title: Meniett device in meniere disease: Randomized, double-blind, placebo-controlled multicenter trial.
abstract: To evaluate the efficacy of portable Meniett low-pressure pulse generator (Medtronic Xomed, Jacksonville, FL) in Meniere disease.
  
  
  
  Randomized, double-blind, placebo-controlled, multicenter trial carried out in 17 academic medical centers.
  
  
  
  One hundred twenty-nine adults presenting Meniere disease (American Academy of Otolaryngology-Head 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-weeks treatment with Meniett (Medtronic Xomed) or placebo device; 3) removal of the device and 6-week follow-up period. The evaluation criteria were the number of vertigo episodes (at least 20 minutes with a 12-hour free interval) and the impact on daily life as assessed by self-questionnaires.
  
  
  
  Ninety-seven 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 ± 0.6 (mean ± standard error of the mean) during the first phase to 2.6 ± 0.5 after 6 weeks of treatment, and to 1.8 ± 0.8 after the removal of the device. Similar results were observed in the Meniett device (Medtronic Xomed) group: 3.2 ± 0.4 episodes during the first phase, 2.5 ± after 6 weeks of Meniett device (Medtronic Xomed) treatment, and 1.5 ± 0.2 after the third phase.
  
  
  
  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.
  
  
  
  1b. Laryngoscope, 2016 127:470-475, 2017.
authors: Department of Otology Auditory Implants and Skull Base Surgery, AP-HP, Pitié-Salpêtrière Hospital, Paris, France.|Inserm UMR-S 1159, Minimally invasive Robot-Based Hearing Rehabilitation UPMC University Paris, Paris, France.|Sensory Organs Department, Sapienza University of Rome, Rome, Italy.
authors: Francesca Yoshie
authors: FY
authors: Russo
authors: Department of Otology Auditory Implants and Skull Base Surgery, AP-HP, Pitié-Salpêtrière Hospital, Paris, France.|Inserm UMR-S 1159, Minimally invasive Robot-Based Hearing Rehabilitation UPMC University Paris, Paris, France.
authors: Yann
authors: Y
authors: Nguyen
authors: Department of Otology Auditory Implants and Skull Base Surgery, AP-HP, Pitié-Salpêtrière Hospital, Paris, France.|Inserm UMR-S 1159, Minimally invasive Robot-Based Hearing Rehabilitation UPMC University Paris, Paris, France.|Sensory Organs Department, Sapienza University of Rome, Rome, Italy.
authors: Daniele
authors: D
authors: De Seta
authors: Department of Otology Auditory Implants and Skull Base Surgery, AP-HP, Pitié-Salpêtrière Hospital, Paris, France.|Inserm UMR-S 1159, Minimally invasive Robot-Based Hearing Rehabilitation UPMC University Paris, Paris, France.
authors: Didier
authors: D
authors: Bouccara
authors: Department of Otology Auditory Implants and Skull Base Surgery, AP-HP, Pitié-Salpêtrière Hospital, Paris, France.|Inserm UMR-S 1159, Minimally invasive Robot-Based Hearing Rehabilitation UPMC University Paris, Paris, France.
authors: Olivier
authors: O
authors: Sterkers
authors: Department of Otology Auditory Implants and Skull Base Surgery, AP-HP, Pitié-Salpêtrière Hospital, Paris, France.|Inserm UMR-S 1159, Minimally invasive Robot-Based Hearing Rehabilitation UPMC University Paris, Paris, France.
authors: Evelyne
authors: E
authors: Ferrary
authors: Department of Otology Auditory Implants and Skull Base Surgery, AP-HP, Pitié-Salpêtrière Hospital, Paris, France.|Inserm UMR-S 1159, Minimally invasive Robot-Based Hearing Rehabilitation UPMC University Paris, Paris, France.
authors: Daniele
authors: D
authors: Bernardeschi
mesh_terms: D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008575:Meniere Disease / Q000175:diagnosis / Q000628:therapy*; D008875:Middle Aged; D008876:Middle Ear Ventilation; D011446:Prospective Studies; D062086:Transtympanic Micropressure Treatment / Q000295:instrumentation*
keywords: Transtympanic tube; endolymphatic hydrops; inner ear; placebo; vertigo