Lucid HEARING INVISIBLE-IN-CANAL 96 Channel Hearing Aid User Manual

Lucid HEARING INVISIBLE-IN-CANAL 96 Channel Hearing Aid

Product Information

The Lucid Hearing Invisible-in-Canal (IIC) and In-the-Canal-Directional (ITC-D) hearing aids are designed to provide a discreet and comfortable solution for individuals with hearing loss. These hearing aids have 96 channels and are suitable for adults who have received medical clearance from a doctor, preferably an ear-nose-throat (ENT) doctor.

It is important to note that individuals under the age of 18 require specialized care, and a medical evaluation is necessary before using these hearing aids. The maximum sound pressure level of these hearing aids should not exceed 132 decibels, as there may be a risk of impairing the remaining hearing of the user.

These hearing aids are not intended to serve as hearing protection. If you are in a loud environment, it is recommended that you use the appropriate ear protection instead of wearing these hearing aids.

If the sound output is uncomfortably loud or painful, you should turn down the volume or remove the device. If you consistently need to turn down the volume, further adjustments may be necessary.

If any part of the hearing aid gets stuck in your ear, it isimportant to seek medical help as soon as possible. Do not attempt to remove the part with tweezers or cotton swabs, as this can cause further injury.

If you experience any adverse events, such as skin irritation or worsening hearing loss, contact the FDA as soon as possible to report the problem.

Product Usage Instructions

• Consult a doctor, preferably an ENT, before using these hearing aids.
• If appropriate, obtain a written statement from the doctor  indicating that the hearing loss has been medically evaluated andthat you are a candidate for a hearing aid.
• If necessary, undergo a hearing aid evaluation by an audiologist to determine the appropriate hearing aid.
• Insert the hearing aid carefully into your ear, following the manufacturer’s instructions.
• Turn on the hearing aid and adjust the volume as necessary.
• If the sound output is uncomfortably loud or painful, turn down the volume or remove the device.
• If any part of the hearing aid gets stuck in your ear, seek medical help immediately.

WARNING: People younger than 18 should go to a doctor before using this. People younger than 18 years old need specialized care, and using this without a medical evaluation may worsen impairment or disability. A hearing aid user who is younger than 18 should have a recent medical evaluation from a doctor, preferably an ear-nose-throat doctor (an ENT). Before using this, a doctor should determine that the use of a hearing aid is appropriate.

WARNING to Hearing Aid Dispensers:

You should advise a prospective hearing aid user to consult promptly with a doctor, preferably an ear specialist such as an ENT, before dispensing a hearing aid if you determine through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions:

• Visible deformity of the ear, either congenital or traumatic
• Fluid, pus, or blood coming out of your ear in the past 6 months
• Painful or discomfort in the ear
• History of excessive ear wax, or suspicion that something is in the ear canal
• Dizziness, either recent or long-standing
• Sudden, quickly worsening, or fluctuation hearing loss within the previous 6 months
• Hearing loss or ringing (tinnitus) only in one ear or a noticeable difference in hearing between ears
• Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000Hz Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 decibels as there may be risk of impairing the remaining hearing of the hearing aid user. (This provision is required only for those hearing aids with a maximum sound pressure capability greater than 132 decibels (dB)).

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.

• 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.

• 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: 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 www.fda.gov/Safety/MedWatch or call 1–800-FDA-1088.
You can also download a form to mail to FDA.

Note: Hearing loss in people younger than 18

• People younger than 18 should see a doctor first, preferably an ear-nose-throat doctor (an ENT), because they may have different needs than adults
• The doctor will identify and treat medical conditions as appropriate
• The doctor may refer the person to an audiologist for a separate test, a hearing aid evaluation
• The hearing aid evaluation will help the audiologist select and fit the appropriate hearing aid

A person who is younger than 18 years old with hearing loss should have a medical evaluation by a doctor, preferably an ENT, before buying a hearing aid. That purpose of a medical evaluation is to identify and treat medical conditions that may affect hearing but that a hearing aid won’t treat on its own.
Following the medical evaluation and if appropriate, the doctor will provide a written statement that the hearing loss has been medically evaluated and the person is a candidate for a hearing aid. The doctor may refer the person to an audiologist for a hearing aid evaluation, which is different from a medical evaluation and is intended to identify the appropriate hearing aid.

