Ménière's disease, also called idiopathic endolymphatic hydrops, is an idiopathic disorder of the inner ear characterized by ear pressure, tinnitus, fluctuating hearing loss, and episodes of vertigo. This document addresses the application of transtympanic micropressure, achieved by applying small bursts of air under pressure directly to the tympanic membrane. This technique is intended to address the underlying pathophysiology of Ménière's disease by attempting to restore the underlying endolymphatic fluid homeostasis.

Note: Please see the following document for additional information related to the treatment of Ménière's disease and vertigo:

• CG-REHAB-01 Vestibular Rehabilitation and Canalith Repositioning

Investigational and Not Medically Necessary:

Transtympanic micropressure applications are considered investigational and not medically necessary for all indications, including, but not limited to, treatment of Ménière's disease.

The symptoms of Ménière's disease (MD) are thought to be related to disturbances in the volume/pressure relationship of the endolymphatic fluid of the middle ear, in part based on documented expansion (hydrops) of the endolymphatic spaces in the temporal bones of symptomatic individuals. Transtympanic application of intermittent bursts of air under pressure to the tympanic membrane delivered with a tympanostomy tube in place has been investigated as a means of reducing endolymphatic hydrops, but the mechanism whereby this may be achieved is poorly understood. Multiple mechanisms have been proposed including that pressure changes may lead to a reduction in endolymphatic volume, hormonal changes (atrial natriuretic peptide), changes in oxygenation, or down-regulation of endolymphatic fluid production. One such pressure-applying generator approved by the U.S. Food and Drug Administration (FDA) in 1999 for the symptomatic treatment of Ménière's disease is the Meniett^® device (Pascal Medical AB, Sweden). In 2001, Medtronic Xomed, Inc, (Jacksonville, FL), purchased the device from Pascal Medical.

Densert and colleagues (1997) documented a clinical placebo-controlled study of 39 individuals with Ménière's disease and demonstrated statistically significant improvement in electrocochleographic findings in the group treated with transtympanic pressure pulses compared to a placebo group. However, there was no statistical difference between the groups in terms of symptoms or audiometric testing.

In a placebo-controlled, prospective, randomized, multicenter trial, Odkvist and colleagues (2000) investigated the effect of overpressure treatment on rotary vertigo, dizziness, aural fullness, tinnitus and hearing function. Fifty-six individuals (31 in the treatment group and 25 in the control group) underwent either pressure treatment or placebo treatment for two weeks. The authors discussed a "significant" improvement in vertigo, tinnitus and functional profile, but provided no statistical evidence of how they reached this conclusion. The mean differences in the hearing threshold levels before and after treatment with active Meniett^® device use were reported to be significantly different from zero at the frequencies 500 Hertz (Hz) (p<0.03) and one kHz (p<0.01), but not at higher frequencies. Electrocochleographic findings improved in the treatment group but not in the placebo group. While this study was promising, it is limited in drawing conclusions by the lack of statistical evidence, the small  number of participants, and the short treatment period and follow-up (two weeks).

In an uncontrolled study of 37 individuals with Ménière's disease, Densert and Sass (2001) suggested treatment with the Meniett^® device improved functionality and decreased episodic vertigo. Hearing thresholds improved in those with moderate hearing loss but not with mild or severe hearing loss. Ventilation tubes (VT) were inserted two to four weeks prior to starting pressure treatment. According to the authors, "The patients included in our study primarily failed to respond to the insertion of a ventilation tube and continued to have vertigo." However, no data was provided to support this statement such as documentation of any changes in the frequency or severity of vertigo, or functionality as a result of VT insertion alone, prior to the initiation of pressure therapy. Improvements in vertigo have been reported by other investigators following VT insertion (Barbara, 2001; Thomsen, 1998).

