US Pharm. 2012;37(5):16-23.
Pharmacists are often asked about ear issues. Some problems require referral to a physician (e.g., ear pain, swimmer’s ear); however, the FDA has found two to be self-treatable.1 Pharmacists can suggest self-treatment for cerumen (earwax) impaction and removing water from the ears.
Prevalence of Minor Ear Problems
The prevalence of minor ear problems is impossible to determine with accuracy, but surveys confirm that 50% to 66% of the population has cerumen impaction.1-3 The incidence of water-clogged ears is presumed to be somewhat smaller.
Cerumen and Its Benefits
The otic canal contains several specialized structures that act together to produce cerumen.1,4 The ceruminous glands are a set of 1,000 to 2,000 coiled, tubular apocrine sweat glands structurally similar to axillary apocrine sweat glands.1 These glands produce peptides, while sebaceous glands opening into hair follicles in the canal secrete saturated and unsaturated long-chain fatty acids, alcohols, squalene, and cholesterol.2 Cerumen also contains lysozyme, an antibacterial enzyme capable of destroying bacterial cell walls, esters, triglycerides, immunoglobulins, and debris.2,4,5
The epidermal cells lining the external ear are virtually identical to those on the skin surface and undergo a predictable process of upward migration and eventual sloughing. When this occurs on the outer skin, the cells simply fall away. However, in the ear, these desquamated cells tend to collect in the ear canal in sheets, becoming 60% by weight of total cerumen.2
Cerumen provides a protective barrier for the external auditory canal that coats and lubricates.5 Its sticky nature traps foreign objects, preventing direct ear canal contact with organisms, pollutants, and insects.6 Cerumen also has an acidic pH (about 4-5), which is unfavorable for organisms, reducing the risk of infection of the external auditory canal.1 It has antibacterial and antifungal properties.7,8
Cerumen can help lower the risk of diffuse acute external otitis.1,7 In this condition, the patient suffers a break in the epidermis of the external otic canal, often through improper ear cleaning methods, such as use of toothpicks, keys, pencils, etc. If there is no protective cerumen to coat and seal the epidermal tear, organisms (e.g., Pseudomonas aeruginosa, staphylococci) can inoculate the wound. If the humidity and temperature are conducive to growth, the patient will develop diffuse acute external otitis, also known as swimmer’s ear.
Safe Earwax Removal
When cerumen is formed next to the tympanic membrane, it is soft, fluid, colorless, and odorless.1 However, it normally moves outward toward the distal part of the ear through a process known as ceruminokinesis, in which normal movements of the mandible (e.g., eating talking) move the cerumen outward.9 As earwax moves outward, it becomes darker, less fluid, and develops a characteristic odor.
How Does Cerumen Impaction Occur?
Cerumen impaction can be a result of ineffective attempts to remove earwax with cotton-tipped swabs or applicators.1,4 When the patient inserts one of these into the ear and withdraws it, he or she notices the brownish discoloration typical of cerumen. The assumption is that the total mass of cerumen has adhered to the applicator. Unfortunately, this is false. While a bit of cerumen does discolor the applicator, the bulk of the more solid mass of cerumen is rammed further into the ear by the applicator. Ceruminokinesis is unable to move this harder wax, and the impaction begins. Cerumen continues to be produced between the impaction and the tympanic membrane (eardrum), adding to the impacted mass. Physicians may discover impactions that resemble a cast of the inside of the ear when removed.
Symptoms of Cerumen Impaction
Impacted cerumen can cause itching of the ear, pain, tinnitus, dizziness, cough, vertigo, and increased risk of infection.1,4,6 It may also compromise hearing, although this is controversial.1,4 The otic canal should be completely clear to allow sound vibrations to impact upon the tympanic membrane. Any obstruction hampers hearing to some degree. A partial cerumen impaction can reduce hearing. However, a total cerumen occlusion produces a conductive hearing loss that can be as complete as that experienced by those who insert hearing protectors (ear plugs) to preserve their hearing in the presence of loud sounds. Patients may also relate that the hearing impairment seems to be worse after showering or bathing. The hygroscopic nature of cerumen causes it to expand when it contacts water.4 Thus, a partial plug may expand following a shower to completely occlude the ear canal for several hours before it desiccates and shrinks to allow hearing to improve.
The Epidemiology of Cerumen Impaction
Patients more prone to cerumen impaction include those who zealously engage in earwax removal activities, those with a tortuous ear canal, those who overproduce cerumen, the elderly (whose cerumen is drier), patients with mental retardation, and those with spinal cord injury.1,4 Further, males are more prone to cerumen impaction, as the hair lining the external auditory meatus is more coarse than in females.5
Nonprescription Earwax Removal
Physicians remove cerumen through the use of operating microscopes, suction, or flushing equipment.10 However, for the patient who wishes to accomplish earwax removal at home, the sole agent recognized by the FDA as safe and effective is carbamide peroxide. Its use is discussed in this month’s Patient Information.
