Cochlear Osia 2 User Manual
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Cochlear Osia 2 User Manual

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Cochlear
Osia
2 and 2(I)
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Sound Processor Kits
User manual

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Summary of Contents for Cochlear Osia 2

  • Page 1 EN-US English Cochlear Osia 2 and 2(I) ™ ® Sound Processor Kits User manual...
  • Page 2 OSI300 implant. When the variant is relevant, the sound processor will be referred to as the Osia 2 Sound Processor or the Osia 2(I) Sound Processor. When the variant is not relevant, the sound processor will simply be referred to as the sound processor.

  • Page 3: About This User Manual 2 Symbols Used In This Manual

    Important information or advice. Time-saving hint. CAUTION (no harm) Special care to be taken to ensure safety and effectiveness. Could cause damage to equipment. WARNING (harmful) Potential safety hazards and serious adverse reactions. Could cause harm to person. © Cochlear Limited 2024...

  • Page 4: Table Of Contents

    Replace the magnet Operating characteristics Replace the magnet of an Wireless communication link Osia 2 Sound Processor ..16 Electromagnetic compatibility Replace the magnet of an Osia 2(I) (EMC) Sound Processor ... . . 18 Guidance and manufacturer’s...
  • Page 5 Summary of safety and clinical performance Serious incidents What is a serious incident? ..54 Reporting a serious incident . . . 54 Legal statement Product order overview Key to symbols Radio symbols © Cochlear Limited 2024...

  • Page 6: Overview

    Overview THIS WAY UP Front, Osia 2/2(I) Sound Processor Indicator light Control button Microphone ports Cover Back, Osia 2 Back, Osia 2(I) Sound Processor Sound Processor Attachment holes for the Safety Line Battery Battery door door Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual...

  • Page 7: Intended Use

    (inner ear) with the purpose of enhancing hearing. Osia 2 Sound Processor / Osia 2(I) Sound Processor The Osia sound processor is intended to be used as part of the Cochlear Osia System. The sound processor picks up surrounding sound and transfers it to the implant through a digital inductive link.

  • Page 8: Contraindications

    • Skin or scalp conditions that may preclude attachment of the sound processor or that may interfere with the use of the sound processor. Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 9: Use

    You can choose between programs to change the way the sound processor manages sound. You and your hearing health professional will have selected up to four preset programs for the sound processor. Program 1 Program 2 Program 3 Program 4 © Cochlear Limited 2024...

  • Page 10: Adjust Volume

    Program 3: 3 beeps, 3 orange flashes Program 4: 4 beeps, 4 orange flashes NOTE You will only hear the audio signal if you are wearing the sound processor. You can also use the Cochlear™ Osia Smart App to change ® programs.* Adjust volume Your hearing health professional has set the volume level for the sound processor.

  • Page 11: Power

    (~30 seconds). When it is attached again, it will automatically turn on again within a few seconds. As sleep mode will still consume some power, the device should be turned off when not in use. © Cochlear Limited 2024...

  • Page 12: Change The Battery

    4. Remove the sticker on the + side of the new battery and let it stand for a few seconds. 5. Insert the new battery with the + sign facing upwards in the battery door. (C) 6. Gently close the battery door. (D) Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 13: Lock And Unlock The Battery

    Batteries can be harmful if swallowed. Be sure to keep batteries out of reach of small children and other recipients in need of supervision. In the event of a battery being swallowed, seek immediate medical attention at the nearest emergency centre. © Cochlear Limited 2024...

  • Page 14: Replace The Magnet

    Replace the magnet There are two sets of magnets and magnet tools, one for the Osia 2 Sound Processor and one for the Osia 2(I) Sound Processor. Refer to the table on page 15 to identify which magnet and magnet tool to use.
  • Page 15 Refer to the section Refer to the section “Replace “Replace the magnet of an the magnet of an Osia 2(I) Osia 2 Sound Processor” on Sound Processor” on page 18. page 16. © Cochlear Limited 2024...

  • Page 16: Replace The Magnet Of An Osia 2 Sound Processor

    Replace the magnet 5. Turn the magnet tool of an Osia 2 Sound anticlockwise to loosen the Processor magnet. Remove the old magnet 1. Open the battery door. 2. Remove the battery. 6. Pull the magnet out. 3. Remove the cover.
  • Page 17 “click” on both sides of the button. (A) 5.3 Press down on the cover between the microphone ports until you feel a “click”. (B) 5.4 Insert the battery. 5.5 Close the battery door. (C) © Cochlear Limited 2024...

  • Page 18: Replace The Magnet Of An Osia 2(I) Sound Processor

    Replace the magnet 5. To loosen the magnet, of an Osia 2(I) turn the magnet tool Sound Processor anticlockwise until the white line on the magnet tool is Remove the old magnet aligned with the white line 1. Open the battery door.
  • Page 19 2. Insert the magnet into the sound processor. Make sure that the white line in the magnet tool is aligned with the white line on the sound processor. © Cochlear Limited 2024...
  • Page 20 If the cover is not correctly attached, you can experience poor Incorrect positions of the sound quality. magnet in the sound processor Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 21: Wear

    Wear Wear the Osia 2 Sound Processor Place the sound processor on your implant with the button/light facing up and battery door facing down. CAUTION It is important to position the sound processor correctly. Correct positioning enables its best performance.

