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Clinical Studies – Meniett Therapy and Ménière’s Disease

Meniett therapy for Ménière’s disease is based on nearly 30 years of clinical research in the US and internationally.1-16 Both short- and long-term results have been studied, showing that Meniett therapy is a safe and effective treatment for the dizziness and vertigo symptoms of Ménière’s disease.1-12

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) is the largest and most well-respected organization of ear, nose, and throat (ENT) specialists. In March 2008, the AAO-HNS issued this statement:

“We find that there is convincing and well-controlled medical evidence to support the use of micropressure therapy (such as the Meniett device) in certain cases of Ménière’s disease. Micropressure therapy is best used as a second level therapy when medical treatment has failed.”17

Clinical studies about Meniett therapy for Ménière’s disease include:

Effect of the Meniett Device in Patients with Ménière’s Disease: Long-Term Results1Effect of the Meniett Device in Patients with Ménière’s Disease: Long-Term Results1

  • Objective: To review and analyze the long-term effectiveness of the Meniett device in controlling vertigo symptoms and how the device affected each Ménière’s disease patient’s functionality level.
  • Design: A 3-year retrospective study of Ménière’s disease patients who weren’t helped by medical therapy and chose Meniett therapy instead of surgical or destructive treatments.
  • Conclusion: “The Meniett device is a minimally invasive, non-destructive treatment that may be used to provide longer-term reduction of vestibular symptoms in patients with Ménière’s disease.”
  • Declaration of Interest: “This study was supported by Grant RR020146 from the National Institutes of Health National Center for Research Resources Center of Biomedical Research Excellence (JLD). The authors report no conflict of interest.”
  • Dornhoffer JL, King D. The effect of the Meniett device in patients with Ménière's disease: long-term results. Otol Neurotol 2008; 29(6):868-874.

Meniett Device for Ménière’s Disease: Use and Compliance at 3 to 5 Years2Meniett Device for Ménière’s Disease: Use and Compliance at 3 to 5 Years2

  • Objective: To see if Ménière’s disease patients kept using the Meniett device for 2 and 3 years after it was first prescribed.
  • Design: Retrospective study of Ménière’s disease patients who weren’t helped by medical therapy and chose Meniett therapy instead of surgical treatments.
  • Conclusion: “We conclude that the Meniett device is a useful minimally invasive, alternative treatment in the management of Ménière’s disease. Among these patients who had failed previous medical management, 71% and 63% required no additional intervention beyond the Meniett device at a minimum of 2 and 3 years of follow-up, respectively. Most patients who failed to gain benefit did so early on in therapy.”
  • Declaration of Interest: “Neither the investigators nor this study was supported financially or otherwise by Medtronic, Inc., or its subsidiaries.”
  • Mattox DE, Reichert M. Meniett device for Ménière's disease: use and compliance at 3 to 5 years. Otol Neurotol 2008; 29(1):29-32.

Clinical Long-Term Effects of Meniett Pulse Generator for Ménière’s Disease3Clinical Long-Term Effects of Meniett Pulse Generator for Ménière’s Disease3

  • Objective: To analyze the long-term effectiveness of pressure treatment for unmanageable vertigo symptoms in Ménière’s disease.
  • Design: Cross-sectional case study of patients with Ménière’s disease that didn’t respond to medical treatment and who chose to try the Meniett device. Patients were followed for a period of 24 to 28 months.
  • Conclusion: “According to this long-term study, the Meniett pulse generator is a safe, effective, and non-destructive therapy that can reduce vertiginous symptoms and associated functional handicap and partly show an improvement of hearing in medically intractable and active Ménière’s disease. Moreover, we recommend considering it before attempting any surgical or chemical vestibular ablation procedure.”
  • Declaration of Interest: “The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.”
  • Weining H, Fang L, Bo G, Jinmei Z. Clinical long-term effects of Meniett pulse generator for Ménière's disease. Acta Otolaryngol 2009; 129(8):819-825.

