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Contents

Intended use ............................................................................................................. 2
Indications ................................................................................................................. 2
Clinical benefit ......................................................................................................... 2
Serious incidents ..................................................................................................... 2
Symbols used in this guide ................................................................................... 2

Osia

®

 2 Aqua+ ........................................................................................ 4

Battery use with Aqua+ ....................................................................... 5

Before you get wet… ............................................................................ 6

Replace batteries .....................................................................................................6
Place sound processor in Aqua+ ......................................................................... 6
Attach Safety Line ...................................................................................................8
Attach goggles .........................................................................................................8
Using your Aqua+ .................................................................................................... 9

Wear ....................................................................................................... 10

After you get wet… care and storage ..............................................................11

 Cautions .......................................................................................12

 Warnings ......................................................................................12

Other information............................................................................... 14

Environmental conditions................................................................................... 14
Product dimensions (Typical values) ............................................................... 14
Product weight ...................................................................................................... 14
Material .................................................................................................................... 14
Certifications and applied standards  .............................................................. 14
Privacy and the collection of personal information .................................... 15
Warranty ................................................................................................................. 15
Legal statement ..................................................................................................... 15

Labelling symbols ................................................................................ 16

Indications

•  The Cochlear Osia System is 

indicated for patients with 
conductive, mixed hearing 
loss and single-sided 
sensorineural deafness 
(SSD).

•  Patients should have 

sufficient bone quality 
and quantity to support 
successful implant 
placement.

•  The Osia System is 

indicated for patients with 
up to 55 dB SNHL.

Clinical benefit

Most recipients of a bone 
conduction hearing solution 
will experience improved 
hearing performance and 
quality of life compared to 
unaided listening.

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.

Symbols used in this guide

NOTE

  

Important information or advice.

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.

Intended use

The Cochlear™ Osia® System uses bone conduction to transmit 
sounds to the cochlea (inner ear) with the purpose of enhancing 
hearing. The Cochlear Osia 2 Aqua+ is intended to be used as an 
accessory to the Cochlear Osia 2 Sound Processor. To maintain 
reasonable hearing above water in situations when there is a risk 
of water immersion of the sound processor, it creates a water tight 
and dust proof seal.

Summary of Contents for Osia 2 Aqua+

Page 1: ...1 Cochlear Osia 2Aqua User manual EN GB English ...

Page 2: ...patients with up to 55 dB SNHL Clinical benefit Most recipients of a bone conduction hearing solution will experience improved hearing performance and quality of life compared to unaided listening 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 avai...

Page 3: ... therefore cannot be used when sealed inside the Aqua You must use other disposable batteries such as alkaline nickel metal hydride or silver oxide batteries when using the Osia 2 Sound Processor with the Aqua Battery type Use with Aqua Estimated battery life Zinc air p675 PR44 No 22 to 35 hours Alkaline LR44 Yes 3 hours 30 minutes Nickel metal hydride P675 Yes 2 hours 20 minutes Silver oxide SR44...

Page 4: ... the button and the battery door aligned with the cut out in the base B 3 Align and place the cover on top of the base and press the two pieces together evenly C NOTE Ensure that as little air as possible is trapped in the Aqua Excess air will create feedback and attenuation CAUTION Make sure the Aqua is properly sealed so that water does not leak in and damage the sound processor CAUTION Make sur...

Page 5: ...r the implant site When you have found the correct spot on the goggle straps for the sound processor slide the band under the long clips A and then under the short clips B A B NOTE There is a wide variety of goggles on the market and you may have to find a model that fits the Aqua Using your Aqua Using the Everyday program with the Aqua will feedback when diving underwater due to the increased pre...

Page 6: ...deeper than 3 metres After you get wet care and storage 1 Rinse Aqua with clean water and dry with a soft cloth 2 Open the Aqua top cover and remove your sound processor 3 Allow your Aqua to dry overnight 4 Once it s thoroughly dry put the two halves together and test the seal by pressing down on the bottom CAUTION If any air leaks out you should not use it again but replace the Aqua with a functi...

Page 7: ...Users and caregivers must monitor for signs of discomfort or skin irritation if a retention aid e g headband is used that applies pressure to the sound processor Remove the aid immediately if there is any discomfort or pain and inform your hearing care professional If you experience tightness or pain from your retention aid e g Headband goggles either loosen it or replace it with a larger retentio...

Page 8: ...vice personal information about the user recipient or their parent guardian carer and hearing health professional will be collected for use by Cochlear and others involved in care with regard to the device For more information please read Cochlear s Privacy Policy on www cochlear com or request a copy from Cochlear at the address nearest you Warranty An undamaged and correctly assembled Aqua allow...

Page 9: ...esentative in the European Community Catalogue number Serial number Batch number Date of manufacture Recyclable packaging Recyclable material This device restricted to sale by or on the order of a physician Ingress Protection Rating Protected against failure from dust penetration Protected against failure from continuous immersion in water up to 3 metres depth for up to 2 hours 0123 CE registratio...

Page 10: ...18 19 Notes Notes ...

Page 11: ...many Tel 49 511 542 770 Fax 49 511 542 7770 Cochlear Americas 10350 Park Meadows Drive Lone Tree CO 80124 USA Tel 1 303 790 9010 Fax 1 303 792 9025 株式会社日本コクレア Nihon Cochlear Co Ltd 113 0033 東京都文京区本郷2 3 7 お茶の水元町ビル Tel 81 3 3817 0241 Fax 81 3 3817 0245 www cochlear com Cochlear 科利耳 コクレア 코클리어 Hear now And always Osia SmartSound the elliptical logo and marks bearing an or symbol are either trademarks ...

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