CEARVOL OTC Intelligent Hearing Aids Nano

Instruction Manual

Introduction

This manual provides comprehensive instructions for the CEARVOL OTC Intelligent Hearing Aids Nano. Please read it thoroughly before use.

Product Name: OTC Intelligent Hearing Aids

Model: Nano

Manufacturer: UNICE Intelligent Medicine Shenzhen Ltd.

Website: www.cearvol.com

What You'll Find In The Box

Get To Know Your Device

Your Hearing Aids

Each hearing aid has the following parts:

Your Charging Case

The charging case includes:

Setup and How to Use

Charge Your Device

Remove the hearing aids from the charging case, peel off the insulation film, then place them back into the charging slots and close the lid. Connect the charging case to a suitable power adapter (not included) using the provided USB cable.

While charging, the three lights on the front of the charging case pulse blue. When fully charged, the blue light changes to a steady glow.

How To Install Ear Tips

  1. Choose an ear tip size that fits you from the provided options (L, M, S).
  2. Hold the ear tip by its edge with both hands, flip it outward, then pinch the edge with your index finger and thumb.
  3. Hold the hearing aid with one hand and the ear tip with the other, then firmly attach the ear tip to the hearing aid.

! Notice: After installation, gently tug on the ear tip to ensure it is securely attached and not easily detachable.

How to Wear and Remove the Hearing Aids

Correctly identify the left and right hearing aids to wear them on the appropriate ears. The "L" and "R" marks on the hearing aids indicate left and right.

Wearing

Removing

! Notice:

Safety Risk: In rare cases, when removing the hearing aid, the ear tip may accidentally remain in the ear canal. Seek medical assistance immediately; do not attempt to remove it yourself or with non-professionals to avoid ear damage.

Power ON/OFF

Power ON:

Power OFF:

Volume Adjustment

The hearing aid has 4 volume levels.

The device has 4 volume levels:

Mode Switching

The hearing aid has 3 modes: Indoor, Restaurant, Outdoor.

! Notice: The hearing aid has a memory function and will automatically recall the last-used volume and mode settings when turned back on.

Table 1: Hearing aid mode prompt sound
ModePrompt sound
Indoor? Indoor mode
Restaurant? Restaurant mode
Outdoor? Outdoor mode

Preset Program Switching

  1. The hearing aid has 3 preset programs.
  2. Switching preset programs: When the hearing aid is on, press the ". " button on the right side of the charging case to cycle through the hearing compensation programs. Each change is accompanied by an audible indicator.
Table 2: Hearing aid program prompt sound
ProgramAudible Indicator
Mild? "Program 1"
Mild-to-Moderate? "Program 2"
Moderate-to-Severe? "Program 3"

The hearing aid has a memory function and will recall the last-used volume and mode settings.

How To Charge Your Hearing Aids

How To Charge The Charging Case

  1. Insert the USB Type-C charging cable into the charging port of the case.
  2. Plug the other end of the cable into a power adapter.
  3. The charging status indicator lights are shown in Table 3-2.

! Notice:

Table 3-1: Hearing Aid Indicator Light Status
Working ConditionsPower LevelIndicator Light Status
Hearing aid in the charging case (charging case not connected to power)1-30%Blue light flashes quickly and continuously
31-95%Blue light breathes and flashes continuously
96-100%Blue light stays on for 5 minutes, then turns off
Hearing aid in the charging case (charging case connected to power)1-30%Blue light flashes quickly and continuously
31-95%Blue light breathes and flashes continuously
100%Blue light stays on, turns off immediately when the charging case is disconnected from power
Table 3-2: Charging Case Indicator Light Status
Working ConditionsPower LevelIndicator Light Status
Charging case not connected to power<30%Blue light flashes quickly and continuously
> 30%Blue light turns off
Charging case connected to power1-30%Blue light flashes quickly and continuously
31-95%Blue light breathes and flashes continuously
96-100%Blue light stays on
100%Blue light stays on, turns off immediately when the charging case is disconnected from power

UV Sterilization

! Notice: The UV sterilization function will be activated only when the charging case is connected to power and the lid is closed. Do not open the charging case lid while the UV sterilization light is working, to avoid UV light leakage, which could harm the human body. When the UV sterilization light is working, the indicator lights will show the following status: The three indicator lights on the charging case will light up sequentially from left to right, repeating in a cycle, until the UV sterilization process is complete. Once the sterilization is finished, the indicator lights will return to showing the charging status of the hearing aids.