Meniett Therapy May Avoid Vestibular Neurectomy in Disabling Ménière’s Disease4Meniett Therapy May Avoid Vestibular Neurectomy in Disabling Ménière’s Disease4

  • Objective: To find out if Meniett therapy could help Ménière’s disease patients avoid a vestibular neurectomy.
  • Design: Consisted of Ménière’s disease patients who weren’t helped by medical therapy and who were recommended for vestibular neurectomy. Patients were followed for more than 2 years.
  • Conclusion: “In those patients for whom vestibular neurectomy has been selected due the disabling recurrence of vertigo spells, Meniett therapy has been shown to allow avoidance of this surgical procedure in a fairly high percentage [69.4%] of patients with Ménière’s disease. Our data would also support a better result when pressure treatment is acting on Ménière’s disease of short duration.”
  • Declaration of Interest: Not disclosed by the authors.
  • Barbara M, Monini S, Chiappini I, Filipo R. Meniett therapy may avoid vestibular neurectomy in disabling Ménière's disease. Acta Otolaryngol 2007; 127(11):1136-1141.

Long-Term Effects of the Meniett Device in Ménière’s Disease: the Western Australian Experience5Long-Term Effects of the Meniett Device in Ménière’s Disease: the Western Australian Experience5

  • Objective: To independently investigate the long-term effectiveness and safety of pressure treatment for unmanageable vertigo in Ménière’s disease.
  • Design: Cross-sectional case study of Ménière’s disease patients who had not been helped by medical therapy.
  • Conclusion: “According to this independent study, the Meniett device seems to be a minimally invasive, non-destructive treatment tool, which can reduce vertigo and associated functional handicap in Ménière’s disease. These effects are maintained up to 18 months after treatment so far.”
  • Declaration of Interest: “Dr. G. Rajan takes responsibility for the integrity of the content of the paper. Competing interests: None declared.”
  • Rajan GP, Din S, Atlas MD. Long-term effects of the Meniett device in Ménière’s disease: the Western Australian experience. J Laryngol Otol 2005; 119:391-395.

Local Overpressure Treatment Reduces Vestibular Symptoms in Patients with Ménière’s Disease: A Clinical, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study6Local Overpressure Treatment Reduces Vestibular Symptoms in Patients with Ménière’s Disease: A Clinical, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study6

  • Objective: To analyze the effectiveness of the Meniett device treatment for Ménière’s disease.
  • Design: Consisted of Ménière’s disease patients who had experienced at least 8 vertigo attacks in the year leading up to the study. Half of the patients received a working Meniett device, and the other half received a non-working Meniett device (placebo). Patients were blinded to which device they received.
  • Conclusion: “It [the Meniett device] significantly reduces vestibular symptoms in patients with Ménière’s disease.”
  • Declaration of Interest: Not disclosed by the authors.
  • Thomsen J, Sass K, Ödkvist L, Arlinger S. Local over-pressure treatment reduces vestibular symptoms in patients with Ménière’s disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Otol Neurotol 2005; 26:68-73.

Bilateral Ménière’s Disease7Bilateral Ménière’s Disease7

  • Objective: To analyze the most up-to-date ideas in the diagnosis and treatment of bilateral Ménière’s disease, due to the lack of articles focused specifically on bilateral Ménière’s disease.
  • Conclusion: “The Meniett mechanical device provides intermittent pulsatile pressure to the middle ear space following long-term tympanostomy tube placement, and the alteration of middle ear pressures are purported to impact inner ear fluid dynamics. This device can be particularly useful for patients with bilateral Ménière’s disease because of the otherwise limited therapeutic options.”
  • Declaration of Interest: Not disclosed by the authors.
  • Nabi S, Parnes LS. Bilateral Ménière’s disease. Curr Opin Otolaryngol Head Neck Surg 2009; 17:356-362.

The Effects of Transtympanic Micropressure Treatment in People with Unilateral Ménière’s Disease8The Effects of Transtympanic Micropressure Treatment in People with Unilateral Ménière’s Disease8

  • Objective: To analyze the effectiveness of the Meniett device in managing the symptoms of Ménière’s disease.
  • Design: A randomized, placebo-controlled, double-blind, multicenter clinical trial of Ménière’s disease patients. At the end of the study, the non-placebo users were unblinded and followed for 2 years with the results published (Gates et al, 2006).
  • Conclusion: “The [Meniett] treatment group experienced significantly less severe vertigo, fewer days with definitive vertigo, and fewer days lost from work (sick days) during the follow-up period than did the control group.”
  • Declaration of Interest: “Funding was provided by Medtronic Xomed as an unrestricted grant to each of the 4 study centers. Dr. Gates served as a paid consultant to Medtronic Xomed at a scientific retreat in 2002.”
  • Gates GA, Green Jr. JD, Tucci DL, Telian SA. The effects of transtympanic micropressure treatment in people with unilateral Ménière’s disease. Arch of Oto – HNS 2004; 130(6):718-725.