  • Page 22: For Users With Two Implants

    If you have two implants, you must use the correct sound processor for each implant. The sound processor will be programmed to recognise the implant’s ID, so it will not work on the wrong implant. Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 23: Pad

    Attach a Cochlear SoftWear™ Pad The Cochlear SoftWear™ Pad is optional. If you experience discomfort when wearing the sound processor, you can attach this adhesive pad to the back of the sound processor. NOTE You may need a stronger magnet and new feedback calibration measurement after attaching the SoftWear Pad.

  • Page 24: Attach A Safety Line

    1. Lift the tab to open the clip. (A) 2. Place the clip on your clothing and press down to close. (B) 3. Wear the sound processor as usual. Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...
  • Page 25 3. Press down on the ends to close the clip. (C) 4. Wear the sound processor as usual. Wear the headband The Cochlear Headband is an optional accessory that holds the sound processor in place on your implant. This accessory is useful for children or when performing physical activities.
  • Page 26 5. Place the headband on your head (C). Make sure that: the anti-slip section is against your forehead the sound processor is over your implant the headband fits firmly the hook-and-loop fastener join is secure (press firmly). Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...
  • Page 27 2. Press down on the cover around the button until you feel a “click” on both sides of the button. (A) 3. Press down on the cover between the microphone ports until you feel a “click”. (B) 4. Close the battery door. (C) © Cochlear Limited 2024...
  • Page 28 (See the “Audio and visual indicators” section on page 32). TO DEACTIVATE FLIGHT MODE: Turn the sound processor off and then on again (by opening and closing the battery door). Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 29: Wireless Devices

    Wireless devices You can use Cochlear wireless devices to enhance your listening experience. To learn more about the options available, ask your hearing health professional or visit www.cochlear.com. TO PAIR THE SOUND PROCESSOR TO A WIRELESS DEVICE: 1. Press the pairing button on your wireless device.

  • Page 30: Care

    • Secure the sound processor with a Safety Line or use the headband during physical activities. If the physical activity involves contact, Cochlear recommends removing the sound processor during the activity. • After exercise, wipe the sound processor with a soft cloth to remove sweat or dirt.
  • Page 31 • If sand or dirt enters the sound processor, try to remove it carefully. Do not brush or wipe in the indents or holes of the casing. © Cochlear Limited 2024...

  • Page 32: Audio And Visual Indicators

    1-4 beeps Volume level increased/decreased by one step. 1 beep Volume limit reached. 1 long beep Low battery warning. 4 beeps 4 times Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...
  • Page 33 2 × ripple tone downward melody MFi pairing confirmation. 6 beeps followed by ripple tone upward melody (about 20 seconds after pairing) Change from one wireless device to another. Ripple tone upward melody © Cochlear Limited 2024...

  • Page 34: Visual Signals

    Volume limit reached. 1 long flash Low battery warning. Rapid flashes for 2.5 seconds Wireless signals Light What it means Wireless streaming activated. 1 long flash followed by 1 short flash Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 35: Troubleshooting

    3. Make sure that the correct battery-type is used. See requirements for battery on page 11. 4. Ensure that the sound processor is placed correctly, see “Wear”, page 21. 5. If the problems continue, contact your hearing health professional. © Cochlear Limited 2024...
  • Page 36 You experience tightness, numbness, discomfort or develop a skin irritation at your implant site 1. Try using an adhesive Cochlear SoftWear pad. See “Attach a Cochlear SoftWear™ Pad”, page 23. 2. If you are using a retention aid, such as a headband, this may be placing pressure on the sound processor.

  • Page 37: Cautions

    If you experience a significant change in performance, remove the sound processor and contact your hearing health professional. • The sound processor and other parts of the system contain complex electronic parts. These parts are durable but must be treated with care. © Cochlear Limited 2024...

  • Page 38: Batteries

    Store spare magnets safely and away from cards that may have a magnetic strip (e.g. credit cards, bus tickets). Batteries • Use only Cochlear supplied or recommended high power 675 (PR44) zinc air battery designed for hearing implant use. • Insert the battery in the correct orientation.

  • Page 39: Warnings

    • Dispose of used batteries promptly and carefully, in accordance with local regulations. Keep the battery away from children. • Do not allow children to replace batteries without adult supervision. © Cochlear Limited 2024...

  • Page 40: Sound Processors And Parts

    Mobile communications (GSM) as used in some countries), may interfere with the operation of your external equipment. You may hear distorted sound when close, 1-4 m (~3-12 ft), to a digital mobile telephone in use. Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 41: Batteries

    • The Osia implant is MR Conditional. For full MRI safety information refer to the information supplied with the system, or contact your regional Cochlear office (contact numbers available at the end of this document). • If the patient is implanted with other implants, consult the manufacturer’s instructions before performing an MRI.

