By Marcello Cherchi, MD PhD
For patients
Positive pressure therapies (such as the Meniett® device) have been tried to treat Ménière’s disease, but have not been very successful.
For clinicians
Overview
Positive pressure therapies — such as the Meniett® device and tympanic membrane massage — have been studied as a treatment for Ménière’s disease. The literature about these approaches is relatively weak, with a paucity of placebo-controlled trials. Most (though not all) meta-analyses and systematic literature reviews conclude that evidence does not support the efficacy of positive pressure therapies for Ménière’s disease.
Introduction
Anecdotal observations that patients with Ménière’s disease reported symptomatic improvement during pressurized airplane travel led to the idea that delivering pressure through the middle ear to the inner ear might somehow treat this disease.
Mechanism of action
The putative mechanism of action underlying positive-pressure therapy for Ménière’s disease is unclear. Since one of the putative pathophysiologies of Ménière’s disease is endolymphatic hydrops (increased labyrinthine pressure), logically one would think that further increasing labyrinthine pressure would have deleterious effects. Odkvist and colleagues postulate that, “The mechanism may be explained by the influence on the round window membrane pressure receptors or an endolymphatic flow out through the pressure release points, such as the endolymphatic duct and sac, thus activating the longitudinal flow. Other mechanisms are also possible” (Odkvist et al. 2000).
The most studied positive pressure therapy for Ménière’s disease is the Meniett® device, patented by Daniel Engvall and Anders Nilsson (Engvall and Nilsson 2003) and sold by Medtronic. This approach requires placement of a tympanostomy tube, followed by intermittent application of an external device that delivers pulses of positive pressure to the external ear that pass through the tympanostomy tube and middle ear, and from there through the oval and round windows into the labyrinth.
A more recent development, sometimes termed “tympanic membrane massage,” involves a similar approach except without placement of the tympanostomy tube — in other words, pressure changes applied to the external ear are transmitted by an intact tympanic membrane through the middle ear to the inner ear (Mudry, Santa Maria, Jackler 2016; Shojaku et al. 2021a; Shojaku et al. 2021b; Watanabe et al. 2011).
Adverse effects
The main “adverse effect” of the Meniett® device is that it requires placement of a tympanostomy tube.
Studies
Studies of positive pressure therapies, particularly the Meniett® device, reach widely divergent conclusions regarding its efficacy. We review some of these here.
Studies concluding that positive pressure therapy is effective
We review here a number of studies that concluded the Meniett® device is efficacious in treating Ménière’s disease, though the reader will note that very few of these studies had a placebo arm (Gates et al. 2004; Odkvist et al. 2000).
A prospective randomized placebo controlled multicenter trial of 56 patients concluded that, “The study showed an improvement in the inner ear symptoms after Meniett® treatment” (Odkvist et al. 2000).
A prospective, unblinded study concluded that, “Although a longer and more reliable long-term follow-up of this treatment is needed, it is possible to propose the use of this therapeutic approach as it has been proven to induce a dramatic improvement in the symptoms affecting patients with Meniere’s disease during reactivation of the disease” (Barbara et al. 2001).
A “short-term, preliminary descriptive report” of 10 patients concluded that, “the Meniett® device is an effective and safe option for people with intractable vertigo from Ménière’s disease” (Gates and Green 2002).
A randomized, placebo-controlled, double-blind, multicenter trial of 67 patients concluded that, “The Meniett® device is a minimally invasive, safe, and efficacious intermediate treatment for people with substantial vertigo uncontrolled by medical therapy” (Gates et al. 2004).
A cross-sectional case study of 18 patients concluded that, “the Meniett® device seems to be a minimally invasive, non-destructive treatment tool, which can reduce vertigo and associated functional handicam in Ménière’s disease” (Rajan, Din, Atlas 2005).
An “unblinded follow-up after a prior randomized, placebo-controlled, multicenter clinical trial of the Meniett® device for Ménière’s disease” studied 61 patients over 2 years and concluded that, “Use of the Meniett® device was associated with a significant reduction in vertigo frequency in about two thirds of the participants, and this improvement was maintained long term. Therapy with the Meniett® device is a safe and effective option for people with substantial vertigo uncontrolled by medical therapy” (Gates et al. 2006).