Warnings and Cautions

Warnings

Cautions

Technical Information

Output

Test item2cc coupler
OSPL 90 (Peak)<117dB SPL
Full-on gain (Peak)30±5dB

Frequency range and noise

Test itemValue
Frequency range250-5500 Hz
Equivalent input noise≤32 dBA
Total harmonic distortion 500 Hz, 70 dB SPL10%
Latency10ms

Battery

Test itemValue
Battery runtimeUp to 54 hours
Battery capacity in the charger180 mAh (666mWh)

All measurements performed according to ANSI 3.22-2014.

Operating and Storage Conditions

Operating conditions

Temperature Range32°F – 104°F (0°C – 40°C)
Humidity Range0 – 95% RH
Pressure Range70 – 110 kPa

Storage/transport conditions

Temperature Range-13°F – 158°F (-25°C – 70°C)

Recommended temperature range for best bat

Performance-4°F – 113°F (-20°C – 45°C)
Humidity Range0 – 90% RH
Pressure Range70 – 110 kPa

Electromagnetic Compatibility

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.

FCC Warning: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

Product IDs:

This product is RoHS compliant.

Electromagnetic Compatibility and Risk Warning:

Through the electromagnetic compatibility test, Medical Hearing-Aid Buds comply with the following standards:

Please strictly follow the guidelines below. Failure to do so may result in electromagnetic interference with other devices, reduced electromagnetic immunity, or loss of essential device functions. Portable and mobile RF communications equipment may affect the normal operation of this medical device. Please maintain a safe distance between the communication equipment and this device. Specific distance requirements are provided in the table.

The length of USB cable should not be longer than 1.8 meters. If the cable is damaged, please contact our company for repair or replacement, otherwise may cause excessive electromagnetic interference. If there is damage, please contact our company in time. Don't repair or replace any components without permission, otherwise it may cause excessive amounts of electromagnetic interference.

Using accessories or cables that are not approved for this device or system may increase emissions or reduce immunity. Please use only the accessories and cables specified by Cannice.

This equipment should not be used in close proximity to or stacked with other devices. If such use is unavoidable, ensure that the device can operate properly in that configuration.

