Post-Market Study Will Add to Growing Body of Treatment Data
Bethlehem, Pa.-September 4, 2007 - Neuromonics today announced the initiation of the first post-market U.S. study, to evaluate long-term outcomes for the Neuromonics Tinnitus Treatment. This is an FDA-cleared therapy proven to interact, interrupt and desensitize tinnitus disturbance for long-term benefit. Unlike traditional therapies, the Neuromonics Tinnitus Treatment comprehensively addresses the neurological, psychological and audiological basis of tinnitus. Patient enrollment is now underway, and the first patient has started treatment at Silverstein Institute.
Primary endpoints for the Customized Acoustic Stimulation for Long-Term Medical Benefit (CALM) Study include clinically significant reductions in tinnitus disturbance and quality-of-life improvements, with patients evaluated after six months and up to 36 months post-treatment. This national study will include up to 10 clinical sites with a planned enrollment of 100 moderate-to-severe tinnitus patients collectively. The study's lead investigator, Jack Wazen, M.D., of the Silverstein Institute, will manage and oversee the trial. The two primary sites for the study are the Silverstein Institute in Sarasota, Fla., and the Cleveland Clinic in Cleveland, Ohio.
Tinnitus affects as many as 50 million people in the U.S. Within this patient population, 10 to 15 million seek medical treatment and 2 million have severe, highly disturbing tinnitus. The Centers for Disease Control and Prevention report 1 million new cases of tinnitus are identified each year and 200,000 per year are severe cases. Tinnitus symptoms can be so extreme that they negatively impact normal daily activities and could lead to additional medical conditions, such as anxiety, depression, sleep deprivation and elevated stress.
"The millions of patients affected by tinnitus have traditionally had limited therapeutic options," said Dr. Wazen. "Neuromonics Tinnitus Treatment represents the first tinnitus treatment with long-term benefit, as demonstrated by previous studies. By leading the CALM Study, I hope to further our understanding of how Neuromonics Tinnitus Treatment improves quality of life and tinnitus disturbance, so that physicians and audiologists nationwide can continue making informed decisions about its clinical use."
"Neuromonics looks forward to expanding upon the positive outcomes that have been seen in previous studies," said Jack Springer, director and CEO of Neuromonics U.S.A. "Neuromonics is committed to sponsoring long-term outcomes-based trials evaluating the therapy's lasting efficacy in this difficult-to-treat patient population. Our goal is to prove that by addressing the underlying neurological and psychological causes of tinnitus, patients may experience long-term, quality-of-life improvements."
Enrollment Information
To inquire about participating in the study, email info@neuromonics.com or call 1-866-606-3876.
CALM Study Primary Investigator
Jack Wazen, M.D., is one of the nation's leading authorities on hearing and balance disorders, pioneering new research in treatments for deafness, hearing loss and other auditory complications. Prior to the Silverstein Institute, Dr. Wazen spent 23 years as a researcher, professor and practitioner with Columbia University and the Columbia-Presbyterian Medical Center.
About the Neuromonics Tinnitus Treatment
Neuromonics' non-invasive, FDA-cleared device is customized to the patient's unique hearing and tinnitus profile. It delivers a customized neural stimulus that promotes neural plastic changes, allowing the brain to filter and process the tinnitus. The delivery system, to carry the neural stimulus, consists of spectrally modified customized music which engages the brain's emotional response center, the limbic system. Research published in the April 2007 issue of Ear & Hearing demonstrates the Neuromonics Tinnitus Treatment offers clinically significant reduction in tinnitus disturbance in 91 percent of treated patients. The Neuromonics Tinnitus Treatment is the most comprehensive, long-term therapy that targets the neurological, audiological and psychological basis of tinnitus.
Clinically administered and monitored, the Neuromonics Tinnitus Treatment is a proven treatment that offers significant long-term reduction of tinnitus disturbance. The therapy is delivered via a compact, lightweight and uniquely designed medical device. Treatment typically occurs over a six-month period, with daily use recommended for two or more hours per day when the tinnitus is most disturbing. The treatment can take place during regular activities such as reading, relaxing or computer work.
About Neuromonics
Based in Bethlehem, Pa., Neuromonics is the manufacturer and distributor of the only FDA-cleared, patented and clinically proven medical device designed for long-term significant relief of tinnitus. With more than 14 years of research and development, the Neuromonics Tinnitus Treatment has treated thousands of tinnitus sufferers worldwide. Neuromonics' goal is to help tinnitus sufferers improve their quality of life and overcome challenges associated with tinnitus.
For more information, go to www.neuromonics.com.