A prospective study of 36 Ménière’s patients “for whom vestibular neurectomy was indicated, underwent Meniett® treatment and composed a group in which long term (>2 years) follow-up was achieved,” concluded that, “In those patients for whom vestibular neurectomy has been selected due to the disabling recurrence of vertigo spells, Meniett® therapy has been shown to allow avoidance of this surgical procedure in a fairly high percentage of patients with Ménière’s disease” (Barbara et al. 2007).
A retrospective case review of 14 patients concluded that, “The Meniett® device is a minimally invasive, nondestructive treatment that may be used to provide longer-term reduction of vestibular symptoms in patients with Ménière’s disease” (Dornhoffer and King 2008).
A retrospective case series of 21 patients concluded that, “the Meniett® device is a useful minimally invasive alternative in the management of Ménière’s disease” (Mattox and Reichert 2008).
A cross-sectional case study of 22 consecutive patients concluded, “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 Meniere’s disease” (Huang et al. 2009).
A trial without a placebo arm concluded that, “The Meniett® device is a minimally invasive and safe treatment that may be used to provide longer-term reduction of vestibular symptoms in patients with delayed endolymphatic hydrops (DEH) as well as those with Ménière’s disease (MD)” (Shojaku et al. 2011).
A systematic review and meta-analysis concluded that, “The Meniett® device is a safe, nondestructive treatment for patients refractory to medical therapy for MD [Ménière’s disease],” but noted that, “Much of the data used in the analysis was derived from retrospective or level 4 studies” (Ahsan, Standring, Wang 2015).
A retrospective, questionnaire-based audit of 33 consecutive Ménière’s patients concluded that, “The Meniett® device is a well tolerated, useful and minimally invasive means of treating Ménière’s disease after medical treatment has failed, and before potentially cochleo- and vestibulo-toxic therapies and invasive procedures are utilised” (Buchanan, Rai, Prinsley 2010).
Studies concluding that positive pressure therapies are effective for disequilibrium but not for hearing
Several studies and reviews (Barbara et al. 2010; Gates 2005; Gurkov et al. 2012; Zhang et al. 2016) report a differential effect of the Meniett® device on vertiginous episodes (beneficial) and hearing (no effect).
One review concluded that, “Long-term success in control of vertigo is over 80%. Although hearing loss is not improved, Meniett® device usage does not adversely affect balance, as do most forms of surgical therapy” (Gates 2005).
A cohort study of 55 patients concluded that, “Meniett® treatment was not shown to avoid deterioration of hearing threshold in patients with Ménière’s disease (MD), even when achieving a fairly good therapeutic outcome on vertigo control” (Barbara et al. 2010).
A randomized, placebo-controlled, double-blinded clinical trial concluded that, “Use of the Meniett® low-pressure generator improved patients’ vertigo but not their hearing or vestibular function” (Gurkov et al. 2012).
A meta-analysis concluded that, “Meniett® therapy may prevent vertigo attacks and substantially reduce its frequency in MD [Ménière’s disease] patients… The impact of Meniett® therapy on hearing remains uncertain” (Zhang et al. 2016).
Studies concluding that positive pressure therapies are ineffective
A series of 12 patients concluded, “Our data indicate that Meniett® therapy is unlikely to be helpful in the long-term treatment of patients with severe, drug-resistant Meniere’s disease (MD) in whom injection of intratympanic gentamicin (ITG) or another destructive procedure would otherwise be performed” (Boudewyns et al. 2005).
A case series of 32 patients “measured hearing and labyrinth sensitivity in patients with established MD [Ménière’s disease] according to American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) criteria at five different time periods: at baseline; before ventilation tube placement; before Meniett® treatment; immediately after Meniett® treatment; and 1 month after cessation of Meniett® treatment,” and concluded that, “No statistically significant changes in labyrinthine function were found during Meniett® treatment” (Stokroos et al. 2006).
A placebo-controlled trial (Meniett® versus sham device) reported that, “An improvement of symptoms was evidenced in all patients, with no difference between the Meniett® (Medtronic Xomed) and the placebo device groups” (Russo et al. 2017).
Overall conclusion of studies
Given that the “positive” studies are largely (though not completely) uncontrolled, the relatively small sample sizes and often relatively limited follow-up, and the studies showing no difference between intervention and placebo, most meta-analysis and systematic reviews generally conclude that the evidence does not support use of the Meniett®.
