Clinical Studies

Efficacy
The relationship between inner ear function and ambient pressure changes was studied by Densert and colleagues, who demonstrated that electrophysiological parameters, (TTECoG),can be improved through application of low pressure pulses to the middle ear induced by the Meniett device.²⁷ The study was conducted in a randomized, placebo-controlled and blinded format. 

In a two-week, randomized, placebo-controlled multi-center, clinical trial ödkvist et al. demonstrated relief of vertigo and improved hearing in ³¹ patients with advanced symptoms of Ménière's disease, as compared to no improvement in 25 control patients, after application of intermittent over-pressures in the middle ear using the Meniett device.²⁸ Figure 7 The study participants had been withdrawn from medical therapy prior to randomization. They found no change in symptoms after tympanostomy tube insertion alone. 

Figure 7.  Patients' estimations of their vertigo, tinnitus and functionality profile after 2 weeks of treatment with either active apparatus (unshaded) or placebo machine (shaded). Click on image to view larger.

A more recent observational study by Gates and Green²⁹ evaluated ten patients who failed medical treatment. Over a period of 3-11 months with an average of 8 months treatment, all ten patients responded to the therapy with vertigo control in 9 of 10 and a 50% reduction in the tenth case. There was also a statistically significant hearing gain of 6dB. Most people noted a recurrence of symptoms when use of the Meniett device was curtailed or their tympanostomy tube became blocked.

Effectiveness
To address the question of long-term effectiveness of this technology, a two-year follow-up study with the Meniett device was conducted on 37 definite Ménière's patients utilizing the diagnosis, staging and reporting criteria based on the AAO-HNS Guidelines.30 Thirty-one of the patients enrolled in the study had failed to respond to medical treatment. Patients were removed from medical therapy during the study period. The following results indicate that the Meniett device provides effective control of symptoms for Ménière's patients without side effects:

• 19 patients were free of vertigo spells.
• 15 patients had a significant decrease in frequency of vertigo spells. 
  (Class B) 
• Functionality improved by at least two levels for all 34 patients who 
  responded to treatment.
• The 34 patients who responded to treatment did not resume their intake 
  of diuretics or other medications.
• Three patients did not respond to pressure treatment (8%).
• No side effects or adverse events related to the pressure treatment 
  occurred during the two years.

Meniett Treatment Plan
The treatment sequence is simple and the requirements on the patient are minimal for administering therapy with the Meniett device:

• Confirmed diagnosis of Ménière's disease
• In-office placement of a tympanostomy tube
• Patient training in-office with a Meniett device
• Patient administered treatment, 3 times/day, ~5 mins./treatment
• Treatments continue until remission and, thereafter, the treatment regimen 
  depends on the duration and severity of symptoms.

Suitable Patients
Because there are many stages and variations in Ménière's disease, it is important for a therapy to be flexible and adaptive in nature in order to address the disease sufferer's conditions. The Meniett's non-invasive treatment modality provides such an opportunity and can treat patients in many conditions beyond the classic unilateral cases, such as patients with:

• intense vestibular and cochlear symptoms
• failed medical therapy
• bilateral Ménière's disease
• involvement in the remaining ear
• >65 years of age
• juvenile Ménière's disease
• imbalance, aural fullness and tinnitus after gentamicin treatment.
  Patients who are not suitable for treatment with the Meniett device are patients with the following conditions:
• perilymph fistula
• vestibular Ménière's disease
• retrocochlear damage, acoustic neuroma or brain tumor
• low-pressure hydrocephalus

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