Transtympanic Micropressure Applications as a Treatment of Ménière's Disease
DESCRIPTION
Transtympanic micropressure applications are being proposed as a treatment of Ménière's disease. Symptoms of Ménière's disease include vertigo, tinnitus, varying levels of hearing loss, and a feeling of fullness/pressure in the ear. Treatment is based on the premise that transtympanic micropressure applications to the middle ear may restore balance to the hydrodynamic system of the inner ear by promoting flow of endolymph out of the cochlea.
Transtympanic micropressure applications are intermittent complex pressure pulses delivered by a hand-held device (e.g., Meniett device by Medtronic Xomed). Use of the device consists of 2 phases. During the first phase, a conventional ventilation tube is surgically placed in the eardrum of the ear to be treated. During the second phase, the individual is instructed to place an ear-cuff in the external ear canal to minimize leakage to the external environment. The device is then used for 5-minute sessions that are self-administered 3 times a day in the home setting. Treatment is continued for as long as the individual is having symptoms.
POLICY
Transtympanic micropressure applications as a treatment of Ménière's disease is considered investigational.
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of transtympanic micropressure applications for the treatment of Ménière's disease compared to alternative treatments.
SOURCES
American Academy of Otolaryngology - Head and Neck Surgery. (2008, March). Micropressure therapy. Retrieved August 12, 2011 from http://www.entnet.org/Practice/micropressure.cfm.
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2010). Transtympanic micropressure applications as a treatment of Ménière's disease (1.01.23). Retrieved August 12, 2011 from BlueWeb. (12 articles and/or guidelines reviewed)
Chaves, A. G., Boari, L., & Lei Munhoz, M. S. (2007). The outcome of patients with Ménières disease. Brazilian Journal of Otorhinolaryngology, 73 (3), 346-350. (Level 3 Evidence - Independent study)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2008, September). Transtympanic micropressure treatment for Meniere’s disease. Retrieved October 27, 2008 from ECRI Institute. (22 articles and/or guidelines reviewed)
Gates, G.A., Verrall, A., Green, J. D., Tucci, D.L., & Telian, S.A. (2006). Meniett clinical trial: Long-term follow-up. Archives of Otolaryngology- Head and Neck Surgery, 132 (12), 1311-1316. (Level 3 Evidence - Industry sponsored)
Mattox, D. E., & Reichert, M. (2008). Meniett device for Ménière's disease: Use and compliance at 3 to 5 years. Otology & Neurotology, 29 (1), 29-32. (Level 4 Evidence - Industry sponsored)
U. S. Food and Drug Administration. (1999, December). Center for Devices and Radiological Health. Premarket Notification Database. K991562. Retrieved August 12, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K991562.pdf.
Vassiliou, A., Vlastarakos, P. V., Maragoudakis, P., Candiloros, D., & Nikolopoulos, T. P. (2011). Meniere's disease: Still a mystery disease with difficult differential diagnosis. Annals of Indian Academy of Neurology, 14 (1), 12-18.
ORIGINAL EFFECTIVE DATE: 1/1/2004
MOST RECENT REVIEW DATE: 9/22/2011
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