User's Manual

2
This guide is intended for recipients and caregivers
using the Cochlear
™
Osia
®
2 Sound Processor as part
of the Cochlear Osia System.
Intended use
The Cochlear Osia System uses bone conduction to transmit
sounds to the cochlea (inner ear) with the purpose of enhancing
hearing. The Osia Sound Processor is intended to be used as part
of the Cochlear Osia System to pick up surrounding sound and
transfer it to the implant through a digital inductive link.
Indications
The Osia System is intended for the following patients and
indications:
• Patients 12 years of age or older.
• Patients who have a conductive or mixed hearing loss and still
can benefit from sound amplification. The pure tone average
(PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2,
and 3 kHz) should be better than or equal to 55 dB HL.
• Bilateral fitting of the Osia System is intended for patients
having a symmetrically conductive or mixed hearing loss. The
difference between the left and right sides’ BC thresholds
should be less than 10 dB on average measured at 0.5, 1, 2, and
3 kHz, or less than 15 dB at individual frequencies.
• Patients who have profound sensorineural hearing loss in one
ear and normal hearing in the opposite ear (i.e., single-sided
deafness or “SSD”). The pure tone average air conduction
hearing thresholds of the hearing ear should be better than or
equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
• The Osia System for SSD is also indicated for any patient who is
indicated for an air-conduction contralateral routing of signals
(AC CROS) hearing aid, but who for some reason cannot or will
not use an AC CROS.
• Prior to receiving the device, it is recommended that an
individual have experience with appropriately fitted air
conduction or bone conduction hearing aids