Download The Meniett Device for treating Ménière`s Disease Mr David K

The Meniett Device for treating Ménière’s Disease
Mr David K Selvadurai
BSc FRCS MD
Consultant Otolaryngologist St Georges Hospital, London
I was very pleased when SPIN asked me to write a short article on a new
treatment option for Ménière’s disease called the Meniett. Actually the
use of this device is not that new. As an ENT surgeon my interest in
treating patients with Ménière’s Disease (MD) was initiated when I
worked for Mr Jim Cook in the Leicester Balance Clinic. He was a
relatively early supporter for the use of the Meniett and indeed
particapted in some research work in this area more than five years ago.
Since then several large studies using the device have been published in
the medical literature, and in the US and Australia use of the device is
increasingly common.
In this article I would like to summarise my understanding of the Meniett,
what the most recent studies on its usefulness tell us and how it fits into
the range of treatment options I use to help patients with MD. The
opinions given in this article are mine, and not endorsed by either the
society or the manufacturers of the Meniett (Medtronic-Xomed).
The Device
The Meniett Device (Medtronic-Xomed) is a portable, battery operated,
low pressure wave pulse generator. It consists of a device box and an
earpiece linked by a clear plastic tube (figure 1). The ear piece is placed
in the ear canal by the user and then the Meniett is switched on. It then
creates a low pressure wave that is transmitted to the ear by the ear piece.
Transmission of the pressure wave to the inner ear relies on a grommet
being present in the ear drum. This is to allow the air pressure wave
through to the middle ear, where it can act on the inner ear via the round
window membrane.
The pressure wave is complex. The machine raises the pressure to 1.2kPa
and then oscillates the pressure. Each pressure cycle takes about 1 minute
followed by a 40 second pause. There are three cycles to each treatment,
so each treatment lasts about five minutes. Patients should use the device
three times per day, ie fifteen minutes per day.
Figure 1. The Meniett
Why should the Device work ?
Readers will be aware that unpredictable vertigo is the most disabling
symptom in MD. Its frequent and severe occurrence not only
incapacitates the sufferer but slowly erodes a patient’s self confidence
and optimism.
Historically some sufferers have been able to link the onset of vertigo
attacks with changes in the weather – particularly changes in atmospheric
pressure and it is this finding that lead to the suggestion that altering the
middle ear pressure might be able to reduce vertigo attacks.
You will remember that whilst the cause of MD remains elusive we do
know that in patients who have had MD the “endolymph” compartment
of the inner ear is dilated. We call this endolymphatic hydrops.
Many experts believe that reducing this endolypmphatic hydrops will
help to control the symptoms of MD. Indeed it is likely that salt reduction
works in MD by doing precisely this.
The Meniett may also work by reducing endolymphatic hydrops. The
device produces pressure waves in the middle ear which are transmitted
to the inner ear across the round window membrane. Once these pressure
waves enter the inner ear they may :
1. Push (or “Milk”) the endolymph into the Endolymphatic Sac part
of the balance system. Here the excess fluid can be dealt with.
2. The pressure waves may reduce the amount of endolymph that the
inner makes by altering the secretion of a hormone in the inner ear
that controls this.
At the moment we do not really know which of these processes occurs (or
even if both occur), but there are some scientific reasons to support them
both.
Endolyphatic hydrops may also be responsible for the fluctuating low
tone hearing loss seen in the earlier stages of MD and therefore pressure
pulse treatment could theoretically be a benefit to hearing loss.
Does the Device Work ?
Like all interventions for MD deciding if the Meniett is effective is not
easy. MD is a cyclical condition. Since patients and doctors only
intervene when symptoms have been uncontrolled, it can be argued that
treatment was during the worst part of the cycle, and therefore things
were going to get better anyway. Nonetheless several well designed
studies have been published in the last 18 months which have tried to
address this and other methodological problems to reach a fair
conclusion. Some of these studies received sponsorship from the
manufacturers.
To make the findings of these studies simpler to follow I have tried to
explain my understanding of them by the symptoms evaluated.
1. Vertigo
Vertigo is a subjective symptom, and every patient’s experience is
slightly different. So to evaluate vertigo researchers have used scoring
systems. In the study by Gates et al (June 2004) patients graded the
severity of their vertigo, and any day with an attack of over 20
minutes was scored as a day with vertigo.
In this study patients either received a functional Meniett or a
“dummy”, but neither the doctors or the patients knew which was
being used. This methodology is called “double blinding” and
removes the risk of bias, or “cheating”. They also allowed for the
effect of putting the grommet in, which some doctors feel can affect
MD.
They found that the vertigo severity diminished in the treated group
within 1 month. The treated patients continued to do better than the
untreated ones during the 4 months of the study, though some of the
untreated patients did improve in this time. This is to be expected in
any study of MD that follows the disease over time.
They also found that the number of days with vertigo was reduced by
treatment, and that this improvement was greater than improvement
seen in the untreated group over the four months of the study.
A similar study by Thomsen et al found again that the severity of
vertigo was reduced by using the device but this study did not prove
that there was any change in the number of attacks of vertigo. A
reduction in vertigo symptoms has also been reported in studies by
Rajan and Odkvist.
In summary there seems to be a definite reduction in vertigo (severity,
frequency or both) in many patients after treatment.
2.Functionality
We might expect that since vertigo is the most disabling symptom in
MD that if this is reduced then patients might be able to function more
successfully. The Gates, Thomsen and Odkvist studies addressed this
directly and all found an improvement after treatment. Thus treated
patients place fewer restrictions on their lifestyle and need fewer days
off work than untreated patients.
