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Users Manual | Users Manual | 5.59 MiB | December 27 2022 / June 25 2023 | delayed release | ||
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Internal Photos | Internal Photos | 368.19 KiB | December 27 2022 / June 25 2023 | delayed release | ||
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ID Label | ID Label/Location Info | 166.80 KiB | December 27 2022 | |||
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Antenna Specification | Test Report | 1.42 MiB | December 27 2022 | |||
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Confidentiality Request Letter | Cover Letter(s) | 106.83 KiB | December 27 2022 | |||
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RF Exposure Evaluation Report | RF Exposure Info | 85.75 KiB | December 27 2022 | |||
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Test Report-BLE | Test Report | 4.85 MiB | December 27 2022 | |||
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Test Setup Photos | Test Setup Photos | 322.06 KiB | December 27 2022 / June 25 2023 | delayed release | ||
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Test Report BT Part 1 | Test Report | 5.04 MiB | December 27 2022 | |||
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1 2 | Users Manual | Users Manual | 5.59 MiB | December 27 2022 / June 25 2023 | delayed release |
1.4.05.A61HT.001 120G 4 90X90mm P52P 1mm 0mm JH-C-A61HT-20221027-01 V0 JH-A61HT () OTC Victor Tibby 20221027 OTC HEARING AID Instruction Manual Model: JH-A61HT VER: A61HT-20221027-V0 Please read this user manual thoroughly and completely before using the product. IV. MAINTENANCE AND CLEAN V. HEARING AID AND CHARGING CASE CARE VI.TROUBLESHOOTING GUIDE VII.REGULATORY AND LEGAL INFORMATION VIII.TECHNICAL SPECIFICATIONS IX. ACCESSORIES X. NORMALIZED SYMBOLS XI. MAINTENANCE,STORAGE,AND DISPOSAL XII.WARRANTY 34 36 37 40 53 54 55 56 57 CONTENTS I. Warnings II. Cautious and Notices III.HOW TO USE YOUR DEVICE 1.HOW TO APPLY EARTIPS 2.LEFT & RIGHT HEARING AID MARKINGS 3.WEAR/REMOVE HEARING AIDS 4.TURN ON/TURN OFF 5.VOLUME ADJUSTMENT 6.HEARING PROGRAMS CHANGE 7.HEARING AIDS CHARGING 8.HOW TO USE THE CHARGING CASE 9.BLUETOOTH FUNCTION 10.HOW TO USE THE APP 03 09 16 19 20 20 22 23 24 25 26 28 29
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I.WARNINGS in your ear 1.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. 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 saw 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
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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 3.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 m a n u f a c t u r e r. I f y o u r p a i n o r d i s c o m f o r t d o e s n t g o away,contact your hearing healthcare professional.You can also report this to FDA as an adverse event according to the instruc-
tions that appear later. 4.WARNING:important safety instruction The device should not be used in the following situations:
Patients with chronic suppurative otitis media (CSOM),con
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genital ear atresia, or any type of ear discharge may result. Keep small parts(hearing instrument, eartips, battery or other detachable parts)that can be swallowed out of childrens reach. Dropping, immersing in liquid, exposure to strong electromagnetic fields 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 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 and consult a doctor. Routine maintenance to keep the device clean is required. Ensure that eartips are free of debris and moisture at all times. Avoid shocks or dropping the product. Do not store or use the product in environments of high humidity or temperature (such as sauna room), to avoid damage. Batteries should be properly recycled and not disposed in the trash. Keep the devices away from children. Injury or damage
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Do not set volume levels too high. Listening with high-out-
put devices for extended period of time at high volume levels can cause further hearing damage. Do not share your hearing aids with others. Using a hearing aid configured for someone else can result in hearing dmage 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. Do not touch the hearing aids to any type of magnet or magnetized object. Your hearing aids are delicate electron-
ic instruments and may be damaged by contact with strong magnetic fields. Do not attempt to open or repair the devices yourself. Damage can result and will void the warranty. Stay away from strong electromagnetic fields when using hearing aid to avoid unexpected damage. Do not store your devices in a hot/humid locations. You should never leave your hearing aids near heating appliances or in direct sunlight. Do not leave your hearing aids in the car as inside tempera tures can reach dangerous levels which could damage the
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devices. If the Bluetooth function is available for your device, do NOT connect the hearing aid and headsets to the mobile phone via Bluetooth simultaneously - noise, distortion or any other unexpected problems may occur to your hearing aid. Please contact the MANUFACTURER:
For assistance, if needed, 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 easily. -Check the TROUBLESHOOTING GUIDE first when failures occur to your devices. Specific warnings / statements Keep small parts away from children to avoid accidental ingestion Do not use the devices in explosive or oxygen-enriched atmospheres, as doing so may damage the devices Warning that it should only be used by intended person as using hearing aids designed for someone else may result in hearing damage 5.WARNING: do not use if any of the followings apply to you Congenital atresia of external ear or deformity of any part of the ear canal Deafness is unstable, 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.
