Neuro-Audio (Technical Manual)
6
Intended Use
The
Neuro-Audio
system is intended for use in electrophysiological and audiologic
evaluation of hearing and vestibular function as an aid in detecting hearing loss and
diagnosing hearing and vestibular related disorders. It can be used for screening and
diagnostic applications. It allows recording auditory brainstem response (ABR) and
other auditory evoked potentials (AEP), otoacoustic emissions (OAE) and screening
pure tone audiometry (PTA).
Neuro-Audio bone conduction amplifier unit is intended to record bone conduction
VEMPs. The target population for
Neuro-Audio
includes all ages.
The
Neuro-Audio
system must be used by trained personnel only, such
as audiologists, ENT surgeons, hearing healthcare professionals, trained technicians
or personnel with a similar level of education in a hospital, clinic, healthcare facility
or other appropriate professional healthcare setting. The device should not be used
without the necessary knowledge and training to understand its use and how results
should be interpreted.
Contraindications
The
Neuro-Audio
system must not be used:
·
if patient suffers from external otitis;
·
if the insertion of the ear probe (or application of any other transducer) in the ear
canal makes patient feel pain.
The
Neuro-Audio
system can be used, but with care:
·
if patient has allergic or infectious skin diseases at the electrode or transducer
application sites.
Side Effects
There are no known undesirable side effects for the
Neuro-Audio
system.