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Insera
in-the-ear (ITE)
hearing aid guide
Powered by Blu
A Sonova brand

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Summary of Contents for Unitron Insera B1-312

  • Page 1 Insera in-the-ear (ITE) hearing aid guide Powered by Blu A Sonova brand...
  • Page 2 Your hearing aid details This user guide applies to the following models: Hearing aids If no box is checked and you do not know the model of your hearing aid, please ask your Wireless models: hearing care professional. Insera B1-312* ™...
  • Page 3: Table Of Contents

    Thank you for choosing these hearing aids. 2. Parts of the hearing aid ............4 Unitron is a hearing solution company that believes 3. Left and right hearing aid markings ........6 people should feel really good about the entire 4.
  • Page 4: Quick Guide

    1. Quick guide On/Off Left and right hearing aid markings Blue marking for left hearing aid. Push button Red marking for right hearing aid. Models with this option only: The push button on your hearing Left Right aid can have various functions. Changing batteries Volume control Models with this option only:...
  • Page 5: Parts Of The Hearing Aid

    2. Parts of the hearing aid Insera B-312 (wireless) Sound outlet / wax protection system The following pictures show the models described in this user guide. You can identify Custom made shell your personal model by: Push button • Checking “Your hearing aid details” inside Battery door Volume control front of this guide.
  • Page 6: Left And Right Hearing Aid Markings

    3. Left and right hearing aid markings 4. Turning your hearing aids on and off There is a red or blue marking to tell you if it is a left or a right hearing aid. The color mark is The battery door is also the on/off switch. located on the battery door, on the shell (text Closed battery door printed in red or blue) or the shell is colored red...
  • Page 7: Batteries

    5. Batteries Low power: You will hear two beeps when the battery is low. You will have Remove the sticker from the approximately 30 minutes to change the new battery and wait two battery (this can vary, depending on the minutes hearing aid settings and battery).
  • Page 8: Putting On The Hearing Aid

    6. Putting on the hearing aid • Check the following table Inserting your hearing aid 1. Hold the hearing aid Model Zinc air Color ANSI between your thumb battery marking on code code size package and index finger with Insera the battery door facing B-312 brown...
  • Page 9: Removing Your Hearing Aid

    7. Removing your hearing aid 8. Push button Your hearing aids may come with two controls With a removal handle that allow you to further adjust them – a push Hold the removal handle button and a rotary dial. and carefully pull the hearing aid up and out of Models with this option only: the ear.
  • Page 10 Push button as program control Push button as volume control If the push button has been configured as If your push button has been configured as a a program control, each time you push the volume control, either: button, you will move to a different hearing aid Push the button on your right hearing aid to •...
  • Page 11: Volume Control Dial

    9. Volume control dial Volume setting Beeps Models with this option only: Suggested volume level 1 beep To increase the volume, Turning volume up short beep turn the volume control Turning volume down short beep forwards (towards nose). Maximum volume level 2 beeps To decrease the volume, turn the volume control...
  • Page 12: Iic Remote Control

    10. IIC Remote Control Promptly remove the magnet as soon as your hearing aid is in the desired program or the Adjusting Insera B-10 NW O hearing aid volume is ideal for you. The IIC Remote Control contains a magnet that If you use a medical device like a pacemaker functions like a remote keychain...
  • Page 13: Connectivity Overview Insera B-312

    11. Connectivity overview Insera B-312 Using the Unitron Remote Plus app Compatibility information The illustration below shows the connectivity options available for your hearing aids. Remote Plus app can be used on phones with Please see the user guide that came with your Bluetooth Low Energy (LE) capability.
  • Page 14: Initial Pairing Insera B-312

    12. Initial pairing Insera B-312 Consult your phone user guide for instructions on pairing a Bluetooth device with your phone. Initial pairing to Bluetooth® enabled device It is only necessary to perform the pairing 1. On your device (e.g. a phone), ensure that procedure once with each device featuring Bluetooth wireless technology is enabled Bluetooth wireless technology.
  • Page 15: Phone Calls Insera B-312

