“Ringing in the ears” is not just a minor annoyance for those suffering with tinnitus. For the 50 million people in the U.S. who suffer from tinnitus, the perception of sound in one or both ears on a regular and sometimes constant basis can be distracting, irritating and often leads to difficulty sleeping. According to the American Tinnitus Association, of those 50 million tinnitus sufferers, 16 million have sought medical attention for the issue, and as many as 2-3 million are completely disabled from it.

Yet, as troubling and intrusive as tinnitus can be, it’s not actually a disease, but rather a symptom of a larger issue. In some rare cases, the sound in one’s ears can be caused by an abnormality in a vein or artery, and can be in sync with one’s heartbeat (and heard by a physician via stethoscope). However, tinnitus is more often a sound no one else can hear, which can present itself as hissing, buzzing, roaring, chirping, clicking or whistling at varying volumes and intensities.

Causes & Treatment
The causes of this disorder also vary, according to Barry Keate, president of Arches Natural Products, Inc., Salt Lake City, UT. “Tinnitus has many causes, some of them associated with disease states. The largest cause of tinnitus, according to the American Tinnitus Association, is noise-induced hearing loss. This accounts for over 70% of tinnitus cases.” He added, “Other major contributors are ototoxic (toxic to the ears) medications. There are over 200 prescription and over-the-counter medications which can cause tinnitus. Among these are SSRI antidepressants, chemotherapy agents and NSAID pain relievers such as aspirin, taken in a large enough dose.”

With many pharmaceuticals actually causing tinnitus symptoms, many consumers see a natural, supplement-based treatment as the preferred course of action. Furthermore, there is not a pharmaceutical treatment specifically for tinnitus at this point in time. When treating tinnitus with drugs “the medications of choice among many doctors are benzodiazepine anti-anxiety medications such as Xanax, Klonopin or Valium,” explained Mr. Keate. “These medications help by calming the person but are extremely addicting and have many unwanted side effects. In fact, when trying to withdraw, increased tinnitus is the predominant side effect.”

 

With lack of sleep and insomnia being among the main hardships of tinnitus, Arches Natural Products developed the sleep aid Arches Tinnitus Sleep Formula. As a natural approach to supporting the tinnitus sufferer, Arches Tinnitus Sleep Formula contains time-released melatonin, a hormone produced by the body in the pineal gland of the brain and in the retina of the human eye. Melatonin secretion forms part of the system that regulates the sleep-wake cycle by chemically causing drowsiness and lowering body temperature. Since melatonin is naturally produced in the body, it is non-addictive and has limited side effects.



Sound Research
In validating melatonin as a treatment option, Arches pointed to several studies linking the hormone to the treatment of tinnitus and tinnitus-related insomnia.

Researchers at the Detroit, MI-based Henry Ford Hospital found a significant association between the severity of perceived tinnitus symptoms and insomnia. Additionally, they found that insomnia can worsen the functional and emotional toll of tinnitus symptoms, and that tinnitus patients suffering from insomnia reported greater emotional distress.

Co-author of the study, Kathleen Yaremchuk, MD explained, “Tinnitus involves cognitive, emotional and psycho-physiological processes, which can result in an increase in a patient’s distress. Sleep complaints, including insomnia, in these patients may result in a decrease in their tolerance to tinnitus.”

The Ear Research Foundation in Sarasota, FL, also found melatonin to be a potent weapon in the treatment of tinnitus and tinnitus-related insomnia. In a double-blind, placebo-controlled, crossover trial, 30 patients with subjective tinnitus were evaluated using the Tinnitus Handicap Inventory (THI) questionnaire. Examiners found that, “Among subjects reporting difficulty sleeping attributable to their tinnitus, 46.7% reported an overall improvement after melatonin.” They concluded, “Melatonin has been shown to be useful in the treatment of subjective tinnitus. Patients with high THI scores and/or difficulty sleeping are most likely to benefit from treatment with melatonin. In light of its minimal side effects, melatonin should be a part of the physician’s armamentarium in the treatment of tinnitus.”

Tinnitus Market & Key Demographics
With thorough research backing the use of melatonin and other supplements for the treatment of tinnitus, Mr. Keate reported that products specifically targeting tinnitus totaled over $9 million in 2011. “Adding in generic products that are used by people for their tinnitus, such as Ginkgo biloba, ear health products and general supplements, the market is about $58 million,” he said.

With tinnitus affecting the aging population most prominently, there is significant market growth predicted as the Baby Boomer generation ages. “Noise damage is cumulative; a little damage from a fire or police siren, a little from a rock concert, and so on, creates long-term damage to hearing that becomes more noticeable as we age. Baby Boomers, such as myself, are the target audience.”