Health Canada’s statement on ‘ear candling’

The following is an excerpt from a statement on ‘ear candling’ sent to CBC
Marketplace from Health Canada:

“Our view on the efficacy of ear candles is that they do not produce the
physical effects claimed by their promoters, namely heating of the ear canal and
the creation of a suction effect. Our laboratory tests demonstrated that the
candle produces no significant heating or suction in the ear canal. The only
test results provided by manufacturers support our conclusions. In 1998, one
manufacturer sent the Therapeutic Products Programme test results conducted for
them by a private laboratory. One test measured the air temperature at a
distance of 10 mm from the base of the cone while the candle was burning. At no
time did the temperature rise above 22 degrees Celsius. Since body core
temperature is 38 degrees Celsius, these tests support our conclusion that the
candle produces no heating effect. Another series of tests measured the pressure
in a closed vessel attached to the burning candle. The laboratory concluded that
“In general, the results observed did not indicate any significant increase or
decrease in the ambient pressure of the vessel.”

These results are also supported by a study conducted by Daniel R. Seely,
Suzanne M. Quigley and Alan W. Langman and published in the journal
Laryngoscope, vol. 106, pp 1226-1229, October, 1996. The authors measured the
pressure in a vessel connected to the ear candle. They concluded that “No
negative pressure was generated by any of the burning ear candles at any point
during the trial.”

The U.S. Food and Drug Administration, in its import alert against ear
candles published September 1, 1998, states that “The product labeling is false
and misleading in that there is no validated scientific evidence to support the
efficacy of the product for its intended use.”

Our view of the safety of ear candles is that they pose a risk of fire and
injury to the ear from dripping wax. This risk is unjustified by the dubious
benefits of the device. The US FDA import alert states that: “CDRH considers the
product to be dangerous when used according to its labeling, since the use of a
lit candle in the proximity of a person’s face would carry a high risk of
causing potentially severe skin/hair burns and middle ear damage.”

The paper by Seely et al. reported that a survey of 122 otolaryngologists
identified 21 ear injuries resulting from the use of ear candles. There were 13
burns of the auricle and external auditory canal, 7 partial or complete
occlusions of the ear canal with candle wax and one tympanic membrane
perforation. Six patients suffered temporary hearing loss. The authors concluded
that “ear candles have no benefit in the management of cerumen (ear wax) and may
result in serious injury.”

With regard to the removal of health claims from the labelling and
advertising for the ear candles, our view is that the public will still perceive
the purpose of ear candles to be for some therapeutic effect, since there is no
other reasonable use for them. We would therefore still regard ear candles as
being medical devices.

In conclusion, our view is that ear candles are considered to be Class I
medical devices that do not meet the safety and efficacy requirements of
Sections 10 to 20 of the Medical Devices Regulations.”

Below is the link to the original article on ear candling from CBC Marketplace.



By lorraine | Posted in News | Comments (0)

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