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Related Manuals for Miracle-Ear MINI 5/4 CIC 312 BL
Summary of Contents for Miracle-Ear MINI 5/4 CIC 312 BL
- Page 1 Miracle-EarMINI ™ 5/4 CIC 312 BL Custom User Manual www.miracle-ear.com...
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Page 2: Warnings, Cautions, & Notices
WARNINGS, CAUTIONS, & NOTICES REQUIRED HEARING AID INFORMATION The following additional information is provided in compliance with U.S. Food and Drug Administration (FDA) regulations: WARNING: People younger than 18 should go to a doctor before using this. People younger than 18 years old need specialized care, and using this without a medical evaluation may worsen impairment or disability. - Page 3 WARNINGS, CAUTIONS, & NOTICES WARNING to Hearing Aid Dispenser, Outputs over 132 dB SPL: You should exercise special care in selecting and fitting a hearing aid with a maximum output that exceeds 132 dB SPL because it may impair the remaining hearing of the hearing aid user.
- Page 4 WARNINGS, CAUTIONS, & NOTICES WARNING: If the hearing aid drops onto a hard surface, it could cause the hearing aid to break or become damaged. This includes mechanical stress or shock of the device. Ensure the hearing aid is intact before placing it in the ear. If you find the device is damaged, discontinue use and see your hearing professional.
- Page 5 WARNINGS, CAUTIONS, & NOTICES As with any hearing aid, misuse of the tinnitus therapy instrument could present some potentially harmful effects. Care should be taken to prevent the unauthorized use and to keep the hearing aid out of the reach of children and pets. CAUTION: This is not hearing protection.
- Page 6 WARNINGS, CAUTIONS, & NOTICES 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 devices, etc.
- Page 7 WARNINGS, CAUTIONS, & NOTICES The audiologist will conduct a hearing aid evaluation to assess the person’s ability to hear with and without a hearing aid. This will enable the audiologist to select and fit a hearing aid for the person’s individual needs. An audiologist can also provide evaluation and rehabilitation since, for people younger than 18, hearing loss may cause problems in language development and educational and social growth.
- Page 8 Some hearing instrument users have reported a buzzing sound in their hearing instrument when they are using mobile phones, indicating that the mobile phone and hearing instrument may not be compatible. It is well-known that mobile phones are potential sources of noise for hearing aids. Your Miracle-Ear Hearing Aids have ®...
- Page 9 Congrats! Your best life begins with better hearing. Custom User Manual...
- Page 11 After all – when you hear better, you live better. Thanks to your new hearing aids. Did you know you can get even more hearing aid features using your mobile device? See the Miracle-Ear App user manual at ® miracle-ear.com/app...
- Page 12 WHAT’S INCLUDED Hearing aid style covered in this user manual: MEMINI CIC 312 BL ™ Serial Number Left: Right: My hearing aid uses a: 312 battery (CIC) – Brown...
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Page 13: Table Of Contents
Additional guidance Intended use ............36 FCC information ..........42 Regulatory information ........43 ¿Necesita un manual de usuario en español? Solicite uno a su audioprotesista o descárguelo de Miracle-Ear.com/manuals Spanish and English User Manuals Miracle-Ear ® User Manuals are available digitally at Miracle-Ear.com/manuals... -
Page 14: Get To Know Your Hearing Aids
Get to know your hearing aids • Meet your hearing aids • Use your hearing aids • Care for your hearing aids... -
Page 15: Meet Your Hearing Aids
MEET YOUR HEARING AIDS Overview MEMINI CIC 312 BL ™ User control (optional) Microphone and cover Vent Wax guard (included accessory) and sound outlet Serial number Side indicator (location may vary) BLUE is for left ear, RED is for right ear White dot indicates top of hearing aid Removal handle antenna (do not remove, cut, or modify) -
Page 16: Use Your Hearing Aids
Use your hearing aids Batteries Your hearing aid uses a battery as its power source. The battery size can be identified by the brown (312) color code on the packaging. To insert or replace the battery: Use the finger pick on the battery door. Open the battery door gently and remove the old battery. - Page 17 Use your hearing aids Remove the colored tab from the new battery. For best results, wait 3-5 minutes after removing tab before inserting battery. Insert into the battery door, “+” side up. Close the battery door.