Dangerous and/or Ineffective Earwax Removal Methods
Healthy ears need no cleaning beyond the use of a soapy washcloth used to wash the outer rim of the ear during the daily shower.10 Medical literature contains several reports of the dangers of home earwax removal beyond the obvious loss of its protective properties.1,4 The common use of cotton-tipped swabs to remove earwax is ineffective and potentially dangerous, increasing the risk of otitis externa and leading to perforation of the eardrum.4 Using any device with adhesive on the end can rupture the tympanic membrane.
Some individuals attempt to use oral irrigation devices (i.e., Waterpik or other flossers) to cleanse the ears, but this can lead to perforation of the tympanic membrane, ossicular disruption, fistulae of the round and oval windows, and dislocation of the footplate of the stapes (in the middle ear).1,4,11 Using the device on a lower setting apparently does not help. In two-thirds of cases, perforation occurs when the irrigator is only at one-third of the maximal power level.1
Ear Candles: Another set of dangerous earwax removal devices are known as ear candles or cones. Their use is becoming increasingly popular in the era of irresponsible Internet medical advice. These unapproved devices were once sold mainly through health food stores, but they are now sold in some pharmacies. The typical ear candle is a rigid 9- to 10-inch long hollow tube made of beeswax-coated fabric.10,12 One tip is tapered with a small hole. The other end of the cylinder is open. The patient lies on the side with the ear to be treated pointing upward. The tapered tip of the candle is inserted into the ear, and the distal end is lit with a match. After the candle burns to perhaps one-third of its length, the flame is extinguished. The patient uses scissors or a knife to open the candle, where a mass of black waxy material is discovered. Proponents say that burning creates a low pressure within the center of the candle and liquefied earwax is drawn into the candle through capillary or negative pressures. Ear candles are sold with claims that they will remove excess wax and help with sinus irritation, “glue ear,” colds, flu, headaches, migraine, tinnitus, and stress. (Apparently, supporters believe the outer otic canal is connected to the sinuses, nasal passages, and brain.)
An objective examination reveals the sellers’ deceptions. First, there is no evidence that a burning object 9 inches away from solid cerumen will liquefy it, which is the core claim of the proponents. Research has demonstrated that there is no negative pressure created by the candle that would draw cerumen into it. In fact, if negative pressure were created, it would be relieved immediately by air entering the large hole at the end of the candle, not through the earwax-immersed hole at the tip. Thus, there would be no pressure-induced phenomenon acting on the cerumen itself. Further, a pressure strong enough to remove solid wax from the ear would also perforate the tympanic membrane due to the pressures of barotrauma.
Supporters point to the mass of black wax in the interior of the candle as proof that it has worked. Researchers demonstrated conclusively that the residue is not cerumen. Rather, it is composed of the beeswax of the candle combined with the burning pieces of the fabric. A pharmacist can demonstrate this to skeptical patients by burning a candle in open air, then opening it. An identical mass of black waxy material will be found inside.
The candles would be a laughable curiosity if they were simply a waste of money due to demonstrated inefficacy. However, ear candles have caused severe damage to patients. Initial alerts were published in otology journals almost two decades ago.13 Complications include external otitis, temporary hearing loss, burns of the ear due to hot wax from the candle, perforation of the tympanic membrane caused by extreme heat, bleeding, and occlusions of the ear canal caused by the candle wax.12-15 Because of the dangers these candles pose to the public, all pharmacies should cease selling them. Patients asking about ear candles must be urged to immediately halt their use to prevent serious harm.
Products containing 95% isopropyl alcohol in a 5% anhydrous glycerin base (e.g., Swim-Ear, Auro-Dri) are safe and effective for drying water-clogged ears.1 They are effective after swimming, showering, bathing, or washing the hair, in a dose of 4 to 5 drops in each affected ear. Patients are cautioned to keep the product away from the eyes and to ask a physician before use if they also have dizziness, a history of ear surgery, ear drainage or discharge, or pain, irritation, or rash in the ear. The label advises patients to cease use and see a doctor if irritation or pain occurs with use. Products with this formula are flammable and must be kept away from open flames.
