The following is an excerpt from a statement on 'ear candling'
sent to 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
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."