HAA-4-0141 DigiEars Pro Digital True Wireless Hearing Aid

Product Information

This product is an over-the-counter (OTC) hearing aid designed
for users who are 18 years of age or older. It is important to note
that individuals younger than 18 with hearing loss should seek
specialized care from a doctor, preferably an ear-nose-throat
doctor (ENT), as they may require medical testing and
management.

The hearing aid should not cause any pain upon or during
insertion. If you experience any discomfort or pain, it is
recommended to remove the device and follow the instructions
carefully if you decide to try inserting it again. If the pain
persists, please contact the manufacturer or your hearing
healthcare professional.

It is important to note that this product is not intended to be
used as hearing protection. If you are exposed to overly loud
sounds, whether short or long-lasting, it is advised to remove the
device and use appropriate hearing protection. If the sound output
of the device becomes uncomfortably loud or painful, you should
turn down the volume or remove the device.

In case any part of the hearing aid, such as the ear tip, gets
stuck in your ear and cannot be easily removed with your fingers,
it is recommended to seek medical help as soon as possible. Do not
attempt to use tweezers or cotton swabs as they may cause further
injury to your eardrum or ear canal.

If you have concerns about your hearing even after using this
device, it is recommended to consult with a hearing healthcare
professional for further assistance.

Product Usage Instructions

1. If you are younger than 18 years old, do not use this product.
   Seek specialized care from a doctor, preferably an ENT.

2. Ensure that the device does not cause any pain or discomfort
   during insertion. If it does, remove the device and follow the
   instructions carefully if you decide to try inserting it
   again.

3. If you experience overly loud sounds, whether short or
   long-lasting, remove the device and use appropriate hearing
   protection.

4. If the sound output of the device becomes uncomfortably loud or
   painful, turn down the volume or remove the device.

5. If any part of the hearing aid gets stuck in your ear and
   cannot be easily removed with your fingers, seek medical help as
   soon as possible. Do not use tweezers or cotton swabs.

6. If you have ongoing concerns about your hearing, consult with a
   hearing healthcare professional.

WARNINGS
& 1. WARNING: If You Are Younger Than 18, Do Not Use This Product.
You should go to a doct or, 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 age 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 profes sional fitting and continuing care are also important.
2. 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 have seen 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 lodged 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 and/or varies, i.e., it gets worse then gets
better again
·You have worse hearing in one ear
·You hear ringing or buzzing in only one ear

3. WARNING: This Hearing Aid Should Not Cause Pain Upon/During

Insertion.

Remove this device from your ear if it causes any pain or discomfort

when you insert or place it in the ear. If you decide to try inserting the

device again, make sure to follow the instructions. If you feel pain or

discomfort again, contact the manufacturer. If your pain and/or

discomfort doesn’t go away, please contact your hearing healthcare

professional.

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You can also report this to the FDA as an adverse event. To do this, please follow the instructions that will appear later in this manual.

4. WARNING: Do Not Use This Product If Any of the Following Apply
To You
· Congenital atresia of external ear or deformity of any part of the ear canal
· Deafness is unstab le, and the degree of hearing loss often fluctuates
· Persistent headaches, dizziness, earaches, tinnitus or other symptoms that are not suitable for adaptation
· Sudden onset of hearing loss within the past 3 months; rapid progressive deafness; unilateral hearing loss or other acute ear disease
· Effusion (secretions/discharge) in the ear and/or frequent purulence (pus).
· Central deafness (central nervous system) or non-organic deafness.
· Patients with acute otitis externa and tympanitis. · Patients with acute and chronic suppurative otitis media
(in the period of purulent infection). · Patients who are allergic to the materials of this product.

5. WARNING: Important Safety Instruction

· Keep small parts (hearing instrument(s), ear tips, battery or other

detachable parts) that can be swallowed out of reach of children.

· Dropping, immersing in liquid, exposure to strong electromagnetic

fields and/or excessive heat will damage the hearing aid. Remove

devices prior to any type of X-ray, MRI, or CT scan.

· If parts become stuck in the ear canal, seek medical assistance. Do

not attempt to remove the device by yourself.

· Do not use at high volume for extended periods of time. Ear injury

can result.

· If you experience any pain or strong discomfort using the devices,

remove them immediately and consult a doctor.

· Routine maintenance to keep the device clean is required. Ensure

that the ear tips are free of debris and moisture at all times.

· Do not store or use the product in environments of high humidity or

temperature (such as a sauna or steam room), to avoid damage.

