In close cooperation with Prof. Burkhard Franz, ENT-surgeon and renowned specialist for inner-ear-diseases,
the P100-For Ménière´s Disease was developed to give people suffering from Ménière´s Disease relief of their symptoms.
Ménière’s disease is a disorder of the inner ear characterized by attacks of vertigo, hearing loss and tinnitus.
The National Institute of Health, USA, estimates 38,000 new diagnoses each year.
There is no cure to date, but positive pressure pulse therapies can be offered to sufferers.
A device already on the market produces positive pressure pulses to the inner ear, and has proven to give relief to patients with Ménière’s disease.
The device operates electrically, is inconvenient to carry around and costs about $ 3,000.
Enttex has developed the P100-For Ménière´s Disease: a manual operated, hand held device that delivers positive pressure pulses.
The P100-For Ménière´s Disease is not larger than a mobile phone and is available for a fraction of the costs.
In pilot studies, the P100 was shown to be equivalent in effectiveness to the more expensive device.
This observation was subsequently confirmed in a recent clinical trial in South Africa and Australia.
Its slim design allows the user to carry the P100-For Ménière´s Disease in a pocket or bag and apply treatment whenever the need arises.
The exact mechanism by which positive pressure pulses to the inner ear are effective in reducing the symptoms of Ménière’s
disease is unknown. However, there is evidence from the literature regarding pressure sensitivity of the inner ear, and the
beneficial effect of applying positive pressure as well as the adverse effect of applying negative pressure to the inner ear.
In a clinical placebo controlled study it was shown, using electrophysiological parameters, that positive pressure pulses of low amplitude improve inner ear physiology
(Densert et al.: Immediate effects of middle ear pressure changes on the electrocochleographic recordings in patients with Ménière’s disease: a clinical placebo controlled study, Am J Otol 18: 726-733, 1997).
Similarly the pressure sensitivity of the inner ear was shown in a study, also using electrophysiological parameters, and demonstrating that negative middle ear pressure had an adverse effect on inner ear function
(Franz et al.: Stress electrocochleography, International Tinnitus J 5: 113-120, 1999).
In a placebo controlled study positive pressure changes in the middle ear of Ménière’s disease patients could show a significant improvement of the frequency and intensity of vertigo, aural pressure and tinnitus
(Ödkvist et al.: Effect of middle ear pressure changes on clinical symptoms in patients with Ménière’s disease – a clinical multicentre placebo controlled study, Acta Otolaryngol Suppl 543: 99-101, 2000).
These experiences were confirmed with two clinical studies that showed the effect of the Meniett device
(Densert et al.: Control of symptoms in patients with Ménière’s disease using middle ear pressure applications: two year follow up, Acta Otolaryngol 121: 616-621, 2001; Gates et al.: Intermittend pressure therapy of intractable Ménière’s disease using the Meniett device: a preliminary report, The Laryngoscope 112: 1489-1493, 2002).