The National Horizon Scanning Centre, Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham, B15 2TT, England, Tel: +44 (0)121 414 7831 Fax +44 (0)121 414 2269 www.publichealth.bham.ac.uk/horizonS

funded by the Research and Development Division of the Department of Health, UK

Meniett is a low-pressure pulse generator for the treatment of Ménière’s disease in people who have not responded to medical treatment and who are otherwise candidates for surgical therapy. Evidence from two small randomised controlled trials (RCTs) indicate that short-term use of Meniett significantly reduces frequency and intensity of vertigo attacks, tinnitus and dizziness compared with placebo and significantly improves hearing at frequencies between 500-1000 Hz. A 2 year follow-up study in 37 patients found a significant reduction in vertigo in 92% of patients. Four RCTs are currently ongoing to evaluate long-term use.

Developer – Medtronic Xomed.

Regulatory status – Launched in the UK in January 2002 with about 30 devices available in the NHS at present.

Unit cost – £2,000 per patient.

NHS or Government priority - National Service Framework for Older People and the Action on ENT Good Practice Guide.

Burden of disease – There are an estimated 172 to 3,432 people with Ménière’s disease who are unresponsive to medical therapy and suitable for Meniett.

Potential clinical benefit - Meniett may provide an alternative to ablative or surgical intervention for severe vertigo without causing permanent hearing loss. Early intervention may also lead to the prevention of future hearing loss. Any reduction in the debilitating symptoms associated with Ménière’s disease will lead to significant improvements in quality of life, allowing patients to return to normal daily activities such as driving and full-time employment. 

NHS or societal resource impact - If all patients who could potentially benefit from this therapy were to receive this device, the cost to the NHS (including grommet insertion) would be in the range of £417,000 to £8.3M. Costs may be offset by a reduction in use of hospital beds and surgical time. There may also be a reduction in rehabilitation or ongoing pharmaceutical therapy.

Ménière’s disease is a complex, debilitating disorder of the inner ear characterised by rotary vertigo, hearing loss, a feeling of fullness in the ear and tinnitus. Ménière’s disease is progressive, but fluctuates unpredictably, making it difficult to distinguish natural resolution from the effects of treatment. Attacks of vertigo, often accompanied by nausea, vomiting and headaches, occur with little or no warning and can vary in intensity and duration. Attacks have an increased frequency during the first few years, then decrease in frequency in association with a sustained deterioration in hearing. Ménière’s disease mainly affects just one ear, but the incidence of disease in both ears is thought to increase with the duration of the disease and is reported to be anywhere between 9% to 50% 1. The cause of Ménière’s disease is unknown but it appears to be due to sudden fluctuations in endolymphatic pressure. Initially the damage is reversible but repetitive attacks can lead to permanent hearing loss. Ménière’s disease is associated with significant deterioration in quality of life. Vertigo attacks can prevent normal daily activities such as working and driving, and in many cases leads to chronic disability and anxiety. In approximately 30% of cases vertigo is unresponsive to conservative medical therapy. In the remaining 70%, symptoms other than hearing loss can improve irrespective of treatment but then usually return intermittently.

Meniett – Medtronic Xomed., is a non-invasive, non-destructive, portable, patient administered device for the treatment of Ménière’s disease. The device delivers intermittent low-pressure pulses through a tympanostomy tube (grommet) to the middle ear space that then act on the round window membrane. Since the fluids of the inner ear are not compressible, the energy of the pressure pulses causes a displacement of the perilymphtic fluid. This stimulates endolymphatic fluid flow, resulting in a reduction of static endolymphatic fluid. Each treatment sequence lasts approximately 5 minutes and consists of three cycles. A cycle consists of 1 minute of pressure pulses and 40 seconds of pause. The device causes little discomfort and is used 3 times daily until remission, and thereafter depending on the duration and severity of symptoms. Symptoms generally improve within days of using Meniett although vertigo control can take between 1-3 weeks. A tympanostomy tube, inserted under local anaesthetic is required prior to use. Only limited patient training is needed and is currently provided by Medtronic. Meniett was launched worldwide in January 2002 and there are approximately 30 devices currently in use within the NHS. A small number have been loaned to patients for evaluation and several have been purchased privately by patients and patient organisations.

