P100-Ménière
Ménière´s Disease and the P100-Ménière
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-Ménière: a manual operated, hand held device that delivers positive pressure pulses. The P100-
Ménière is no larger than a mobile phone and costs a fraction of the cost (approx. 1,5%). In pilot studies, the P100-Ménière 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.
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).
P100-Ménière, Pilot Studies
The P100-Ménière delivers pressure pulses which are far below the pressures that the inner ear can tolerate. Von Bekesy in his
experiments in hearing has estimated and measured that the round window membrane can withstand pressures up to three to four
atmospheres (von Bekesy: Experiments in hearing. New York. Mc Grawe-Hill. 102: 433-434, 1960; Kringlebotn M: Rupture pressures
of membranes in the inner ear, Ann Otol Rhinol Laryngol 109: 940-944, 2000). Side effects have not been currently observed with
the use of the P100-Ménière or the more expensive electronic device, although a comment was made at a recent Ménière’s
conference in Zell, Austria, that overuse can cause return of symptoms.
A general comment from patients that have used the P100-Ménière was that it was very user friendly.
It was easy to store in ones handbag, and it was easy to find in the handbag.
How the pressure pulse therapy operates is still open to speculation. However, there is the possibility of an ion shift, particularly
potassium. It has been known for some time that a gradual potassium shift from the scala vestibuli towards the scala tympani occurs
in Ménière’s disease. The potassium concentration gradually increases from the base towards the apex in the scala vestibuli, and
decreases from the apex towards the base in the scala tympani. When an ion shift occurs in direction of the scala tympani an increased
concentration of potassium will be observed at the apical end of the scala tympani. Potassium is toxic to neurons. As
neurons are bathed in perilymph and thus exposed to potassium in the scala tympani, it will intoxicate these neurons. The
consequence is a low frequency hearing loss. The forerunner of Ménière’s disease, the COO-Syndrome, typically shows a reverse
of this intoxication following the insertion of a middle ear ventilation tube. It can be demonstrated electrophysiologically by an
improved SP/AP ratio in the electrocochleogram. The improvement is caused by a larger AP voltage, a consequence of detoxication
(Franz et al.: The Cervicogenic Otoocular Syndrome: A Suspected Forerunner of Ménière’s Disease, International Tinnitus J 5:
125-130, 1999).
This might be one of the reasons that positive pressure pulses might also be helpful in the treatment of tinnitus.
The mechanism of intoxication is facilitated with a particularly mild Eustachian tube disorder which results in a mild suction on the
round window membrane. The naturally existing flow of perilymph towards the round window is thus increased causing the ion shift
towards the scala tympani. Positive pressure pulses will simply reverse this intoxicating ion shift.
The response of patients treated was excellent. Not all patients suffering from Ménière’s disease were willing to have a ventilation
tube inserted which is a prerequisite for the treatment with the electronic device and the P100-Ménière. There was hardly a patient
that failed to respond. This might be due to a careful selection of patients. Patients were not given a ventilation tube simply because
they suffered from Ménière’s disease. The demonstration of a mild Eustachian tube disorder was regarded as a very important test
that justified the procedure. However, it is very rare that patients with Ménière’s disease have normal Eustachian tube function.
This is a feature which is often overlooked by ENT surgeons. We found that the modified Holmquist test is well suited to demonstrate
the unbalanced relationship between the middle ear and the inner ear. We recommend that it is employed in every patient that is
suspected to have Ménière’s disease. The results will give the treating physician the confidence that more options for treatment
are available.
Electro-cochleogram following insertion of a ventilation tube
in a patient with early stages of Ménière’s disease.
Electro-physiological improvement is due to an AP effect.
P100-Ménière, Case Studies
The following shows the results of a pilot study for the P100-Ménière.
This study was supervised by Associate Professor Burkhard Franz.
CASE 1
Mrs. M.L., a 58 year old lady presented with an 18 months history of intermittend attacks of vertigo, nausea and fluctuating hearing.
The hearing was gradually deteriorating. A main concern was a constant blockage in the left ear, and the urge to unblock it.
She has been on methothrexate for rheumatoid arthritis. The neurootological assessment confirmed Ménière’s disease in the
left ear with a typical low frequency hearing loss of moderate degree. An MRI scan was clear. She was treated with perscription
drugs for a period of 3 months without effect. As she showed a mild Eustachian tube disorder in the preliminary assessment a
ventilation tube was inserted into the left ear. Her balance improved immediately but the annoying pressure symptoms remained.
She was given the prototype P100. It effectively got rid of all her Ménière’s symptoms. She uses the P100-Ménière regularly,
at least three times a day, or intermittently if pressure builds up in the ear. She has her P100-Ménière on her all the time.
CASE 2
Mrs. D.K., a 51 year old lady presented with a 9 year history of Ménière’s disease. She had regular attacks of vertigo and nausea,
and her hearing was gradually deteriorating in the right ear. She has been on Chlotride, Stemetil and Serc with no effect.
