Fewer Sick Days and Significantly Less Severe Vertigo with Low-Pressure Treatment

Results of a U.S. study published in the June issue of the Archives of Otolaryngology, an American Medical Association publication, demonstrate that patients who used the Medtronic Meniett™ Low-Pressure Pulse Generator to control their symptoms of Ménière's Disease suffered less severe vertigo and missed fewer work days because of the disease than patients in the control group. All patients in the study received optimal medical therapy. Severe vertigo, which can cause nausea and vomiting, is considered by patients to be the most problematic symptom of Ménière's Disease.

The randomized, placebo-controlled, double-blind, multicenter trial showed that participants who used the Meniett device experienced significantly less severe vertigo, fewer days with vertigo (as defined by the patient), and fewer days missed from work compared to patients in the control group. There were no complications from using the Meniett device. 

For four months, the study evaluated 62 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). 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.

"The Meniett device is a minimally invasive, safe and efficacious intermediate treatment for people with substantial vertigo uncontrolled by medical therapy," writes George Gates, M.D., principal investigator of the study, and professor of otolaryngology and director of the Virginia Merrill Bloedel Research Center, University of Washington Medical Center. "We recommend that patients, physicians and healthcare insurers recognize the Meniett device as a second-level therapy for Ménière's Disease [after medical therapy fails and before surgical or destructive treatment is considered]."

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. 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 study showed that 70 percent of patients who use the Meniett device are either totally free of vertigo or have their vertigo significantly reduced, which may help some patients avoid destructive surgery. 

"Use of the Meniett device provides an additional treatment option prior to undertaking ablative therapy [destructive surgery] for treatment failures," writes Gates.

How the Meniett Device Works
The Meniett device, manufactured by Medtronic Xomed, 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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