New Data On Neuromonics Tinnitus Treatment Presented
Editor: Most of us with hearing loss also have tinnitus, and for most of us, it’s an annoyance rather than a calamity. But those with severe tinnitus can find it debilitating. The folks at Neuromonics have been treating tinnitus for several years and are now reporting on their results. And they look very encouraging! Here’s their press release.
Neuromonics, Inc, Bethlehem, Pa, announced on April 3 new, interim results of its Customized Acoustic Stimulation for Long-Term Medical Benefit (CALM) study, at the AudiologyNOW! 2009 convention. 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 US 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, 6 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, PhD, director, Audiology Clinical Services, Head and Neck Institute, at Cleveland Clinic, who presented 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 was presented:
* Reducing Tinnitus Distress: The mean Tinnitus Reaction Questionnaire (TRQ) scores dropped from 40 to 14, 6 months following treatment. The TRQ is a self-report questionnaire designed to evaluate tinnitus distress. Importantly, a score of 14 represents non-clinically significant tinnitus.
* Two-Month Relief: The largest proportion of benefit occurred after the first 2 months of treatment. Mean 2-month THI and TRQ scores decreased from 46 to 31, and 40 to 21, respectfully.
* Moderate-to-Severe Patients: Patients reporting severe tinnitus handicap at the start of treatment, as measured by THI, demonstrated the largest clinical benefit. Significant THI reductions were reported in 100% of patients with initially severe tinnitus handicap scores (THI more than 58 points), and 60 percent with initially moderate THI scores (THI between 38 and 56).
These interim results are the first publicly presented data from the CALM study initiated in 2007. 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 at Neuromonics. “This first independent US 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.