Her previous surgeon died and she was seeking another opinion regarding her condition. The diagnosis of Ménière’s disease was
now confirmed in both ears, but she also demonstrated bilaterally very mild Eustachian tube dysfunctions. Ventilation tubes were
inserted. Her symptoms improved, and her attacks of vertigo were less frequent. Medication was now reduced to Serc only.
The introduction of the P100-Ménière, however, controlled her symptoms completely. She had no attacks of vertigo since using
the P100-Ménière which she uses up to eight times a day.
CASE 3
Mrs. E.L., a 61 year old lady presented with a 40 year history of diagnosed Ménière’s disease. The attacks have been rare, but
recently increased in frequency, and this was associated with a marked deterioration of the hearing in the right ear. Serc did not
help much. The diagnosis of Ménière’s disease was confirmed, but also a mild Eustachian tube dysfunction in both ears
Ventilation tubes were inserted. Her symptoms improved, but were still not satisfactory. With the P100-Ménière she felt so much
better that she stopped using it for a while. She went back on the P100-Ménière and symptoms were controlled.
CASE 4
Mrs. M.F., a 51 year old lady presented with a 20 year history of diagnosed Ménière’s disease. During these years she only had five
attacks of vertigo associated with nausea and tinnitus. The hearing however, was gradually deteriorating in the left ear and recently
attacks of vertigo have become quite frequent. The diagnosis of Ménière’s disease was confirmed with a typical mild to moderate
low frequency sensory neural hearing loss in the left ear. Specific Eustachian tube function tests revealed a mild Eustachian tube
dysfunction in the left ear despite a type A tympanogram. Her response to Serc was limited and ventilation tubes were inserted,
and she was given the P100-Ménière. This settled her symptoms temporarily. She had one attack while on Serc, using the P100-
Ménière as well as Zinc as an antioxidant. This attack of vertigo was confirmed by a neurologist as a migraine variant.
CASE 5
Mrs. P.C., a 73 year old lady presented with a long history of diagnosed Ménière’s disease. She had a sac decompression in the right
ear aliquo loco, but this had not settled her symptoms. The diagnosis of Ménière’s disease in the right ear was confirmed. There was
a moderate to severe sensory neural hearing loss equally spread along the speech frequencies in the right ear. Despite a type A
tympanogram a mild Eustachian tube dysfunction could be demonstrated with the modified Holmquist test. A ventilation tube was
inserted. It marginally improved her symptoms. She was given the Meniett. This improved her symptoms. However it was inconvenient
to carry around. The introduction of the P100-Ménière controlled her symptoms equally. She is back playing bowls with her friends.
The P100-Ménière has changed her life. She carries it with her all the time.
CASE 6
Mrs. J. McN., a 50 year old lady presented for seeking a second opinion regarding her recently diagnosed Ménière’s disease.
She did not respond to Serc or Nicotinic acid. Her hearing was gradually deteriorating in both ears. The neurootological assessment
confirmed early stages of Ménière’s disease now affecting both ears. Despite bilateral type A tympanograms there was evidence of
a mild Eustachian tube dysfunction in both ears. Ventilation tubes were inserted. Symptoms improved a little. She used the P100-
Ménière successfully. It controlled her balance and pressure symptoms.
CASE 7
Mr. D.H., a 73 year old gentleman presented with a pulsating noise in the left ear. The noise increased with intermittent attacks of
vertigo. The hearing was gradually deteriorating. The diagnosis of Ménière’ disease was confirmed in the right ear. He responded
to the insertion of a middle ear ventilation tube. Symptoms returned once the ventilation tube was rejected. He responded to the
insertion of a ventilation tube only over a period of 9 years. However, recently the middle ear ventilation tube became less effective.
He was given the Meniette for a trial. He felt it to be too cumbersome. He was given the P100-Ménière, and it controlled his symptoms.
CASE 8
Mr. K.R., an 86 year old gentleman presented with a gradual deterioration of the hearing in the left ear and frequent episodes of lightheadedness
and nausea. The neurootological pattern was consistent with Ménière’s disease affecting the left ear. There was a
moderate to severe sensory neural hearing loss in the left ear almost equally affecting the speech frequencies. He also demonstrated
a mild Eustachian tube dysfunction in the left ear despite a type A tympanogram. A ventilation tube was inserted. This has partially
improved his symptoms. The P100-Ménière controlled his symptoms. He does not want to be without it.
CASE 9
Mrs. P.F., a 67 year old lady presented with a long history of intermittend vertigo and a gradual deterioration of the hearing. The
attacks of vertigo have been infrequent in the past, but recently have increased dramatically. The neurootological pattern was
consistent with Ménière’s disease affecting the left ear. There was also a mild Eustachian tube dysfunction despite a type A
tympanogram. There was a week response to Serc. A ventilation tube was inserted, and she was given the P100-Ménière.