Meniett Clinical Trial: Long-Term Follow-Up9Meniett Clinical Trial: Long-Term Follow-Up9

  • Objective: To determine the effectiveness of Meniett therapy over 2 years in Ménière’s disease patients who weren’t helped by medical therapy.
  • Design: A 2-year unblinded follow-up to a previous randomized, placebo-controlled, multicenter clinical trial of the Meniett device for Ménière’s disease (Gates et al, 2004).
  • Conclusion: “Long-term evaluation of the Meniett device shows the pressure therapy to be a safe and effective treatment to control the acute vertigo attacks associated with Ménière’s disease.”
  • Declaration of Interest: “Drs. Gates and Green have served as paid consultants for Medtronic Xomed, Inc., of Jacksonville, Fla. Dr. Gates was an otology consultant and assisted the company in informing regulators and industry decision-makers about the Meniett device. Dr. Green consulted on safety issues and with regard to new and emerging technology in the area of otologic surgery. The Meniett Clinical Trial and the 2-year follow-up were supported by an unrestricted grant from Medtronic Xomed, Inc.”
  • Gates GA, Verrall A, Green Jr. JD, Tucci DL, Telian SA. Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg 2006; 132:1311-1316.

Control of Symptoms in Patients with Ménière’s Disease using Middle Ear Pressure Applications: Two Years Follow-Up10Control of Symptoms in Patients with Ménière’s Disease using Middle Ear Pressure Applications: Two Years Follow-Up10

  • Objective: To study the safety and effects of middle ear pressure pulses for Ménière’s disease treatment in patients who didn't respond to medical therapy.
  • Design: Measured the number of vertigo spells during the 6 months before treatment and at 6, 18, and 24 months after starting treatment.
  • Conclusion: “Overall, the results indicate that pressure treatment provides efficient control of symptoms in patients with intractable forms of Ménière’s disease without producing any adverse effects on the inner ear.”
  • Declaration of Interest: Not disclosed by the authors.
  • Densert B, Sass K. Control of symptoms in patients with Ménière’s disease using middle ear applications: two years follow-up. Acta Otolaryngol 2001; 121(5):616-621.

Effects of Middle Ear Pressure Changes on Clinical Symptoms in Patients with Ménière’s Disease – A Clinical Multicenter Placebo-Controlled Study11 Effects of Middle Ear Pressure Changes on Clinical Symptoms in Patients with Ménière’s Disease – A Clinical Multicenter Placebo-Controlled Study11

  • Objective: To analyze the effects of overpressure treatment with the Meniett device on the symptoms of rotary vertigo, dizziness, aural fullness, tinnitus, and hearing in patients with Ménière’s disease.
  • Design: Prospective randomized, placebo-controlled, multicenter trial where one group of patients used an active Meniett device and the other group used a placebo device.
  • Conclusion: “A significant improvement in frequency and intensity of vertigo, dizziness, aural pressure, and tinnitus was found in the active [Meniett device] group. In many patients in the active group, changes in the functionality profile have been quite dramatic and have shown an improvement in the key functions concerning work, rest, social life, and driving…”
  • Declaration of Interest: Not disclosed by the authors.
  • Ödkvist LM, Arlinger S, Billermark E, Densert B, Lindholm S, Wallquist J. Effects of middle ear pressure changes on clinical symptoms in patients with Ménière’s disease: A clinical, multicenter, placebo-controlled study. Acta Otolaryngol Suppl 2000; 543: 99-101.