Table 4: Guide and Cannice's Statement - Electromagnetic Emission
Launch ExperimentComplianceElectromagnetic Environment - Guide
Radio Frequency Emission CISPR 11Group 1Medical Hearing-Aid Buds use RF energy only for its internal function. So its RF emission is very low, and the possibility of interference with electronic devices is very small.
Radio Frequency Emission CISPR 11Class BMedical Hearing-Aid Buds are suitable for use in all non - domestic and not directly connected to all facilities of the residential public low-voltage power supply network.
Harmonic Current Emission IEC 61000-3-2Not applicable
Voltage Fluctuations & Flicker IEC 61000-3-3Compliance
Table 4-1: Guide and Cannice's Statement - Electromagnetic Immunity
Immunity TestIEC Test Level GuideCoincidence LevelElectromagnetic Environment - Guide
Electrostatic Discharge IEC 61000-4-2±8kV, ±15kV air; ±2kV, ±4kV contact±2kV, ±4kV, ±8kV, ±15kV air; ±2kV, ±4kV contactThe ground shall be wood, concrete or ceramic tile. If the ground is covered with synthetic material, the relative humidity should be at least 30%.
Electrical Fast Transient and Burst IEC 61000-4-4±2kV 100kHz repetition frequencyNot applicableNot applicable
Table 4-2: Surges and Voltage Dips/Interruption
TestLevelGuideCoincidence Level
Surges IEC 61000-4-5Line to line: ±0.5kV, ±1kV; Line to ground: ±0.5kV, ±1kV, ±2kVNot applicableNot applicable
Voltage Dips and Interruption IEC 61000-4-110% UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315°
0% UT; 1 cycle and 70% UT; 25 cycles Single phase: at 0°
0% UT; 250 cycle
Not applicableNot applicable
Table 4-3: Power frequency magnetic field immunity
TestLevelCoincidence Level
Power frequency magnetic field immunity IEC 61000-4-830A/m 50Hz or 60Hz30A/m, 50Hz and 60HzIn the event of malfunction, it may be necessary to keep Medical Hearing-Aid Buds away from the power frequency magnetic field or install a magnetic shield in the field. And the power frequency magnetic field in the expected installation site shall be measured to meet the requirements below the Coincidence level.
Table 4-4: Proximity magnetic fields immunity
TestLevelCoincidence Level
Proximity magnetic fields immunity IEC 61000-4-3930kHz, CW, 8A/m
1342kHz, Pulse modulation 2.1kHz, 65A/m
1356MHz, Pulse modulation 50kHz, 7.5A/m
30kHz, CW, 8A/m
1342kHz, Pulse modulation 2.1kHz, 65A/m
1356MHz, Pulse modulation 50kHz, 7.5A/m
While communication might not be possible when the device that includes radio equipment is tested in its passband, the device shall still be able to provide its BASIC SAFETY and ESSENTIAL PERFORMANCE.
Table 5-2: Electromagnetic Immunity
Immunity TestIEC 60601 Test Level GuideCoincidence level
Conducted disturbances, induced by RF fields IEC 61000-4-63V, 0.15MHz~80MHz6V, in ISM and amateur radio bands between 0.15MHz and 80MHz 80% AM at 1kHzNot applicable
Radiated RF Electromagnetic fields immunity IEC 61000-4-310V/m 80MHz~2.7GHz 80% AM at 1kHz10V/m, 80MHz ~ 2.7GHz 80% AM at 1kHz RF Band 10V/m, 0.65-0.96GHz and 1.4-2.7GHz
Table 5-3: Electromagnetic Environment - Guide
Recommended isolation distance
Portable and mobile radio communication equipment should not be closer to any part of Medical Hearing-Aid Buds including cable than the recommended isolation distance. The distance should be calculated using the formula corresponding to the transmitter frequency.
d=1.2 √P 150kHz~80MHz
d=1.2 √P 80kHz ~ 800MHz
d=2.3√P 800MHz ~ 2.7GHz
In the formula: P--Maximum output rated power of transmitter supplied by transmitter Cannice, in watts (W) as the unit; d--Recommended isolation distance in Meter (m) as the unit.
The field strength of a fixed RF transmitter is determined by the investigation of the electromagnetic fields and each frequency range should be lower than the Coincidence level. Interference may occur near the device marking the following symbol. ?
Table 5-4: Notes
Note 1:Note 2:
In the MHz and MHz frequency, the higher frequency band should be used.These guides may not be appropriate for all situations. Electromagnetic propagation is affected by the absorption and reflection of buildings, objects, and the human body.
a Fixed transmitter field strength in theory cannot be accurately predicted, Such as: wireless (cellular phone / cordless) and ground mobile radio base station, amateur radio, FM radio and television broadcasting etc. In order to assess the electromagnetic environment of fixed RF transmitters, electromagnetic site survey should be taken into account. If the measured field strength of the Medical Hearing-Aid Buds is higher than the RF compliance level, the Medical Hearing-Aid Buds should be observed to verify its normal operation. If observed performance is abnormal, supplemental measures may be necessary, such as reorienting the direction or location of the Medical Hearing-Aid Buds.b The field strength should be less than V / m over the whole frequency range of KHz to MHz.
Table 6-1: Recommended separation distance
Recommended separation distance between portable and mobile radio-frequency communication equipment and Medical Hearing-Aid Buds.
Medical Hearing-Aid Buds intend to be used in a controlled electromagnetic environment for RF radiation disturbance. Based on the maximum output power of the communication device, the purchasers or users of Medical Hearing-Aid Buds can maintain the minimum distance between the portable and mobile RF communication devices (transmitters) and Medical Hearing-Aid Buds to prevent electromagnetic interference.
Table 6-2: Isolation distance corresponding to different frequency of transmitter /m
Transmitter maximum rated output powerIsolation distance corresponding to different frequency of transmitter /m
150 KHz ~ 80 MHz d=1.2√P800 MHz ~ 800 MHz d=1.2√P2.7 GHz d=2.3√P
0.010.120.120.23
0.10.380.380.73
11.21.22.3
103.83.87.3
100121223
Table 6-3: Transmitter ratings and formula
Note 1:Note 2:
For transmitters maximum ratings not listed above, the recommended separation distance in meters (m) as a unit, can be determined by the corresponding transmitter frequency bar formula, where P is the maximum rated output power of the transmitter provided by the transmitter Cannice, in Watt (W) as a unit.In the MHz and MHz frequency, the higher frequency band should be used. These guides may not be appropriate for all situations. Electromagnetic propagation is affected by the absorption and reflection of buildings, objects, and the human body.

