Pixie OTC Hearing Aids User Guide Warnings Warning: If you are younger than 18, do not use this. You should go to a doctor, 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 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 professional fitting and continuing care are also important. 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 saw blood, pus, or fluid coming out of your ear in the past 6 months You have a lot of ear wax, or you think something could be 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: it gets worse then gets better again You have worse hearing in one ear You hear ringing or buzzing in only one ear Warning: This hearing aid should not cause pain when inserting it. Remove this device from your ear if it causes pain or discomfort when you insert or place it. To try again, make sure to follow the instructions. If you feel pain or discomfort again, contact the manufacturer. If your pain or discomfort doesn't go away, contact your hearing healthcare professional. You can also report this to FDA as an adverse event according to the instructions that appear later. Warnings:
Keep and store hearing aids and components out of reach of children. Contains small parts which may be a choking hazard. Check before using the hearing aids in areas where electronics or wireless devices are restricted. This may cause interference. Do NOT dry hearing aid with a hairdryer. Heat may damage hearing aid. Do NOT use the hearing aids without the supplied ear tips attached. Do NOT use the hearing aids in explosive or oxygen-enriched atmospheres. Otherwise, a fire or explosion could occur. Do NOT resell the hearing aids or share them with others. They are intended for use by a single user. Using resold or shared hearing aids may lead to infection. Do NOT submerge in water, wear in the shower, or wear while participating in water sports, e.g., swimming, waterskiing, surfing, etc. Prolonged exposure to water may damage the hearing aids. Do NOT repair or replace the lithium-ion rechargeable battery yourself. Contact us if you believe a battery replacement is required. Do NOT insert hearing aids into the ear canal while sleeping. Do NOT use hearing aids during X-rays, MRIs, CT scans or other similar medical treatment to prevent damage to the hearing aid. Do NOT expose hearing aid to contaminants such as hair spray, mousse, gel, lotions, etc. to prevent damage to the hearing aid. Do NOT use an instrument, such as a cotton swab, to push the hearing aid in the ear canal. Hearing aids may be placed too deep and cause damage to the ear. Do NOT place charging case in clothing pocket while charging with the USB power cable. The charging case may overheat and malfunction. Cautions 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. 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. Caution: You might need medical help if a piece gets stuck in your ear. If any part of your hearing aid, like the eartip, 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. Notes Note: If you remain concerned, 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. 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 https://www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088. You can also download a form to mail to FDA. Cautions:
Do NOT use the hearing aids or their components if any part of them is damaged, if they emit any loud unusual noise, if you experience a warming sensation, or if you experience loss of audio. Do NOT make unauthorized alterations to this product. Only use attachments/components specified by the manufacturer. Avoid using ear tips, adapters, cables, and other accessories not specified or provided by the manufacturer as it could result in increased electromagnetic emissions or decreased electromagnetic immunity of the hearing aids as well as improper operation. Avoid use of hearing aid systems directly next to other electronic equipment, which could result in decreased performance. If such use is necessary, monitor the performance of your hearing aid system and the other equipment to ensure they are operating normally. If the battery leaks, do NOT allow the liquid to come in contact with the skin or eyes. If contact made, seek medical advice. Keep hearing aids away from fire and excessive heat (e.g., from storage in direct sunlight, near candles, or