BETHLEHEM, Pa. & DALLAS--(BUSINESS WIRE)--Neuromonics, Inc. today announced new, interim results of its Customized Acoustic Stimulation for Long-Term Medical Benefit (CALM) study, at the AudiologyNOW! 2009 meeting in Dallas. The data show that treatment with Neuromonics reduces psycho-social consequences and distress from tinnitus. Treatment response occurs within two months and improves over time. Neuromonics is an FDA-cleared treatment that addresses the neurological processes of tinnitus, specifically its audiological, attention-based and emotional aspects.
This interim, multi-site U.S. study evaluated 45 patients with varying forms of tinnitus, a widespread condition most commonly characterized by ringing in the ears. In the study, the mean Tinnitus Handicap Questionnaire (THI) scores decreased from 46 to 20, six months following treatment, representing a clinically significant improvement. The THI is a standard clinical measure evaluating the psycho-social consequences of tinnitus.
“For millions of Americans with tinnitus, it can cause significant psychological and social hardships, impacting sleep, mood, and the ability to concentrate,” said Sharon Sandridge, Ph.D., Director, Audiology Clinical Services, Head and Neck Institute, at Cleveland Clinic, who will present the data. “I am committed to conducting rigorous clinical tinnitus research, and helping patients who have traditionally had limited viable therapeutic options.”
The following additional Neuromonics data will be presented:
These interim results are the first publicly presented data from the CALM study. The trial’s primary objective is to demonstrate clinically significant long-term reductions in tinnitus disturbance and quality-of-life improvements, up to 36 months post-treatment.
Initiated in August 2007, the CALM post-market study is being conducted by a broad range of prestigious academic institutions and private practices, including the Cleveland Clinic, Silverstein Institute, House Ear Clinic, Michigan Ear Institute, North Shore Audio-Vestibular Lab, Shohet Ear Associates, The Polyclinic, Doctors’ Hearing and Balance Centers of ENT Associates of South Florida, and Ear Institute of Chicago.
“We are committed to working with the leading U.S. medical centers, including academic hospital and private practices, to demonstrate the Neuromonics Tinnitus Treatment’s efficacy,” said Rick Giancola, CEO of Neuromonics. “This first independent U.S. data further confirms previous findings—Neuromonics helps patients regain control over their lives, by reversing the downward spiral of psychological and emotional disturbances caused by tinnitus. Neuromonics targets the neurological root causes of tinnitus, helping thousands of patients to manage and treat tinnitus, and in turn, improve their quality of life.”
The Neuromonics Tinnitus Treatment is currently in use in more than 200 medical centers. It is a compact, non-invasive medical device that delivers a prescribed acoustic neural stimulus, customized for each patient’s individual audiological profile, and incorporates specially processed, relaxing music. After clinical customization, the patient listens to the device daily for six-plus months. The treatment can help the brain filter out the tinnitus perception, so that it no longer intrudes on the patient’s conscious attention, and no longer has a disturbing impact on quality of life.
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 targets the brain’s auditory pathways and is believed to aid in neuroplasticity, or the process of neuronal change. This process appears to be involved in allowing the brain to filter out the disturbing tinnitus perception. This stimulus incorporates spectrally modified, customized music, which engages the brain’s emotional response center, the limbic system, and thereby reduces tinnitus-related disturbance. Research published in the April 2007 issue of Ear & Hearing demonstrates the Neuromonics Tinnitus Treatment yields clinically significant reduction in tinnitus disturbance in more than 90 percent of suitable patients in a formal clinical trial setting. The Neuromonics Tinnitus Treatment is a comprehensive, long-term therapy that targets the neurological processes of tinnitus, specifically its audiological, attention-based and emotional aspects.
Clinically administered and monitored, the Neuromonics Tinnitus Treatment is proven to yield significant long-term reduction of tinnitus disturbance. The therapy is delivered via a compact, lightweight and uniquely designed medical device. Treatment typically occurs over an approximately six-month period, with daily use recommended for two or more hours per day, especially when the tinnitus is most disturbing. The treatment can take place during regular activities such as reading, relaxing or computer work.
With global headquarters 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 research and development beginning in the early 1990s, the Neuromonics Tinnitus Treatment has been used to treat thousands of tinnitus sufferers worldwide. Neuromonics’ goal is to help tinnitus sufferers improve their quality of life and overcome the daily-life challenges associated with tinnitus. For more information, go to www.neuromonics.com.