For Products That Include Batteries

Instructions for Users on Removal, Recycling and Disposal of Used Batteries: Do not attempt to disassemble the product's battery on your own. We strongly recommend that you leave such tasks to qualified professionals to ensure safety and compliance with warranty terms. For products with a built-in battery that lasts for the lifetime of the product, removal may not be possible for the user. In such cases, authorized recovery centers should handle the dismantling of the product and the removal of the battery. If, for any reason, it becomes necessary to replace such a battery, the procedure should be performed by authorized service centers. In the European Union and other regions, it is prohibited to dispose of any battery with household trash. All batteries must be disposed of in environmentally sound manner. Contact your local waste-management officials for information environmentally sound collection, recycling and disposal of used batteries.

Warning: Danger of explosion if battery is incorrectly replaced. To reduce risk of fire explosion or leakage of flammable liquid/gas, don't disassemble, crush, puncture, short external contacts, expose to temperature above 60°C(140° F), sunshine or smoke, expose to extremely low air pressure or dispose of in fire or water. Replace only with specified batteries. The symbol indicating 'separate collection' for all batteries accumulators shall be the crossed-out wheeled bin shown below: ?️

WARNING-For Products Contain Coin/Button Cell Batteries: DO NOT INGEST BATTERY. CHEMICAL BURN HAZARD. This product contains a coin/button cell battery. If the coin/button cell battery is swallowed, it can cause severe internal burns in just 2 hours and can lead to death. Keep new and used batteries away from children. If the battery compartment does not close securely, stop using the product and keep it away from children. If you think batteries might have been swallowed or placed inside any part of the body, seek immediate medical attention.

Normalized Symbols

SymbolDescription
?Follow operating instructions
BB type applied part
♻️Disposal in accordance with Directive 2012/19/EU (WEEE)
?Date of manufacture
SNSerial number
MDManufacturer information
⚠️Warning/Danger: Improper use might cause serious injuries.
LOTIndicates the manufacturer's batch code so that the batch or lot can be identified
?️
?️
Permissible storage and transport temperature and humidity
?️
?️
Permissible operating temperature and humidity
?
✔️
Keep Dry
☑️Comply with Directive 2011/65/EU
?Paper Packaging Recycling
IPX5IP code of the device: this device's grade of against ingress of solid foreign objects – Not dust proof; the grade of waterproof is splash proof type, liquid from any direction into the shell without harm.

Maintenance and Cleaning

Daily Maintenance

Care and Maintenance

Clean

Keep your hearing aids clean. Heat, moisture and foreign substances can result in poor performance.

Product FAQ and Troubleshooting

Hearing Aid Troubleshooting Checklist

QuestionPossible reasonsSuggested solutions
Hearing aid has no soundBattery is dead.Place the hearing aids into the charging case to charge.
Sound outlet or microphone inlet is blocked.Clean the sound outlet or microphone inlet.
Not worn correctly, infrared light not sensed.Remove the hearing aid, reinsert it, adjust the angle, and clean the filter of the light-sensing part until sound is produced.
Ear cap/cerumen cap is blocked.Clean the ear cap/cerumen cap.
Sound is weak and unclearBattery power is insufficient.Place the hearing aids into the charging case to charge.
Volume is too low.Increase the volume.
Ear tips is loose.Adjust the ear tip and then rewear the hearing aid tightly.
Sound outlet or microphone inlet is blocked.Clean the sound outlet or microphone inlet.