in a hot car) to avoid burns or damage to product. Be aware that some sounds may sound different when youre using the hearing aids. Keep this in mind when you need to be aware of your surroundings. You should adjust to this over time. Consult a hearing care professional, preferably an ear-nose-throat doctor (ENT) if you experience any unusual side effects like skin irritation, excessive accumulation of ear wax, dizziness, change in your hearing, or if you think there may be a foreign object in your ear canal. Content Daily Use Intended Use Indications for Use Your Hearing Aids Whats in the Box Overview Download the Zepp Clarity App Charging the Hearing Aids Hearing Aids Instructions Charge the Charging Case Charging Case Instructions Inserting the Hearing Aids Removing the Hearing Aids Find the Most Suitable Dome The Size of Dome Program Recommendation Adjusting Volume Mute Checking the Battery Level Switching the Hearing Program Clarity Boost Smart Phonecall Zepp Clarity App 01 01 02 02 04 05 06 06 07 08 09 10 12 13 14 15 15 16 17 17 18 20 21 Care and Maintenance Daily Care Remove the Dome Replace the Mic Caps Technical Information Troubleshooting Further Information Operating, Transport & Storage Conditions Safety Information Waste Disposal Compliance Information Wireless Technical Description Symbols and Descriptions Repair Exclusions from Warranty Repair Coverage Loss and Damage Warranty and Service 22 22 22 22 23 23 25 25 27 27 29 29 31 31 31 31 31 31 33 33 33 33 36 36 37 37 39 39 39 39 40 40 42 42 Intended Use The Zepp Clarity Pixie hearing aids are a pair of OTC wireless air conduction hearing aids intended for use by individuals 18 years and older with perceived mild to moderate hearing impairment. Indications for Use The Zepp Clarity Pixie hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. No programming or user-fitted is necessary. The device is intended for over-the-counter sale and use without the assistance of a hearing care professional. 01 Your Hearing Aids Whats in the Box 2 Zepp Clarity Pixie Hearing Aids*
Charging Case 2 Size S Open Domes 2 Size S Closed Domes 2 Size M Open Domes 2 Size M Closed Domes 2 Replaceable Mic Cap
*Size M Open Domes are pre-attached to the devices. 02 USB Power Adapter USB-C Power Cable Cleaning Cloth Cleaning Brush Pixie OTC Hearing Aids User Guide Pixie Quick Start Guide Scan the QR code to get to know your Zepp Clarity Pixie. User Guide Quick Start Guide 03 Overview Charging Contacts Replaceable Mic Cap Removal Cord Removal Cord Grip Replaceable Dome Lid Charging Slots Hearing Aids Indicator Lights Charger Case Indicator Light USB Power Port 04 Download the Zepp Clarity App With the Zepp Clarity App, you can customize your hearing aids to suit your preferences. You can adjust the volume, change the hearing programs, locate your hearing aids, update the firmware, and more. To get the app, go to the Apple App Store or Google Play Store on your smartphone and search for Zepp Clarity. Or, you can scan the QR code below with your smartphones camera and download it directly. 05 Daily Use Charging the Hearing Aids Place the right hearing aid in the charging slot marked with an "R", and the left one in the slot with an "L". Make sure the domes are pointing outwards, and the removal cord is pointing upwards. Gently press down on the hearing aids with your thumb or index finger to make sure they are properly placed in the charging slots. 06 Hearing Aids Instructions White light: Hearing aids are correctly placed and have sufficient battery. Orange light: Hearing aid have insufficient battery and are charging. Indicator light off: Hearing aids are not properly placed or charging case is out of power. Please place the hearing aid again or charge the charging case.
*Indicator lights time out after about 15 seconds. 07 Charge the Charging Case Charge the charging case by connecting to a power socket or using a Qi-certified wireless charging pad*. It takes about 2.5 hours to fully charge the charging case by using power socket.
*Wireless charging pad is not included and needs to be purchased separately. 08 Charging Case Instructions White light: The charging case battery is sufficient. Orange light: The charging case battery is low or charging. Indicator light off*: Charging case is out of power. Please charge the charging case.
