will become acclimated to the device.

Technical Specifications

Power adapter Input: 100-240VAC, 50-60hz Output: 5VDC 1A, USB-A

For additional specifications, go to audienhearing.com/pages/ion-manual

Production Date & Product Life

That is, normal working time of the product. The product needs to be stored and used as required. After exceeding the specified service time, its expected that the function will be affected. (e.g unable to meet the requirements of product performance indicators, etc). The product life of hearing aids are 5 years.

Please see the label for the production date.