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II.CAUTIONS AND NOTICES possibly seriously. 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 consis-
tently need to turn the volume down, you may need to further adjust your device. 3.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, 4.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. 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 listeningfor example, noisy environments.
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6.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 prob-
lem. 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. 7.Note:If 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 for you:
Move closer to and look at the speaker. Sit face-to-face in a quiet room if possible. Try out different locations to find the optimal places to listen Minimize distractions. Background noises may be frustrating at first; remember, you have not heard them for a while. Let others know what you need; keep in mind that people cannot see your hearing loss. Develop realistic expectations of what your hearing aids can and cannot do. Better hearing with hearing aids are a learned skill combin-
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ing 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:
Get your full attention before beginning to speak. 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. 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
(1) Please review the following simple communication tips for miss. you:
Move closer to and look at the speaker. Sit face-to-face in a quiet room if possible. Try out different locations to find the optimal places to listen Minimize distractions. Background noises may be frustrating at first; remember, you have not heard them for a while. Let others know what you need; keep in mind that people cannot see your hearing loss. Develop realistic expectations of what your hearing aids can and cannot do. Better hearing with hearing aids are a learned skill combin-
ing 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:
Get your full attention before beginning to speak. 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.Caution The use of accessories and cables other than those specified by manufacturer, with the exception of 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 electromagnetic security systems such as metal detectors environment 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 and that if adjacent or stacked use is necessary, 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 frequencies, may impair the units essential performance. The device has passed EMC highest interference level test, and the parameters do not deviate the essential performance requirement.
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The device displays abnormally. 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-
ence, attempt to correct the problem by one or more of the following measures:
If feeling too weak or too strong 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. Re-orient or re-locate 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. III.HOW TO USE YOUR DEVICE 1 2 3 4 5 1. Multi-function touch button - switches between hearing programs and change the volume level 2. Microphone - sound enters your hearing aids through the microphone 3. Eartip - holds the hearing aids in place in your ear canal 4. Charging Contacts - for hearing aids charging 5. In Ear Detection Sensor - when the sensors detect blocked, the hearing aids will turn on
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1 2 3 5V 1A 5 6 7 4 8 9 Micro USB Cable 1. Upper Cover 2. Charging slots - charge and store the L/R hearing aid 3. Charging indicator light of hearing aid(L) - displays the charging status of the left hearing aid 4. Charging indicator light of charging case - displays the charging status of the charging case 5. Charging indicator light of hearing aid(R) - displays the charging status of the right hearing aid 6. Power switch - turns on/off the power supply of the charging case. 7. Charging port - connects the charging case to USB cable 8. Port B of USB cable 9. Port A of USB cable Instruction for insertion depth For adults,the average length of the ear canal has been estimat-
ed to be 23-28mm and the maximum insertion size of the hearing aid is 9.2mm. So the distance from the eartip 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. 23~28mm
(adult) Insertion depth=9.2mm
(MAX)
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1.HOW TO APPLY EARTIPS Please follow the following steps to apply eartips.The eartips may remain in the ear canal with incorrect replacement when taking the hearing aids off the ear,which will cause hearing damage. Step 1: Choose a suitable size of eartip. 2.LEFT & RIGHT HEARING AID MARKINGS There is a L or R marking on the hearing aid. This will tell you that it is a left or a right hearing aid. Step 2: Push the eartip rim membrane outward. Step 3: Hold on the end of the hearing aids and push firmly to ensure that the eartip is fastened securely. 1 2 L marking is for left hearing aid. R marking is for right hearing aid. 3WEAR/REMOVE HEARING AIDS Your hearing aids are equipped with in-ear detection sensor. 1) The hearing aids will enter the standby status automatically when removed from your ear. 2) The hearing aids will turn on automatically when placed back in your ear. 3.1 Wearing hearing aids Step 1:Hold the hearing aids and place it in your right or left ear. Step 2:Move the hearing aids slightly into auricle for holding. 11 2 Notes:Please pull the eartips gently to check if it is installed firmly and ensure the eartips wont fall off easily.
