Version 2.0 June 18. In-The-Ear (ITE) Hearing Aid User Manual

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Version 2.0 June 18 In-The-Ear (ITE) Hearing Aid User Manual

Contents Preface... 1 Features... 4 Preparation... 5 Operation... 5 Charging System... 6 Assembling your hearing aids... 8 How to wear your hearing aid... 9 How to remove your hearing aid... 10 Program button... 11 Maintenance... 12 Troubleshooting... 12 Cleaning care and precautions... 14 Whistling/feedback noise helpful tips... 15 Frequently Asked Questions... 16 Appendix... 18 Working condition... 18 FDA information... 19 Service and warranty... 23

Preface Welcome to our Hearing Assist family, and thank you for entrusting us with your hearing enhancement needs. Enclosed is our most innovative In-the-Ear hearing aid to date, designed to enhance the quality of sounds in your everyday life! This user manual only applies to the 2018+ model Recharge! (ITE) rechargeable hearing aid. Intended use This ITE Hearing Aid is an electronic device which amplifies sounds from the surrounding environment. It will help people with mild to moderate hearing loss or those who just want to enhance their ability to hear conversations in a noisy environment. Precautions Please consult with your hearing healthcare professional first if you have any questions about your hearing or your hearing instrument. THE MANUFACTURER RESERVES THE RIGHT TO MODIFY THE TECHNICAL SPECIFICATIONS OF THE PRODUCT WITHOUT ANY PRIOR NOTICE. 1 Hazard warnings and product safety Please read before using your hearing instrument the first time. Hazard Warnings Remove your hearing aid when exposure to moisture is possible (showering, washing your face, etc.) Remove your hearing aid prior to vigorous exercise to avoid injury or damage to yourself or to the hearing aid. Keep this product away from children, infants and pets. If pain, discomfort, skin irritation in the ear or excessive accelerated earwax occurs, please discontinue use and consult a physician. In the unlikely case of the dome being stuck in your ear canal, it is highly recommended that you see a physician for safe removal of the dome. 2

Features Hazard Warnings (continued) 5 Dome Hearing Aids are not designed to restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Contact point Do not attempt to use the hearing aid in a method not instructed within this manual. 4 Program Button 6 NOT SUITABLE FOR USE BY ANYONE UNDER 18. FOR MILD TO MODERATE HEARING LOSS. 2 1 USB cable Proper disposal of electronic products protects our environment. At the end of its useful life, rather than dispose of the hearing aid, please contact Hearing Assist and return it to us so we can recycle the product contents. 3 L R Accessories storage Charging base/ Drying case -GREEN LIGHT BLINKING = CHARGING 3 -GREEN LIGHT SOLID = FULLY CHARGED -BLUE LIGHT BLINKING = DRYING 4

Preparation Operation Kit includes: ITE hearing aid(s) 1 x User manual 1 x Cleaning tool 1 x charging base 1 x AC adapter 1 x USB cable 1x package assorted domes Charging System 2 Step 2: Connect the charging cable to the charging base. Battery helpful tips 1. A full charge takes about 3 hours, and will allow up to 25 hours of use. 2. Recharging process will automatically shut off when battery is fully charged. Leaving the unit in the charging case will not damage the battery. 3. To maximize the extended life of the battery, keep the hearing instrument in the charging base when not in use for an extended period of time. WARNING: Power is supplied by a custom lithium polymer battery that is built-in and should not be removed EXCEPT by an authorized service center. Removing or attempting to remove the battery will void your warranty. Contact Hearing Assist for battery replacement service. 5 Step 1: Connect your charging cord to a power source using the included AC Adaptor. 1 L R 3 Step 3: Place your hearing aid into the appropriate charging slot. L stands for Left, and R stands for Right. The green light will start blinking to notify you that the unit is charging. Warning: Do not use portable battery charger as your power resource. 6

Charging steps: 1. Once connected successfully, a BLINKING GREEN light indicates that your hearing aid is correctly positioned in the slot and charging. A SOLID GREEN light means your hearing aid is fully charged, which takes about 3 hours if the battery is depleted. 2. Your charging case has a built-in dehumidifier that helps to remove moisture from your hearing aid(s). The drying process starts 15 minutes after charging is complete and takes up to 3 hours. While drying, the BLUE indicator light will BLINK. When complete, the blue light will turn off. 3. One complete hearing aid charge will last up to 25 hours of use. Assembling your hearing aids Your hearing aid should arrive fully assembled with a medium sized dome already attached to the hearing aid housing. You'll have better success and fewer issues with whistling/feedback with a proper fitting dome. If you want to change to a different size dome, ensure that it is fitted securely onto the threaded connector on the hearing aid body. Tip: The memory foam domes can be pinched and compressed for fitting; they will return to their original size afterwards. Additional domes are available from Hearing Assist. Tip: It is fine to use the hearing aid before the drying process is completed. You can also use the hearing aid before the charging process is complete, just know that the battery will not last as long as it would if it were complete. 7 8