- Page 18 Use your hearing aids Battery Indicators An indicator will sound when the battery voltage is low. You have approximately 30 minutes to replace the battery. An indicator may also sound just before the battery stops working. Helpful battery tips • NEVER FORCE THE BATTERY DOOR SHUT; this could result in serious damage.
- Page 19 Use your hearing aids WARNINGS Batteries are dangerous if swallowed. To help prevent the accidental ingestion of batteries: • Keep out of the reach of children and pets. • Check your medications before taking them — batteries have been mistaken for pills. •...
- Page 20 Use your hearing aids To put on your hearing aids: Gripping the outer edges of your hearing aid, gently insert canal tip into your ear canal and rotate the hearing aid backward. Gently press the hearing aid into place. Done!
- Page 21 Use your hearing aids To remove your hearing aids: Grip the outer edges of your hearing aid. Rotate the hearing aid forward and pull outward. - OR - If your hearing aid has a removal handle: Grip this and gently remove the hearing aid from your ear.
- Page 22 Use your hearing aids To turn OFF: Open the battery door until the battery is no longer touching the battery contacts. Auto ON/OFF Your hearing aid may support the ability to automatically go into a low-powered state to conserve battery. This control can be configured by your hearing care professional or via the hearing aid mobile app.
- Page 23 Use your hearing aids Turning ON Turning OFF Insert your battery and close Each hearing aid will turn OFF the battery door securely. when you open the battery A 3-second delay occurs door (and the battery is no before your hearing aid turns longer touching the battery ON.
- Page 24 Use your hearing aids Battery indicators • Low battery: An indicator voicing the word “battery” will sound when battery voltage is low. NOTE: Actual time between low battery indicator and shutdown will vary depending on environmental noise levels and your use of the product.
- Page 25 User control Smart feature Short press (1 second) Long press (3 seconds) Tap Control Did you know you can also control your hearing aids using your mobile phone or other smart device? See the Miracle-Ear ® user manual at miracle-ear.com/app.
- Page 26 • Mobile calls To stream mobile phone calls to your hearing aids, see the Miracle-Ear App user manual at miracle-ear.com/app. ® This shows how to connect (“pair”) your smartphone to your hearing aids. Questions? Your hearing care professional can help.
- Page 27 Use your hearing aids Wipe hearing aids daily over a soft cloth to prevent damage should they drop to a hard surface. If the hearing aid falls/ drops onto a hard surface, it could cause the shell or casing to break and/or become damaged. This includes mechanical stress or shock of the device.
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Page 28: Care For Your Hearing Aids
Care for your hearing aids Storage tips When you’re not wearing your hearing aids, protect them from damage using these storage tips: • Store them inside your storage case, so they’re ready to use again. • Choose a cool, dry location, away from heat and moisture. Avoid direct sunlight if you can. - Page 29 Care for your hearing aids To replace your wax guards: Insert the empty end of the application stick straight into the used wax guard of your hearing aid. Push firmly. Pull the application stick straight out to remove the used wax guard.
- Page 30 Care for your hearing aids Use the opposite end of the application stick to insert the new wax guard straight into the hearing aid. Push firmly. Pull straight out to remove the application stick. Do not twist. Discard the application stick. Done!
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Page 31: Troubleshooting Guide
Troubleshooting guide... - Page 32 Troubleshooting guide If, for any reason, your hearing aid does not operate properly, do NOT attempt to fix it yourself. Not only are you likely to violate any applicable warranties or insurance, you could easily cause further damage. Should your hearing aid fail or perform poorly, check this troubleshooting guide for possible solutions.
