Estudo clínico

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Treatment of Meniere's disease with MeniQ Pulse Generator - A Clinical Pilot Study


- Mikael Sandström, MSc, MD, The Stockholm Private Hearing Clinic, Stockholm, Sweden and - Kajsa-Mia Holger, MD, PhD, Dept.. of Reseach, Development and Education, Hospital Varberg and The Sahlgrenska Academy, Göteborg University, Sweden

The MeniQ pulse generator has been designed for the treatment of Meniere’s disease. This device allows the pressure delivered to be set individually for each patient (IPC), which means that the treatment can be performed without inserting a transmyringeal tube (TMC). The treatment is administered by the patient.


The Study

A total of 66 patients participated in the study (37 women and 29 men in the age range 35-82 years). The MeniQ group consisted of 30 patients, two of which had bilateral Meniere’s disease, and one a transmyringeal tube, and the control group of 36 patients. The distributions of gender and age in the two groups were similar. Each patient was studied for 15 weeks. Participants were asked to fill in the instruments at the beginning and end of the study. Also, in order to establish when the therapeutic effect was could be expected, the participants recorded their symptoms on visual analogue scales after 4 weeks.


The following instruments were used to evaluate the effects of treatment.

The data were self-reported.

  • The AAO-HNS (American Academy of Otolaryngology-Head and Neck Surgery) scale (1-6)
  • Visual analogue scales (VAS, 0-100) for vertigo, imbalance, sensation of fullness, imbalance, tinnitus and hearing
  • The Gibson score for Meniere’s disease (0-10)


The Results.

The figure above shows the results expressed as the average values of the difference for each group on each occasion. After 15 weeks, the MeniQ group showed a significant improvement regarding vertigo, imbalance, sensation of fullness and tinnitus (p=0.000) and hearing (p=0.023) compared with the control group. A significant improvement can be seen after four weeks’ treatment with the MeniQ pulse generator.


The figure above shows the group averages of the AAO-HNS score and the Gibson score. The AAO-HNS score of the MeniQ group shows a significant improvement compared with the control group. The results of the Gibson score show the same trend, viz. a significant improvement in the MeniQ group.


The Conclusions

The MeniQ pulse generator offers safe, non-invasive and non-destructive treatment of Meniere’s disease without the need of a transmyringeal tube. The symptoms of the disease are significantly reduced, and the patients showed improved function. The fact that the pressure can be chosen individually by each patient is thought to be a contributing factor.