CAM 10123

Transtympanic Micropressure Applications as a Treatment of Meniere’s Disease

Category:Durable Medical Equipment   Last Reviewed:April 2021
Department(s):Medical Affairs   Next Review:April 2999
Original Date:April 2003    

Description:
Meniere disease is an idiopathic disorder of the inner ear characterized by episodes of vertigo, fluctuating hearing loss, tinnitus and ear pressure. Conservative therapy includes a low sodium diet and diuretics to reduce fluid accumulation (i.e., hydrops) and pharmacologic therapy to reduce vestibular symptoms. Transtympanic pressure treatment has been proposed as an alternative treatment for Meniere disease. This treatment involves use of a handheld device (e.g., Meniett) that delivers air pressure pulses to the ear.

For individuals who have Meniere disease who receive transtympanic micropressure therapy (Meniett), the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life and treatment-related morbidity. Six RCTs of positive pressure therapy have been reported, with 5 trials specifically investigating the Meniett device. A systematic reviews of 5 of these trials found that micropressure therapy does not result in a greater reduction in vertigo than placebo. The sixth trial also found no significant benefit of the transtympanic micropressure therapy for Meniere disease. The evidence is sufficient to determine that the technology is unlikely to improve the net health outcome.

Background 
MENIERE DISEASE
Meniere disease is an idiopathic disorder of the inner ear characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and ear pressure. The vertigo attacks are often unpredictable, incapacitating, and may impede activities of daily living. Therapy addresses symptoms, not the underlying pathophysiology. Although the pathophysiology of Meniere disease is not precisely known, it is thought to be related to a disturbance in the pressure-volume relationship of the endolymph within the inner ear.

Treatment
Conservative therapy includes a low sodium diet and diuretics to reduce fluid accumulation (i.e., hydrops) and pharmacologic therapy to reduce vestibular symptoms. Persons who do not respond to these conservative measures may receive gentamicin drops in the ear, as a technique of chemical labyrinthectomy to ablate vestibular function on the affected side. No therapy is available to restore hearing loss.

There has been interest in developing a more physiologic treatment approach by applying local transtympanic pressure to restore the underlying fluid homeostasis. Researchers have noted that symptoms of Meniere disease improve with fluctuations in ambient pressure, and patients with acute vertigo have been successfully treated in hypobaric chambers. It is hypothesized that the application of low-frequency, low-amplitude pressure pulse to the middle ear functions to evacuate endolymphatic fluids from the inner ear, thus relieving vertigo.

Transtympanic micropressure treatment for Meniere disease involves the use of a handheld air pressure generator (Meniett) that delivers intermittent complex pressure pulses. For this device to be used, a conventional ventilation tube is surgically placed in the eardrum. Patients then place an ear-cuff in the external ear canal and treat themselves for 3 minutes, 3 times daily. Treatment continues for as long as patients have vertigo attacks.

Regulatory Status 
In 1999, the Meniett® device (Medtronic, Minneapolis, MN) received clearance to market through an FDA 510(k) process specifically as a symptomatic treatment of Meniere disease.

Policy:
Transtympanic micropressure application as a treatment of Meniere's disease is considered NOT MEDICALLY NECESSARY.

Policy Guidelines
Use of the Meniett device requires a prior tympanostomy procedure, a novel indication for this common procedure.

Please see the Codes table for details. 

Rationale 
This evidence review was created in April 2003 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through November 27, 2019.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function -- including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical uses of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Meniere disease has a variable natural history, with waxing and waning symptomatology and spontaneous recovery. Also, some outcome measures are subjective and, thus, may be particularly susceptible to placebo effects. For of these reasons, controlled trials are essential to demonstrate the clinical effectiveness of treatment of transtympanic micropressure therapy compared with alternatives (e.g., continued medical management).

Transtympanic Micropressure Therapy for Meniere Disease
Clinical Context and Therapy Purpose
The purpose of transtympanic micropressure therapy is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as medical management, in patients with Meniere disease.

The question addressed in this evidence review is: does transtympanic micropressure therapy improve the net health outcome for individuals with Meniere disease?

The following PICO was used to select literature to inform this review.

Patients
The relevant population of interest are individuals with Meniere disease.

Interventions
The therapy being considered is transtympanic micropressure therapy.

Comparators
The main comparator of interest is medical management.

Outcomes
The outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.

