The Food and Drug Administration (FDA) is warning consumers not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions. FDA has found no valid scientific evidence to support the safety or effectiveness of these devices for any medical claims or benefits.
How the candles are used
An ear candle is a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin or a mixture of the two. In ear candling, also called ear coning or thermal auricular therapy, a patient lies on his or her side while a candle is placed in the outer ear and lit.
- burns to the face, ear canal, eardrum and middle ear
- injury to the ear from dripping wax
- plugging of the ears by candle wax
- perforation of the eardrum
- delay in seeking needed medical care for an underlying condition
FDA has received reports of burns, perforated eardrums and blockage of the ear canal which required outpatient surgery from the use of ear candles. And a survey of ear, nose and throat physicians published in 1996 in the medical journal Laryngoscope reported 13 cases of burns of the ear, seven cases of wax occlusion of the ear canal, and one case of a perforated eardrum. The authors of this study also reported that the burning ear candles dripped candle wax on the eardrum of the test subjects and in a model of the ear.
According to some advertised claims, the burning ear candle draws ear wax and “impurities” or “toxins” out of the ear canal. Other claims for ear candles include relief from sinus and ear infections, headache and earache, as well as improved hearing, “blood purification,” improvements in brain function, and cure cancer.
FDA is especially concerned because some ear candles are being advertised for use in children. Children of any age, including babies, are likely at increased risk for injuries and complications if they are exposed to ear candles. Small children and infants may move during the use of the device, increasing the likelihood of wax burns and ear candle wax plugging up the ear canal. Also, their smaller ear canal size may make children more susceptible than adults to injuries.
In the Laryngoscope study noted above, it was found that burning ear candles produced no measurable vacuum pressure, or suction on a model of the ear. Ear candles were also found to be ineffective in removing ear wax in 4 test subjects. In fact, using ear candle on these subjects appeared to have pushed ear wax further into the ear canal.
In addition, Health Canada, the Canadian health regulatory agency, performed their own tests and found that ear candles produce no measurable effect in the ear and have no therapeutic value.
FDA enforcement actions
Ear candles are sold and promoted in a variety of locations, including health food stores, flea markets, health spas and salons, as well as on commercial web sites. The FDA and Health Canada have taken actions against manufacturers of ear candles, including import alerts, seizures, injunctions, and warning letters. The FDA will continue to take enforcement action when appropriate.
Talking to a healthcare provider
In addition to risking injury, people who use ear candles may delay seeking needed medical care for conditions that are treatable, such as sinus and ear infections, temporomandibular joint syndrome (TMJ), hearing loss, and cancer. People who experience earache, ear infection or a sudden loss of hearing should contact their doctor or other health care provider.
Reporting injuries and complaints
Consumers and health care professionals are strongly encouraged to report injury related to the use of ear candles to FDA's MedWatch Adverse Event Reporting program online, by mail or by FAX.
- Mail: use postage-paid FDA form 3500 available at: Medwatch Form Downloads
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- FAX: 1-800-FDA-0178
For more information:
Don't Get Burned: Stay Away From Ear Candles, FDA Consumer Update February 18, 2010
Seely DR, Quigley SM, Langman AW. Ear Candles-Efficacy and Safety. Laryngoscope. October 1996;106:1226-9
Ear Candling. It’s Your health. Health Canada. December 15, 2006