Doctors
CLiKX® Tympanostomy Tube Delivery System (CLiKX®
TTDS) is a “point, click and insert” surgical device system
allowing grommet tube insertion procedure to be made simpler
with lesser procedural steps. A single-use CLiKX® Shaft is
loaded with a tympanostomy tube, assembled with the CLiKX®
device and inserted into the ear canal close to the patient’s
tympanic membrane (eardrum) by a surgeon trained to perform
the myringotomy and tympanostomy tube insertion procedure,
where it is activated with a trigger press to perform an automated
myringotomy and tympanostomy tube insertion. Other features
include ergonomic design for surgeon to hold the device
comfortably, intuitive user interface for ease of application.
Intended Use
The CLiKX® TTDS is intended to create a myringotomy and
deliver a tympanostomy tube (also referred to as a ventilation
tube) through the tympanic membrane of the patient and is
indicated to be used in clinical settings for patients aged 6
months through adults. For professional use only. The CLiKX®
TTDS is indicated to be used for recurrent otitis media, chronic
otitis media with effusion or other conditions where the surgeon
chooses to insert a tympanostomy tube.
Contraindications
The following conditions are not suitable to be treated with the
CLiKX® TTDS
- Patients with severely atrophic (thin), dimeric or atelectatic eardrum
- Patients with severely thickened eardrum
- Patient with severely retracted eardrum
- Patients with soft tissues or tumor in the middle ear
- Ear canal condition that is too tortuous or narrow (<4mm) to provide sufficient visualization or access the targeted quadrant of the eardrum
- Patients with near horizontal or vertical eardrum angle
- Patients diagnosed with acute sensorineural hearing loss
- Previous tube placement less than a year ago
- Patients unable to or at high risk for any type of anaesthesia
- Pregnant woman
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