She responded well and has been without symptoms for the last two months.
CASE 10
Mrs. A.S., a 39 year old lady presented with a four year history of diagnosed Ménière’s disease. Her hearing was deteriorating in the
right ear. She was seeking another opinion as she did not respond to conventional treatment. The assessment confirmed Ménière’s
disease in the right ear, and a mild Eustachian tube dysfunction despite a type A tympanogram. She had a moderate to severe
sensory neural hearing loss in the right ear. Her response to the insertion of a ventilation tube improved marginally her symptoms.
She responded very well to the P100-Ménière.
CASE 11
Mrs. L.C., a 44 year old lady presented with a forerunner of Ménière’s disease eight years ago. She represented recently with
frequent attacks of vertigo and deterioration of her hearing in the left ear. She did not respond to Serc. The neurootological
assessment confirmed Ménière’s disease in the left ear. The insertion of a middle ear ventilation tube improved her symptoms only
marginally. Increasing the dosage of Serc did not help. The P100-Ménière has improved her symptoms, but she is still experiencing
intermittend blockage in the left ear, there were no more attacks of vertigo.
CASE 12
Mr. D.S., a 46 year old gentleman presented with a ten months history of almost daily attacks of vertigo, nausea and pressure in the
left ear. His hearing was deteriorating quickly. He was a diabetic and did not respond to Serc. The neurootological assessment
confirmed Ménière’s disease in the left ear. He also had a mild Eustachian tube dysfunction in both ears despite bilateral type A
tympanograms. He had a moderate sensory neural hearing loss in the right ear almost equally affecting the speech frequencies.
The insertion of bilateral ventilation tubes did not help. He was desperate to be prescribed the Meniett device. Instead the P100-
Ménière was given for a trial. His response was excellent. He used the P100-Ménière at least six times a day. As soon as he feels
pressure building up in his left ear, the P100-Ménière gets rid of it immediately. He does not want to return the device.
CASE 13
Mrs. H.L., a 65 year old lady presented with a forerunner of Ménière’s disease six years ago. At that time she responded to the
insertion of a middle ear ventilation tube. She represented recently with a pulsating noise in the right ear, deteriorating hearing,
nausea and intermittend attacks of vertigo. The neurootological assessment confirmed Ménière’s disease in the right ear.
There was a mild mainly low frequency sensory neural hearing loss in the right ear. Specific Eustachian tube function tests revealed
a mild Eustachian tube dysfunction in the right ear. Her response to Serc was limited. The reinsertion of a ventilation tube improved
symptoms a little more. She responded well to the P100-Ménière. There were no more balance problems, the nausea was controlled
and the pulsating noise in the right ear diminished.
P100-Ménière, Clinical Trial
Patients suffering from Ménière’s disease are particularly sensitive to negative pressure in the middle ear. For example,
attacks of vertigo can be triggered by a descent in an aircraft when ventilation of the middle ear can become critical.
Positive pressure pulse therapy has shown to have a beneficial effect on the sufferer by relieving the symptoms, and is now
a true alternative in the treatment of Ménière’s disease.
A clinical trial was conducted by the Ear Institute, Queenswood, Pretoria, South Africa (Dr. Frits van der Laan) and Tinnitus
Research and Balance Clinic, Melbourne, Australia (Ass. Prof. Burkhard Franz). In this study two devices were compared that
produced positive pressure pulses delivered to the inner ear via the external ear canal and after the insertion of a middle
ear ventilation tube.
The aim was to investigate the effectiveness of positive pressure pulses delivered by the handheld manually operating device
P100-Ménière and the electronic Meniett device. Twenty five patients took part in this study. All patients that participated
in this trial had a confirmed diagnosis of Ménière’s disease (AAO criteria) and had frequent attacks. 19 of these were seeking
further treatment options for the relief of their symptoms as the insertion of a ventilation tube alone did not give enough relief.
A ventilation tube was either inserted in the office, or alternatively in the operating theatre. Five days following the insertion
of the ventilation tube a decision was made whether to proceed with the trial. Although some patients experienced an improvement
of their symptoms, 19 were keen to proceed with the positive pressure pulse treatment. Positive pressure treatment was either
conducted with an expensive electronic device or a new manually operated alternative. Nine patients opted for the electronic device,
10 opted for the manual device.
Symptoms before and after treatment with positive pressure pulses were recorded. Statistical testing was performed using a
nonparametric, Kruskall-Wallis single factor analysis of variance by rank. Each symptom was considered separately, comparing
the mean rank before and after treatment with either the manual device or the electronic device. If a significant difference between
means was detected, then post hoc, nonparametric multiple comparisons for unequal sample sizes were used to determine which
mean ranks differed. In all cases a = 0,05.