  • Page 42: Other Information

    Sound processor enclosure: PA12 (Polyamide 12) • Magnet housing, Osia 2 Sound Processor: PA12 (Polyamide 12) • Magnet housing, Osia 2(I) Sound Processor: ABS TX-0520K • Magnets: Gold coated Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 43: Environmental Conditions

    (0.409 in) Product weight Sound processor Weight Sound processor (no batteries or magnet) 6.2 g Osia 2 Sound Processor (including Magnet, 7.8 g strength 1) Osia 2 Sound Processor (including Magnet, 9.4 g strength 1, and a zinc air battery) Osia 2(I) Sound Processor (including 9.8 g...

  • Page 44: Operating Characteristics

    Turn the sound processor on and off, activate flight mode Battery One PR44 (zinc air) button cell battery, 1.4V (nominal) Only high power 675 zinc air batteries designed for cochlear implants should be used Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 45: Wireless Communication Link

    It continuously switches between channels to avoid interference on any specific channel. Bluetooth Low Energy also operates in the 2.4 GHz ISM band, using frequency hopping over 37 channels to combat interference. © Cochlear Limited 2024...

  • Page 46: Electromagnetic Compatibility (Emc)

    Class B directly connected to public low- voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions applicable IEC 61000-3-2 Voltage fluctuations/ applicable flicker emissions IEC 61000-3-3 Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 47: Guidance And Manufacturer's

    Power frequency Hz) magnetic field magnetic fields IEC 61000-4-8 should be at levels The functionality is characteristic of a assessed by monitoring typical location in a the stimulation typical commercial or sinusoidal audio signal. hospital environment © Cochlear Limited 2024...
  • Page 48 30 cm (12 in.) to any part of the sound processor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 49: Radio Frequency Identification

    WARNING Use of accessories, transducers and cables other than those specified or provided by Cochlear could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. NOTE At 80 MHz and 800 MHz, the higher frequency range applies.

  • Page 50: Environmental Protection

    This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications made to this equipment not expressly approved by Cochlear Limited may void the FCC authorization to operate this equipment. Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual...
  • Page 51 Increase the separation between the equipment and receiver. • Connect the equipment into an outlet or a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. © Cochlear Limited 2024...

  • Page 52: Osia 2 Sound Processor

    Certification and applied standards Hereby, Cochlear declares that the radio equipment of the Osia 2/2(I) Sound Processor is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: https://www.cochlear.com/intl/about/company-information/ declaration-of-conformity Cochlear™...

  • Page 53: Privacy And The Collection Of Personal Information

    Cochlear and others involved in care with regard to the device. For more information please read Cochlear’s Privacy Policy on www.cochlear.com/privacy or request a copy from Cochlear at the address nearest you.

  • Page 54: Serious Incidents

    Serious incidents Serious incidents are rare, any serious incident in relation to your device should be reported to your Cochlear representative and to the medical device authority in your country, if available. What is a serious incident? A ‘serious incident’ means any event that directly or indirectly has...

  • Page 55: Product Order Overview

    The below items are available as accessories and spare parts for the sound processor. NOTE Items that are named Nucleus or Baha are also compatible ® ® with the Osia 2/2(I) Sound Processor. Product Product code Sound processors P1233400 Osia 2 Sound Processor Kit P1900830...
  • Page 56 Baha Remote Control 2, GB 94791 Baha Remote Control 2, US Sound processor magnets P1631251 Osia 2 Sound Processor Magnet – strength 1 P1631252 Osia 2 Sound Processor Magnet – strength 2 P1631263 Osia 2 Sound Processor Magnet – strength 3 P1631265 Osia 2 Sound Processor Magnet –...
  • Page 57 Sound processor covers P1244703 Black – 2 pcs P1244706 Chocolate Brown – 2 pcs P1244705 Sandy Blonde – 2 pcs P1244701 Silver Grey – 2 pcs P1244702 Slate Grey – 2 pcs Inner case P1247104 Inner Case © Cochlear Limited 2024...

  • Page 58: Key To Symbols

    Separate disposal of electronic device Body number electronic device 0123 Keep dry UK Conformity mark with approved body 0168 number Medical device Store at room temperature Unique device identifier Cochlear™ Osia 2 and 2(I) Sound Processor Kit User manual ®...

  • Page 59: Radio Symbols

    Radio symbols FCC ID: QZ3OSIA2 USA product label requirements IC: 8039C-OSIA2 Canada product label requirements 8039C-OSIA2I Australia/New Zealand label requirements © Cochlear Limited 2024...
  • Page 60 U.S. and other countries. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cochlear Limited is under license. © Cochlear Limited 2024. All rights reserved.

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Osia 2i

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