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 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."