The onset of Ménière’s disease is most common between 40-60 years of age, although younger people can be affected and prevalence linearly increases with age. Reported incidence figures vary from between 5 to 100 per 100,0002 (population equates to between 2,600 and 52,000 people in England and Wales). The Ménière’s Society has a membership of about 5,750 people in England and Wales2. Ménière’s disease may be over diagnosed as there is no specific diagnostic test. The fourth national study of morbidity statistics from general practice (1991-1992) show that the number of new and first ever episodes of Ménière’s disease is 65 per 10,000 person years at risk associated with 107 consultations with a doctor per 10,000 person years at risk3. There is equal prevalence between sexes but the disease predominantly affects Caucasians1. It is estimated that 4 out of 5 patients with Ménière’s disease are controlled by medical therapies alone1. The remaining 20% may be considered for surgical ablation (equivalent to between 520 and 10,400 in England and Wales (estimate based on incidence figures and not prevalence). There are no figures for the number of patients receiving non-surgical ablation. About one third of patients who do not respond to medical therapy may be suitable for Meniett (172 – 3,432 people).

Diuretics alone or in combination with salt restriction can be of benefit to some people. Acute attacks of vertigo and nausea can be managed with prochlorperazine and cinnarzine that sedate the vestibulo-brainstem axis. Prophylaxis with betahistine can improve symptoms of vertigo and tinnitus and the frequency and intensity of attacks, but does not alter the course of the disease. Vestibular rehabilitation is used in some situations. Patients not well controlled on medical therapy may need an ablative or surgical procedure in order to control their vertigo. Ablative treatment with aminoglycosides (gentamicin) given locally into the inner ear can reduce and control vertigo in some people and is currently the treatment of choice in refractory cases. Surgical treatments that are not destructive to hearing include endolymphatic sac surgery and vestibular nerve section/neurectomy, while destructive treatments such as labyrinthectomy are occasionally used in severe cases.

The Meniett device costs £2,000 with no associated maintenance costs. Grommet insertion is normally carried out on a day case basis and costs a mean average of £428 (interquartile range of between £293 and £485). The device could potentially be interchanged between patients, but the rubber earplug which is inserted into the ear canal during the treatment cycle would need to be replaced between patients at a cost of £2-3 each time. Current prophylactic treatment with betahistine costs between £62 to £190 per annum depending on the dose required, while short courses of antihistamine for acute attacks of vertigo usually lasting between 3-4 days cost between below £1.50 per course. Endolymphatic sac surgery, vestibular nerve section/neurectomy and labyrinthectomy cost between £750 to £1500 (interquartile range) with an average length of hospital stay of around 3 days.

In a 2-week prospective, multicentre RCT, 56 patients with confirmed Ménière’s disease were randomised to receive either active pressure treatment with Meniett (n=31) or a placebo device (n=25)4. Insertion of the grommet alone did not improve any variables measured. Statistically significant improvements regarding the frequency and intensity of vertigo, dizziness, aural pressure, tinnitus and qualitative function in professional and family life were demonstrated in the treatment group according to visual analogue scales. Hearing significantly improved at frequencies of 500 and 1,000 Hz, by 4 dB (p<0.03) and 5 dB (p<0.01) respectively, following treatment but not in controls. Some patients in the placebo group had worsening of symptoms, which were not reported in the active group. A further 2-week prospective RCT in 39 patients also found that cochlear electric potentials significantly improved (p<0.005) immediately after exposure to low-pressure pulses (n=21), indicating improvements in inner ear electrophysiology5. No significant changes were found in subjective symptoms (vertigo, tinnitus and aural pressure) and no changes were recorded due to prior grommet insertion. An uncontrolled study in 20 patients comparing the effect of the grommet alone (inserted for 20 days) to that of subsequent use of the Meniett device for a further 20 days, demonstrated that middle ear ventilation alone and not the device was responsible for significant improvements in episodes of vertigo6. Hearing gain however was evident in two patients following use of Meniett that had not been evident just through ventilation. An unblinded study in 10 patients with intractable vertigo unresponsive to medical treatment demonstrated complete vertigo control in 9 of the 10 patients following an average treatment period with Meniett of 8 months (range 3 to 11 months)7. A 50% reduction in vertigo was evident in the remaining patient. Improvement in symptoms was accompanied by a statistically significant mean hearing gain of 6 dB (p=0.046). Most patients experienced a recurrence of vertigo when use of the device was curtailed. A longer-term observational study conducted over 2 years in 37 people with confirmed Ménière’s disease (31 of which had not responded to conventional medical treatment prior to enrolment) demonstrated a complete reduction of vertigo in 19 patients (p<0.0005) and a significant reduction in frequency of vertigo in 15 patients (p=0.001) 8. Three patients did not respond to treatment. Functionality profile improved by at least 2 levels according to the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) criteria in the 34 patients who responded to treatment, and they did not need to resume intake of diuretics or other medications.