A systematic review of the literature regarding positive pressure treatment for Ménière’s disease concluded that the, “available evidence does not support positive pressure device treatment in patients with Ménière’s disease” (Devantier et al. 2019).
A meta-analysis of placebo-controlled trials of the Meniett® device concluded that, “No evidence was found to justify the use of the Meniett® device in Ménière’s syndrome/disease” (Syed et al. 2015).
Cochrane reviews of positive pressure therapies for Ménière’s disease concluded that there is “no evidence” (van Sonsbeek, Pullens, van Benthem 2015), or that the evidence is “very uncertain” (Webster et al. 2023) of its efficacy.
A cynical commentator, discussing positive pressure therapies in general, concluded that, “The golden era of pneumomassage illustrates the ingenuity of otologists and medical instrument makers in creating a proliferation of clever devices, as well as how highly touted treatment methods may become widely adopted by practitioners despite the lack of efficacy” (Mudry, Santa Maria, Jackler 2016).
References
Ahsan SF, Standring R, Wang Y (2015) Systematic review and meta-analysis of Meniett therapy for Meniere’s disease. Laryngoscope 125: 203-8. doi: 10.1002/lary.24773
Barbara M, Consagra C, Monini S, Nostro G, Harguindey A, Vestri A, Filipo R (2001) Local pressure protocol, including Meniett, in the treatment of Meniere’s disease: short-term results during the active stage. Acta Otolaryngol 121: 939-44.
Barbara M, Lazzarino AI, Biagini M, Costa M, Monini S (2010) Influence of Meniett(R) treatment on hearing. Acta Otolaryngol 130: 1256-9. doi: 10.3109/00016481003782033
Barbara M, Monini S, Chiappini I, Filipo R (2007) Meniett therapy may avoid vestibular neurectomy in disabling Meniere’s disease. Acta Otolaryngol 127: 1136-41. doi: 10.1080/00016480701200319
Boudewyns AN, Wuyts FL, Hoppenbrouwers M, Ketelslagers K, Vanspauwen R, Forton G, Van de Heyning PH (2005) Meniett therapy: rescue treatment in severe drug-resistant Meniere’s disease? Acta Otolaryngol 125: 1283-9. doi: 10.1080/00016480510012237
Buchanan MA, Rai A, Prinsley PR (2010) Initial UK experience of patient satisfaction with the Meniett(R) device for Meniere’s disease treatment. J Laryngol Otol 124: 1067-72. doi: 10.1017/S0022215110001118
Devantier L, Guldfred FL, Djurhuus BD, Handel MN, Schmidt JH, Hougaard DD, Edemann-Callesen H (2019) Positive pressure device treatment for Meniere’s disease: an overview of the current evidence and a meta-analysis. Eur Arch Otorhinolaryngol 276: 1263-1273. doi: 10.1007/s00405-019-05359-y
Dornhoffer JL, King D (2008) The effect of the Meniett device in patients with Meniere’s disease: long-term results. Otol Neurotol 29: 868-74. doi: 10.1097/MAO.0b013e318182025a
Engvall D, Nilsson A (2003) Apparatus for treatment of meniere’s disease and similar conditions. In: Office USPaT (ed), A61H 23/00 edn. Metronic, Inc., United States of America, pp 8
Gates GA (2005) Treatment of Meniere’s disease with the low-pressure pulse generator (Meniett device). Expert Rev Med Devices 2: 533-7. doi: 10.1586/17434440.2.5.533
Gates GA, Green JD, Jr. (2002) Intermittent pressure therapy of intractable Meniere’s disease using the Meniett device: a preliminary report. Laryngoscope 112: 1489-93. doi: 10.1097/00005537-200208000-00029
Gates GA, Green JD, Jr., Tucci DL, Telian SA (2004) The effects of transtympanic micropressure treatment in people with unilateral Meniere’s disease. Arch Otolaryngol Head Neck Surg 130: 718-25. doi: 10.1001/archotol.130.6.718
Gates GA, Verrall A, Green JD, Jr., Tucci DL, Telian SA (2006) Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg 132: 1311-6. doi: 10.1001/archotol.132.12.1311
Gurkov R, Filipe Mingas LB, Rader T, Louza J, Olzowy B, Krause E (2012) Effect of transtympanic low-pressure therapy in patients with unilateral Meniere’s disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial. J Laryngol Otol 126: 356-62. doi: 10.1017/S0022215112000102
Huang W, Liu F, Gao B, Zhou J (2009) Clinical long-term effects of Meniett pulse generator for Meniere’s disease. Acta Otolaryngol 129: 819-25. doi: 10.1080/00016480802468146
Mattox DE, Reichert M (2008) Meniett device for Meniere’s disease: use and compliance at 3 to 5 years. Otol Neurotol 29: 29-32. doi: 10.1097/MAO.0b013e31815dbac4
Mudry A, Santa Maria P, Jackler RK (2016) Ossicular calisthenics: Pneumomassage of the tympanic membrane. Laryngoscope 126: 1180-6. doi: 10.1002/lary.25556
Odkvist LM, Arlinger S, Billermark E, Densert B, Lindholm S, Wallqvist J (2000) Effects of middle ear pressure changes on clinical symptoms in patients with Meniere’s disease–a clinical multicentre placebo-controlled study. Acta Otolaryngol Suppl 543: 99-101.