Among the symptoms that improved significantly were vertigo, fullness in the ear and nausea (Fig. 1). There was a slight difference
between the two devices with the electronic device not quite performing as well as the manually operated device. The differences,
however, were not significant. The difference might have been due to the convenience of the manual device, which was immediately
available when needed and did not require the cumbersome setting up of the other device. There was also a slight difference between
the severities of symptoms in both groups which could have accounted for the differences, but these differences were not significant.
Several patients from the clinical trial refused to return the manually operated device after the clinical trial. It has improved their life so much that they did not want to part with it.
Both the insertion of a middle ear ventilation tube and positive pressure pulse treatment address a disturbed relationship between the middle ear and the inner ear. Our clinical trial confirms that positive pressure pulse therapy in Ménière’s disease is a true alternative to current treatment modalities. The manually operated device is the preferred option for its convenience of use and its lower cost.
This trial was published in the ‘International Tinnitus Journal’, Vol. 11, No. 2, 146-149 (2005).
References
1. Ingelstedt S, Ivarsson A, Tjerstrom O. Immediate relief of symptoms during acute attacks of Ménière’s disease,
using a pressure chamber. Acta Otolaryngol 82: 368-378, 1976
2. Densert B, Densert O. Overpressure in treatment of Ménière’s disease. Laryngoscope 92: 1285-1292/ 1982
3. Gates GA, Green JD, Tucci DL, Telian SA. The effect of transtympanic micropressure treatment in people with unilateral Ménière’s
disease. Arch Otolaryngol Head Neck Surg 130: 718-723, 2004
4. Committee on Hearing and Equilibrium guidelines for the diagnosis and evaluation of therapy in Ménière’s disease. American
Academy of Otolaryngology Head and Neck Foundation, Inc. Otolaryngol Head and Neck Surg 113: 181-185, 1995
5. Zar JH. Biostatistical Analysis. Prentice-Hall, London 1984
6. Densert B, Densert O, Arlinger S, Sass K, Odkvist L. 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
7. Sakikawa Y, Kimura RS. Middle ear overpressure treatment of endolymphatic hydrops in guinea pigs. ORL J Otorhinolaryngol
Relat Spec 59: 84-90, 1997
8. Horner KC. Old theme and new reflections: hearing impairment associated with endolymphatic hydrops.
Hear Res 52: 147-156, 1991
9. Franz B, Altidis P, Altidis B, Collis-Brown G. The Cervicogenic Otoocular Syndrome: A suspected forerunner of Ménière’s disease.
Int Tinnitus J 5: 125-130, 1999
P100-Ménière, Frequently Asked Questions
Can pressure pulse therapy cure my Ménière´s disease?
No, a cure has yet to be developed. Pressure pulse therapy is intended to give a patient relief from symptoms.
Do I need a grommet (ventilation tube) to benefit from positive pressure pulse therapy?
We recommend that you seek advice from your doctor on how to obtain the best outcome from this type of therapy.
Clinical studies have shown that positive pressure pulse therapy is most effective when used in conjunction
with a grommet.
Is the created pressure safe for my ear?
The P100-Ménière has been designed using a special valve which limits the pressure. Therefore the device has a
safety limit. No matter how hard you pump the device, the P100-Ménière will not produce excessive pressures.
Our products underlie a permanent quality control and are being double-checked before being released for sale.
Does the P100-Ménière have regularly approvals?
Yes.
Has the P100-Ménière undergone clinical trials?
The P100-Ménière has undergone clinical trials at various clinics around the world.
How do I use the P100-Ménière?
The P100-Ménière contains ear tips in different size (small, medium and large).
The ear tips can be cleaned with a mild detergent.
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Distributors
Please be aware of copied, unlicensed and inferior devices, especially from the Far East, which do not meet German quality
standards. Genuine Enttex products can only be purchased via this online-shop or from our officially licensed international
distributors, signalized with our own quality-seal.
The Enttex logo is a trademark, officially copyrighted and the property of the Enttex GmbH Germany.
Downloads:
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P100-Ménière Brochure
P100-Ménière Poster
Contact
Imprint
|
In close cooperation with Prof. Burkhard Franz, ENT-surgeon and renowned specialist for inner-ear-diseases, the P100-Ménière was developed to give people suffering from Ménière´s Disease relief of their symptoms. Its slim design allows the user to carry the P100-Ménière in a pocket or bag and apply treatment whenever the need arises. |
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Ménière´s Disease and the P100-Ménière
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-Ménière: a manual operated, hand held device that delivers positive pressure pulses. The P100-
Ménière is no larger than a mobile phone and costs a fraction of the cost (approx. 1,5%). In pilot studies, the P100-Ménière 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.
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).
P100-Ménière, Pilot Studies
The P100-Ménière delivers pressure pulses which are far below the pressures that the inner ear can tolerate. Von Bekesy in his
experiments in hearing has estimated and measured that the round window membrane can withstand pressures up to three to four
atmospheres (von Bekesy: Experiments in hearing. New York. Mc Grawe-Hill. 102: 433-434, 1960; Kringlebotn M: Rupture pressures
of membranes in the inner ear, Ann Otol Rhinol Laryngol 109: 940-944, 2000). Side effects have not been currently observed with
the use of the P100-Ménière or the more expensive electronic device, although a comment was made at a recent Ménière’s
conference in Zell, Austria, that overuse can cause return of symptoms.
