OTC Audien BTE - User Manual

1
OTC
Audien
BTE
U S
E R M A N U A L

Summary

Important Warnings and Cautions

Age Restrictions and Medical Consultation

Hearing aid for users 18+. Consult doctor for ear defects, pain, discharge, dizziness, or sudden hearing changes.

Device Usage Precautions

Ensure comfortable insertion, do not use as hearing protection, adjust volume for comfort, avoid foreign objects.

Reporting and Expectations

Report adverse events to FDA. Understand device limitations and seek professional help if concerns persist.

Intended Use and Contraindications

For mild/moderate hearing loss; not for specific ear conditions or therapeutic value.

Device Diagram

Package Contents

Setting Up Your Device

Fitting Ear Domes

Instructions on how to attach and remove ear domes for a proper fit and better user experience.

Inserting Hearing Aid Into Ear

Step-by-step guide on how to properly insert the Audien BTE hearing aid into the ear canal.

Powering the Device On and Off

Two methods to turn the Audien BTE on or off: automatic via charging case or manual button press.

Adjusting Volume and Modes

Switching Environmental Modes

Guide to changing between 4 environmental modes using button presses, indicated by beeps.

Volume Control

Instructions on increasing and decreasing volume levels, with 11 levels indicated by beeps.

Charging Your Device

Charging Process and Indicators

Steps for plugging in the charging case, inserting the hearing aid units, and understanding indicator lights.

Charging Time and Battery Life

Details on the 2-hour full charge time and approximately 20 hours of battery life per charge.

Light Key for Charging Status

Explanation of indicator lights (Light 1, 2, 3) for left ear, charging case, and right ear status.

Cleaning Your Device

Dome Cleaning

Use the included cleaning brush to remove earwax, dust, and debris from ear domes.

Audien BTE Cleaning

Clean the device body with a soft cloth; avoid alcohol, water, or solvents that may cause damage.

Product Care and Maintenance

Keep clean, avoid extreme temperatures/moisture, never use solvents, keep contacts clean and dry.

Continued Product Care Guidelines

Do not use fluids on charging ports, keep lid closed, store in dry location, do not remove batteries, recharge weekly.

Technical Specifications

Hearing Aid Performance Metrics

Details output, gain, distortion, noise, latency, and frequency response of the hearing aid.

Charging Case Specifications

Provides input/output voltage and current for the charging case.

Disposal Guidance

Instructions for disposing of the device according to WEEE directive.

Precautions and Policies

Information Availability

How to access additional information online, via email, or by mail.

Manufacturers Return Policy

Details the 45-day return policy, including eligibility and refund processing.

Regulatory and Legal Information

Electromagnetic Compatibility (EMC)

Information regarding EMC, EN60601-1-2 standard, and necessary separation distances for RF equipment.

Electromagnetic Emission Guidance

Guidance on electromagnetic emission for the device and its intended environment.

Electromagnetic Immunity Guidance

Guidance on electromagnetic immunity for the device and its intended environment.

Separation Distances for RF Equipment

Recommended separation distances between portable/mobile RF equipment and hearing aids.

Overview

1. Function Description
2. Usage Features
3. Setting Up Your Device
4. Adjusting Volume
5. Switching Between Modes
6. Inserting Into Ear
7. Powering ON/OFF
8. Charging Your Device
9. Light Key Indicators
10. Important Warnings and Cautions
11. Contraindications
12. Manufacturer's Return Policy
13. Maintenance Features
14. Cleaning Your Device
15. Dome Cleaning
16. Audien BTE Cleaning
17. Product Care

The Audien BTE is an Over-The-Counter (OTC) hearing aid designed for individuals aged 18 and older with mild to moderate air conduction hearing loss. It aims to provide hearing compensation and improve the user's ability to hear in various environments. The device is not intended to restore normal hearing, prevent or improve medical conditions causing hearing loss, or serve as hearing protection.

Function Description

The Audien BTE hearing aid is a Behind-The-Ear (BTE) device that includes an ear tube and an ear dome, which are inserted into the ear canal. It features two microphones to capture sound, a receiver to deliver amplified sound, and a magnetic charging connection point. The device offers 11 volume levels and 4 environmental modes to adapt to different listening situations.

Usage Features

Setting Up Your Device:

The Audien BTE comes with small, medium, and large ear domes. To remove an ear dome, pull it off with sufficient force. To attach a new ear dome, hold the end of the ear tube and push the dome firmly to ensure it is securely fastened. Choosing the most suitable dome size is crucial for a better user experience.

Adjusting Volume:

The device has 11 volume levels.

• Higher volume: Press the volume up button for 1 second to increase the volume. You will hear one beep for each level increase.
• Lower volume: Press the volume down button for 1 second to decrease the volume. You will hear one beep for each level decrease.
• When you reach the highest or lowest setting, you will hear two beeps.

Switching Between Modes:

The Audien BTE offers four environmental modes to optimize hearing in different settings:

• M1 (Conversation): Indicated by 1 beep.
• M2 (Restaurant): Indicated by 2 beeps.
• M3 (Outdoor): Indicated by 3 beeps.
• M4 (Music): Indicated by 4 beeps. To switch between these modes, press the volume up button for 3 seconds. The number of beeps heard after 3 seconds indicates the current mode.

Inserting Into Ear:

1. Step 1: Insert the ear dome into your ear canal.
2. Step 2: Gently wrap the Audien BTE over your ear until it rests securely behind your ear.
3. Step 3: Push the ear tube into your ear canal until it is snug and comfortable.