*The charging case indicator light will only illuminate when you open the lid or connect the power adapter. 09 Inserting the Hearing Aids Remove the hearing aids from the charging case and check the markings on them. "L" is for the left ear and "R" is for the right ear. Gently insert the hearing aid into your ear. 10 Slowly push the hearing aid into place. The black Mic Cap should rest at your ear canal opening. If the device feels loose in your ear, see page 14 to learn how to choose the right dome size. For most ears, the Removal Cord Grip should be in this position. If the Removal Gord Grip rests more deeply in your ear, grasp it and pull the device out a bit. 11 Removing the Hearing Aids Pinch the Removal Cord Grip with your thumb and index finger and gently pull outwards to remove the hearing aids from the ear canal. Wipe the device gently with the cleaning cloth. Placing them into the charging case. 12 Find the Most Suitable Dome Zepp Clarity Pixie ship with open and closed domes, each in S and M sizes. If the domes dont feel comfortable or secure, choose another dome size. Open Dome The Open Dome have two layers of blades, each with three openings. This design make your voice sound more natural. Closed Dome Closed Dome consists of two layers of blades, each with two openings. This design provide more bass, and can also be effective at eliminating feedback noise. 13 The Size of Dome Once you have chosen the type of domes, the next step is to choose the right size. Ideal domes should be slightly larger than the ear canals but exert no extra pressure. If your domes are too small, they cannot stay fixed in the ear canals and cannot provide the standard sound quality and volume. If your domes are too large, they may get stuck in your ear canals and may cause pain inside your ears. Some people have left and right ear canals that are not the same size, and if this is the case for you, you may need to use a M-sized dome for one ear and a S-sized dome for the other. Don't worry, this is very common. Besides, we recommend that you wear the domes for at least one hour to decide which dome suits you best. During this time, you can try having conversations, eating, drinking, exercising, etc. This may help you select the dome that provides maximum comfort throughout the day. 14 Zepp Clarity App Program Recommendation If you are using Zepp Clarity Pixie hearing aids for the first time, we highly recommend that you use the program recommendation feature. This feature can recommend one of three standardized output profiles for you based on your hearing impairment situation, and automatically set the volume, which will significantly improve your hearing experience. Please run this feature in a relatively quiet room. The whole process may take 3-5 minutes. 15 Adjusting Volume You can adjust the volume of your hearing aids with the Zepp Clarity App:
You can swipe the volume bar upwards or downwards to adjust the volume of your hearing aids. Tap the button in the middle, you can adjust the volume of the Left and Right ear separately. 16 Mute The mute feature enables you to hear sounds like you're not wearing hearing aids. Perform the following operations on the home screen of the Zepp Clarity App:
Tap the mute button under the volume bar. If you want to unmute, tap the mute button again. Checking the Battery Level At the top of the home screen of the Zepp Clarity App, you can check the battery level of the hearing aids and the charging case. indicates the available battery percentage. indicates charging. 17 Switching the Hearing Program The hearing aids support 8 preset hearing programs for you to choose freely in different scenarios. 18 By tapping the edit button below the preset hearing program, you can customize the preset hearing program according to your own needs:
Adjust pitches (Bass, Middle, Treble);
Adjust noise cancellation depth. 19 Clarity Boost This feature can help you make conversations more easily. You can be enabled on the "More" page at the bottom of the home screen of the Zepp Clarity App. Quickly double tap your ear to turn this feature on or off. Please note that the requires you to operate separately on each ear separately. 