Gates and colleagues (2004) published the results of a multi-institutional study of 62 individuals with unilateral Ménière's disease who were randomized to receive either the Meniett^® device or a sham device. Outcomes were assessed based on participants' self report of vertigo severity and frequency. Although there was a significant decrease in the incidence of vertigo in the treatment group compared to controls, this difference diminished toward the four-month study endpoint, apparently due to spontaneous improvement in the control group. There was no difference between the groups, however, with regard to hearing and electrocochleographic results. The investigators agreed a longer term clinical study was warranted, in part because the difference between treatment and control groups diminished over time. In the two-year follow-up phase of this trial, Gates and colleagues (2006) reported on 61 of 67 participants from both the control and active treatment groups who were treated openly with the Meniett^® device; three participants were subsequently lost to follow-up or excluded due to concurrent health problems. Vertigo episodes were reported on a daily symptom diary (44 participants) or by a structured telephone interview (17 participants). Of the 58 participants, 15 were in remission at the time of entry and of the 43 who had active vertigo, 20 went into remission during the two-year follow-up; 14 (24%) dropped out to seek alternative surgical treatment, five (9%) showed little or no improvement, and 39 (67%) reported being in remission or substantially improved. For participants who went into remission, there was an 80% probability of remaining in remission for the two years. This assessment is limited, however, by the lack of a control group and treatment blinding. The authors acknowledge that the outcomes may reflect the effects of therapy, placebo, and the natural history of the disorder.

Thomsen and colleagues (2005) conducted an eight week randomized multi-center, double-blind, placebo-controlled clinical trial (n=40) using the Meniett^® device in individuals with active Ménière's disease. The primary endpoints were change in frequency of vertigo, change of functionality profile and change in the participant's perception of vertigo as measured on a visual analogue scale. Participants were evaluated for two months to obtain a baseline, after which tympanostomy tubes were placed, followed by two months without treatment to account for the effect of the tympanostomy tubes. Twenty participants then received the Meniett^® device for therapy and the other 20 participants received a sham device that was identical to the active device but applied only a slight pressure increase to two centimeters water for five seconds. The authors state the participants were unable to detect whether they were using the active or placebo device, but the basis for this statement is not discussed. Participants were evaluated at two, four, and eight weeks of use. Outcomes demonstrated significant improvement in functional level and in the participant's perception of vertigo in those receiving therapy with the Meniett^® device compared to the control group. However, there was no significant reduction in frequency of vertigo in those using the Meniett^® device and no statistical difference between the groups for tinnitus, hearing, or aural pressure perception. In addition to the marginal improvement in efficacy over placebo, study limitations include a small population, a high dropout rate (37%), lack of intent-to-treat analysis, and the inability to rule out the possibility participants were able to discern the type of device they were assigned.

An uncontrolled study by Rajan and colleagues (2005) reported on 18 individuals with Ménière's disease treated using the Meniett^® device and followed for a mean of 18 months. Of these 18 individuals, 12 had an improved functional score, five had improvement in hearing and six did not improve. In another uncontrolled study, Barbara and colleagues (2001) demonstrated reduction of vertigo after the placement of VT in the tympanic membrane in 90% of the Ménière's disease subjects, with no significant difference between the effect of VT alone (20 individuals) and VT plus Meniett^® device (18 individuals) over a 20-day period.

In a small study (n=12) reported by Boudewyns and colleagues (2005), individuals with drug resistant Ménière's disease were treated with the Meniett^® device for a mean follow-up of 39 months. There was some initial decrease in the frequency of vertigo episodes in these individuals, but no improvement in functional level, self-perceived dizziness handicap, hearing status or tinnitus. After one year, only two individuals preferred to continue with the therapy. The authors concluded Meniett^® therapy is unlikely to be helpful in the long-term treatment of severe, drug resistant Ménière's disease. The authors also point out the contrasting findings and recommendations in prior studies by Odkvist, Densert and Sass, and Gates, in regard to individuals with Ménière's disease (e.g., age, stage of disease and severity of vertigo) who are likely to benefit from the treatment.

Kim and colleagues (2005) polled 300 members of the American Neurotology Society (ANS) regarding the evaluation and treatment of individuals with Ménière's disease. Responses were received from 203 members. In treating Ménière's disease, conservative medical management was preferred, and less than 10% recommended the Meniett^® device. The authors noted, "The Meniett^® device has not gained widespread acceptance by the ANS membership. This is likely secondary to the limited experience that exists with this device." Also, "The role of the Meniett^® device in the treatment of Ménierè's disease will likely continue to evolve with greater experience and longer follow up." 

