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Hearing loss or ringing (tinnitus) only in one ear or noticeable difference in hearing between ears
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Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz.
Outputs over 132 dB SPL:
You should exercise special care in selecting and fitting a hearing aid with a maximum output that exceeds
132 dB SPL because it may impair the remaining hearing of the hearing aid user.
Sound pressure level in the ears of children:
The developed sound pressure level in the ears of children can be substantially higher than in average
adults.It is recommended to perform an RECD measurement in order to ensure the correct target for the
fitted OSPL90.
CAUTION:
This is not hearing protection
You should remove this device if you experience overly loud sounds, whether short or long-lasting. If
you're in a loud place, you should use the right kind of hearing protection instead of wearing this device. In
general, if you would use ear plugs in a loud place, you should remove this device and use ear plugs.
The sound output should not be uncomfortable or painful
You should turn down the volume or remove the device if the sound output is uncomfortably loud or
painful. If you consistently need to turn the volume down, you may need to further adjust your device.
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FDA warnings and cautions (US only)
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