20 Smart Phonecall This feature can be enabled on the "More" page at the bottom of the home screen of the Zepp Clarity App. After this feature is enabled, your hearing aids will play a tone as a reminder when there is an incoming call. Meanwhile, the hearing aids automatically switch to Phone mode during a call, which effectively avoids the feedback of the hearing aids when you're on a phonecall, and makes it easier for you to listen to the call. 21 Care and Maintenance With daily use, please clean your hearing aids each day to avoid dirt buildup wich could cause degradation, damage, oran ear canal allergic reaction. Daily Care Brush the Dome to remove wax and debris. Brush around the Mic Cap to remove wax and debris. 22 Wipe the main body with the Cleaning Cloth. Replace the Dome Pinch the body of the hearing aids firmly with your thumb and index finger, then use your other hand to grab the dome and remove it. Brush the sound outlet to remove wax and debris. 23 Select a new Dome. Align the sound outlet with the center of the new Dome. Press into place until you feel a click. Click 24 Replace the Mic Caps Insert the crowbar at the end of the Cleaning Brush into the orange/grey marked groove at the end of the hearing aids. Gently pry the Mic Cap off the hearing aids. Gently pinch the Mic Cap with the other hand and pull it through the removal cord and remove it. Use a Cleaning Brush to gently brush off the ear wax and skin debris on the Mic Cap, and then use a wipe to clean the oil and sweat around the microphone opening. 25 Take a new Mic Cap. Pass the circular hole on the Mic Cap through the Removal Cord Grip. Attach the Mic Cap to the hearing aids, you will hear the sound of clicks. Click 26 Technical Information Measurements per ANSI/CTA2051:2017 Maximum output (OSPL90) Maximum output (OSPL90) curve High-frequency average (HFA) OSPL90 Average full-on gain (HFA-FOG) Reference test gain Frequency response bandwidth
/ range Result 110 dB SPL See Figure 1 106 dB SPL 31 dB 28 dB 200 7500 Hz Frequency response curve See Figure 2 Total harmonic distortion Total harmonic distortion +
noise Equivalent input noise (noise reduction disabled) Equivalent input noise (noise reduction enable) Latency Power supply specification Battery current drain (hearing aid) 27 500 Hz @70 dB 800 Hz @70 dB 1600 Hz @65 dB 500 Hz @70 dB 500 Hz @100 dB 0.9%
0.7%
0.5%
4.5%
1.5%
26 dB SPL 13 dB SPL 6 ms Input: 100-240V~
50/60 Hz, 0.4A Output: 5V, 1A 530A max current Figure 1: Nominal OSPL90 curve as measured in a 2 cc coupler. 120 OSPL-90 110 100
) L P S B d
0 9
L P S O 90 80 70 60 100 1000 10000 Frequency (Hz) Figure 2: Nominal frequency response curve as measured in a 2 cc coupler. 60 50 40 30 20 10 0
) B d
0 6
P S E R RESP-60 100 1000 10000 Frequency (Hz) 28 Troubleshooting Issue No Sound. Solutions 1. Ensure hearing aids and charging case are charged. 2. Change or clean dome. 3. Change or clean microphone cover. Too soft / sound quality seems low, weak or diminished. 1. Use the Clarity App to change volume in programs. 2. Change or clean dome. 3. Change or clean mic cap. Too loud. 1. Use the Clarity App to change volume in programs. Different volumes in right and left ear. 1. Use the Clarity App to change volume in programs. Hearing aids whistle, ring or buzz. 1. Try the closed dome style, or choose a larger size dome. 2. Sound inlet too close to another object (e.g., a phone); ensure there is space around the sound inlet. No Lights on charging case. 1. Ensure hearing aids and charging case are charged. 2. Open / closed charging case Lid. 29 Issue Solutions Dome remains in ear. Mic cap remains in ear. 1. Have the item removed from your ear by a healthcare professional. Do NOT attempt to remove the item yourself. 1. Have the item removed from your ear by a healthcare professional. Do NOT attempt to remove the item yourself. Physical fit not as expected. 1. Change or clean dome. 2. Try different dome types and Cannot adapt to hearing amplified sound (e.g., own voice too loud, background sounds audible, etc.). Hearing aids will not turn off. sizes. 3. Ensure hearing aid is correctly inserted. 1. Get help from a customer service advisor. Dial (855) 619-4327 to contact us. 1. Clean hearing aids, Cradles on charging case with cleaning brush / cloth. 2. Ensure correct orientation and placement in charging case. Hearing aids does not work. 1. Ensure hearing aids and charging case are charged. 30 Further Information Operating, Transport & Storage Conditions Operating conditions Temperature Relative humidity Operating 5 to 40 C (41 to 104 F) Storage
-20 to 50 C (-4 to 122 F) Transport
-20 to 50 C (-4 to 122 F) 0 to 90 %
0 to 90 %
0 to 90 %
Safety Information Warning A lithium-ion rechargeable battery is permanently built into your hearing aid. Incorrect use of the hearing aid can cause the lithium-ion rechargeable battery to burst, risk of injury, fire or explosion!