    13. Phone calls Insera B-312 Making a call Enter the phone number and press the dial button. Your hearing aids connect directly with Bluetooth® enabled phones. When paired and You will hear the ring tone through your hearing connected to your phone, you will hear the aids.
  • Page 16 Ending a call Rejecting a call A call can be ended by a long press on the An incoming call can be rejected by a long press push button on either hearing aid (more than 2 on the push button on either hearing aid (more seconds) or directly on your phone.
  • Page 17: Flight Mode B-312

    14. Flight mode B-312 Insera B-312 NW O and Insera B-10 NW O only: Your hearing aids operate between 2.4 GHz– Easy-t 2.48 GHz frequency range. When flying, some Your hearing aids may also have a telephone operators require all devices to be switched feature, which automatically switches to a into flight mode.
  • Page 18: Assistive Listening Devices

    15. Assistive listening devices Exit flight mode To enable the wireless function and Listening in public places exit flight mode in each hearing aid: Telecoil is only available on Insera B-312 NW O, and Insera B-10 NW O models. Open battery door. Telecoils pick up electromagnetic energy and convert it into sound.
  • Page 19: Care And Maintenance

    16. Care and maintenance If your hearing aid is performing weakly or fails to operate, clean or replace the wax guard Diligent and routine care of your hearing aid system. If your hearing aid fails to operate after contributes to outstanding performance and you have correctly cleaned or replaced your wax a long service life.
  • Page 20: Operating, Transport And Storage Conditions

    17. Operating, transport and storage Insera B-10 NW O hearing aids are classified as IP68. This means that they are water and conditions dust resistant and designed to withstand daily life situations. It can be worn in the rain but The product is designed such that it functions should not be fully submerged in water or used without problems or restrictions if used as...
  • Page 21: Service And Warranty

    18. Service and warranty Warranty limitation This warranty does not cover damage from Local warranty improper handling or care, exposure to Please ask the hearing care professional where chemicals or undue stress. Damage caused you purchased your hearing aid about the terms by third parties or non-authorized service of the local warranty.
  • Page 22: Compliance Information

    19. Compliance information Notice 1 This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to Declaration of conformity the following two conditions: Hereby, Sonova AG declares that this product meets the 1) this device may not cause harmful interference, and requirements of the Medical Devices Regulation MDR 2) this device must accept any interference received,...
  • Page 23 • Reorient or relocate the receiving antenna Radio information of your wireless hearing aid • Increase the separation between the equipment and Antenna type Resonant loop antenna receiver Operation frequency 2.4 – 2.48 GHz • Connect the device into an outlet on a circuit different Modulation GFSK, Pi/4 DPSK, GMSK from that to which the receiver is connected...
  • Page 24: Information And Explanation Of Symbols

    20. Information and explanation of Immunity standards EN 60601-1-2 IEC 60601-1-2 symbols EN 61000-4-2 With the CE symbol, Sonova AG confirms that IEC 61000-4-2 this product – including accessories – meets the xxxx EN IEC 61000-4-3 requirements of the Medical Devices Regulation IEC 61000-4-3 MDR 2017/745 as well as the Radio Equipment EN 61000-4-4...
  • Page 25 Indicates the Authorized representative in the The symbol with the crossed-out garbage bin is European Community. The EC REP is also the to make you aware that this device may not be importer to the European Union. thrown away as normal household waste. Please dispose of old or unused devices, at waste This symbol indicates that it is important for the disposal sites intended for electronic waste,...
  • Page 26: Troubleshooting Guide

    21. Troubleshooting guide Keep dry Cause Possible remedy Issue: No sound, hearing aid not functioning This symbol confers that the electromagnetic interference from the device is under limits Not turned on Turn on approved by the US Federal Communications Low/dead battery Replace battery Commission.
  • Page 27 Cause Possible remedy Cause Possible remedy Issue: Not loud Issue: Intermittent Low volume Turn up volume; see hearing Low battery Replace battery healthcare professional for Dirty battery contact Consult your hearing models without a manual healthcare professional volume control or if problem persists Issue: Two long beeps Low battery...
  • Page 28 Cause Possible remedy Cause Possible remedy Issue: mobile phone calls not being heard through Issue: Not clear, distorted hearing aids (Insera B-312 hearing aids) Poorly fitting hearing Consult your hearing healthcare professional aids Hearing aids are in flight Exit flight mode: open Hearing aids blocked See “Care and maintenance”...
  • Page 29: Important Safety Information

