{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T23:33:32Z","timestamp":1792020812887,"version":"4.4.0"},"reference-count":31,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,8,12]],"date-time":"2016-08-12T00:00:00Z","timestamp":1470960000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2017,2]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy of portable Meniett low\u2010pressure pulse generator (Medtronic Xomed, Jacksonville, FL) in Meniere disease.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design<\/jats:title><jats:p>Randomized, double\u2010blind, placebo\u2010controlled, multicenter trial carried out in 17 academic medical centers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>One hundred twenty\u2010nine adults presenting Meniere disease (American Academy of Otolaryngology\u2013Head and Neck Surgery criteria) not controlled by conventional medical treatment were included. The protocol included three phases: 1) placement of a transtympanic tube and evaluation of its effect (if resolution of symptoms, the patient was excluded); 2) randomization: 6\u2010weeks treatment with Meniett (Medtronic Xomed) or placebo device; 3) removal of the device and 6\u2010week follow\u2010up period. The evaluation criteria were the number of vertigo episodes (at least 20 minutes with a 12\u2010hour free interval) and the impact on daily life as assessed by self\u2010questionnaires.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Ninety\u2010seven patients passed to the second phase of the study: 49 and 48 patients received the Meniett (Medtronic Xomed) or the placebo device, respectively. In the placebo group, the number of vertigo episodes decreased from 4.3 \u00b1 0.6 (mean \u00b1 standard error of the mean) during the first phase to 2.6 \u00b1 0.5 after 6 weeks of treatment, and to 1.8 \u00b1 0.8 after the removal of the device. Similar results were observed in the Meniett device (Medtronic Xomed) group: 3.2 \u00b1 0.4 episodes during the first phase, 2.5 \u00b1 after 6 weeks of Meniett device (Medtronic Xomed) treatment, and 1.5 \u00b1 0.2 after the third phase.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>An improvement of symptoms was evidenced in all patients, with no difference between the Meniett (Medtronic Xomed) and the placebo device groups. The decrease in the number of vertigo episodes could be explained by an effect of the medical care.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of Evidence<\/jats:title><jats:p>1b. <jats:italic>Laryngoscope<\/jats:italic>, 2016 127:470\u2013475, 2017<\/jats:p><\/jats:sec>","DOI":"10.1002\/lary.26197","type":"journal-article","created":{"date-parts":[[2016,8,12]],"date-time":"2016-08-12T10:37:56Z","timestamp":1470998276000},"page":"470-475","source":"Crossref","is-referenced-by-count":32,"title":["Meniett device in meniere disease: Randomized, double\u2010blind, placebo\u2010controlled multicenter trial"],"prefix":"10.1002","volume":"127","author":[{"given":"Francesca Yoshie","family":"Russo","sequence":"first","affiliation":[{"name":"Department of Otology Auditory Implants and Skull Base Surgery, AP\u2010HP Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital Paris France"},{"name":"Inserm UMR\u2010S 1159 Minimally invasive Robot\u2010Based Hearing Rehabilitation UPMC University Paris 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