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3.2 Removing the hearing aids Grasp the protruding hearing aids and remove it from your auricle gently. 4.TURN ON/TURN OFF TURN ON:The hearing aids will turn on automatically in about 3 seconds when it is worn correctly . You will hear prompt tone according to the hearing program(refer toHEARING PROGRAM CHANGE) Notes:
1. The creak sound can be used as a reference to determine whether the hearing aids are secured. 2. If the hearing aids give out squeaking, please check if they are taken on correctly. If so, but the squeaking remains, please replace with the other size of eartip. When the hearing aids are not in use, please turn them off without delay. 3. When the hearing aids are not functioning properly,please check the TROUBLESHOOTING GUIDE. If none of the solutions work, please contact our after-sales service team. Turn Off: The hearing aids will enter the standby status automati-
cally when it is removed from your ear. When placed back into the correct slot of the charging case, they will turn off and start charging automatically.
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1 2 6.HEARING PROGRAMS CHANGE There are four4 preset programs in the hearing aids. You could change the hearing program by long-pressing the touching control area for about 3 seconds. The hearing aids are designed with the memory function:The hearing aids can record the previous hearing program automatically. The hearing aids will give out the beep tone to indicate which hearing program you are in. 5.VOLUME ADJUSTMENT The hearing aids have six6volume levels. You could cycle the volume level from minimum to maximum by tapping the touching control area once.The hearing aids will give out the prompt tone Beep The hearing aids will give out the prompt tone Beep-Beep-Beep at maximum volume. Touch Control area one second Hearing program Prompt tone 1 2 3 4 Standard Beep Restaurant Beep Beep Outdoor Beep Beep Beep Music Beep Beep Beep Beep
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7.HEARING AIDS CHARGING The hearing aids will turn off and start charging automatically when placed back into the correct slot of the charging case. The orange indicator light indicates that the hearing aids are charging and the green indicator light indicates that the hearing aids are fully charged. The indicator lights of hearing aids will go out in about five minutes when the hearing aids are fully charged.
*Note: Low battery warning:You will hear the notification sound when the remaining battery capacity is almost used out. 8.HOW TO USE THE CHARGING CASE 8.1 Charging case TURN ON/OFF Press and hold the power switch of the charging case for about 5 seconds to turn off the charging case.You can turn the charging case back on or check the battery status by short press the power switch. 8.2 How to charge the charging case Step 1:Connect the B port of the USB cable to the charging port of the charging case. Step 2:Connect the A port of the USB cable to the power supply. L CASE R L CASE R B port A port Micro USB Cable
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8.3 The orange indicator light indicates that the charging case is charging, and the green indicator light indicates that the charging case is fully charged. L CASE R L CASE R 9.BLUETOOTH FUNCTION 9.1 How to connect Bluetooth Be sure Bluetooth is available on your phone. Step 1 : Remove your hearing aids from the charging case before connect Bluetooth. Step 2 : Check the Bluetooth setting on your phone to "Pair New Device". Step 3 : Select device name OTC Clarity Units to pair(connect) the Bluetooth of your phone. Connection status Connect successfully Disconnect Prompt tone Connected Disconnected 8.4 The charging case will charge the hearing aids whatev-
er the upper cover is open or closed. The charging process will stop automatically when the case and hearing aids are fully charged.