The peer-reviewed published literature contains few participants enrolled in randomized, placebo-controlled trials which are considered vital to contrast treatment effect to spontaneous improvement which may reflect the natural history of Ménière's disease, including its remissions and recurrences (Gates, 2004). Follow-up has been short term in most studies and long term evidence of benefit is generally lacking. In addition, there is conflicting data regarding improvement in electrocochleographic findings and improved hearing using transtympanic micropressure therapy. As noted by Boudewyns (2005), the data is conflicting as to which subsets of individuals with Ménière's disease may benefit from the therapy. Two other reviews of Ménière's disease (da Costa, 2002; Thai-Van, 2001) do not mention transtympanic micropressure as a treatment option and a third review (Gates, 2005) acknowledges the mechanism of action remains incompletely understood and acceptance of this therapy has been slow, in part due to uncertainty about its long-term effectiveness. Coelho and Lalwani (2008) suggest that "The capricious nature of the disease has made it difficult to prospectively determine the efficacy of therapeutic intervention, and thus the treatment of Ménière's disease is primarily empiric. Absence of robust prospective, randomized placebo-controlled studies has led to a variety of medical and surgical therapeutic interventions of uncertain value" (Thorp, 2000).

Several retrospective case series (12 to 36 subjects) reporting two- to four-year outcomes in individuals who had failed medical therapy have been published in the peer-reviewed literature (Barbara, 2007; Dornhoffer, 2008; Mattox, 2008; Park, 2009; Shojaku, 2011). Although these reports suggest a potential benefit of transtympanic micropressure, they are limited in drawing conclusions due to lack of randomization and treatment blinding. Park and colleagues reported no improvement in vestibular function was found with objective testing after placement of VTs alone. The authors of the Mattox study concluded that "as Ménière's disease has an unpredictable remitting and relapsing course, the outcomes, in part, reflect the natural history of the disease, nor can the possibility of placebo effect be discounted."

Martín González and colleagues (2010) reported on a case series of 252 subjects studied in the vestibular unit of a European hospital between 1998 and 2008. These subjects were diagnosed with definitive or probably Ménière's disease. The authors found "no evidence for the most adequate medical treatment among the different alternatives described in the literature." For the use of the Meniett^® device for Ménière's disease, "long-term results (over two years) remain unknown."

In March 2008, the Equilibrium Committee of the American Academy of Otolaryngology- Head and Neck Surgery and the Board of Directors of the American Academy of Otolaryngology-Head and Neck Surgery issued a statement titled, Micropressure Therapy, on the use of transtympanic micropressure for Ménière's disease. "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 Meniere's disease. Micropressure therapy is best used as a second level therapy when medical treatment has failed. The device represents a largely non-surgical therapy that should be available as one of the many treatments for Meniere's disease." This statement, however, did not identify the peer-reviewed evidence in support of this recommendation. 

In summary, additional data is needed in the form of large, multicenter, randomized, placebo-controlled trials with longer follow-up to establish the efficacy of transtympanic micropressure therapy as a treatment for Ménière's disease.

According to the National Institutes of Health (NIH), there are approximately 615,000 individuals with Ménière's disease in the United States, with 45,500 newly diagnosed cases each year. The cause of Ménière's disease is unknown, although it has been associated with abnormalities in the fluid held in the canals of the inner ear. The disease is characterized by episodes of vertigo, fluctuating hearing loss, tinnitus (ringing in the ears), and ear pressure. Symptoms are frequently limited to one side but, according to the American Academy of Family Physicians, up to 30% of sufferers have bilateral disease. The disease is neither contagious nor fatal, but it is associated with significant morbidity. There is no cure available at this time.

Individuals with Ménière's disease do not suffer from constant symptoms. The disease is characterized by occasional "attacks" which may occur as frequently as daily or as rarely as once a year. The most frequent and serious symptom is vertigo, which involves a whirling dizziness that forces the sufferer to lie down. Vertigo may lead to nausea, vomiting and sweating. Most attacks also involve tinnitus, fullness in the ears and some loss of hearing. All these symptoms are temporary; however progressive hearing loss in the affected ear over the course of time is common. There is frequently little or no warning of an attack. Individuals who do have warning signs of an attack, report having hearing loss, ringing, or "fullness" in their ear prior to the attack. Attacks may last anywhere from 20 minutes to several hours, and are often unpredictable and incapacitating.