Expected battery life: 2 Years Follow the safety instructions for lithium-ion rechargeable battery in this section. Keep out of reach of children and pets. 31 Observe the operating conditions. Refer to the section "Operating, transport, and storage conditions". Check your medications before taking them hearing aids have been mistaken for pills. Pay special attention to protect your aid from extreme heat (e.g., fire, microwave oven, induction oven or other high induction fields) and sunlight. Never put hearing aids in your mouth, as they can easily be swallowed. Charge your hearing aids only with the approved charging case and cable. Do NOT disassemble your hearing aids. Do NOT use hearing aids in explosive atmospheres. Do NOT use deformed or visibly damaged hearing aids. Possible physiological side effects: please contact us if you develop skin irritation or accelerated ear wax buildup. 32 Waste Disposal The hearing aids, charging case, USB-C power cable, and USB-C power cable must be recycled at an e-waste facility or sent back to Zepp. Everything else goes in normal waste. Compliance Information This device complies with FCC 47 CFR Part 15, subpart C. 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. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
33 Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Changes or modifications not expressly approved by Huami could void the users authority to operate this equipment. 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. 34 This device complies with FCC radiation exposure limits set forth for general population. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. FCC ID: 2AC8UA2285 Hearing Aid Model: A2285 Charging Case Model: A2207Y Radio Transceiver Frequency Range: 2.4 to 2.4835 GHz Radio Receiver Bandwidth: 2 MHz Antenna Type: Monopole antenna Modulation: GFSK Range: < 10m 35 Wireless Technical Description Classification: Your Zepp Clarity Pixie hearing aid is classified as Class II exempt per 21 CFR 874 and Type B per IEC 60601-2-66. This hearing aid model has been tested to, and has passed, the following EMC, emissions, and immunity tests:
IEC 60601-1-2 radiated emissions requirements for a Group 1, Class B device as stated in CISPR 11. Immunity to ESD levels of +/- 8 kV conducted discharge and +/-15 kV air discharge. 36 Symbols and Descriptions Warning/Caution: Important information for injury prevention, handling, and product safety. Consult instructions for use. Note. Keep magnets away from hearing aids to avoid damage. 90%
Relative humidity: Store between 0% to 90%
relative humidity. 1000 hPa Atmospheric pressure should be 600 hPa to 1000 hPa. 0%
600 hPa Contains electronics, dispose according to local regulations, or return to the manufacturer. Do NOT use if package is damaged. Bluetooth low energy technology. 37 Manufacturer. Date of manufacture. REF Catalogue number. Type B applied part. SN Serial number. 38 Warranty and Service 45-day right to return: Zepp Clarity Pixie grants you a 45-day right to return starting from the date of delivery. To receive a return authorization, please contact our customer support team at (855)619-4327. If you are not satisfied with your Zepp Clarity hearing aids, you have the option of returning the device within forty-five (45) days after delivery. As long as the device is in its original condition and has not been damaged, lost or modified (including repaired without our prior written consent) in any way, we will credit back the purchase price to the account used at the time of purchase, less any expedited shipping if any. Warranty period: Zepp Clarity Pixie offers you a two-year limited warranty valid starting from the date of delivery. Repair What your warranty policy covers: This limited warranty covers defects in material and workmanship for the Zepp Clarity Pixie hearing aids, which includes the hearing aids, internal components, and charger within the limited warranty period. This warranty is guaranteed by Zepp North America, Inc. 39 Number of repairs: Unlimited during warranty period for repairs covered by warranty terms. What you get with your repair: For valid repairs, Zepp Clarity pledges to secure functionality at least equivalent to the original hearing aid. At the discretion of Zepp Clarity, hearing aids may be replaced by new products or products manufactured from new or serviceable used parts or repaired using new or refurbished replacement parts. Exclusions from Warranty Repair Coverage Normal wear and tear. Cosmetic damage, including but not limited to scratches, dents, and broken plastic on ports unless failure has occurred due to a defect in materials or workmanship. Defects or damage caused by misuse, accident
(including without limitation collision, fire, flood, earthquake and the spillage of food or liquid), neglect, abuse, alteration, unusual stress, modification, improper or unauthorized repair, installation, wiring, or testing, improper storage, use with unsuitable devices, software, or services. 40 Use not in accordance with the technical specification of the product. Damage caused by third party equipment with which the product is used. Commercial use or resale. Features or performance parameters pertaining to any software or services beyond the products normal use function substantially in accordance with Zepp's technical specifications or accompanying product documentation. A product that is returned with removed, damaged or tampered labels (including serial number of product) or any alterations (including the unauthorized removal of any component or external cover). 41 Loss and Damage Loss & damage: Zepp Clarity Pixie offers a one-time
(1x) replacement for each Zepp Clarity hearing system
("two hearing aids and one charging case") that is lost or damaged during the warranty period, for a fee
(stated and updated at clarity.zepp.com). Devices damaged from improper use or care will not be replaced. How to submit request for repair: Call (855) 619-4327 and we will be happy to assist. Customer support can also be accessed within the Clarity App. 42 clarity.zepp.com
(855) 619-4327 2023 Zepp Health. All rights reserved. Zepp Clarity and the Zepp Clarity logo are trademarks or registered trademarks of Zepp Health Group. A10803205000000-XX XXXX A10803205400000 Duet_ V1.2 2023.6.2 200g105g
0.1mm 0.5mm PANTONG Black C CMYK 1:1 mm