*Note:Check the TROUBLESHOOTING GUIDE when failure occurs to your devices. Accept any prompts given by your phone regarding the Bluetooth connection. Note: Once the first pairing is done, the hearing aids will reconnect to your phone automatically as long as Bluetooth of your phone is available. Attention: Do NOT use the Bluetooth function of your hearing aids for any medical purposes.
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9.2 Bluetooth function description 9.2.1 Listening to music Play or stop the music via the mobile phone or related device. Change the music volume via the mobile phone or related device. 9.2.2 Phone calls Answer the incoming call by short pressing the Multi-function button. Reject the incoming phone call by long pressing the Multi-func-
tion button for about 2 seconds. Hang up the phone by long pressing the Multi-function button for about 2 seconds. 10.HOW TO USE THE APP Read all the information in this instruction before using.
-Printed version of this instruction is available via customer support. 10.1 Download
*The "OTC Clarity" is compatible with iOS and Android. You could download it from the App Store or Google Play Store. Requirement for running the app: iOS 14 or later; Android 5.0 or later.
*iPhone is a trademark of Apple Inc.,registered in the U.S. and other countries. Android is a trademark of Google Inc. IOS is a trademark of Cisco Inc.
- 10.1.1 Download the "OTC Clarity" for Apple devices The "OTC Clarity" makes it easy to control and adjust your hearing aids with your compatible Apple device. Access app for iPhone, iPad and iPod touch-download on the App Store by following steps:
Step 1: Tap to start App Store on a compatible apple device. Step 2: Search "OTC Clarity" on APP Store. Step 3: Tap GET to download the OTC Clarity APP. Follow the system prompts to finish the installation. Step 4: Tap to start the OTC Clarity APP.
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10.3 Homepage 1. Program Selection Part 2. Volume Adjustment 3. Connection status 4. Battery status 5. Navigational menu Program
- 10.1.2 Download the "OTC Clarity" for Android devices The "OTC Clarity" makes it easy to control and adjust your hearing aids with your compatible Android device.Download the app by following steps:
Step 1: Tap to start Google Play Store on a compatible Android device. Step 2: Search "OTC Clarity" on Google Play Store. Step 3: Tap GET to download the OTC Clarity APP. Follow the system prompts to finish the installation. Step 4: Tap to start the OTC Clarity APP. 10.2 Pairing with your hearing aids Step 1.Turn on the hearing aids. Step 2.Enable Bluetooth on the phone. Step 3.Search the name OTC Clarity Units on the device. Step 4.Tap to connect your hearing aids with your phone. Step 5.Tap "OTC Clarity" to start. On the bottom of first screen, tap
"connect aids"
*Search and connect the device name of OTC Clarity Units-L or OTC Clarity Units-R. Step 6.You are now ready to go.
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*Note:Further instruction is available on Profile Help . IV. MAINTENANCE AND CLEAN 1. Daily maintenance Keep your devices clean and dry by using soft cloth or tissue,to avoid potential damage from humidity or perspi-
ration. Do NOT use the electronic dryer to store the rechargeable hearing aid. 2. Care and maintenance Keep your devices away from children and pets. Keep your hearing aid away from high-temperature and/or high-humidity atmosphere. Do not poke the microphone with any sharp objects to avoid damage. Do not attempt to disassemble or repair your devices by yourself. Doing so will void your warranty. Clean the charging contacts of the rechargeable hearing aid with dry soft cloth irregularly to ensure the normal charging. 3. Cleaning
(1) Cleaning the eartips
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Clean up earwax adhered to the eartips by using the thin side of enclosed tool. Remove eartips from the hearing aid before cleaning, and push the eartips rim membrane outward 1 2 3 The thin side of the cleaning brush Clean the eartips with alcohol and dry cloth and wait for the eartips to dry before attaching them to the hearing aid.
*Note:
We recommend that changing the eartips every three months. If the eartips get stiff , brittle or discolored over time, please change them as soon as possible.
