eMKW-TD0054-21- Page 3
to use:
1. Inside a sound-treated booth, similar to traditional audiometer/ booth setup,
2. In healthcare facilities,
3. In the clinician's consultation room,
4. At schools, factories, shops and old age homes,
5. In conditions where open air testing is clinically required - for example, in cases of subjects with
contagious diseases (i.e. MDR-TB),
6. Alongside a hospital bed, or inside a prison cell,
7. Where test room ambient noise certification services are limited,
8. Where trusted testing is needed in conditions where ambient noise levels fluctuate,
9. Where there is a need to conduct a remote test as a result of not having a clinician onsite to
perform the test,
10. Where there is a need for automatic testing as a result of mass audiometric testing and/ or lack
of qualified professionals onsite,
11. Where there are poor infrastructure and a shortage of technicians to calibrate audiometers
and certify test rooms to be quiet enough for compliant testing, and
12. Where the audiometer needs to travel regularly from one test site to the next.
Contra-Indications
The KUDUwave cannot be used to do behavioural testing in subjects that cannot clearly indicate when
they heard the sounds presented, for example younger children (less than 12 months of age) and mentally
compromised test subjects.
The KUDUwave acoustic immittance and pure tone testing should not be conducted if;subjects have
otorrhea, otitis externa, or the presence of a foreign body in the ear canal.
Residual Risk
● Cross-infection between patients when eartips are re-used. Please do not re-use eartips on
various patients.
● Cross-contamination between patients when applied parts are not sufficiently cleaned
according to the instructions provided. Please ensure that these parts are cleaned sufficiently
between patients.
● Temporary threshold shift (TSS) can occur when loud tones are played for extended periods of
time. Please do not present loud tones over extended periods of time.
● Possible temporary patient discomfort caused by the silicone sleeve of the KUDUwave OH.
Although discomfort may be experienced by some patients, please do not modify the sleeve
as it provides robustness and physical protection from shock, based on the device's intended
purpose.
Device Description and Application
The KUDUwave is a portable, PC controlled, USB-powered, audiometric device capable of performing
diagnostic testing for pure-tone, speech and aural acoustic impedance/admittance audiometry outside a
certified sound room.
The device is manufactured as a headset with two ear cups and a head-band joining the two earcups. It
connects to a Windows PC using two 3 m USB cables and is supplied with a USB Patient Response Button
which can be plugged into the PC or the headset itself.
The device makes use of insert earphones and passive noise-attenuating ear cups to allow for compliant
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