Neuromonics Inc, Bethlehem, Pa, reports the publication of the largest private-practice study evaluating the Neuromonics Tinnitus Treatment, which comprehensively targets the condition’s neurological processes.
Tinnitus affects some 40 to 50 million Americans. Published in the November issue of Annals of Otology, Rhinology & Laryngology, the 470-patient study shows that 92% of the patient cohort who met suitability criteria significantly improved following the treatment.
This is the first study that has evaluated the treatment’s efficacy for the entire tinnitus population. The study did not just include the most suitable patients, but also more difficult-to-treat sufferers with complicating clinical factors. The research showed the treatment also improved symptoms for those patients with complications, including patients who also presented with decreased loudness tolerance (hyperacusis) or severe hearing loss. The results provide instructive guidance to health care professionals, by demonstrating how defined criteria relating to treatment suitability impacts treatment outcomes.
"This is the first study to reflect the broad diversity of patients seen in a ‘real world’ private-practice clinic setting, and demonstrates that the (treatment) leads to significant improvements for a broad cross-section of patients with tinnitus," says Peter Hanley, PhD, study co-author. By comprehensively addressing tinnitus’ underlying neurological processes, he says the company is uniquely positioned to help the millions of patients seeking quality-of-life improvements.
Traditional treatment options for tinnitus sufferers have offered limited long-term benefit. Some% of the patients in the study had previously tried other common treatments, with limited success. Unlike traditional therapies, the treatment led to rapid changes in tinnitus disturbance in the study. The data shows 78% of the overall benefit reported by patients through the course of treatment occurred during the first 10 weeks of treatment.
While the study’s 470 patients all had tinnitus, they differed in their level of symptom severity and clinical profile; for example, the existence of associated clinical complications. All patients were fitted with the device and provided with treatment in a network of private-practice clinics. The study compared treatment outcomes across three cohorts, to which patients were assigned based on pre-defined criteria, including their psychological state and level of hearing loss.
The treatment delivers a prescribed acoustic neural stimulus, customized for each patient’s individual audiological profile, and incorporating specially processed, relaxing music. The stimulus is designed to provide relief and relaxation in the initial phase of treatment, and then progressively over a period of several months, to facilitate desensitization to the tinnitus. In this way, the therapy 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. By targeting the condition’s underlying neurological basis, the company may offer enhanced effectiveness for patients compared to alternatives, it says.
The 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. The process appears to be involved in allowing the brain to filter out the disturbing tinnitus perception. The 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 treatment yields clinically significant reduction in tinnitus disturbance in more than 90% of suitable patients in a formal clinical-trial setting. It is the most comprehensive, long-term therapy that targets the neurological processes of tinnitus, specifically its audiological, attention-based and emotional aspects, the company says.
Clinically administered and monitored, the treatment is proven to yield significant long-term reduction of tinnitus disturbance. Treatment typically occurs over an approximately 6-month period, with daily use recommended for 2 or more hours a day, especially when the tinnitus is most disturbing. Treatment can take place during activities such as reading, relaxing, or computer work.