2
3
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.