The data submitted to the U.S. Food and Drug Administration (FDA) as part of the FDA approval process of the Meniett device consisted of a case series of 20 patients.1, Other case series have been published in the peer-reviewed literature, some reporting 2- to 4-year outcomes in patients who had failed conservative medical therapy.2,3,4,5,6,7,8, These case series do not provide significant information about the comparative effectiveness of the Meniett device due to the lack of control groups, and they will not be discussed further in this review. The remaining literature review focuses on systematic reviews and RCTs.

Systematic Reviews
A 2015 Cochrane review on positive pressure therapy for Meniere disease included 5 double-blind, placebo-controlled randomized trials (total n=265 patients).9, Three trials were considered to be at low-risk of bias, one was at unclear risk, and one was at high-risk. Results on the primary outcome measure (control of vertigo) could not be pooled due to heterogeneity in measurement, but most trials showed no significant difference in vertigo between Meniett therapy and placebo. Reviewers concluded that evidence did not support the effectiveness of positive pressure therapy for the treatment of Meniere disease and there was some evidence that hearing is impaired with this treatment. Another systematic review (2015), which included four of the same RCTs that specifically used the Meniett device, also found no significant difference between low-pressure therapy and placebo for the frequency of vertigo.10,

Randomized Controlled Trials
The three trials, considered to be of low-risk of bias in the Cochrane review, are described next.

Gates et al. (2004) reported on the 4-month results of a randomized, multi-institutional trial that enrolled 67 patients with active unilateral Meniere disease refractory to a 3-month trial of medical management.11, All patients underwent tympanostomy, and patients were additionally randomized to a sham device or a Meniett device. Over the entire four-month trial, there was a significant difference in the total number of episodes of vertigo in the treatment group compared with the control group. However, the difference between the groups was most apparent at one month, while at four months the treatment effect had disappeared almost entirely. Similarly, overall, there was a significant decrease in the frequency of vertigo in the treatment group, but again this difference was most apparent at the one month interval and almost disappeared at four months. This trial was limited by a number of methodologic issues related to the data analysis, and results did not permit drawing conclusions about the impact of this device on patient outcomes.

Gates et al. (2006) reported on the 2-year, open-label, follow-up to the 2004 randomized trial.12, At the end of the randomized phase of the trial, 61 of 67 patients from both the control and active treatment arms were treated with the Meniett device. Vertigo episodes were reported on a daily symptom diary or by a structured telephone interview. Of the 58 patients followed for 2 years, 14 (24%) dropped out to seek alternative surgical treatment, 5 (9%) showed little or no improvement, and 39 (67%) reported being in remission or substantially improved. Patients who went into remission had an 80% probability of remaining in remission for the 2 years. This assessment was limited, however, by the lack of a control group followed over the same period.

A multicenter, double-blind, placebo-controlled trial of 63 patients by Thomsen et al. (2005) compared micropressure devices with ventilation tubes and sham pressure devices.13, This trial reported an improvement in functionality (American Academy of Otolaryngology–Head and Neck Surgery criteria) and a trend (p=0.09) toward a reduction in episodes of vertigo for the active treatment group compared with controls. The frequency of attacks decreased from 10.5 to 4.0 in the placebo group and from 9.6 to 1.9 in the active group. There were no significant differences in secondary outcome measures (patient’s perception of tinnitus, aural pressure, hearing). In addition to a marginal improvement in efficacy over ventilation tubes with sham pressure, this trial was limited by a high dropout rate (37%), lack of intention-to-treat analysis, and short (2-month) monitoring period.

Gurkov et al. (2012) reported on a randomized, double-blind, sham-controlled trial with the Meniett device.14, After a 4-week baseline period, 74 patients underwent ventilation tube placement and were monitored for another 4 weeks. Patients were then randomized to 16 weeks of active or sham treatment (5 minutes, 3 times daily). The primary outcomes were subjective vertigo score, number of definitive vertigo days, and number of sick days as recorded on a daily log over the last four weeks of treatment. Sixty-eight (92%) patients completed the trial. The cumulative vertigo score decreased by 6.5 in the active group and by 1.19 in the sham group (p=0.048). The number of vertigo days decreased by 2.42 in the active treatment group and by 0.42 in the sham group (p=0.102), and the number of sick days decreased by 2.32 in the active treatment group and increased by 0.58 days in the sham group (p=0.041). There was no significant difference between groups in the vertigo-free days, activity score, hearing level, or slow phase velocity. This trial showed a modest improvement in two of five subjective measures, but not in objective outcome measures, with the Meniett device.