    22. Important safety information Any serious incident that has occurred in relation to the hearing aid, should be reported Please read the information and limitations-of- to the manufacturer representative and the use information on the following pages before competent authority of the state of residence. using your hearing aid.
  • Page 30 The Tinnitus feature is intended for use Indications: by people with tinnitus who also desire General clinical indications for the use of amplification. It provides supplementary noise hearing aids and Tinnitus feature are: stimulation which can help defocus the user`s Presence of hearing loss •...
  • Page 31 pathologies such as absent/non-viable • Inflammation of the external auditory auditory nerve) canal • Perforated eardrum The primary criteria for the referral of a patient • Other abnormalities which the hearing for a medical or other specialist opinion and / or care professional believes are of medical treatment are as follows: concern...
  • Page 32 The recommendation will not have any and/or rashes, plugged or fullness and their • adverse effects on the patients health or consequences like headache and/ or ear pain, general well being; may be resolved or reduced by your hearing care professional. The records confirm that all necessary •...
  • Page 33: Warnings

    Warnings ! If you feel pain in or behind your ear, if it is inflamed or if skin irritation and accelerated ! WARNING: Device batteries are hazardous and can accumulations of earwax occur, please check with cause serious injuries if they are swallowed or your hearing care professional or physician.
  • Page 34 ! The following is only applicable for persons with manufacturer. Otherwise, degradation of the active implantable medical devices (i.e. performance of this equipment could result. pacemakers, defibrillators, etc.) ! Avoid strong physical impacts to the ear when wearing in-the-ear hearing aids. The stability of in- •...
  • Page 35 ! Patients implanted with magnetic externally Important information programmable CSF shunt valves may have a risk of These hearing aids are water resistant and not waterproof. They are designed to withstand normal experiencing an unintended change in their valve activities and occasional accidental exposure to setting when exposed to strong magnetic fields.
  • Page 36: Labeling

    The batteries used in these hearing aids should not Labeling exceed 1.5 Volts. Please do not use silver-zinc or Li-ion The serial number and year of manufacture are located on (lithium-ion) rechargeable batteries as these may the outside of the hearing aid. cause severe damage to your hearing aids.
  • Page 37 Mobile phone compatibility rating The performance of individual hearing aids Some hearing aid users have reported a may vary with individual cell phones. Therefore, please try the hearing aid with your cell phone buzzing sound in their hearing aids when they or, if you are purchasing a new phone, be sure are using cell phones.
  • Page 38: Tinnitus Masker

    Should you develop any side effects whilst Tinnitus masker using the noise generator such as headaches, The Tinnitus masker noise generator is a nausea, dizziness or heart palpitations or broadband sound Generator which may have experience a decrease in auditory function, you been enabled in your hearing aid.
  • Page 39: Warning To Hearing Aid Dispensers (To Comply With The U.s. Food And Drug Administration (Fda) Regulations)

    Warning to hearing aid dispensers Important notice for prospective hearing aid users (to comply with the U.S. Food and Drug Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician Administration (FDA) regulations) (preferably a physician who specializes in diseases of the ear) A hearing aid dispenser should advise a prospective before purchasing a hearing aid.
  • Page 40 beliefs that preclude consultation with a physician. The Patient feedback exercise of such a waiver is not in your best health interest Record your specific needs or concerns and bring to and its use is strongly discouraged. your first office visit after getting your hearing aids. Children with hearing loss This will help your hearing healthcare professional to In addition to seeing a physician for a medical evaluation,...
  • Page 42 Australian Sponsor : Sonova Australia Pty Ltd. 12 Inglewood Place, Norwest NSW 2153 Australia And importer for European Union : Sonova Deutschland GmbH Max-Eyth-Str. 20 70736 Fellbach-Oeffingen, Germany Pat. www.sonova.com/en/intellectualproperty For a listing of Unitron group companies, please visit www.unitron.com...
  • Page 43 Distributor Manufacturer: Sonova AG Laubisrütistrasse 28 CH-8712 Stäfa Switzerland 7 6 1 3 3 8 9 5 7 2 7 7 3...

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