- Page 33 Troubleshooting guide Symptom Possible causes Solutions 1. Clean your hearing aids. Blocked microphone or wax 2. Replace the wax guards guard and sound outlet. as needed. Clean the microphone, as well Hearing aids as the wax guard and sound Buildup of debris. are not loud outlet with your cleaning tool enough.
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Page 35: Additional Guidance
Additional guidance • Intended use • FCC information • Regulatory information... -
Page 36: Intended Use
Intended use Intended Use: An air conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing. Hearing aids are available in multiple gain/output levels appropriate to treat hearing losses ranging from mild to profound. Your hearing aids are designed to operate in public and residential environments and are designed to comply with international Electromagnetic Compatibility emissions and immunity standards for medical devices. - Page 37 Intended use CAUTION: • If the product is hot, do not touch it until cool. • If the product is not working, do not disassemble. Due to a shock hazard, please send in for repair. • Keep out of reach from children. Do not ingest anything in the package, including desiccant, cleaning tool, etc.
- Page 38 Intended use Required Custom Tinnitus+ Information for Hearing Care Professionals ™ INDICATIONS FOR USE The Custom Tinnitus+ Technology is a tool to generate sounds to be used in a ™ Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age.
- Page 39 Intended use For the Patient A tinnitus therapy instrument is an electronic instrument intended to generate noise of sufficient intensity and bandwidth to treat ringing in the ears. It can also be used as an aid in hearing external sounds and speech. Custom Tinnitus+ Technology is a tool to generate sounds.
- Page 40 Intended use CAUTION: If set to the maximum output level and worn for periods of time exceeding the recommendations below, your exposure to sound energy has the potential to exceed noise exposure limits. You should not use your hearing aid for more than sixteen (16) hours a day if your hearing aid is set at the maximum output level, nor should you use your hearing aid if your hearing care professional has set the hearing aid at levels that exceed your comfort level.
- Page 41 Intended use WIRELESS TECHNICAL DESCRIPTION Your hearing aids contain a radio transceiver utilizing Bluetooth Low Energy wireless technology operating in the 2.4-2.4835 GHz frequency band with a maximum effective radiated power of 0 dBm using GFSK transmission modulation. The receiver section of the radio has a bandwidth of 1.5 MHz.
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Page 42: Fcc Information
Intended use WIRELESS NOTICES FCC ID: EOA-24GENCICZN IC: 66903A-24GENCICZN FCC information These devices comply with part 15 of the FCC rules and with ISED Canada license- exempt RSS standards. Operation is subject to the following two conditions: (1) The device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation of the device. -
Page 43: Regulatory Information
Regulatory information Manufactured for: Miracle-Ear 150 South Fifth Street, Suite 2300 Minneapolis, MN 55402 Waste from electronic equipment must be handled according to local regulations Consult user manual Keep dry Instructions for Disposal of Old Electronics Miracle-Ear encourages and your local community laws may require, that your ®... - Page 44 Regulatory information Symbol Symbol Symbol Meaning Applicable Standard Number BS EN ISO Manufacturer 5.1.1 15223-1:2021 Manufacturer symbol – To identify the manufacturer of a product Authorized representative BS EN ISO in the European 5.1.2 15223-1:2021 Community BS EN ISO EEA/EU/EC European Authorised Date of Manufacture 5.1.3 Representative symbol...
- Page 45 Regulatory information Symbol Symbol Symbol Meaning Applicable Standard Number EC 60601-1, Reference no. General warning sign ISO 7010-W001 Table D.2, Safety sign 2 Refer to instruction EC 60601-1, Reference no. ISO 7010-M002 manual/booklet Table D.2, Safety sign 10 DIRECTIVE 201 Collect Separately Annex IX 2/19/EU (WEEE)
- Page 46 Notes...
- Page 47 Notes...
- Page 48 Distributed By Miracle-Ear, Inc. 150 South Fifth Street, Suite 2300 Minneapolis, MN 55402 www.miracle-ear.com Use of the Made for Apple badge means that an accessory has been designed to connect specifically to the Apple product(s) identified in the badge, and has been certified by the developer to meet Apple performance standards.