New study in Otology and Neurotology (official publication of the American Otological Society and American Neurotology Society)
further demonstrates effectiveness of Meniett therapy1
Significantly improved patient functionality with low-pressure treatment
Results of a study published in the January 2005 issue of Otology and Neurotology, the official publication of the American Otological Society and American Neurotology Society, demonstrate that patients who used the Meniett Low-Pressure Pulse Generator to control their symptoms of Ménière's Disease experienced significantly less severe vertigo and significantly improved functionality compared to patients in the control group. Severe vertigo, which can cause nausea and vomiting, is considered by many patients to be the most problematic symptom of Ménière's Disease. All patients in the study had exhausted medical therapy options prior to enrolling in the study.
The randomized, placebo-controlled, double-blind, multicenter study showed that participants who used the Meniett therapy experienced significantly less severe vertigo (as defined by the patient) and significantly increased their functionality level. There were no complications from the Meniett therapy.
The study evaluated 40 people with established Ménière's Disease in one ear that was unresponsive to medical therapy. All participants had a ventilation tube inserted into the affected ear (necessary for the pressure therapy to reach the inner ear). To eliminate the possibility of symptom improvement related to the ventilation tube, there was a two-month waiting period after the ventilation tube was inserted before treatment was begun. Only patients who had a minimum of two, 20-minute vertigo attacks during the two-month waiting period participated in the study. Each patient was randomly assigned to a treatment group or a control group. The treatment group received functioning Meniett devices that delivered low-pressure air pulses to the inner ear, while the control group received a placebo Meniett device that looked the same but delivered no pressure. All participants performed three Meniett treatments per day for two months, lasting five minutes each.
"Local overpressure treatment is…non-destructive and safe. It reduces hydrops [the excess inner ear fluid that causes disease symptoms] and can be repeated as many times as needed," writes Jens Thomsen, MD, principal investigator of the study and professor of otolaryngology-head and neck surgery at Gentofte University Hospital in Denmark.
Few Treatment Options Available for Perplexing Disease
More than 600,000 Americans suffer from Ménière's Disease, an inner ear disorder that can cause debilitating vertigo with nausea and
vomiting.2 Many patients say they feel "robbed" of their quality of life.
Its origin is unknown and there is no cure, so managing Ménière's Disease can be difficult. Before the Meniett device, patients whose symptoms did not improve with medical therapy had very few treatment options. Patients could either hope that their symptoms would eventually improve or resort to surgical methods that offered only varying rates of success. The Meniett device, writes Thomsen, "significantly reduces vestibular [vertigo] symptoms in patients with Ménière's Disease."
How the Meniett Device Works
The Meniett device allows patients to self-administer their treatment at home or work for a few minutes each day by delivering low-pressure air pulses through a tube connected to an earpiece placed in the outer ear. It is believed that the low-pressure pulses displace the excess inner ear fluid, normalizing the pressure within the ear and helping to relieve the symptoms of Ménière's Disease. The device has been cleared for use in the United States since December 1999, and in Europe since 1997.
For a copy of the US clinical study, please call Meniett Customer Service at 877-966-3350 or email Meniett Customer Service at
rs.jaxmeniettcustomerserv@medtronic.com.
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