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 are considered investigational.
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
Barbara, M., Consagra, C., Monini, S., Nostro, G., Harguindey, A., Vestri, A., et al. (2001). Local pressure protocol, including Meniett, in the treatment of Ménière's disease: Short-term results during the active stage. Acta Otolaryngology, 121 (8), 939-944. Abstract retrieved July 17, 2003 from PubMed database.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2007). Transtympanic micropressure applications as a treatment of Ménière's disease (1.01.23). Retrieved October 28, 2008 from BlueWeb.
Densert, B., & Sass, K. (2001). Control of symptoms in patients with Ménière's disease using middle ear pressure applications: Two years follow-up. Acta Otolaryngology, (121 (5), 616-621. Abstract retrieved July 17, 2003 from PubMed database.
ECRI Institute. Health Technology Information Service. Evidence Report. (2008, September). Transtympanic micropressure treatment for Meniere’s disease. Retrieved October 27, 2008.
Gates, G. A., & Green, J. D. Jr. (2002). Intermittent pressure therapy for intractable Ménière's disease using the Meniett device: A preliminary report. Laryngoscope, 112 (8 Pt 1), 1489-1493.
Gates, G.A., Green, J.D., Tucci, D.L., & Telian, S.A. (2004). The effects of transtympanic micropressure treatment in people with unilateral Meniere’s disease. Archives of Otolaryngology- Head and Neck Surgery, 130 (6), 718-725.
Gates, G.A., Verrall, A., J.D. Green, Tucci, D.L., & Telian, S.A. (2006). Menitt clinical trial: long-term follow-up. Archives of Otolaryngology- Head and Neck Surgery, 132 (12), 1311-1316.
Odkvist, L. M., Arlinger, S., Billermark, E., Densert, B., Lindholm, S., & Wallqvis, J. (2000). Effects of middle ear pressure changes on clinical symptoms in patients with Ménière's disease - A clinical multicentre placebo-controlled study. Acta Otolaryngology, 543, 99-101. Abstract retrieved July 17, 2003 from PubMed database.
U. S. Food and Drug Administration. (1999, December). Center for Devices and Radiological Health. 510(k) approval Meniett device. Retrieved October 29, 2008 from http://www.fda.gov/cdrh/pdf/k991562.pdf.
ORIGINAL EFFECTIVE DATE: 1/1/2004
MOST RECENT REVIEW DATE: 1/8/2009
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.