One cost-effectiveness study that was conducted in Australia has been identified, but we were unable to obtain details from the company at the current time.

Apart from problems associated with infections of the ventilation tubes8 and an occasional need for grommet reinsertion (twice per patient on average over 2 years)7,8 no adverse events or worsening of symptoms related to the use of Meniett have been reported.

In the UK, a trial at Leicester Royal Infirmary has recruited 15 patients to date. Three separate multicentre trials are ongoing in France (n=90), Scandinavia (n=42) and the US (n=63). All of the trials listed are sponsored by Medtronic Xomed and are double-blind, RCTs involving both patients that have responded to medical treatments and those that are drug-refractory. Results are expected in October/November 2003.

If ongoing clinical trials confirm the efficacy of Meniett in long-term use, it is likely that Meniett’s place in management is in patients with treatment-resistant Ménière’s disease before any surgical or other destructive means is considered. Although the cost of the device is not dissimilar to surgical intervention, its non-destructive nature, conserving and potentially improving hearing, is a major clinical benefit. If the 172 to 3,432 patients with Ménière’s disease who may be suitable receive Meniett the cost would be in the range of £417,000 to£8.3M (including grommet insertion but not hospital costs). However, multiple patients could use each Meniett device perhaps by making it available in a primary or community care setting when required. Meniett may substantially increase patients’ quality of life, preserving hearing, avoiding painful ablative procedures, and allowing them to resume normal daily activities such as driving and full-time employment. Early intervention may also lead to the prevention of future hearing loss. Costs may be offset by a reduction in use of hospital beds and surgical time. There may also be a reduction in rehabilitation or ongoing pharmaceutical therapy.

1 Prodigy Guidance. Ménière’s disease. Available at http://www.prodigy.nhs.uk/guidance accessed 14/4/03.

2 Ménière’s Society. Available at http://www.menieres.co.uk/ accessed 14/4/03.

3 McCormick A, Fleming D, Charlton J. Morbidity statistics from General Practice; Fourth national study 1991-1992. A study carried out by the Royal College of General Practitioners, the Office of Population Censuses and Surveys, and the Department of Health. Series MB5, no. 3. London: HMSO. 1995.

4 Odkvist LM, Arlinger S, Billermark E, Densert B, Lindholm S, Wallqvist. Effects on middle ear pressure changes on clinical symptoms in patients with Ménière’s disease - a clinical multicentre placebo-controlled study. Acta Otolaryngol. 2000; suppl 543: 99-101.

5 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 Otology. 1997; 18: 726-733.

6 Barbara M, Consagra C, Monini S, Nostro G, Harguindey A, Vestri A, Filipo R. Local pressure protocol, including Meniett, in the treatment of Ménière’s disease: short-term results during the active stage. ActaOtalaryngol. 2001; 201: 939-944.

7 Gates GA, Green D Jr. Intermittent pressure therapy of intractable Ménière’s Disease using the Meniett Device:A preliminary report. Laryngoscope. 2002; 112: 1489-1493.

8 Densert B, Sass, K. Control of Symptoms in patients with Ménière’s disease using middle ear pressure applications: Two years follow-up. Acta Otolaryngol. 2001; 121: 616-621.