A general comment from patients that have used the P100-Ménière was that it was very user friendly.
It was easy to store in ones handbag, and it was easy to find in the handbag.
How the pressure pulse therapy operates is still open to speculation. However, there is the possibility of an ion shift, particularly
potassium. It has been known for some time that a gradual potassium shift from the scala vestibuli towards the scala tympani occurs
in Ménière’s disease. The potassium concentration gradually increases from the base towards the apex in the scala vestibuli, and
decreases from the apex towards the base in the scala tympani. When an ion shift occurs in direction of the scala tympani an increased
concentration of potassium will be observed at the apical end of the scala tympani. Potassium is toxic to neurons. As
neurons are bathed in perilymph and thus exposed to potassium in the scala tympani, it will intoxicate these neurons. The
consequence is a low frequency hearing loss. The forerunner of Ménière’s disease, the COO-Syndrome, typically shows a reverse
of this intoxication following the insertion of a middle ear ventilation tube. It can be demonstrated electrophysiologically by an
improved SP/AP ratio in the electrocochleogram. The improvement is caused by a larger AP voltage, a consequence of detoxication
(Franz et al.: The Cervicogenic Otoocular Syndrome: A Suspected Forerunner of Ménière’s Disease, International Tinnitus J 5:
125-130, 1999).
This might be one of the reasons that positive pressure pulses might also be helpful in the treatment of tinnitus.
The mechanism of intoxication is facilitated with a particularly mild Eustachian tube disorder which results in a mild suction on the
round window membrane. The naturally existing flow of perilymph towards the round window is thus increased causing the ion shift
towards the scala tympani. Positive pressure pulses will simply reverse this intoxicating ion shift.
The response of patients treated was excellent. Not all patients suffering from Ménière’s disease were willing to have a ventilation
tube inserted which is a prerequisite for the treatment with the electronic device and the P100-Ménière. There was hardly a patient
that failed to respond. This might be due to a careful selection of patients. Patients were not given a ventilation tube simply because
they suffered from Ménière’s disease. The demonstration of a mild Eustachian tube disorder was regarded as a very important test
that justified the procedure. However, it is very rare that patients with Ménière’s disease have normal Eustachian tube function.
This is a feature which is often overlooked by ENT surgeons. We found that the modified Holmquist test is well suited to demonstrate
the unbalanced relationship between the middle ear and the inner ear. We recommend that it is employed in every patient that is
suspected to have Ménière’s disease. The results will give the treating physician the confidence that more options for treatment
are available.
Electro-cochleogram following insertion of a ventilation tube
in a patient with early stages of Ménière’s disease.
Electro-physiological improvement is due to an AP effect.
P100-Ménière, Case Studies
The following shows the results of a pilot study for the P100-Ménière.
This study was supervised by Associate Professor Burkhard Franz.
CASE 1
Mrs. M.L., a 58 year old lady presented with an 18 months history of intermittend attacks of vertigo, nausea and fluctuating hearing.
The hearing was gradually deteriorating. A main concern was a constant blockage in the left ear, and the urge to unblock it.
She has been on methothrexate for rheumatoid arthritis. The neurootological assessment confirmed Ménière’s disease in the
left ear with a typical low frequency hearing loss of moderate degree. An MRI scan was clear. She was treated with perscription
drugs for a period of 3 months without effect. As she showed a mild Eustachian tube disorder in the preliminary assessment a
ventilation tube was inserted into the left ear. Her balance improved immediately but the annoying pressure symptoms remained.
She was given the prototype P100. It effectively got rid of all her Ménière’s symptoms. She uses the P100-Ménière regularly,
at least three times a day, or intermittently if pressure builds up in the ear. She has her P100-Ménière on her all the time.
CASE 2
Mrs. D.K., a 51 year old lady presented with a 9 year history of Ménière’s disease. She had regular attacks of vertigo and nausea,
and her hearing was gradually deteriorating in the right ear. She has been on Chlotride, Stemetil and Serc with no effect.
Her previous surgeon died and she was seeking another opinion regarding her condition. The diagnosis of Ménière’s disease was
now confirmed in both ears, but she also demonstrated bilaterally very mild Eustachian tube dysfunctions. Ventilation tubes were
inserted. Her symptoms improved, and her attacks of vertigo were less frequent. Medication was now reduced to Serc only.
The introduction of the P100-Ménière, however, controlled her symptoms completely. She had no attacks of vertigo since using
the P100-Ménière which she uses up to eight times a day.