Immediate Effects of Middle Ear Pressure Changes on the Electrocochleographic Recordings in Patients with Ménière’s Disease: A Clinical Placebo-Controlled Study12 Immediate Effects of Middle Ear Pressure Changes on the Electrocochleographic Recordings in Patients with Ménière’s Disease: A Clinical Placebo-Controlled Study12

  • Objective: To analyze the effects of middle ear pressure changes on the electrocochleographic responses in Ménière’s disease patients.
  • Design: Measured Ménière’s disease patients’ electrocochleographic responses before and after a ventilation tube was inserted in the affected ear and immediately after they received pressure treatment with a working device or placebo device.
  • Conclusion: : “The results show that electrophysiologic parameters can be improved by the application of positive pressure pulses of low amplitude in the middle ear.”
  • Declaration of Interest: Not disclosed by the authors.
  • Densert B, Densert O, Arlinger S, Sass K, Ödkvist LM. Immediate effects of middle ear pressure changes on the electrocochleographic recordings in patients with Ménière’s disease: A clinical placebo-controlled study. Am J Otol 1997; 18:726-733.

References

View full listView full list

  1. Dornhoffer JL, King D. The effect of the Meniett device in patients with Ménière's disease: long-term results. Otol Neurotol 2008; 29(6):868-74.
  2. Weining H, Fang L, Bo G, Jinmei Z. Clinical long-term effects of Meniett pulse generator for Ménière's disease. Acta Otolaryngol 2009; 129(8):819-825.
  3. Mattox DE, Reichert M. Meniett device for Ménière's disease: use and compliance at 3 to 5 years. Otol Neurotol 2008; 29(1):29-32.
  4. Barbara M, Monini S, Chiappini I, Filipo R. Meniett therapy may avoid vestibular neurectomy in disabling Ménière's disease. Acta Otolaryngol 2007; 127(11):1136-1141.
  5. Rajan GP, Din S, Atlas MD. Long-term effects of the Meniett device in Ménière’s disease: the Western Australian experience. J Laryngol Otol 2005; 119:391-395.
  6. Thomsen J, Sass K, Ödkvist L, Arlinger S. Local over-pressure treatment reduces vestibular symptoms in patients with Ménière’s disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Otol Neurotol 2005; 26:68-73.
  7. Nabi S, Parnes LS. Bilateral Ménière’s disease. Curr Opin Otolaryngol Head Neck Surg 2009; 17:356-362.
  8. Gates GA, Green Jr. JD, Tucci DL, Telian SA. The effects of transtympanic micropressure treatment in people with unilateral Ménière’s disease. Arch of Oto – HNS 2004; 130(6):718-725.
  9. Gates GA, Verrall A, Green Jr. JD, Tucci DL, Telian SA. Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg 2006; 132:1311-1316.
  10. Densert B, Sass K. Control of symptoms in patients with Ménière’s disease using middle ear applications: two years follow-up. Acta Otolaryngol 2001; 121(5):616-621.
  11. Ödkvist LM, Arlinger S, Billermark E, Densert B, Lindholm S, Wallquist J. Effects of middle ear pressure changes on clinical symptoms in patients with Ménière’s disease: A clinical, multicenter, placebo-controlled study. Acta Otolaryngol Suppl 2000; 543: 99-101.
  12. Densert B, Densert O, Arlinger S, Sass K, Ödkvist LM. Immediate effects of middle ear pressure changes on the electrocochleographic recordings in patients with Ménière’s disease: A clinical placebo-controlled study. Am J Otol 1997; 18:726-733.
  13. Densert B, Densert O. Overpressure in treatment of Ménière’s disease. Laryngoscope 1982; 92:1285-1292.
  14. Densert B. Effects of overpressure on hearing function in Ménière’s disease. Acta Otolaryngol (Stockh) 1987; 103:32-42.
  15. Feijen RA, Segenhout JM, Wit HP, Albers FWJ. Monitoring inner ear pressure changes in normal guinea pigs induced by the Meniett 20. Acta Otolaryngol 2000; 804-809.
  16. Densert B, Sass K, Arlinger S. Short-term effects of induced middle ear pressure changes on the electrocochleogram in Ménière’s disease. Acta Otolaryngol (Stockh) 1995; 115: 732-737.
  17. American Academy of Otolaryngology – Head and Neck Surgery Policy Statement: Micropressure Therapy. March 2008.

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Last updated: 19 Jul 2011

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