8.2 Serious incidents
Serious incidents are rare. Any
serious incident in relation to your
device should be reported to your
8.3 Performance characteristics
Measurements according to IEC 60118-9:2019 2nd Ed.
Output vibratory force level (re. 1 μN)
(90 dB SPL input, FOG)
Acousto-mechanical sensitivity level (re. 1 μN /
20 μPa) (50 dB SPL input, FOG)
Reference test acousto-mechanical sensitivity
level (re. 1 μN / 20 μPa)
(60 dB SPL input, RTS)*
Frequency range*
Equivalent input noise*
Battery current*
(65 dB SPL input at 1 kHz)
Total Harmonic Distortion*
70 dB SPL at 500 Hz
70 dB SPL at 800 Hz
65 dB SPL at 1600 Hz
60 dB SPL at 3200 Hz
*Performed with reference test setting
(RTS) of the gain control according to
IEC 60118-9:2019. The RTS is set to full-
on-gain minus 7 dB.
Cochlear representative and to the
medical device authority in your country,
if available.
Max 121 dB
HFA 113 dB
Max 48 dB
HFA 42 dB
HFA 35 dB
200-9850 Hz
24 dB SPL
1.8 mAh
< 3%
< 0.3%
< 0.3%
< 0.3%
FOG = Full On Gain
RTS = Reference Test Setting
HFA = High Frequency Average
SPL = Sound Pressure Level re. 20 μPa
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