CASE 3
Mrs. E.L., a 61 year old lady presented with a 40 year history of diagnosed Ménière’s disease. The attacks have been rare, but
recently increased in frequency, and this was associated with a marked deterioration of the hearing in the right ear. Serc did not
help much. The diagnosis of Ménière’s disease was confirmed, but also a mild Eustachian tube dysfunction in both ears
Ventilation tubes were inserted. Her symptoms improved, but were still not satisfactory. With the P100-Ménière she felt so much
better that she stopped using it for a while. She went back on the P100-Ménière and symptoms were controlled.
CASE 4
Mrs. M.F., a 51 year old lady presented with a 20 year history of diagnosed Ménière’s disease. During these years she only had five
attacks of vertigo associated with nausea and tinnitus. The hearing however, was gradually deteriorating in the left ear and recently
attacks of vertigo have become quite frequent. The diagnosis of Ménière’s disease was confirmed with a typical mild to moderate
low frequency sensory neural hearing loss in the left ear. Specific Eustachian tube function tests revealed a mild Eustachian tube
dysfunction in the left ear despite a type A tympanogram. Her response to Serc was limited and ventilation tubes were inserted,
and she was given the P100-Ménière. This settled her symptoms temporarily. She had one attack while on Serc, using the P100-
Ménière as well as Zinc as an antioxidant. This attack of vertigo was confirmed by a neurologist as a migraine variant.
CASE 5
Mrs. P.C., a 73 year old lady presented with a long history of diagnosed Ménière’s disease. She had a sac decompression in the right
ear aliquo loco, but this had not settled her symptoms. The diagnosis of Ménière’s disease in the right ear was confirmed. There was
a moderate to severe sensory neural hearing loss equally spread along the speech frequencies in the right ear. Despite a type A
tympanogram a mild Eustachian tube dysfunction could be demonstrated with the modified Holmquist test. A ventilation tube was
inserted. It marginally improved her symptoms. She was given the Meniett. This improved her symptoms. However it was inconvenient
to carry around. The introduction of the P100-Ménière controlled her symptoms equally. She is back playing bowls with her friends.
The P100-Ménière has changed her life. She carries it with her all the time.
CASE 6
Mrs. J. McN., a 50 year old lady presented for seeking a second opinion regarding her recently diagnosed Ménière’s disease.
She did not respond to Serc or Nicotinic acid. Her hearing was gradually deteriorating in both ears. The neurootological assessment
confirmed early stages of Ménière’s disease now affecting both ears. Despite bilateral type A tympanograms there was evidence of
a mild Eustachian tube dysfunction in both ears. Ventilation tubes were inserted. Symptoms improved a little. She used the P100-
Ménière successfully. It controlled her balance and pressure symptoms.
CASE 7
Mr. D.H., a 73 year old gentleman presented with a pulsating noise in the left ear. The noise increased with intermittent attacks of
vertigo. The hearing was gradually deteriorating. The diagnosis of Ménière’ disease was confirmed in the right ear. He responded
to the insertion of a middle ear ventilation tube. Symptoms returned once the ventilation tube was rejected. He responded to the
insertion of a ventilation tube only over a period of 9 years. However, recently the middle ear ventilation tube became less effective.
He was given the Meniette for a trial. He felt it to be too cumbersome. He was given the P100-Ménière, and it controlled his symptoms.
CASE 8
Mr. K.R., an 86 year old gentleman presented with a gradual deterioration of the hearing in the left ear and frequent episodes of lightheadedness
and nausea. The neurootological pattern was consistent with Ménière’s disease affecting the left ear. There was a
moderate to severe sensory neural hearing loss in the left ear almost equally affecting the speech frequencies. He also demonstrated
a mild Eustachian tube dysfunction in the left ear despite a type A tympanogram. A ventilation tube was inserted. This has partially
improved his symptoms. The P100-Ménière controlled his symptoms. He does not want to be without it.
CASE 9
Mrs. P.F., a 67 year old lady presented with a long history of intermittend vertigo and a gradual deterioration of the hearing. The
attacks of vertigo have been infrequent in the past, but recently have increased dramatically. The neurootological pattern was
consistent with Ménière’s disease affecting the left ear. There was also a mild Eustachian tube dysfunction despite a type A
tympanogram. There was a week response to Serc. A ventilation tube was inserted, and she was given the P100-Ménière.
She responded well and has been without symptoms for the last two months.
CASE 10
Mrs. A.S., a 39 year old lady presented with a four year history of diagnosed Ménière’s disease. Her hearing was deteriorating in the
right ear. She was seeking another opinion as she did not respond to conventional treatment. The assessment confirmed Ménière’s
disease in the right ear, and a mild Eustachian tube dysfunction despite a type A tympanogram. She had a moderate to severe
sensory neural hearing loss in the right ear. Her response to the insertion of a ventilation tube improved marginally her symptoms.
She responded very well to the P100-Ménière.