Many people equate earwax with dirt, using cotton-tipped swabs or applicators (e.g., Q-tips) to remove every trace after morning showers. They perceive the brown stain on the cotton applicator as successful dirt removal. However, removing earwax every day is actually dangerous. Earwax helps fight bacterial ear infections and protects the inside of the ear. Removing it can make you more prone to swimmer’s ear and other ear infections. Earwax moves outward naturally as your jaw moves. Using cotton-tipped swabs can disrupt the normal outward movement, creating a hard clot of impacted earwax. Impacted earwax can cause reduced hearing, a feeling of fullness in the ears, itching in the ear, or ringing in the ear.
Dangerous or Ineffective Earwax Removal Techniques
To prevent ear injury, never insert any device in the ears to remove earwax. Home use of oral irrigators (i.e., Waterpik or other flossers) can rupture your eardrum.
You may also see ads for hollow, wax-soaked cloth tubes called ear candles, available at health food stores, pharmacies, and hundreds of Internet sites. Ear candles are advertised to remove earwax when they are inserted into your ear and set on fire. However, they do not work, and physicians find that the burning wax from the candle can enter the ear and cause burns or even a hole in your eardrum. They should never be used, under any circumstances.
Safe Earwax Removal
Several legitimate products remove impacted earwax safely at home, such as Debrox, Mack’s Wax Away, and Murine for Ear Wax Removal System. They all contain carbamide peroxide. It is similar to hydrogen peroxide placed on a skin wound, in that it releases oxygen when it is placed in the ear. The foaming action gently causes the earwax impaction to loosen, so it can be washed out. Earwax removal products are only for those over the age of 12 years. They should not be used if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or an injury or perforation of the eardrum. They should also not be used if you feel dizzy or have recently had ear surgery.
To use the products, lie on the bed with one ear pointed upward. Place 5 to 10 drops of the solution into the upward ear and allow it to remain for several minutes. Then gently wash the ear with warm water from an ear syringe (supplied with some of the packages). This can be repeated twice daily for up to 4 days if needed. If excessive earwax remains after this, you should consult a physician. Always remember that the proper way to clean the ears is to use a wet washcloth over your finger during your morning shower.
The only other condition you can treat without seeing a physician is water-clogged ears. Such products as Auro-Dri and Swim-Ear, which contain 95% isopropyl alcohol, can safely dry water that is trapped in the ear when used as directed on the package. If pain or discharge is present, the problem could be an infection known as swimmer’s ear, which should treated by a physician with antibiotic ear drops.
Remember, if you have questions, Consult Your Pharmacist.
1. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
2. Moore AM, Voytas J, Kowalski D, et al. Cerumen, hearing, and cognition in the elderly. J Am Med Dir Assoc. 2002;3:136-139.
3. Burton MJ, Doree C. Ear drops for the removal of ear wax. Cochrane Database Syst Rev. 2009;(1):CD004326.
4. Hanger HC. Cerumen: its fascination and clinical importance: a review. J R Soc Med. 1992;85:346-349.
5. Stransky K, Valterova I, Kofronova E, et al. Non-polar lipid components of human cerumen. Lipids. 2011;46:781-788.
6. Wax blockage. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/000979.htm. Accessed March 29, 2012.
7. Lum CL, Jeyanthi S, Prepageran N, et al. Antibacterial and antifungal properties of human cerumen. J Laryngol Otol. 2009;123:375-378.
8. Schwaab M, Gurr A, Neumann A, et al. Human antimicrobial proteins in ear wax. Eur J Clin Microbiol Infect Dis. 2011;30:997-1004.
9. Afolabi AO, Kodiya AM, Bakari A, et al. Attitude of self ear cleaning in black Africans: any benefit? East Afr J Pub Hlth. 2009;6:43-46.
10. Earwax. American Academy of Otolaryngology. www.entnet.org/HealthInformation/earwax.cfm. Accessed March 29, 2012.
11. Leach K. How to dissolve ear wax. eHow Health. www.ehow.com/how_4464778_dissolve-ear-wax.html. Accessed March 29, 2012.
12. Don’t get burned: stay away from ear candles. FDA. February 18, 2012. www.fda.gov/ForConsumers/ConsumerUpdates/ucm200277.htm. Accessed March 29, 2012.
13. Ear candles: risk of serious injuries. MedWatch. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201108.htm. Accessed March 29, 2012.
14. Advice for patients: ear candles. FDA. Medical devices. February 22, 2010. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm200896.htm. Accessed March 29, 2012.
15. Walker EP. No hearing for ear candles case against FDA, court says. MedPage Today. January 7, 2012. www.medpagetoday.com/PrimaryCare/AlternativeMedicine/30534. Accessed March 29, 2012.
16. Coppin R, Wicke D, Little P. Randomized trial of bulb syringes for earwax: impact on health service utilization. Ann Fam Med. 2011;9:110-114.
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