Ear Candling

Products and Procedures

Most ear candles sold in the United States are manufactured here or in Canada and retail for between $2 and $10. They can be made of linen or cotton (often unbleached, as practitioners claim that chlorine is bad for the ears) soaked in wax or paraffin and allowed to harden. (Ironically, one manufacturer uses only pure beeswax, claiming that paraffin is carcinogenic.). Some candles are colored, which is controversial in ear-candling circles, though the color of pure beeswax varies. Home varieties include wax-soaked newspaper and cones of pottery into which herbal smoke is blown. Some waxes contain herbs or other substances, including sage, chamomile, rose, rosemary, burdock root, osha root, periwinkle, jojoba, quassia bark, yucca root, or honey. White Egret, Inc., of Dallas, Texas, offers candles, plate guards, a 73-page manual, a 30-minute videotape, flame-retardant cloths, ear oil, and an otoscope. Its wholesale flyer states that its candles are “for entertainment only” and that its kits “supply you with everything you need for a safe and effective session of entertainment.” [1]

Most instructions direct the person undergoing the procedure to lie on his or her side. A collecting plate is placed above the ear, and the candle is inserted through a hole in the plate and into the ear canal. The candle is lit, and as the wick burns down, it is often trimmed. Some advocate using a toothpick to maintain a hole in the top of the hollow candle throughout the procedure. After the candle is blown out and removed, a cotton swab is used to gently remove visible earwax from the ear, and “ear oil” is often applied. Some practitioners place the still-hot candle in a bowl of water, and claim that everything in it which is not obviously beeswax is earwax, toxins, dead skin, drug residues, or remnants of past yeast infections, none of which has been verified. Nearly all package directions indicate that the ear will feel warm but not hot, and that the experience will be relaxing or even spiritual in nature.

Testing By Skeptics

Candling is occasionally offered as a service at health expositions. Rebecca Long, president of the Georgia Council Against Health Fraud, made the following observations at the 1992 Discovery Expo in Atlanta, Georgia:

One exhibition was doing ear candling for $30. The people selling this said that the suction created by the candle “cleared your mind and sinuses.” I questioned them enough to establish that they meant this literally and believed the ear was an opening from the brain and sinuses. The woman running the booth stated, “It cleans the whole head, brains and all – they’re all connected you know.” The candling was performed on a table at the front of the booth, so the curious sight of a person lying there with a burning candle sticking out of his ear drew many spectators. During the procedure, a gray mixture of soot and wax drippings collected on a pie plate under the candle. It did not look like melted candle wax, but was quite foul in appearance. Customers were told that these were the “impurities” of which they had been cleansed, and many went around proudly showing them off, comparing their debris to that of others, and making knowing comments. The vendor also peddled “psychic readings.”

After the show, Long bought a package of ear candles at a local health-food store and, with help from a friend, carefully followed the package directions. She found that the candling produced a hissing sound similar to that of a conch shell held against the ear, but much louder. However, the air inside her ear became so hot that she had to stop the experiment.

More recently, two investigators tested candles to see whether the wax accumulated after burning came entirely from the candle or included wax that came from the ear. To do this they burned candles with the tip (a) inside the ear, (b) outside the ear, so the wax dripped into a bowl of water, and (b) inside the ear but with a tube in place that would permit ear wax to move into the tube but would block candle wax from moving downward. They demonstrated that all residue originated from the candle and that no ear wax was removed from the ear [2].

Why Candling Can’t Work

Since wax is sticky, the negative pressure needed to pull wax from the canal would have to be so powerful that it would rupture the eardrum in the process. However, candling produces no vacuum. Researchers who measured the pressure during candling of ear models found that no negative pressure was created. The same investigators candled eight ears and found that no ear wax was removed and candle wax was actually deposited in some of them! [3]

The notion that the ear canal is connected to structures beyond the eardrum is false. A review of a good anatomy book should dispel this notion. The external ear canal, with an intact eardrum, is not connected to the brain, the sinuses targeted by the procedure (those above your eyes), or the Eustacean tubes (the passageways between the internal ear and the back of the throat). While some claim that the eardrum is porous and quickly allows impurities to pass through, this is untrue. The “impurities” that appear in the collected wax (usually on a paper plate or other collecting device) are nothing more than the ashes from the burnt wick and wax of the cone itself.

Dangers Reported

Candling poses several dangers, the most serious of which involve burning caused by the hot wax. Candle manufacturers claim that their candles will drip only down the outside of the ear, but shamefully few direct the user to hold the candle horizontally to prevent this. A 1996 survey of 144 ear, nose, and throat physicians, found that 14 had seen patients who had been harmed by ear candling, including at least 13 cases of external burns, 7 cases of ear canal obstruction with candle wax, and 1 perforated eardrum [3].

Another case was reported by The London Free Press, a Canadian newspaper. A woman who experienced stuffiness in the nose and ear pains while scuba diving went to a local health-food store and was referred to a “qualified” candler. During the “treatment,” she felt an intense burning in her ear. At the emergency room, attempts to remove wax that had dripped from the candle onto her eardrum failed. Surgery was required, and a hole in her eardrum was discovered, which presumably was caused by the procedure. She recovered fully, and luckily her hearing was not affected. The practitioner apologized, compensated the woman, and stopped performing ear coning.