The audiologist will conduct a hearing aid evaluation to assess the person’s ability to hear with and without a hearing aid. This will enable the audiologist to select and fit a hearing aid for the person’s individual needs. An audiologist can also provide evaluation and rehabilitation since, for people younger than 18, hearing loss may cause problems in language development and educational and social growth. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of hearing loss in people younger than 18.

UNDERSTANDING YOUR HEARING AID

1. Directional Microphone
2. Push Button
3. Battery Door
4. Removal Cord
5. Vent
6. Product ID Serial Number
7. Sound Port with Wax Stop
   Red Serial Number or Shell – Right Hearing Instrument
   Blue Serial Number or Shell – Left Hearing Instrument

INCLUDED ACCESSORIES

Your hearing instruments are shipped with a variety of accessories, a sampling pictured above, including the following:

• Storage Case
• 1 Card of Batteries
• Battery Holder
• WaxStop
• Cleaning Tool
• Brush

If you have any questions about the use of these accessories please contact your hearing care professional or our Customer Service team at 1-800-785-6052.

BATTERY INSERTION

The IIC hearing aid is powered by a type 10a battery while the ITC-D hearing aid requires a type 312 battery. We recommend using a zinc-air type battery for the best performance.
To insert a zinc-air type battery, remove the adhesive label and wait thirty seconds for air to activate the battery. Wipe any moisture off the battery surface. Open the battery door and with the positive side up, insert battery into the battery door.
To remove, open the battery door and lift the battery out of the battery door.

When your battery is low and needs replaced you will hear the low battery voice prompt. The prompt will be repeated until the battery is changed. The low battery voice prompt will be repeated every 15 – 20 minutes.

POWER & VOLUME CONTROL

After inserting the battery, close the door completely to turn the unit on. To turn the unit off, simply open the battery door partially. To help prolong battery life, open the battery door each time you remove your hearing aids.
Once the battery door is completely shut, you will hear the unit turn on. The Invisible-In-Canal (IC) and In-The-Canal-Directional (ITC-D) models feature automatic volume control. The volume self-adjusts and the aid has no visible volume control.

INSERTING HEARING AIDS

Inserting your hearing aids for the first time can be challenging. There can be feedback (whistling) if your hearing aids are not fully inserted, so we suggest you practice inserting them without the battery until you have perfected this process.

Follow these steps to insert your hearing aid:

For lIC Hearing Aid

1. Grasp the removal cord with your thumb and forefinger with the serial number facing the front portion of your ear canal.
2. Gently insert the hearing aid into your ear canal. When positioned correctly, the hearing aid is practically invisible and only the removal cord is visible.
   To remove the aid, it is important to grasp the knob on the end of the nylon removal cord and gently pull the instrument from the ear canal.

For ITC-D Hearing Aid

1. Hold the hearing aid with your thumb and forefinger with the serial number facing the front portion of your ear canal.
2. Gently insert the hearing aid into your ear canal, rotating it slightly to ensure proper placement.
   When positioned correctly the hearing aid is barely visible.
   To remove the aid, grasp the outer edges with your thumb and forefinger and gently pull the instrument from the ear canal.

PROGRAM SELECTION

• Your hearing aid features four listening programs.
• Program 1 (Lucid) is automatically selected when the hearing aid is turned on and is the best choice for most listening situations.
• For special listening situations, you have additional options.
• Program 2 (Noisy) is best for loud, noisy environments.
• Program 3 and 4 are available if you need customized settings based on your hearing loss.
• To change programs simply press and hold the Push Button for 2 seconds. A voice prompt will announce the program change. Press and hold again to cycle through the programs.