CASE 11
Mrs. L.C., a 44 year old lady presented with a forerunner of Ménière’s disease eight years ago. She represented recently with
frequent attacks of vertigo and deterioration of her hearing in the left ear. She did not respond to Serc. The neurootological
assessment confirmed Ménière’s disease in the left ear. The insertion of a middle ear ventilation tube improved her symptoms only
marginally. Increasing the dosage of Serc did not help. The P100-Ménière has improved her symptoms, but she is still experiencing
intermittend blockage in the left ear, there were no more attacks of vertigo.
CASE 12
Mr. D.S., a 46 year old gentleman presented with a ten months history of almost daily attacks of vertigo, nausea and pressure in the
left ear. His hearing was deteriorating quickly. He was a diabetic and did not respond to Serc. The neurootological assessment
confirmed Ménière’s disease in the left ear. He also had a mild Eustachian tube dysfunction in both ears despite bilateral type A
tympanograms. He had a moderate sensory neural hearing loss in the right ear almost equally affecting the speech frequencies.
The insertion of bilateral ventilation tubes did not help. He was desperate to be prescribed the Meniett device. Instead the P100-
Ménière was given for a trial. His response was excellent. He used the P100-Ménière at least six times a day. As soon as he feels
pressure building up in his left ear, the P100-Ménière gets rid of it immediately. He does not want to return the device.
CASE 13
Mrs. H.L., a 65 year old lady presented with a forerunner of Ménière’s disease six years ago. At that time she responded to the
insertion of a middle ear ventilation tube. She represented recently with a pulsating noise in the right ear, deteriorating hearing,
nausea and intermittend attacks of vertigo. The neurootological assessment confirmed Ménière’s disease in the right ear.
There was a mild mainly low frequency sensory neural hearing loss in the right ear. Specific Eustachian tube function tests revealed
a mild Eustachian tube dysfunction in the right ear. Her response to Serc was limited. The reinsertion of a ventilation tube improved
symptoms a little more. She responded well to the P100-Ménière. There were no more balance problems, the nausea was controlled
and the pulsating noise in the right ear diminished.
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P100-Ménière, Clinical Trial
Patients suffering from Ménière’s disease are particularly sensitive to negative pressure in the middle ear. For example,
attacks of vertigo can be triggered by a descent in an aircraft when ventilation of the middle ear can become critical.
Positive pressure pulse therapy has shown to have a beneficial effect on the sufferer by relieving the symptoms, and is now
a true alternative in the treatment of Ménière’s disease.
A clinical trial was conducted by the Ear Institute, Queenswood, Pretoria, South Africa (Dr. Frits van der Laan) and Tinnitus
Research and Balance Clinic, Melbourne, Australia (Ass. Prof. Burkhard Franz). In this study two devices were compared that
produced positive pressure pulses delivered to the inner ear via the external ear canal and after the insertion of a middle
ear ventilation tube.
The aim was to investigate the effectiveness of positive pressure pulses delivered by the handheld manually operating device
P100-Ménière and the electronic Meniett device. Twenty five patients took part in this study. All patients that participated
in this trial had a confirmed diagnosis of Ménière’s disease (AAO criteria) and had frequent attacks. 19 of these were seeking
further treatment options for the relief of their symptoms as the insertion of a ventilation tube alone did not give enough relief.
A ventilation tube was either inserted in the office, or alternatively in the operating theatre. Five days following the insertion
of the ventilation tube a decision was made whether to proceed with the trial. Although some patients experienced an improvement
of their symptoms, 19 were keen to proceed with the positive pressure pulse treatment. Positive pressure treatment was either
conducted with an expensive electronic device or a new manually operated alternative. Nine patients opted for the electronic device,
10 opted for the manual device.
Symptoms before and after treatment with positive pressure pulses were recorded. Statistical testing was performed using a
nonparametric, Kruskall-Wallis single factor analysis of variance by rank. Each symptom was considered separately, comparing
the mean rank before and after treatment with either the manual device or the electronic device. If a significant difference between
means was detected, then post hoc, nonparametric multiple comparisons for unequal sample sizes were used to determine which
mean ranks differed. In all cases a = 0,05.
Among the symptoms that improved significantly were vertigo, fullness in the ear and nausea (Fig. 1). There was a slight difference
between the two devices with the electronic device not quite performing as well as the manually operated device. The differences,
however, were not significant. The difference might have been due to the convenience of the manual device, which was immediately
available when needed and did not require the cumbersome setting up of the other device. There was also a slight difference between
the severities of symptoms in both groups which could have accounted for the differences, but these differences were not significant.
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Fig. 1: Improvement of the symptoms vertigo, fullness in the ear and nausea were
statistically significant, and there was statistically no difference between
the electronic device and the manual device.
statistically significant, and there was statistically no difference between
the electronic device and the manual device.
Several patients from the clinical trial refused to return the manually operated device after the clinical trial. It has improved their life so much that they did not want to part with it.
