Don't Get Burned: Stay Away From Ear Candles
In February 2010, FDA issued warning letters to three large manufacturers of ear candles. These firms were informed that FDA had determined that there was no agency approval or clearance, no manufacturing facility registration or device listing, and no adverse-event reporting systems in place in regard to their ear candles.
FDA will continue to take enforcement action when appropriate.
Concern for Children
Claims that ear candling is appropriate for kids have caused great concern at FDA. "Children of any age, including babies, are at increased risk for injuries and complications if they are exposed to ear candles," says Mann.
He adds that small children and infants may move while the device is being used, increasing the likelihood of wax burns and ear candle wax plugging the ear canal. "Also, their smaller ear canal size may make children more susceptible than adults to injuries from ear candles," he says.
Since FDA views ear candles as medical devices, manufacturers seeking approval to sell them must submit evidence to FDA that the products are safe and effective.
Reports of Injuries
FDA believes that injuries associated with ear candles are likely underreported, and encourages consumers and health care professionals to report such injuries to FDA's MedWatch Adverse Event Reporting program4.
Over the past decade, FDA has received reports of burns, punctured eardrums, and blockage of the ear canal which required outpatient surgery from the use of ear candles.
In its testing, Health Canada found that ear candles produce no measurable effect in the ear and have no therapeutic value.
And in a survey published in 1996, the medical journal Laryngoscope reported 13 cases of burns of the ear, seven cases of ear canal blockage due to wax, and one case of a punctured eardrum.
That study also reported that ear candles produced no measurable vacuum pressure or suction on a model of the ear, and that burning ear candles dripped candle wax onto the eardrum of test subjects and of the ear model.
For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).
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