Meniett Low Pressure Pulse Generator for Menieres Disease
© Blue Cross and Blue Shield of Montana
Current Effective Date:
December 27, 2013
Original Effective Date:
March 16, 2011
December 27, 2013
December 6, 2012; December 12, 2013
Ménière's disease is a complex progressive disorder of the inner ear characterized by dizziness or a spinning sensation (rotary vertigo), hearing loss, fullness or pressure in the ear, and roaring or ringing (tinnitus) in the ear. Nausea or vomiting frequently accompanies severe attacks of vertigo. Some patients also experience headaches as part of their symptoms. Attacks can last from 20 minutes to a day or more with a recovery period often lasting from one to three days. The effect of these symptoms can be debilitating. About 80% of patients with Mèniére's disease experience the problem in one ear (unilateral), while 20% of patients have the disease in both ears.
Research has shown that by applying pressure to the inner ear the excess endolymph fluid can be reduced and thus relieve the symptoms. It is believed that the mechanism of the reduction is a combination of mechanical and chemical processes.
The Meniett Low Pressure Pulse Generator delivers a complex algorithm of low-pressure pulses (a maximum of 35 cm of H2O) that are transmitted to the middle ear space and act on the round window membrane. It is believed that the energy of the pressure pulses causes a displacement of the perilymphatic fluid which stimulates endolymphatic fluid flow resulting in a reduction of endolymphatic fluid. This treatment requires the prior insertion of a tympanostomy tube through the eardrum to enable the pressure pulses to be transmitted into the middle ear where they have a positive effect.
The patient receives in-office training with the device. The stimulator is used to administer treatment three times a day (five minutes per session). The treatments continue until remission. Thereafter, treatment depends on the duration and severity of symptoms.
There is no cure for Ménière’s disease. If conservative treatment is not effective, surgeries and other procedures are sometimes performed. A list of these procedures includes:
- Endolymphatic sac decompression,
- Vestibular neurectomy,
- Chemical labyrinthectomy (using gentamycin or streptomycin).
- State of Texas Insurance Code. Speech and Hearing. Article 3.70-2(G). Austin, Texas. Update (2004 March 22).
- State of Oklahoma Insurance Code. §36-6060.7. Added by Laws 1999, c. 136, § 1, eff. Nov. 1, 1999. Amended by Laws 2002, c. 30, § 1, effective. (2002 November 1).
- Odkvist, L.M., Arlinger, S., et al. Effects of middle ear pressure changes on clinical symptoms in patients with Mèniére's disease – a clinical multicentre placebo-controlled study. Acta Otolaryngologica Supplementum (2000) 543: 99-101.
- Densert, B., Sass K. Control of symptoms in patients with Mèniére's disease using middle ear pressure applications: two year follow-up. Acta Otolaryngoogica (2001 July) 121(5): 616-21.
- Barbara, M., Consagra, C. et al. Local pressure protocol, including Meniett, in the treatment of Mèniére's disease: short term results during active stage. Acta Otolaryngoogical (2001 December) 121(8): 939-44.
- Gates, G.A., Green, J.D. Intermittent pressure therapy of intractable Mèniére’s disease using the Meniett device: a preliminary report Laryngoscope (2002 August) 112(8 Pt 1): 1489-93.
- Gates, G.A., Green, J.D., et al. The effects of transtympanic micropressure treatment in people with unilateral Meniere’s disease. Archives of Otolaryngology – Head and Neck Surgery (2004) 130(6):718-25.
- Thomsen, J., Sass, K., et al. Local overpressure treatment reduces vestibular symptoms in patients with Mèniére’s disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Otology and Neurotology: official publication of the Otological society, American Neurological Society and European Academy of Otology and Neurotology. (2005 January) 26(1): 68-73.
- Perez, R., Ducati, A., et al. Retrosigmoid approach for vestibular neurectomy in Mèniére’s disease. Acta Neurochirurgica. (2005 April) 147(4): 401-4.
- Rajan, G.P., Din, S., et al. Journal of Laryngology and Otology (2005 May) 119(5): 391-5.
- Kim, H.H., Wiet, R.J., et al. Trends in the diagnosis and the management of Mèniére’s disease: results of a survey. Otolaryngology – Head and Neck Surgery (2005 May) 132(5): 722-6.
- eMedicine.com – Inner ear, Mèniére’s disease, medical treatment November 2, 2005. eMedicine (accessed-- 2005 June 2) http://www.emedicine com .
- Gates, G.A., Verrall, A., et al. Meniett clinical trial: long-term follow-up. Archives of Otolaryngology Head and Neck Surgery (2006) 132(12):1311-6.
- Transtympanic Micropressure Applications as a Treatment of Meniere’s Disease. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2013 May) Durable Medical Equipment 1.01.23.
||Policy formatting and language revised. Title changed from "Transtympanic Micropressure Applications as a Treatment of Meniere's Disease" to "Meniett Low Pressure Pulse Generator for Menieres Disease". Policy statement changed from investigational to possibly medically necessary.|