(2) Cleaning Tool Using soft cloth or tissue to wipe any moisture or perspiration from the surface of the cleaning tool. V.HEARING AID AND CHARGING CASE CARE 1.Hearing aid care Keep your hearing aid clean. Extreme temperature (heat or cold), moisture, and foreign substance can result in poor performance. Use the cleaning tool to clean debris adhered to the buttons, microphones, and charging contacts; inspect the receiver, eartips, and charging case regularly. Do NOT clean your hearing aid with water, solvent or oils. Charging contacts should always be kept clean and dry. Always store your hearing aid in the charging case when not in use. 2.Charging case care Keep your charger clean. Heat, moisture and foreign substance can result in poor performance. Use the enclosed cleaning brush to keep the charging ports clear of debris. Do not use water, solvents or cleaning fluids to clean the charging ports. Store your charger in a clean and dry location.
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VI.TROUBLESHOOTING GUIDE Issue Possible Causes Potential solution Issue Possible Causes Potential solution Feedback or whistling Are the hearing aids inserted correctly in your ears?
Is the volume very loud?
Are the eartips broken or clogged?
Are you holding an object (e.g. a hat or a telephone mouthpiece) close to the hearing aids?
Is your ear full of wax?
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Reinsert the hearing aids in your ears. Reduce the volume. Replace the eartips No sound Move your hand away to create more space between the hearing aids and the object. Hearing aids are not charging Are the hearing aids turned on?
Turn the hearing aids on. Are the hearing aids charged?
Charge the hearing aids. Is the charging case charged?
Charge the charging case. Is your ear full of wax?
Are the hearing aids sitting correctly in the charging case?
Is the charging case charged or plugged into a power source?
Visit your physician. Reinsert the hearing aids in the charging case. Charge the charging case. Visit your physician. Hearing aids fault self-checking table
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Issue Possible Causes Potential solution Poor contact between hearing aids and charging case Reinsert the hearing aids into the charging case Hearing aids are not inserted correctly into charging case Insert hearing aids correctly into charging case Charging case is not connect to power supply Are the hearing aids charged?
Dirty charging contacts Connect charging case to external power supply Charge the hearing aids Clean the contact of the hearing aids and the charging case Indicators light of hearing aids do not light up when hearing aids placed in charging case Charging does not start Hearing aids are not inserted correctly into charging case Insert hearing aids correctly into charging case Charging case fault self-checking table
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VII.REGULATORY AND LEGAL INFORMATION This part applies to the product with Bluetooth or APP func-
tion. 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 instal-
lation. 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 interfer-
ence will not occur in a particular installation. If this equip-
ment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and by one or more of the following measures:
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.
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Changes or modifications not expressly approved by manufacturer could void the users authority to operate this equipment. This device complies with part 15 of the FCC Rules. Opera-
tion 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. This device complies with FCC radiation exposure limits set forth for general population. This transmitter must not beco-located or operating in conjunction with any other antenna or transmitter. Radio Technology: Bluetooth Low Energy (BLE) and propri-
etary technologies. Radio Transceiver Frequency Range: 2.4 to 2.480 GHz Radio Receiver Bandwidth: 2MHz. Modulation Type: 1 Mb/s GFSK Peak Effective Isotropic Radiated Power: 0 dBm. This equipment has been tested and found to comply with the limits per CISPR 11 class B. Important information regarding Electro Magnetic Compatibility (EMC) With the increased number of electronic devices such as PC and mobile (cellular) telephones, radio transceivers, mobile radio transmitters, radio-controlled toys, and so on, Medical devices in use may be susceptible to electromagnetic interfer-
ence from other device. Electromagnetic interference may result in incorrect operation of the medical devices and create a potentially unsafe situation. Medical devices should also not interfere with other devices. In order to regulate the requirements for EMC (Electro Mag-
netic Compatibility) with the aim to prevent unsafe product situations, the EN60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromag-
netic interference as well as maximum levels of electromag-
netic emissions for medical devices. This unit has been thoroughly tested and inspected to assure proper performance and operation! This product needs spe-
cial precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, the following tables recommend minimum separation distanc-
es between portable and mobile RF communications equip-
ment and the RJADAT-1 unit.