CLEANING

The most common cause of instrument failure is wax buildup, and it is the easiest to avoid. By wiping your hearing aids with a soft, dry cloth every day and carefully removing any traces of wax and debris, you will reduce wax buildup.
A brush is provided to further assist you in cleaning your instrument. It is important to keep your hearing aids as clean as possible to maintain maximum performance and durability.
IIC hearing aids come with a vent cleaning tool to help remove wax and debris from the vent. To clean the vent,gently insert the end of the cleaning tool into the Sound Port until it exits from the vent. Clear away excess wax and debris from the hearing aid and delicately remove the cleaning tool. Your hearing specialist can show vou the correct method to insert vent cleaning tool.

WAXSTOP INSTRUCTIONS

Removal Side New WaxStop Side
The WaxStop is inserted in the sound tip to prevent ear wax from damaging the hearing aid speaker. We recommend you visit your hearing specialist to replace your Wa×Stop. Improper replacement could result in the Waxstop coming off the tube and being lodged in the ear canal. If you would like to replace it yourself, below are the instructions for WaxStop Removal and Insertion.

WaxStop Removal: Firmly press the removal tip into WaxStop until it clicks into place. Pull WaxStop from sound tip.

WaxStop Insertion: Insert new WaxStop into sound tip, pull the tool straight out. The tool will release and the WaxStop will remain in place. Press WaxStop firmly into sound tip making certain that is fully inserted.
WaxStops can be cleaned in hot water with a mild detergent, dried thoroughly and then reused.

ANSI SPECIFICATIONS

GENERAL INSTRUCTION

About Lucid® Hearing Aids
Lucid hearing aids are highly sophisticated devices which have the capacity to make a real impact on the overall quality of life for those who have hearing loss.
Patented Lucid smart technology delivers natural sound quality that is superior to traditional “compression” hearing aid technology. Powered by Lucid hearing aids help you hear the sounds that are most important to you and ensure they are at the most understandable and comfortable volume. Our Lucid technology constantly analyzes your environment making automatic adjustments to ensure you hear what you want to hear while minimizing noise and sounds you don’t want to hear. This allows you to move from one sound environment to another, like a one-on-one conversation and then a noisy group, without having to make adjustments to your hearing aid settings.
While our hearing aids won’t restore your hearing to normal, you will experience a very positive difference. These differences vary between individuals and depend on a number of factors including your level of hearing loss and the type of hearing aid you choose. Our Lucid Certified Hearing Specialists are committed to fitting you with the best device for your level of loss and unique lifestyle.
Important Hearing Aid Information

Intended Use:
A wearable sound amplifying device intended to aid adult persons with or compensating for impaired hearing.
The device (custom programmed for individual hearing loss) must only be used by the intended person. They should not be used by any other person as they could damage the individual’s hearing. The instruments are not intended for infants, small children or mentally disabled persons.

Getting Started

Helpful Hints:

• Start in quiet places with simple communication and then progress as you feel comfortable.
• Keep a positive attitude.
• Communicate any issues with your hearing care professional; they can make adjustments as necessary
• Hearing aids will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions.
• In most cases infrequent use of a hearing aid does not permit a user to attain full benefit from it.
• The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lip-reading.

General Instrument Care:
Your instruments are delicate, precision electronic devices and require special care and handling that should be provided to such devices. Please read and follow the listed precautions to ensure quality performance and long instrument life

• Remove batteries when hearing instruments will not be in use for prolonged periods of time
• Do not throw or drop your instruments
• Do not immerse hearing instruments in liquid or water
• Do not wear during bathing, showering or swimming
• Store out of the reach of children and pets
• Do not expose instruments to excessive heat, such as stove top, microwave, dash board of a hot car, or hair dryer
• Do not expose the instruments to chemicals such as hair spray, insect repellent, perfume, or cosmetics.
• Do not use the product with higher volume for a long period of time, in order to avoid hearing damage. Stop using if discomfort occurs.
• Do not disassemble the device
• To avoid possible electromagnetic radiation, the devices should be removed in any high frequency, heat treatment or operation, radiotherapy and strong magnetic field environments.
• Please avoid use in a potentially explosive or dangerous situation.
• Only qualified accessories should be used with this device.
• Take off the hearing aid at night, which should be placed in stay dry jar (hearing aid specialist can supply), avoid light, high temperature, high humidity environment, or falling touch
• Please keep the surface of hearing aid clean, clean wax build up in earplugs or tips
• Please use the Dual Function Rocker Switch correctly, avoid excessive force as far as possible