3.Hearing
The case for improving hearing with treatment is less strong. Neither
the Gates or Thomsen study found any change in hearing, but the
Odkvist study did. All these studies used a “dummy” machine in some
patients to allow for any changes that might occur with time rather
than with treatment. Rajan’s study showed some hearing gain but did
not involve “dummy” machines, and so the natural fluctuation in the
disease might be responsible.
4.Tinnitus
I do not think there is any evidence that tinnitus is really altered by
using the device.
5.Pressure in the Ear
Again, the studies have not clearly addressed this and there is
consequently no evidence that this symptom will respond to treatment
from the device.
In summary then it seems likely that the device successfully reduces
vertigo symptoms in patients with active disease. This in turn allows
patients to lead a more normal life, with fewer days off work and less
time incapacitated. There is limited evidence that hearing will improve,
although in a proportion of patients this may be the case. It is not possible
to predict any likely change in tinnitus or ear pressure at this time.
The role of the Meniett in treating MD
Many factors need to be considered when discussing the most appropriate
treatment for an individual. For instance is the disease bilateral, has it
been present for a long time, what treatments have been tried and what
effect are the symptoms having on the patients life. In general though it is
true that most specialists use a stepped approach to treatment.
In my practice I always start by looking at diet, particularly salt reduction
for all patients who are likely to have MD. In addition for some
individuals there are other known precipitants such as caffeine, chocolate
and cheese which can be avoided.
If patients fail to improve after about six weeks I usually discuss
introducing a diuretic trial. In this instance it is important not to restrict
your salt too much, as the diuretic will also cause salt loss. I tend to
advise a 3 month course of diuretic, and often bring patients off this once
they are back in remission. This keeps the diuretic ready to use in case
symptoms deteriorate again.
When drug and diet fail to control symptoms it is sometimes necessary to
consider surgery. However many of the surgical modalities such as
Gentamicin injection and labyrinthectomy destroy the balance function in
the treated ear. This is very good for controlling vertigo from that ear but
is associated with either some risk of hearing loss (Gentamicin) or
guaranteed hearing loss (labyrinthectomy). Of course the other
disadvantage of this treatment is that if the remaining ear becomes
affected with MD then the loss of balance function in the treated ear is
more noticeable.
Endolymphatic Sac decompression has a much lower risk of hearing loss
and also does not necessarily reduce the balance function in the treated
ear. Nonetheless it is not universally successful in controlling vertigo. It
is a significant operation and will necessitate a night in hospital and a
couple of weeks off work.
The advantage of the Meniett is that it fits between non-surgical and
traditional surgical approaches. A grommet insertion is required, but this
can be carried out with local anaesthetic. Complications from the
grommet are unusual, but it is generally necessary to use precautions
against water ingress and have the grommet looked after by an ENT
surgeon. Complications from the use of the device itself are very unusual.
Using the device is simple and painless and need not alter your lifestyle.
Further if at some time the MD becomes more severe it is still possible to
move onto any of the more traditional surgical options.
The studies have shown that vertigo control is the most useful benefit of
the device and that this benefit is maximal in patients having frequent
attacks. It also seems to work better in patients with greater vestibular
loss. Patients who have had previous sac surgery or chemical treatments
(like Gentamicin) may not respond well. This again suggests that the
Meniett should fit into the treatment ladder between diet /drugs and
traditional surgery.
So why are we not using the Meniett more ?
Well I think there are two main reasons :
1. Cost.
Xomed currently charge about £2000 for the device. The device is
not generally available on the NHS (except in some limited
research studies). In the UK private health insurance does not
usually cover the cost of the device. This is not the case in the US
and Australia. Currently Medtronic do offer a refund service if you
and your doctor agree it has not been helpful after six weeks.
2. Clinical opinion.
As sufferers know many clinicians are sceptical about new
treatments for MD. This is entirely prudent, especially as this
device is so expensive and we have all believed in treatments that
have later proved to be disappointing. However I think the results
published during the last 18 months are very encouraging, and we
should be much more positive about recommending the Meniett’s
use in suitable patients.
References and further reading ;
The company web site “Meniett.com” is very detailed but company
sponsored. My website (davidselvadurai.com) will have more on the
device (including this article) in the new year.
Long-term effects of the Meniett device in Ménière's Disease: the Western Australian
experience.
Rajan, G.P., S. Din, and M.D. Atlas
2005. J Laryngol Otol 119:391-395.
Local over-pressure treatment reduces vestibular symptoms in patients with Ménière's Disease:
a clinical, randomized, multicenter, double-blind, placebo-controlled study.
Thomsen, J., K. Sass, L. Ödkvist, and S. Arlinger
Otol Neurotol 26:68-73.
The effects of transtympanic micropressure treatment in people with unilateral Ménière's
Disease.
Gates G.A., J.D. Green, Jr., D.L. Tucci, and S.A. Telian
2004. Arch of Oto - HNS, June:130(6): 718-725.
Control of symptoms in patients with Ménière's Disease using middle ear applications:
Densert, B., and K. Sass
2001. A two-year follow-up. Acta Otolaryngol (Stockh) 120:5.
Effects of middle ear pressure changes on clinical symptoms in patients with Ménière's Disease:
A clinical, multicenter, placebo-controlled study.
Ödkvist, L.M., S. Arlinger, E. Billermark, B. Densert, S. Lindholm, and J. Wallquist
2000. Acta Otolaryngol (Stockh). Suppl 543: 99-101.