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1 2 3 4 Guidance and manufacturers declaration-
electromagnetic emission Acupuncture treatment device is intended for use in the electromagnetic environment specified below. The customer of the user of Acupuncture treatment device should assure that it is used in such an environment. Emission test Compliance RF emissions CISPR 11 Class B Group 1 Electromagnetic environment guidance Acupuncture treatment device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. 5 RF emissions CISPR 11 Class B Group 1 6 Class B Class A N/A 7 Voltage fluctuations /
flicker emissions IEC 61000-3-3 The hearing-aid treatment device is suitable for use in all establishments, other domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
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Guidance and manufacturers declaration-electromagnetic immunity Acupuncture treatment device is intended for use in the electromagnetic environment specified below. The customer or the user of Acupuncture treatment device should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electros-
tatic discharge
(ESD) IEC 61000-4-2 Contact dis-
charge:
8 kV Contact dis-
charge:
8 kV Air dischar-
ge: 2 kV, 4 kV,8 kV, 15 kV Air dischar-
ge: 2 kV, 4 kV,8 kV, 15 kV Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transi-
ent/burst IEC 61000-4-4 2 kV for power supply lines 1 kV for input/output lines Surge IEC 61000-4-5 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commer-
cial or hospital environment. Mains power quality should be that of a typical commer-
cial or hospital environment. N/A N/A
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(2) Cleaning Tool Using soft cloth or tissue to wipe any moisture or perspiration from the surface of the cleaning tool. Voltage dips, short interrup-
tions and voltage variations on power supply input lines IEC 61000-4-11
<5% UT
(>95% dip in UT)for 0.5 cycle 40% UT
(60% dip i n UT) for 5 cycles 70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec N/A Mains power quality should be that of a typical commer-
cial or hospital environment. If the user of Acupuncture treatment device requires continued operation during power mains interruptions, it is recommended that Acupunc-
ture treatment device be powered from an uninterrupt-
ible power supply or a battery. Guidance and manufacturers declaration-electromagnetic immunity The acupuncture treatment device and acupuncture treatment device is intended for use in the electromagnetic environment specified below. The customer or the user of acupuncture treatment device should assure that it is used in such an environment. Immunity test IEC 60601 test level Conducted RF IEC 61000-4-6 10 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000-4-3 10V/m 80 MHz to 2.5 GHz Compliance level 10 Vrms 10 V/m
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The acupuncture treatment device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of The acupuncture treatment device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and acu-
puncture treatment device as recommended below, according to the maximum output power of the communications equip-
ment. Rated maxi-
mum output power of transmitter
(W) Separation distance according to frequency of transmitter (m) 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 0.1 0.12 0.38 0.12 0.38
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0.23 0.73 1 10 100 1.2 3.8 12 1.2 3.8 12 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1:
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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VIII.TECHNICAL SPECIFICATIONS Test Item Program One Program Two Program Three Program Four Max. Output(OSPL90) 117dB(Max.) The battery life of a hearing aid is up to 12 hours. The fully charged case offers 3 full charging cycles for a pair of hearing aids. The data is derived from the measured value of the product at the laboratory,not guaranteed values. 26dB5dB 27dB5dB 28dB5dB 24dB5dB Status The full-on gain value
(HFA FOG@50) Frequency response bandwidth The total harmonic distortion value The self-generated noise value The Latency value Frequency response smoothness F1250Hz, F25000Hz 5%
32dB 15ms 12dB Test StandardANSI3.22-2014 Test EquipmentFONIX 8000 Test CouplerHA-1 The standard ambient conditions shall be:Temperature:235 739F Relative humidity:0% to 80%
Atmospheric pressure:760(+37.5,-150)mm of Hg or 101.3(+5,-20)k-
Pa Bluetooth disconnected Bluetooth connected
(without entertainment , phone call o r using "OTC Clarity" APP ) Bluetooth connected