·

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· Keep the devices away from children. Injury or damage may result. · Do not share your hearing aids with others. Using a hearing aid
configured for someone else can result in hearing damage or injury. · Monitor for any unusual skin reaction. If you notice any allergic
reaction (itchiness, swelling, or rash), stop wearing the hearing aids and consult a medical specialist. · Stay away from strong electromagnetic fields when using the hearing aids to avoid unexpected damage. Your hearing aids are delicate electronic instruments and may be damaged by contact with strong magnetic equipment such as electromagnetic ovens, microwave ovens, ultrasonic cleaners, etc. · If the Bluetooth function is available for your device, do not con nect the hearing aid and a wireless headset to the mobile phone via Bluetooth simultaneously. Noise distortion or any other unexpected defect may occur to your hearing aid and result in the forfeiture of the warranty on your device. · If needed, please contact the manufacturer for assistance in setting up, using or maintaining your devices. Or to report any unexpected operation or events. · Contact your hearing professional for assistance if needed. · Do NOT fix your devices by yourself. Doing so will not only void the warranty but also cause further damage – Check the “TROUBLESHOOTING GUIDE” first when failures occur to your devices.
CAUTIONS AND NOTICES
1. 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.
2. 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.
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3. Caution: 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.
4. No te: If You Remain Co ncerned, 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.
5. 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.
6. Note: Tell The FDA About Injuries, Malfunctions, or Other Adverse Events. To report a problem involving your hearing aid, you should submit infor mation 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 worsen ing hearing loss from using the device, etc. Instructions for reporting are a v a i l a b l e at h t t p s :/w w w.f da.g o v/S a f e t y MedWa t c h , or c a l l 1-800-FDA-1088. You can also download a form to mail to FDA.
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7.Note:lf You Experience Side Effects, Contact A Hearing Care Professional. Possible side effects from wearing the hearing aid may be: – Dizziness – Tinnitus – Perceived worsening of hearing loss – Nausea – Headache – Skin reaction – Excessive ear wax accumulation
8.Note:Tips For Better Communication It will take practice, time, and patience for your brain to adapt to the new sounds that your hearing aids provide. Hearing is only part of how we share thoughts, ideas and feelings. Reading lips, facial expressions, and gestures can help the learning process and add to what amplification alone may miss.
(1) Please review the following simple communication tips: (2) Move closer to and look at the speaker. (3) Sit face-to-face in a quiet room if possible. (4) Try out different locations to find the optimal places to listen. (5) Minimize distractions. (6) Background noises may be frustrating at first; remember, you have
not heard them for a while. (7) Let others know what you need; keep in mind that people cannot
“see” your hearing loss. (8) Develop realistic expectations of what your hearing aids can and
cannot do. (9) Better hearing with hearing aids are a learned skill combining desire,
practice, and patience. (2) You will learn and adjust, it just takes a little time. Remem-
ber to be patient with yourself. (3) For Your Family and Friends: Your family and friends are also affected by your hearing loss. Request that they do the following:
· Get your full attention before beginning to speak.
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· Look at you or sit face-to-face. · Speak clearly and at a normal rate and level; shouting can actually
make understanding more difficult. · Rephrase rather than repeat the same words; different words may be
easier to understand. · Minimize distractions while speaking.
9.Additional Cautions: · The use of accessories and cables other than those specified by the manufac turer (except for cables sold by manufacturer as replacement parts for internal components) may result in increased emission or decreased immunity of the device. · Do not use a mobile phone or other devices that emit electro magnetic fields, near the unit. This may result in incorrect operation of the unit. · Do not bring the device into any MRI, CT, diathermy, RFID and/or electromagnetic security systems such as metal detectors environ ment or near any of this equipment. Consult manufacturer if you have any questions. · This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is nec essary, this device should be observed to verify normal operation in the configuration in which it will be used. · Refer to further guidance below regarding the EMC environment in which the device should be used.
There is no guarantee that interference will not occur in a particular installation. Radiated or conducted electromagnetic signals can cause:

1. As to devices: · Deviation of the values of pulse duration, amplitudes, and repetition
   frequenc ies, may impair the unit’s essential performance. The device has passed EMC highest interference level test, and the parameters do not deviate the essential performance requirement. · Abnormality in the display. 2) As to patients: · The sensitivity of stimulation may be weaker or stronger, but it does not produce safety issues. · It cannot achieve expected effect. If this equipment is found to cause or respond to interfer-
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ence, attempt to correct the problem by one or more of the follow ing measures: · If feeling too weak or too strong of a stimulation, adjust the strength level to an acceptable level. · If the device display is abnormal, power off and restart the device and check whether it shows properly. · Reorient or relocate the affected device. · Increase the separation between the unit and the affected device. · Power the equipment from a source other than that of the affected device. · Consult the service representative for further suggestions.
Getting Started Remove the product from the box. Please retain all packaging until you have thoroughly checked and counted all the parts and the contents against the parts list.
Package Contents Digital Hearing Aid Ear tips x 3 pairs (2pcs each for small, medium & large) Charging Case USB Cable Cleaning Tool Carrying Pouch Instruction Manual
Features Discreet True Wireless Earbud Design Seamless In Ear Detection Technology Active Noise Reduction Minimal Noise Interference Bluetooth Connectivity for Streaming Music Built-in Mic for Hands-Free Calling Simple +/- Volume Adjustment 4 Programmed presets: Standard, Restaurant, Outdoor and Music Charging time (Case): s 2hr Working time: .!:12hr x 5 times = 60 Full Charge Case Carries 4 Full Recharges for Up To 60 Hrs of Usage
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3. Instruction for insertion depth For adults, the average length of the ear canal has been estimated to be 23-28mm and the maximum insertion size of the hearing aid is 9.2mm. So the distance from the ear tip to the tympanic membrane after wearing the hearing aid is at least 13.8mm, which is greater than the lower limit of 10mm specified by OTC. Therefore, the device is safe and complies with OTC regulations.