Alaska Fire Marshall Gary L. Powell has reported two instances of significant fires associated with ear candling., one of which led to the user’s death. On January 27, 2005 a 59-year-old woman ignited her bedding when she dropped an ear candle that she was attempting to use the ear without any assistance. The candle ignited the bedding and quickly spread to curtains and other combustibles in the room. The woman did escaped but suffered an asthma attack and died in a hospital emergency room [4].

Regulatory Actions

Candles marketed with health claims are classified by the FDA as medical devices. As such, they are illegal to market without FDA approval, which none of them have. During the past few years, the agency has banned the importation of auricular candles marketed by at least four Canadian companies [5]:

• Europe Cosmetiques, St. Lawrence, Quebec, which had claimed that its products were effective for treating ear wax build-up, hearing problems, sinus congestion, frequent migraines, and ear aches.
• Kencayd Consulting (aka Candela Ear Candles), Victoria, British Columbia, which had claimed that its products promoted better hearing, better lymphatic circulation, and pressure regulation.
• Superior Ear, a division of J&P Holdings, Parson, British Columbia, which had claimed that its products promoted better hearing, better lymphatic circulation, and pressure regulation .
• Purity of Life, Action, Ontario.

In 1993, the FDA seized about $6,000 worth of candles, components, and brochures from Quality Health Products, of Fayette, Ohio. An FDA summary stated:

Adulterated – The article is a class III medical device for which no approved premarket approval application is in effect; and, the methods used in, and the facilities and controls used for, its manufacture, packing, and storage are not in conformity with current good manufacturing practice. Misbranded—The article’s labeling represents and suggests that it is adequate and effective for reducing ear wax, fever, and infections associated with a ruptured ear drum, and that it may be used as a replacement for surgical tubes inserted in the ear, which representations and suggestions are contrary to fact. The article’s labeling fails to bear adequate directions for use for the purposes for which it is intended. The article is dangerous to health when used in the manner recommended and suggested in the labeling. The article was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered and was not included in a required list; a notice or other required information was not provided as required prior to its introduction into interstate commerce [6].

Early in 1998, the FDA ordered the president of Earth Care, of Ukiah, California, to stop marketing the Ear Candles advertised in his company’s catalog. The letter noted that the product had been advertised as a “remedy for earaches, sinus headaches, swimmer’s ear, allergies, and hearing difficulty effectively removes impurities from the passages by drawing excess wax, yeast, fungus, and bacteria . . . from the sinuses and lymph glands.” [7] In September 1998, the agency issued an Import Alert which stated:

The Center for Devices and Radiological Health (CDRH), has determined that “Ear Candles” are medical devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (The Act). An Ear Candle is a hollow wax cylinder (about ten inches long) intended to remove excess ear wax. This is accomplished by lighting the top of the candle-like product, and allowing it to create a vacuum to draw wax and other impurities from the ear.

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. Also, the label of the product contains inadequate directions for use since adequate directions cannot be written for the product’s purported use. 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.

Additionally, there has been no premarket notification filed (510(k)) for these products and the products appear to have been manufactured in establishments not duly registered or listed with the . . . FDA [8].

In November 1998, the FDA warned Nature’s Way, of West Columbia, South Carolina, that it would be illegal to continue marketing ear candles because they are unapproved devices that would be dangerous to use as suggested in its catalog [9].

Ear candles cannot be legally sold in Canada. The Medical Devices Regulations of Canada’s Food and Drug Act states that medical device of this type must be licensed by Therapeutic Products Programme of Health Canada before the product can be sold. No licenses have been granted for this product. Some promoters, in an attempt to avoid medical device regulations, advertise ear candles as being “for entertainment only”. However, Health Canada considers that this product is sold for medical purposes, because there is no other reasonable use for ear candles. Canada has issued directives prohibiting the importation ear candles [10].

Despite these actions, ear candles are still widely available through the Internet and at health-food stores. From 1998 through 2005, the Awareness Institute of Lake Wales, Florida, not only sold products but even offered an inexpensive correspondence course leading to “certification as an earconolgist.”

The Bottom Line

For most people, ear wax moves along the ear canal and eventually makes it to the outside, taking with it any accumulated dirt or other matter. Compacted ear wax should be removed by a physician or other health professional using legitimate instruments. Candling is both ineffective and dangerous.

References

1.     Flyer mailed to health-food retailers in September 1998 by White Egret, Inc., of Dallas, Texas.

2.     Kaushall PP, Kaushall JN. On ear cones and candles. Skeptical Inquirer 24(5):12-13, 2000.

3.     Seely DR, Quigley SM , Langman AW. Ear candles: Efficacy and safety. Laryngoscope 106:1226-1229, 1996.

4.     Powell GL. E-mail to Dr. Stephen Barrett, April 15, 2005

5.     FDA Import Alert 80-06. Automatic Detention of Fraudulent and Deceptive Medical Devices, Attachment. Issued, Sept 28, 1992, revised May 9, 1997.

6.     FDA Enforcement Report, Dec 15, 1993.

7.     Gill LJ. Warning letter to John Schaesser, Jan 20, 1998.

8.     FDA Import Alert #77-01. Detention without Physical Examination of Ear Candles. Sept 1, 1998.

9.     Gill LJ. Warning letter to John Fisher, November 18, 1998.

10. Ear candling. Health Canada Web site, Revised, Dec 15, 2006