(with entertainment ,phone call or using "OTC Clarity" APP ) Battery life About 20 hours About 10 hours About 3 hours The fully charged case offers about 3 full charging cycles for a pair of hearing aids. The data is derived from the measured value of the product at the laboratory,not guaranteed values. IX. ACCESSORIES Eartip 6 holds the hearing aid in place in your ear canal USB Cable 1 used to charge the charging case Cleaning Tool 1 used to clean hearing aids and charging case Manual 1 used for users to read and understand how to use hearing aids and other objects
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X.NORMALIZED SYMBOLS Follow operating instructions B type applied part Disposal in accordance with Directive 2002/96/EC (WEEE) Date of manufacture Manufacturer information Serial number Five years Warning/ Danger: Improper use might cause serious injuries. Medical Device Permissible storage and transport temperature and humidity Permissible operating temperature and humidity Notes:This hearing aid is produced under the strict quality system of Huizhou JINGHAO Medical Technology Co.,Ltd. The device fulfills the provisions of the EC directive 93/42/EEC
(Medical Device Directive) and the Harmonize Standard as IEC 60601-1, IEC60601-2-66,IEC60118-7,IEC 60118-13,EN ISO 10993-1/-5/-10 ENISO 14971,and FCC CFR47 Part 15. RED directive 2014/53/EU.The RED information is applicable to our products with Bluetooth functionSubpart B, Class B. XI.MAINTENANCE, STORAGE AND DISPOSAL Maintenance 1) We do not authorize any institution or individual to maintain and/or repair the product.If you suspect that the products may be in question,please contact us immediately. 2) The user must not attempt any repairs to the device or any of its accessories.Please contact us for any repair needs. 3) Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty. Warning :
No modification of this equipment is permitted. Storage 1) Always store your rechargeable devices in the Charging Case when not in use. 2) Do not store or expose the devices and/or case to extreme hot/cold temperatures,moist/humid environments, or shock/vibration. 3) Keep the devices and case in following environmental ranges:-10
~55
,10%-90%RH, 700-1060hPa 4) The hearing aids should be fully charged before used for the first time. The hearing aids should be charged at least every 6 months if they are not used for an extended period of time.
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Disposal Please dispose of the device in accordance with the directive 2002/96/EC - WEEE(Waste Electrical and Electronic Equipment). If you have any questions, please refer to your local authority responsible for waste disposal. XII. WARRANTY This limited warranty covers defects in material and workm-
anship for a period of one (1) year from the date of purchase, which includes the hearing devices, charger case, and cord within the warranty period. Any damage caused by improper handling and care, expo-sure to elements or chemicals, or unauthorized service will not be covered by the warranty. All other damage claims excluded. A warranty claim must be submitted with the purchase receipt. To return the item, you may also call: 0086-752-2299187 or write to hearingservice@hotmail.com or 23D floor, World Trade Center Building, No.1 Henanan Road,Huicheng District, Huizhou, Guangdong Province, China Zip Code:
516007 to ensure that both your return and credit refund are processed accurately. Huizhou Jinghao Medical Technology Co., Ltd. Address: Floor 6, Huicheng Industry Building, No.9 Huifeng Donger Road, Zhongkai High-tech Zone, Huizhou City, Guang-
dong Province, China. Tel: +86-752-2266961 Website: www.jinghao.cc Email: emily@jhhearingaids.com CERTIFICATE Product Name Product Life Model Lot No. Inspector Hearing Aid 5 years JH-A61AT Outside packaging P A S S Q A 0 1 The product conforms to the national and industrial standards and has passed inspection.
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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:
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 manufacturer 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. 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: 2A39M-JH22A61H Radio Technology: Bluetooth Low Energy (BLE) and proprietary technologies. Radio Transceiver Frequency Range: 2.4 to 2.480 GHz Radio Receiver Bandwidth: 2MHz. Modulation Type: 1 Mb/s GFSK Peak Effective Isotropic Radiated Power: 0 dBm. This equipment has been tested and found to comply with the limits per CISPR 11 class B.