2(a3du-lt2) 8mm

Insertion depth=9.2mm (MAX)

4. Wearing & removing hearing aid
Your hearing aids are equipped with an in-ear detection sensor. a: The hearing aids will enter standby mode automatically when removed from the ears. b: The hearing aids will turn back on automatically when placed back in your ears.

Wearing:

Step 1: Hold the hearing aid body

(hard part) firmly, then gently place the

ear tip in the ear.

Step 2: Move the body slightly into ear lobe for stability.
[i] Removing: Grasp the protruding part of
the hearing aid and remove ii from your
ear lobe gently.

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Note: · The squeaking sound can be used as a reference to determine whether the hearing aid is securely placed back in the case or not. · If the hearing aid makes a squeaking sound, please make sure the case is free of any debris that could be blocking the hearing aids. If inserted correctly, but the squeaking remains, please replace with the other size of ear tip. When the hearing aid is not in use, please turn it off without delay. · When the hearing aid is not functioning properly, please check the “TROUBLESHOOTING ” guide. If none of the solutions work, please contact the Nuvomed Inc. Expert Care Team.
5. Turning on/off the hearing aids
Turning on the hearing aid: The hearing aid will turn on automatically in about three (3) seconds when it is worn correctly. You will hear prompt tone according to the hearing program (refer to”HEARING PROGRAM CHANGE”)
Turning off the hearing aids: The hearing aid will enter the standby status automatically when it is removed from the ear. When placed back into the correct slot of the charging case, the hearing aids will turn off and start charging automatically.

Turn On
6. Volume adjustment

Standby

Tum Off

· The hearing aid has three (3) volume levels. · You could increase the volume by pressing the”+” button. · You could decrease the volume by pressing the”-“button.
· The hearing aid will give out the prompt tone”Beep” when you increase or decrease the volume.
· The hearing aid will give out the prompt tone”Beep-Beep-Beep” at maximum or minimum volume.

L-tt?1/——1 “+” button button

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7. Hearing program change
· There are four (4) preset programs in the hearing aid. · You can change the hearing program by pressing and holding the “+” or
“-” button for about three (3) seconds. · The hearing aid is designed with a memory function: The hearing aid
can recognize the previous hearing program automatically. · You’re hearing aid beeps to indicate which hearing program you are in.

Hearing program

1

Standard

2

Restaurant

3

Outdoor

4

Music

Prompt tone One (1) Beep Two (2) Beeps Three (3) Beeps Four (4) Beeps

Program Standard program

Application situation
For quiet environments, such as: home and office.

Restaurant program

For very quiet environments, such as: meeting, restaurant.

Outdoor program

For outdoor environments, such as road or supermarket.

Music program

For very noisy environments, such as: bar or crowded places.

8. Charging the hearing aid
· The hearing aid will turn off and start charging automatically when placed back into the charging case correctly.
· The blue indicator light indicates that the hearing aid is properly charging, and the white indicator light indicates that the hearing aid is fully charged.
· The indicator lights of the hearing aid will go out in about five (5) minutes after the hearing aids are fully charged.
· Low battery warning: You will hear five (5) Beeps every 10 minutes when the remaining battery capacity is at a critical level.

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Specification
Test Standard: ANSI 3.22-2014 Test Equipment: FONIX 8000 Test Coupler: HA-1 The standard test ambient conditions shall be: Temperature: 23 ·c ±5 t: (73°±9°F) Relative humidity: 0% to 80% Atmospheric pressure: 760(+37.5,-150)mm of Hg or 101.3(+5,-20)kPa

1). OTC Hearing aids technical specifications

Test Items
Max. Output (OSPLso) The full-on gain value (HFA FOG@50)
The total harmonic distortion value {THO) The self-generated noise value {EIN) The Latency value
Frequency response bandwidth

Program 1
109dB
25dB
0.4%
19dB
14ms F1=210Hz F2=5400Hz

Program 2
106dB
25dB

Program 3
110dB
28dB

0.3%

0.5%

14dB
14ms
F1=220Hz F2=5600Hz

12dB
14ms
F1=230Hz F2=5000Hz

Program 4
104dB
23dB
0.4%
16dB
14ms F1=200Hz F2=5700Hz

Frequency response smoothness

5dB

4dB

5dB

3dB

2). Battery life & Discharge time of the charging case
Test Items
Battery life of hearing aids A pair hearing aids charging time with fully charging case

Value 12h 4 times

· The data is derived from values measured in a laboratory. The values may vary during real life applications of the product.

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