Turning ON and OFF Remove your hearing aid from the charging slot and hold the Program Button for 3-5 seconds until the unit turns ON. There will be a 3 second delay from the time the unit turns on until it amplifies sound, so that you can avoid feedback while setting it in your ear. The ReCharge! ITE will start in volume level 1 every time. To turn your hearing aid OFF, hold down on the Program Button again for 3-5 seconds. Your hearing aid will also turn OFF automatically when you return it to the charging slot. How to wear your hearing aid If inserting the right hearing aid, hold the body of your hearing aid between your thumb and the index finger of your right hand. If inserting the left hearing aid, use your left hand. Insert the hearing aid into your ear canal. While gently tugging on your ear lobe, use your index finger to gently push your hearing aid into position. If necessary, rotate the body of the hearing aid until it feels comfortable to you. (See diagram on next page) 9 How to wear your hearing aid (image) How to remove your hearing aid 1. Insert your thumb behind your ear lobe and gently press your ear upward to push the hearing aid out of your ear canal. Moving your jaw in a chewing motion will help to ease the hearing aid out of your ear canal. 2. Grasp the hearing aid and remove it from your ear canal WARNING: To prevent instrument damage, NEVER attempt to remove your instrument by pulling on the program button! Doing so will void your warranty. 10

Maintenance Program Button Your hearing aid has a Program button on the outside housing that allows you to toggle between the different volume levels. Each time you remove your hearing aid from the charging slot, it will start at volume 1. When you press the program button, you will hear a number of beeps, which indicates the volume level; one beep = volume level 1, two beeps = volume level 2, three beeps = volume level 3, four beeps = volume level 4. Troubleshooting SYMPTOM No sound or low sound POSSIBLE CAUSE Low battery Recharge the instrument Volume too low Choose another program Sound outlet blocked or damaged Clear up dome or contact hearing healthcare professional Wait a few seconds for the device to turn on Built-in delay power ON feature Hearing aid not fitted well in the ear Program Button Whistling, feedback 11 SOLUTIONS Remove and reinsert the hearing aid Excessive ear wax built-up If in dome/hearing aid, remove/clear wax build up If in ear, contact your hearing care professional Excessive earwax in your ear Contact your hearing care professional Volume too loud/high Choose another program The instrument was not fitted well in the ear Re-adjust or re-insert the instrument 12

Cleaning care and precautions SYMPTOM Sound: distorted, unclear, intermittent, too much bass, static Too much **Bass Static **Noise 13 POSSIBLE CAUSE SOLUTIONS Low or dead battery Recharge the hearing aid Sound outlet blocked or damaged Clean sound outlet or contact hearing healthcare professional May need reprogramming Contact hearing healthcare professional Too close to other electromagnetic devices/fields (such as other cell phones, speakers, etc.) Move away from other devices/fields Keep your hearing aid clean and dry. Use a soft cloth to remove any body oil or moisture from the hearing aid housing. Use the provided cleaning tools to clean wax built-up. Routinely allow your hearing aid to complete the drying cycle to prolong the life of your hearing aid. DO NOT use water, harsh chemicals, strong cleaners or other fluids to clean the hearing aid. DO NOT leave your hearing aid in the direct sun or in areas where the temperature can rise over 60 C / 140 F for extended periods of time. ALWAYS handle the hearing aid with care; it s important to prevent your hearing aid from dropping on hard surfaces such as counter tops, tables or floors. 14