Special Note. Your hearing instruments are built with the finest quality materials. However, in rare instances an individual may experience sensitivity to the materials used. Please consult with your physician if you exhibit any signs of skin irritation, allergic reaction, or accelerated accumulation of cerumen (wax)
Should you experience a sensitivity problem, please see your hearing care provider to inquire about special hypoallergenic coatings available to assist with these situations.
If your instrument is equipped with wireless capabilities check first before using the hearing instrument in areas where electronics or wireless devices are restricted such as on an airplane.

Note: Your Hearing Care Professional can perform a thorough professional cleaning and maintenance. It is recommended that you contact your hearing care professional at least annually for a new hearing test and a clean and check of your device.

The average hearing aid lifespan will vary significantly due to the amount of care provided and the use conditions. On average the life expectancy is approximately 4 years. The lifespan of consumable supply items will also vary significantly (i.e. wax stop, tubes). Ask your Hearing Care Professional for recommendations on supplies, maintenance intervals and for support.
Battery Safety Information

HEARING AID BATTERIES ARE DANGEROUS IF SWALLOWED
Keep out of the reach of children or anyone who may accidentally swallow them. Never put batteries in your mouth for any reason. Do not store batteries in pill containers where they may be mistaken for medication and swallowed. Use batteries recommended by your hearing care professional. Batteries of low quality may leak and cause bodily harm. Batteries with incorrect voltage may cause damage to your device. Never attempt to recharge your batteries. They may explode and cause serious injury. Do not expose your batteries to heat, such as an open flame, microwave or oven. There is a risk that they will explode and cause serious injury. Remove batteries when instrument is not in use. Please discard old batteries in a safe place in accordance to local recycling rules.
Visit http://www.poison.org/prevent/battery.asp to learn more important information about battery safety.
If a battery or hearing instrument is swallowed, see a doctor immediately and call the National Capital Poison Center, 202-625-3333.

Important Notice
Prospective Hearing Aid Users: Good health practice requires a person with a hearing loss to 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 the diseases of the ear are often referred to as otologists, otolaryngologists, or otorhinolaryngologists. The purpose of a medical evaluation is to assure all medically treatable conditions that may affect the hearing are identified and treated before the hearing aid is purchased.

Following the medical evaluation, the physician will give you a written statement stating your hearing loss has been medically evaluated and 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 which a physician. The exercise of the waiver is not in your best interest and its use is strongly discouraged.

Troubleshooting Guide

physician
Aid improperly inserted| Insert hearing aids properly
“Dead” or No Sound| Microphone opening and/or sound port clogged with wax, moisture or debris| Clean microphone opening and/or sound port
Dead battery| Replace battery
Hearing aids are not inserted properly| Insert hearing aids properly
Intermittent Beeping| Weak battery| Replace battery
Fades or Intermittent Sound| Moisture clogged microphone opening| Purchase and use a drying kit

If you experience any problems with your instruments that you are unable to resolve at the place of purchase, contact Hearing Lab Technology, LLC. (contact information on back) for assistance. Please do not attempt to make repairs yourself. Doing so could cause additional damage and will void any warranties.

Disposal of Instruments
Waste from electronic equipment must be handled according to local regulations.

Environmental Conditions
During transport or storage, the temperatures should not exceed the limit value of -25 to 70°C. (-13 to 158°F) 0 to 90%, 700hPa to 1060hPa. Battery should be removed from the device while transporting or storing.
Operating Condition: your hearing instruments are designed to operate beyond the rand of temperature comfortable to you, from very cold up to 40°C (104°F).

Manufactured By: Sound Quest, LLC 806 Beaver Street Bristol, PA 19007 USA 215-785-5437

Distributed By:
Lucid Hearing Holding Company, LLC PO Box 535596 Grand Prairie, TX 75053

IP22 Protection against dripping water at all angles Protection against objects ≥ 12.5 mm in diameter

lucidhearing.com

References

• Home | Lucid Hearing - Lucid Hearing
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
• Button batteries

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