Diagnosis of Ménière's disease involves several factors, including medical history and physical examination, a battery of hearing and balance tests, and imaging of the ear and associated neurological system. Proper diagnosis is important because there are several other conditions that may be confused with Ménière's disease. In a review by Coelho and Lalwani (2008), the presentation of Ménière's disease is reported as "highly variable and its clinical course characterized by acute exacerbation and spontaneous remission. The diagnosis is based on clinical presentation because there is no definitive objective test available." Mattox and Reichert (2008) report that

Ménière's disease is difficult to study because of the high variability of symptoms between subjects and even within the same subject over time. Furthermore, individuals with seemingly similar symptoms exhibit wide variation in tolerance or intolerance to the disease and its impact on personal and professional needs. The ideal treatment for Ménière's disease - effective, minimally invasive, and inexpensive - remains elusive.

Therapy for Ménière's disease is symptomatic in nature and does not address the underlying cause. Although the pathophysiology of Ménière's disease is not precisely known, it is thought to be related to a disturbance in the pressure/volume relationship of the fluid within the inner ear. The current therapy for attacks is for the individual to lay supine on a non-moveable surface such as a floor, limiting food and fluid intake until the symptoms subside, and visually focusing on a single immobile object. Conservative therapy includes a low sodium diet and diuretics to reduce the fluid accumulation, and pharmacologic therapy to reduce vestibular (balance) symptoms. Individuals who do not respond to these conservative measures may receive intratympanic gentamicin as a technique to chemically ablate vestibular function on the affected side. When symptoms continue and the unpredictability and fear of attacks persist, some individuals elect for more invasive therapy, including surgical procedures such as endolymphatic sac surgery, labyrinthectomy, or vestibular neurectomy. There is currently no therapy available to restore hearing loss that may occur.

Researchers have noted symptoms of Ménière's disease improve with fluctuations in ambient pressure; some individuals with acute vertigo have been successfully treated in hyperbaric chambers. It is hypothesized the application of low-frequency, low-amplitude pressure pulses to the middle ear to evacuate endolymphatic fluids from the middle ear relieves vertigo.

In 1999, the Meniett^® device received Class II device approval from the FDA as a symptomatic treatment of Ménière's disease. The device consists of a hand-held air pressure generator which delivers intermittent complex pressure pulses. Use of the device consists of two phases: 1) a conventional ventilation tube is surgically placed in the eardrum of the ear to be treated; and, 2) individuals are instructed to place an ear-cuff in the external ear canal to minimize leakage to the external environment. Individuals are typically instructed to use the device three times daily for three to five minutes each application.

Endolymphatic fluid: Pale, transparent, potassium-rich fluid present in the labyrinth of the inner (middle) ear, separated by a membrane from sodium-rich perilymphatic fluid.

Ménière's disease: A disease of the inner ear associated with vertigo, tinnitus and deafness.

Transtympanic micropressure: A treatment for Ménière's disease involving small variations in air pressure applied to the affected ear.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

Peer Reviewed Publications:

1. Barbara M, Consagra C, Monini S, et al. Local pressure protocol, including Meniett, in the treatment of Ménière's disease: short-term results during the active stage. Acta Otolaryngol. 2001; 121(8):939-944.
2. Barbara M, Monini S, Chiappini I, Filipo R. Meniett therapy may avoid vestibular neurectomy in disabling Meniere's disease. Acta Otolaryngol. 2007; 127(11):1136-1141.
3. Boudewyns AN, Wuyts FL, Hoppensbrouwers M, et al. Meniett therapy: rescue treatment in severe drug-resistant Meniere's disease. Acta Otolaryngol. 2005; 125(12):1283-1289.
4. Coelho DH, Lalwani AK. Medical management of Ménière's disease. Laryngoscope. 2008; 118(6):1099-1108.
5. da Costa SS, de Sousa LC, Piza MR. Ménière's disease: overview, epidemiology, and natural history. Otolaryngol Clin North Am. 2002; 35(3):455-495.
6. Densert B, Densert O, Arlinger S, et al. 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(6):726-733.
7. Densert B, Sass K. Control of symptoms in patients with Ménière's disease using middle ear pressure applications: two years follow-up. Acta Otolaryngol. 2001; 121(5):616-621.
8. Dornhoffer JL, King D. The effect of the Meniett device inpatients with Ménière's disease: long-term results. Otol Neurol. 2008; 29(6):868-874.
9. Gates GA. Meniere's disease review-2005. J Am Acad Audiol. 2006; 17(1):16-26.
10. Gates GA, Green JD Jr, Tucci DL, Telian SA. The effects of transtympanic micropressure treatment in people with unilateral Meniere's disease. Arch Otolaryngol Head Neck Surg. 2004; 130(6):718-725.
11. Gates GA, Verrall A, Green JD Jr, et al. Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg. 2006; 132(12):1311-1316.
12. Kim HH, Wiet RJ, Battista RA. Trends in the diagnosis and management of Ménière's disease: results of a survey. Otolaryngology Head Neck Surg. 2005; 132 (5):722-726.
13. Martín González C, González FM, Trinidad A, et al. Medical management of Ménière's disease: a 10-year case series and review of literature. Eur Arch Otorhinolaryngol. 2010; 267(9):1371-1376.
14. 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.
15. Odkvist LM, Arlinger S, Billermark E, et al. Effects of middle ear pressure changes on clinical symptoms in patients with Ménière's disease – a clinical multicentre placebo-controlled study. Acta Otolaryngol Suppl. 2000; 543:99-101.
16. Park JJ, Chen YS, Westhofen M. Meniere's disease and middle ear pressure - vestibular function after transtympanic tube placement. Acta Otolaryngol. 2009; 129(12):1408-1413.
17. Rajan GP, Din S, Atlas MD. Long-term effects of the Meniett device in Meniere's disease: the Western Australian experience. J Laryngol Otol. 2005; 119(5):391-395.
18. Shojaku H, Watanabe Y, Mineta H, et al. Long-term effects of the Meniett device in Japanese patients with Meniere's disease and delayed endolymphatic hydrops reported by the Middle Ear Pressure Treatment Research Group of Japan. Acta Otolaryngol. 2011; 131(3):277-283.
19. Thai-Van H, Bounaix MJ, Fraysse B. Ménierè's disease: pathophysiology and treatment. Drugs. 2001; 61(8):1089-1102.
20. Thomsen J, Sass K, Odkvist L, Arlinger S. Local overpressure treatment reduces vestibular symptoms in patients with Ménierè's disease: a clinical, randomized, multicenter, double-blind placebo-controlled study. Otol Neurotol. 2005; 26(1):68-73.
21. Thorp MA, Shehab ZP, Bance ML, Rutka JA. Does evidence-based medicine exist in the treatment of Menière's disease? A critical review of the last decade of publications. Clin Otolaryngol Allied Sci. 2000; 25(6):456-460.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Micropressure therapy. March 2008. Available at: http://www.entnet.org/Practice/micropressure.cfm. Accessed on May 9, 2011.
2. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. Pascal Medical AB Meniett 20. Summary of Safety and Effectiveness. No. K991562. Rockville, MD: FDA. December 28, 1999. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Accessed on May 9, 2011.

1. American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Ménière's disease. Updated December 2010. Available at: http://www.entnet.org/HealthInformation/menieresDisease.cfm. Accessed on May 9, 2011.
2. National Institute on Deafness and Other Communication Disorders (NIDCD). Health information: Ménière's disease. Updated July 2010. Available at: http://www.nidcd.nih.gov/health/balance/meniere.asp. Accessed on May 9, 2011.
3. Vestibular Disorders Association (VEDA). Ménière's disease. Modified March 15, 2011. Available at: http://vestibular.org/vestibular-disorders/specific-disorders/meniere-s-disease.php?searchresult=1&sstring=meniere%26%2339%3Bs. Accessed on May 9, 2011.

Ménière's Disease
Meniett^® Device
Transtympanic Micropressure

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