Whistling / Feedback noise helpful tips Frequently Asked Questions Whistling is common in hearing aids and is also known as 'feedback'. This phenomenon is caused by amplified sound leaving the ear, being received back into the microphone and being re-amplified. The following tips will help reduce the effect of whistling/feedback noise: 1. How do I charge my hearing aid? Connect the tiny end of the micro-usb cable to the charging case. Insert the larger USB end into the AC adapter and plug it into a wall outlet (120/220 volt compatible). As an alternative, plug the USB end into a USB port on a computer. Never use a portable battery charger. 1. Lower the volume. Keep volume at lowest setting while inserting the hearing aid into your ear. 2. How long will it take for my hearing aid to charge? It takes approximately 3 hours to fully charge your hearing aid. 2. Secure the positioning of the dome within the ear. Feedback/whistling noise will stop when the hearing aid is securely fitted/ sealed in the ear with the best fitting dome size. 3. How long will my fully charged hearing aid work until next charge? In most environments, your fully charged hearing aid will work up to 25 hours. If the surroundings are loud, the hearing aid may require more power to filter out unwanted sounds, resulting in a slightly shorter usage duration. 3. Clear the ear canal of wax or debris. Seek guidance from your physician for excessive wax built-up. 4. Replace the dome. Change to a new dome with a better fitting size. 15 4. How do I know when my hearing aid is fully charged? LED light indicator turns SOLID GREEN when fully charged. LED light indicator is BLINKING GREEN when charging. 16

Appendix 5. How do I best preserve my hearing aid and battery performance? To best preserve your hearing aid and battery, we recommend that you always let it charge and complete the drying process overnight and leave it in the charging base when not in use. Because a sensor stops the charging process once the battery is full, there is no risk of battery degradation if the hearing aid is kept in the charging base. 6. Can I replace the built-in battery? No, this is a custom battery that can only be replaced by the manufacturer. For battery replacement service, contact Hearing Assist. Working condition Temperature: 20 /60 Celsius -4 F/140 F Air humidity: 85% Air pressure: 500~ 1100 KPa Technical data Technical Data Recharge! ITE Peak OSPL 90(dB SPL)...107 HFA OSPL 90(dB SPL)...102 Peak Gain(dB)...30 HFA full on Gain(dB)...23 Total Harmonic Distort: 500Hz(%)... 2.0 800Hz(%)... 1.0 1600Hz(%)... 1.0 EQ Input Noise(dB)... 30 Frequency Range(Hz)...400-6000 ANSI S3.22-2003 17 IEC 60118-7/2005 18

FDA information 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 a Hearing Healthcare Professional 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 healthcare provider to select and fit a hearing aid to your individual needs. 19 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 Healthcare Professionals 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. Notice to hearing healthcare providers A 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 of any other available information concerning the prospective user, that the prospective user has any of the following conditions, then consult a physician. 20

* Visible congenital or traumatic deformity of the ear. * Unilateral hearing loss of sudden or recent onset within the previous 90 days. * History of active drainage from the ear within the previous 90 days. * Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1000Hz, and 2000 Hz. * History of sudden or rapidly progressive hearing loss within the previous 90 days. * Visible evidence of significant cerumen accumulation or a foreign body in the ear canal. * Acute or chronic dizziness. * Pain or discomfort in the ear. Stop Using Hearing aids and Consult a Physician if: * Hearing in one or both ears worsened. * Your ear becomes occluded with excessive ear wax. * Hearing does not improve while using the provided hearing aid * You develop an infection of your ear or ear canal. * Skin irritation develops in or around your ear canal. 21 Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 decibels because there may be risk of impairing the remaining hearing of the hearing aid user. A hearing aid 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 hearing aid(s) is only part of hearing rehabilitation and may need to be supplemented by auditory training and instruction in lip reading. Children with hearing loss In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation. Hearing loss may cause problems in language development, educational growth, and social growth of a child. Training and experience qualify an audiologist to assist in the evaluation and rehabilitation of a child with a hearing loss. This hearing aid is not suitable for use by anyone under the age of 18. 22

Service and warranty Hearing Assist provides a one year warranty against defects from manufacture. We also offer product protection plans that cover all forms of damage except for loss. Please contact us at 800-640-9785 or cs@hearingassist.com to learn about our protection plan options or for any other service, warranty, or product inquiries. NOT FOR USE BY ANYONE UNDER AGE 18. KEEP HEARING AID OUT OF REACH OF INFANTS, CHILDREN AND PETS AS IT MAY CAUSE A CHOKING OR INGESTION HAZARD Hearing Assist II, LLC PO Box 2259 Virginia Beach, VA, 23450 FDA Registration #: 3007386887 FDA Owner/Operator #: 10028285 This is a Class 1 Hearing Aid device under FDA Regulations per 21 C.F.R. Sec 874.3300 23 Made in China