1 2 | Internal Photos | Internal Photos | 368.19 KiB | December 27 2022 / June 25 2023 | delayed release |
1 2 | ID Label | ID Label/Location Info | 166.80 KiB | December 27 2022 |
Labeling information Name: Hearing aids Model No.:
Mode of operation-continuous JH-A61HT Input: D.C.3.7V No AP/APG IP21 Manufacturer : Huizhou Jinghao Medical Techology Co., Ltd Address:Floor6,Huicheng Industry Building,No.9 Huifeng Dong'er Road,ZhongKai High tech Zone,Huizhou City,Guangdong Province,China FCC ID: 2A39M-JH22A61H 20210707 Remarks: The label will be reflected in the instruction manual.
1 2 | Confidentiality Request Letter | Cover Letter(s) | 106.83 KiB | December 27 2022 |
Huizhou Jinghao Medical Technology Co., Ltd Floor 6, Huicheng Industry Building, No.9 Huifeng Dong'er Road, ZhongKai High tech Zone, Huizhou City, Guangdong Province, 516000, P.R.China Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Gentlemen:
Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Permanent Permanent*1 Permanent Permanent Permanent*
Exhibit Block Diagrams Internal Photos Operation Description/Theory of Operation Schematics Test Setup Photos Users Manual The above material contains trade secrets or technical data, which would customarily be guarded from competitors. We do not want these documents to be accessible to the general public. Pursuant to sections 0.457 and 0.459 of CFR 47 and to avoid premature release of sensitive information prior to marketing or release of the product to the public, the applicant requests the following documents contained in this certification application be temporarily withheld from public disclosure for an initial period of 180 days. Sincerely, By:
(Signature) Liu Jian
(Print name) Title: Manager On behalf of: Huizhou Jinghao Medical Technology Co., Ltd. Telephone: 0752-2266961
(Company Name)
1 2 | Power of Attorney | Cover Letter(s) | 98.31 KiB | December 27 2022 |
Huizhou Jinghao Medical Technology Co., Ltd Floor 6, Huicheng Industry Building, No.9 Huifeng Dong'er Road, ZhongKai High tech Zone, Huizhou City, Guangdong Province, 516000, P.R.China
(FCC ID2A39M-JH22A61H) POWER OF ATTORNEY DATE: 2022-12-02 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 To Whom It May Concern:
We, the undersigned, hereby authorize ITL Co., Ltd (MR. Pauler LI, Manager) on our behalf, to apply to the Federal Communications Commission on our equipment. Any and all acts carried out by ITL Co., Ltd (MR. Pauler LI, Manager) on our behalf shall have the same effect as acts of our own. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. We, Huizhou Jinghao Medical Technology Co., Ltd. are not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 USC853a, and no party to the application is subject to a denial of federal benefits pursuant to that section. Sincerely, Huizhou Jinghao Medical Technology Co., Ltd
(Manager)
1 2 | Test Setup Photos | Test Setup Photos | 322.06 KiB | December 27 2022 / June 25 2023 | delayed release |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-12-27 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
2 | 2402 ~ 2480 | DSS - Part 15 Spread Spectrum Transmitter |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2022-12-27
|
||||
1 2 | Applicant's complete, legal business name |
Huizhou Jinghao Medical Technology Co.,Ltd
|
||||
1 2 | FCC Registration Number (FRN) |
0031836711
|
||||
1 2 | Physical Address |
Floor6,Huicheng Industry Building, No.9 Huifeng Dong'er Road,ZhongKai High tech Zone
|
||||
1 2 |
Floor6,Huicheng Industry Building
|
|||||
1 2 |
Huizhou, N/A
|
|||||
1 2 |
China
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
c******@vista-compliance.com
|
||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
2A39M
|
||||
1 2 | Equipment Product Code |
JH22A61H
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
Y**** M****
|
||||
1 2 | Telephone Number |
0086-********
|
||||
1 2 | Fax Number |
0086-********
|
||||
1 2 |
m******@jinghao.info
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 06/25/2023 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | DSS - Part 15 Spread Spectrum Transmitter | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | HEARING AIDS/ hearing amplifier | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | RF output power listed is conducted. | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
ITL Co., LTD
|
||||
1 2 | Name |
B******** D******
|
||||
1 2 | Telephone Number |
0-177********
|
||||
1 2 | Fax Number |
86-02********
|
||||
1 2 |
s******@i-testlab.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0004370 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0001260 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC