The
most common cause of vertigo caused by the inner ear is a disease called Benign
Paroxysmal Positional Vertigo (BPPV) or Benign Paroxysmal Vertigo (BPV)
The ear normally uses small crystals called “otoconia” to determine
the direction of gravity. In a disease state these crystals come loose and float
around inside the inner ear. These crystal particles cause the sensation of vertigo
(spinning) every time they are disturbed by head motion.
The general objective of the DizzyFIX device is to visually guide
the user though the particle repositioning maneuver (Epley maneuver) and achieve successful treatment
of BPPV.
The device attaches to any common baseball hat. The device consists of a special
tube filled with fluid. The device also contains a particle representing the otoconia
found in the inner ear. The shape of the tube and the motion of the particle provide
feedback as to the performance of the particle repositioning maneuver.
Simply put, guide the particle through the device and you will have treated your BPPV.
The device enables people to diagnose BPPV, determine the affected side and treat
BPPV with similar success as an Otolaryngologist.
The device enables the user to repeat the maneuver as often as required. BPPV
may be a chronic condition and up to 60% of people will experience relapse in
their lifetime. The DizzyFIX enables people to treat recurrent episodes quickly
and effectively.
When you order the DizzyFIX, you will promptly receive the DizzyFIX device, a DizzyFIX hat, an easy-to-understand written instruction manual, a quick reference card, and an full instructional DVD video. (Everything is in both English and French). You will also gain access to our toll-free support line if you have any questions.
More about the DizzyFIX
The DizzyFIX is highly effective. Preliminary tests by Clearwater Clinical indiciate
that using the device affects the way people perform the maneuver. Clinical trials
at the University of Western Ontario indicate that it effectively treats active
BPPV with a 92% success rate. Although the DizzyFIX may be of use in Vestibular Rehabilitation
its primary use is in the treatment of BPPV. The DizzyFIX is not recommended for
the treatment of other vestibular disorders.
The DizzyFIX is a scientific but entirely non-pharmaceutical therapy. The nature
of the disease necessitates that people who use the device experience vertigo,
for one last time, as the particles which cause BPPV are repositioned. There are
no side effects to this maneuver and it can be repeated as often as required. Common
sense should be employed while using this device. Users are encouraged to have
supervision while using the device and to conduct the maneuvers on the floor such
that a fall during repositioning is not possible. People with limited neck mobility
or other neck problems should consult their family doctor prior to use of the device.
The DizzyFIX device for treatment of BPPV is a Class I medical device according
to Rule 7( 1) of the Medical Devices Regulations and has been reviewed and determined
to be such by the Device Licensing section of the Medical Devices Bureau of Health
Canada.
The DizzyFIX also complies with Canada's Medical Devices Regulations, which include:
Safety and effectiveness (Sections 10 to 20)
Labelling (Sections 21 to 23)
Distribution records (Sections 52 to 58)
Mandatory problem reporting (Sections 59 to 62)
Recall requirements (Sections 63 to 65)
It also complies with the requirements of Sections 3 and 19 to 21 of Canada's Food
and Drugs Act.
CLEARWATER has made application for an Establishment Licence from Canada's Health
Products and Food Branch (HPFB) Inspectorate.
DizzyFIX is CE registered in the EU.
Clearwater Holdings EU limited (authorized representative)
The
most common cause of vertigo caused by the inner ear is a disease called Benign
Paroxysmal Positional Vertigo (BPPV) or Benign Paroxysmal Vertigo (BPV)