Powering ON/OFF:

There are two methods to turn the Audien BTE on or off:

1. Using the charging case:
   • Turn on: Remove the Audien BTE from the charging case, and it will automatically turn on.
   • Turn off: Place the Audien BTE back into its charging port, and it will automatically turn off.
2. Using the volume down button: Press the volume down button for 3 seconds. You will hear an indicator sound saying "Power On" or "Power Off."

Charging Your Device:

The Audien BTE units are charged using a dedicated charging case.

1. Step 1: Plug the charging case into a standard outlet using the provided USB cable and wall charger. Light 2 on the charging case will flash blue to indicate that the case is charging.
2. Step 2: Insert the Audien BTE units into their respective charging ports (left unit into the left port, right unit into the right port). Light 1 (for the left ear) and Light 3 (for the right ear) will turn blue to indicate that the hearing aids are charging.
3. Step 3: A full charge for both Audien BTE units and the charging case takes approximately 2 hours. A full charge provides about 20 hours of use. The charging case has an internal battery, allowing you to charge your devices on the go.

Light Key Indicators:

• Light 1 (Left Ear): Solid white indicates the left ear unit is fully charged.
• Light 2 (Charging Case): Solid blue indicates the charging case is fully charged.
• Light 3 (Right Ear): Solid white indicates the right ear unit is fully charged.

Important Warnings and Cautions:

• Age Restriction: Do not use if younger than 18. Individuals under 18 with hearing loss should consult an ENT.
• When to See a Doctor: Consult an ENT if you have birth defects or unusual ear shapes, ear injuries, blood/pus/fluid discharge, ear pain/discomfort, excessive ear wax, or experience sudden hearing changes, fluctuating hearing, worse hearing in one ear, or ringing/buzzing in only one ear.
• Insertion Pain: The hearing aid should not cause pain during insertion. If it does, remove it and re-insert carefully. If pain persists, contact the manufacturer or a hearing healthcare professional.
• Not Hearing Protection: Remove the device if you experience overly loud sounds. Use appropriate hearing protection (like earplugs) in noisy environments.
• Sound Output: The sound output should not be uncomfortable or painful. Turn down the volume or remove the device if it's too loud. Consistent need to turn down volume may indicate a need for further adjustment.
• Stuck Parts: If any part of the hearing aid (e.g., eartip) gets stuck in your ear and cannot be easily removed with fingers, seek medical help immediately. Do not use tweezers or cotton swabs, as this can push the part deeper and cause injury.
• Consult a Professional: If you continue to struggle or are concerned about your hearing after trying the device, consult a hearing healthcare professional.
• Expectations: Hearing aids do not restore normal hearing and may not eliminate all difficulty hearing over noise. They do not prevent or improve medical conditions. It may take several weeks to adjust to using hearing aids, and training or counseling can be beneficial. Using hearing aids in both ears can be more effective, especially in noisy environments.
• Adverse Events: Report any injuries, malfunctions, or adverse events (e.g., skin irritation, injury from the device, stuck parts, worsening hearing loss) to the FDA. Instructions are available at https:/www.fda.gov/Safety/MedWatch or by calling 1-800-FDA-1088.

Contraindications:

• Patients with chronic suppurative otitis media or congenital ear atresia should not use this device.
• This hearing aid is for compensating hearing impairment and has no therapeutic value.

Manufacturer's Return Policy:

Audien offers a 45-day return policy from the date of shipment receipt. To initiate a return, request a shipping label from Audien's support team. The package must be dropped off at the post office and show as "accepted" in tracking information within the 45-day period to be eligible for a refund. Returns past 45 days are not eligible. Refunds are processed within approximately 3 business days after the team receives the package and typically take 3-5 business days to reach your bank account.

Maintenance Features

Cleaning Your Device:

Regular cleaning is essential to maintain the performance and longevity of your Audien BTE.

Dome Cleaning:

• Use the included cleaning brush to remove earwax, dust, and any other debris from the ear domes.
• Periodically remove the ear dome to clean any earwax buildup underneath it.

Audien BTE Cleaning:

• Use a soft cloth or tissue to clean the body of the Audien BTE, including the push buttons, charging contacts, and shell.
• DO NOT use alcohol, water, or other cleaning solvents, as they may damage the device.

Product Care:

• Cleanliness: Keep your Audien BTE and charging case clean.
• Temperature and Moisture: Avoid extreme temperatures (hot or cold), moisture, and foreign substances, as these can damage the product.
• Cleaning Agents: Never use alcohol, water, solvents, cleaning fluids, or oils to clean your Audien BTE or its charging ports.
• Charging Contacts: Always keep the charging contacts clean and dry.
• Charging Ports: Use the provided cleaning brush to keep the charging ports clear of dust or dirt.
• Lid: Keep the charging case lid closed as much as possible to prevent dust and debris buildup.
• Storage: Store your charger in a clean and dry location, such as a dresser or shelf, away from humid environments like bathrooms or kitchens.
• Batteries: Do not remove the batteries from the Audien BTE or charging case.
• Recharging: Recharge the Audien BTE and charging case at least once a week. Extended periods without power can damage the battery.

OTC Audien BTE Specifications

General

Type	Behind-the-Ear (BTE)
Technology	Digital
Bluetooth Connectivity	No
Noise Reduction	Yes
Water Resistance	No
Battery Type	Size 312
Charging Time	Not applicable (disposable batteries)
Volume Control	Yes
Warranty	1 year