Charger Troubleshooting Checklist

QuestionPossible reasonsSuggested solutions
Charging case does not light upAdapter is not powered.Check if the adapter is plugged in properly, check if the 110/220V AC socket has power, and if there is any poor contact.
USB cable is not plugged in properly.Check if both ends of the USB cable are loose, replug and ensure they are fully inserted.
Can't charge the hearing aidHearing aid is not placed into the charging slot according to the left and right ear positions.Follow the charging instructions to place the hearing aid back into the charging case's charging slot.
Charging case battery is depleted.Connect the USB cable to charge the charging case.
Charging contact points are dirty.Use a clean, dry cloth to clean the charging contact points.
Charging case charging indicator light does not turn on or flashesAfter the charging case indicates low battery, it was not charged in time.Avoid continuing to use the charging case after the low battery warning; charge it promptly. If the indicator light does not turn on or flashes, insert the USB cable and charge continuously for more than 2 hours to restore it to normal charging state. If it still cannot be restored, please contact after-sales service.
Charging case battery is depleted.Charge the charging case promptly to restore its battery to a working state.
After inserting the hearing aid into the charging case correctly, It does not automatically turn offCharging case battery is depleted.Charge the charging case promptly to restore its battery to a working state.
After charging, the hearing aid does not turn on, and when placed back into the charging case correctly, the charging Indicator light does not turn onCharging case battery is depleted.Charge the charging case promptly to restore its battery to a working state.

Support and Warranty

Support

Have questions? We're here to help. If your Cearvol devices experience any issues, please consult the Solutions Guide on the previous pages. We are also standing by and ready to help you. Simply give us a call at 1(959)-206-0088 to speak with our friendly Professional Support team. You can also access our Troubleshooting Hearing Helper from the Cearvol app or by visiting www.cearvol.com

Warranty Policy

We are committed to ensuring your satisfaction with your Cearvol devices. If you are not satisfied with your purchase, you may return the product within 30 days of receipt. Our devices come with a 3-year warranty period. For assistance or any inquiries, please contact our customer service team at 1(959)-206-0088. We are here to help.

Contact Us

Well, that's it! You've made it to the end. Bravo! Now, get out there and start hearing life to the fullest.

? 1(959)-206-0088

MON-FRI 9AM-6PM PST

? www.cearvol.com

✉️ Email: support@cearvol.com

Safety Instruction and Warranty Card

1. Introduce

1.1 What's is hearing loss?

A speech frequency puretone average (average of hearing thresholds at 0.5, 1, 2, and 4 kHz) of greater than 25 dB hearing level (HL) in both ears was defined as hearing loss per World Health Organization criteria, and this is the level at which hearing loss begins to impair communication in daily life. (Extracted from the literature of: World Health Organization Prevention of Blindness and Deafness (PBD) program. Prevention of Deafness and Hearing impaired Grades of Hearing Impairment)

1.2 What's the hearing aids?

OTC Intelligent Hearing Aids are used the air-conduction type to compensate of impaired hearing. It is a wearable sound, amplifying device. The fundamental operating principle of hearing aids is to receive, amplify, and transfer sound to the ear drum of a hearing impaired person.

2. Intended use

2.1 Medical purpose

The patient is an intended operator OTC Intelligent Hearing Aids Buds is an air-conduction hearing aid, and it is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

2.2 Intended patients and environment

The hearing aids are expected to be used in both indoor and outdoor environments. It is intended to amplify sound for individuals aged 18 or older with perceived mild to moderate hearing impairment. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

2.3 Side effects

3. Important safety instructions

Read all the information in the instruction manual and any other literature included in the box before use the device.

3.1 Contraindication

The device is unsuitable and should not be used in the following situations:

3.2 Warnings

3.3 Notice

Important Safety Instructions For All Products:

Manufacturer and Producer Information

Manufacturer

ShenZhen Cannice Technology Co., Ltd.

Address: 20/F, Tower A, Building 7, Baoneng Science and Technology Park, Qingxiang Road #1, Longhua New District, Shenzhen, China, 518129

Tel: +86-755-61880577

Website: http://www.cannice.hk

Producer

Guangxi Cannice Precision Technology Co., Ltd.

Block C, South of Longtuan West Road Zhongshan Town, Zhongshan County Hezhou Guangxi 542600 China

Models: 2ADTV-NANOC, 2ADTVNANOC, Z1359, Nano OTC Hearing Aids, Nano, OTC Hearing Aids, Hearing Aids, Aids
GetApplicationAttachment.html Acrobat Distiller 18.0 (Windows)

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