Rajan GP, Din S, Atlas MD (2005) Long-term effects of the Meniett device in Meniere’s disease: the Western Australian experience. J Laryngol Otol 119: 391-5. doi: 10.1258/0022215053945868
Russo FY, Nguyen Y, De Seta D, Bouccara D, Sterkers O, Ferrary E, Bernardeschi D (2017) Meniett device in meniere disease: Randomized, double-blind, placebo-controlled multicenter trial. Laryngoscope 127: 470-475. doi: 10.1002/lary.26197
Shojaku H, Aoki M, Takakura H, Fujisaka M, Asai M, Tsubota M, Ito Y, Watanabe Y (2021a) Effects of transtympanic intermittent pressure therapy using a new tympanic membrane massage device for intractable Meniere’s disease and delayed endolymphatic hydrops: a prospective study. Acta Otolaryngol 141: 907-914. doi: 10.1080/00016489.2021.1942979
Shojaku H, Takakura H, Asai M, Fujisaka M, Ueda N, Do TA, Tsubota M, Watanabe Y (2021b) Long-term effect of transtympanic intermittent pressure therapy using a tympanic membrane massage device for intractable meniere’s disease and delayed endolymphatic hydrops. Acta Otolaryngol 141: 977-983. doi: 10.1080/00016489.2021.1989485
Shojaku H, Watanabe Y, Mineta H, Aoki M, Tsubota M, Watanabe K, Goto F, Shigeno K (2011) 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 131: 277-83. doi: 10.3109/00016489.2010.526142
Stokroos R, Olvink MK, Hendrice N, Kingma H (2006) Functional outcome of treatment of Meniere’s disease with the Meniett pressure generator. Acta Otolaryngol 126: 254-8. doi: 10.1080/00016480500388869
Syed MI, Rutka JA, Hendry J, Browning GG (2015) Positive pressure therapy for Meniere’s syndrome/disease with a Meniett device: a systematic review of randomised controlled trials. Clin Otolaryngol 40: 197-207. doi: 10.1111/coa.12344
van Sonsbeek S, Pullens B, van Benthem PP (2015) Positive pressure therapy for Meniere’s disease or syndrome. Cochrane Database Syst Rev: CD008419. doi: 10.1002/14651858.CD008419.pub2
Watanabe Y, Shojaku H, Junicho M, Asai M, Fujisaka M, Takakura H, Tsubota M, Yasumura S (2011) Intermittent pressure therapy of intractable Meniere’s disease and delayed endolymphatic hydrops using the transtympanic membrane massage device: a preliminary report. Acta Otolaryngol 131: 1178-86. doi: 10.3109/00016489.2011.600331
Webster KE, George B, Galbraith K, Harrington-Benton NA, Judd O, Kaski D, Maarsingh OR, MacKeith S, Ray J, Van Vugt VA, Burton MJ (2023) Positive pressure therapy for Meniere’s disease. Cochrane Database Syst Rev 2: CD015248. doi: 10.1002/14651858.CD015248.pub2
Zhang SL, Leng Y, Liu B, Shi H, Lu M, Kong WJ (2016) Meniett Therapy for Meniere’s Disease: An Updated Meta-analysis. Otol Neurotol 37: 290-8. doi: 10.1097/MAO.0000000000000957