Both the insertion of a middle ear ventilation tube and positive pressure pulse treatment address a disturbed relationship between the middle ear and the inner ear. Our clinical trial confirms that positive pressure pulse therapy in Ménière’s disease is a true alternative to current treatment modalities. The manually operated device is the preferred option for its convenience of use and its lower cost.
This trial was published in the ‘International Tinnitus Journal’, Vol. 11, No. 2, 146-149 (2005).
References
1. Ingelstedt S, Ivarsson A, Tjerstrom O. Immediate relief of symptoms during acute attacks of Ménière’s disease,
using a pressure chamber. Acta Otolaryngol 82: 368-378, 1976
2. Densert B, Densert O. Overpressure in treatment of Ménière’s disease. Laryngoscope 92: 1285-1292/ 1982
3. Gates GA, Green JD, Tucci DL, Telian SA. The effect of transtympanic micropressure treatment in people with unilateral Ménière’s
disease. Arch Otolaryngol Head Neck Surg 130: 718-723, 2004
4. Committee on Hearing and Equilibrium guidelines for the diagnosis and evaluation of therapy in Ménière’s disease. American
Academy of Otolaryngology Head and Neck Foundation, Inc. Otolaryngol Head and Neck Surg 113: 181-185, 1995
5. Zar JH. Biostatistical Analysis. Prentice-Hall, London 1984
6. Densert B, Densert O, Arlinger S, Sass K, Odkvist L. 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
7. Sakikawa Y, Kimura RS. Middle ear overpressure treatment of endolymphatic hydrops in guinea pigs. ORL J Otorhinolaryngol
Relat Spec 59: 84-90, 1997
8. Horner KC. Old theme and new reflections: hearing impairment associated with endolymphatic hydrops.
Hear Res 52: 147-156, 1991
9. Franz B, Altidis P, Altidis B, Collis-Brown G. The Cervicogenic Otoocular Syndrome: A suspected forerunner of Ménière’s disease.
Int Tinnitus J 5: 125-130, 1999
P100-Ménière, Frequently Asked Questions
Can pressure pulse therapy cure my Ménière´s disease?
No, a cure has yet to be developed. Pressure pulse therapy is intended to give a patient relief from symptoms.
Do I need a grommet (ventilation tube) to benefit from positive pressure pulse therapy?
We recommend that you seek advice from your doctor on how to obtain the best outcome from this type of therapy.
Clinical studies have shown that positive pressure pulse therapy is most effective when used in conjunction
with a grommet.
Is the created pressure safe for my ear?
The P100-Ménière has been designed using a special valve which limits the pressure. Therefore the device has a
safety limit. No matter how hard you pump the device, the P100-Ménière will not produce excessive pressures.
Our products underlie a permanent quality control and are being double-checked before being released for sale.
Does the P100-Ménière have regularly approvals?
Yes.
Has the P100-Ménière undergone clinical trials?
The P100-Ménière has undergone clinical trials at various clinics around the world.
How do I use the P100-Ménière?
Simply pull off the protective cap... |
... and uncoil the tube.
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Once the ear tip is in place,
press the center diaphragm
of the device with your thumb,
and release.After repeating this process and acquiring the desired relief, coil the tube around the device and replace the protective cap. Ensure the protective cap is on the device at all times when not in use. |
While sitting comfortably,
place the ear tip in your
ear canal and hold it
in place to maintain a
snug fit and the feeling
of a seal.
The P100-Ménière contains ear tips in different size (small, medium and large).
The ear tips can be cleaned with a mild detergent.
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• The P100-Ménière may be utilizes repeatly (approximately two to three times) |
Shop
Please be aware of copied, unlicensed and inferior devices, especially from the Far East, which do not meet German quality
standards. Genuine Enttex products can only be purchased via this online-shop or from our officially licensed international
distributors, signalized with our own seal of quality.
The Enttex logo is a trademark, officially copyrighted and the property of Enttex GmbH Germany.
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Distributors
Please be aware of copied, unlicensed and inferior devices, especially from the Far East, which do not meet German quality
standards. Genuine Enttex products can only be purchased via this online-shop or from our officially licensed international
distributors, signalized with our own quality-seal.
The Enttex logo is a trademark, officially copyrighted and the property of the Enttex GmbH Germany.
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Downloads:
Here you find our actual English brochures and posters.
P100-Ménière Brochure P100-Ménière PosterContact
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Enttex GmbH
Postfach 61 03 41 D-30603 Hannover Germany Phone: +49 (0) 511 54 131 50 Fax: +49 (0) 511 54 131 60 email: info@enttex.de |
Imprint
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Enttex GmbH
Wolfsburger Damm 26a 30625 Hannover Germany Phone: +49 (0) 511 54 131 50 Fax: +49 (0) 511 54 131 60 email: info@enttex.de Managing Director: Jens-Peter Franz © Copyright Enttex GmbH Website Design: www.artwork3.de Programming: Johannes Kümmel |
