According to the American Tinnitus Association, tinnitus affects over 50 million Americans; about 15 million Americans are reported to seek medical attention for the condition annually.
Barry Keate, President of Arches, told us that 70% of the tinnitus cases are caused by hearing loss. The other 30% is caused by 20-30 other factors. “Stress is perhaps the biggest aggravator of tinnitus,” he said.
Difficulty getting to sleep and staying asleep is also a concern for many people with tinnitus, he said. The company has just added to its suite of products with the launch of the Arches Tinnitus Sleep Formula, which is a high dose, time-release melatonin product. “There are studies to show that melatonin actually helps with the worst cases of tinnitus,” he said.
The company’s flagship product (Arches Tinnitus Formula) uses a combination of ginkgo, garlic, and zinc. With stress being such an aggravator, the company also offers a stress formula; a B-vitamin complex product to support the flagship product. A separate B-12 lozenge product, which dissolves under the tongue, completes the suite of products.
Keate explained that there are three potential mechanisms of action for ginkgo. First of all, the herbal is a glutamate antagonist, or inhibitor. Damage to the inner ear can lead to excessive release of the neurotransmitter glutamate, which causes nerves to fire over and over. By inhibiting this, the ‘firing’ can be eased. Ginkgo may also offer antioxidant potential, which could reduce additional damage to the inner ear, he said, while the herbal has also been reported to increase blood flow.
While some systematic reviews and meta-analysis have yielded null effects for ginkgo for tinnitus (including a Cochrane systematic review), Keate noted that the company has 35 clinical trials for ginkgo and tinnitus that are “all extremely positive”.
Indeed, ginkgo is prescribed extensively in Germany for tinnitus, he added. The dose is important, he said, with a daily intake of 480 milligrams needed.
According to Tom Clough, Managing Director of HSC, who has been consulting for Arches for about nine months, the US tinnitus market is being addressed either directly through tinnitus positioned products, or indirectly through general ear health or leveraging Gingko for its potential to enhance blood flow.
Within the tinnitus-positioned products, the marketplace is fragmented amongst about 20 players, Clough told us. Most tinnitus products are homeopathic (60% vs 40% supplements), he added, and capsules are the most common form.
In addition, data from HSC indicates that less than 200,000 sufferers are using products, meaning market penetration is only about 1.4%. With supplements making up 40% of the market, and a lot of people not using product, there is considerable potential for growth.
Indeed, Keate is confident of the potential for Arches: “We think we can easily double the size of the business, maybe more,” he said.
The company conducted a survey of 3,500 customers in 2006, with a 10% response rate. The results indicated that the majority over 35% of customers who responded were recommended the Arches Tinnitus Formulas via their ENT physician.
The survey also indicated that 70% of those who used the Arches Tinnitus Formula for 100 days (the recommended minimum) had a reduction of tinnitus and indicated their tinnitus improved. Thirty percent did not improve. “The product doesn’t work for everyone and we don’t claim that it does,” said Keate.
“We find that the majority of our consumers, once they use and continue using the product, then they stay with us long-term. We have very good customer loyalty.”