Subsequent to the 2015 Cochrane review, Russo et al. (2017) reported on an industry-sponsored, multicenter, double-blind RCT of the Meniett device.15, A total of 129 patients with Meniere disease not controlled by medical treatment were withdrawn from any vertigo treatment and received placement of a transtympanic tube. Patients (n=97 [75%]) who continued to have symptoms (≥2 vertigo episodes during a 6-week period) after placement of a transtympanic tube were randomized to an active or sham device for 6 weeks and then were followed for an additional 6 weeks. The number of vertigo episodes during the baseline period did not differ significantly between groups (p=0.07). The trial was powered to detect a 30% difference in vertigo episodes compared with the sham group. Per protocol analysis showed a significant decrease in vertigo episodes in both groups (see Table 1), but no between-group difference (p=0.11), suggesting a possible effect of the transtympanic tube. Vertigo-related quality of life also did not differ between groups.

Table 1. Number of Vertigo Episodes

Treatment Arms

Before Treatment (SEM)

During Treatment (SEM)

After Treatment (SEM)

Active

3.2 (0.4)

2.5 (NR)a

1.5 (0.02)b

Sham

4.3 (0.6)

2.6 (0.05)a

1.8 (0.8)b

NR: not reported; SEM: standard error of the mean.
a p<0.05 vs baseline
b p<0.005 vs during treatment.

Summary of Evidence
For individuals who have Meniere disease who receive transtympanic micropressure therapy (Meniett), the evidence includes randomized controlled trials and systematic reviews. The relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Six randomized controlled trials of positive pressure therapy have been reported, with five specifically investigating the Meniett device. Systematic reviews of these five trials found that micropressure therapy does not result in a greater reduction in vertigo than placebo. The sixth trial also found no significant benefit of the transtympanic micropressure therapy for Meniere disease. The evidence is sufficient to determine that the technology is unlikely to improve the net health outcome.

Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received through 1 physician specialty society (2 reviewers) and 2 academic medical centers while this policy was under review in 2008. Input was mixed regarding whether this treatment would be considered investigational, as adopted in the policy in 2008.

Practice Guidelines and Position Statements
American Academy of Otolaryngology- Head and Neck Surgery
American Academy of Otolaryngology– Head and Neck Surgery (2016) updated its position statement on the use of transtympanic micropressure: “We find that there is some medical evidence to support the use of micropressure therapy (such as the Meniett device) in certain cases of Meniere diseaseMicropressure therapy is best used as a second level therapy when medical treatment has failed. The device represents a largely non-surgical therapy that should be available as one of the many treatments for Meniere’s disease.”16, No supporting evidence was provided.

National Institute for Health and Care Excellence
The guidance from the U.K.’s National Institute for Health and Care Excellence (2012) concluded that “[c]urrent evidence on the safety of micropressure therapy for refractory Ménière’s disease is inadequate in quantity. There is some evidence of efficacy, but it is based on limited numbers of patients. Therefore this procedure should only be used with special arrangements….”17,

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in November 2019 did not identify any ongoing or unpublished trials that would likely influence this review.

References:  

  1. U.S. Food and Drug Administration (FDA). FDA 510(k) marketing clearance information for the Meniett device (K991562). 1999; http://www.accessdata.fda.gov/cdrh_docs/pdf/K991562.pdf. Accessed November 27, 2019.
  2. Barbara M, Consagra C, Monini S, et al. Local pressure protocol, including Meniett, in the treatment of Meniere's disease: short-term results during the active stage. Acta Otolaryngol. Dec 2001;121(8):939-944. PMID 11813899
  3. Densert B, Sass K. Control of symptoms in patients with Meniere's disease using middle ear pressure applications: two years follow-up. Acta Otolaryngol. Jul 2001;121(5):616-621. PMID 11583396
  4. Gates GA, Green JD, Jr. Intermittent pressure therapy of intractable Meniere's disease using the Meniett device: a preliminary report. Laryngoscope. Aug 2002;112(8 Pt 1):1489-1493. PMID 12172267
  5. Barbara M, Monini S, Chiappini I, et al. Meniett therapy may avoid vestibular neurectomy in disabling Meniere's disease. Acta Otolaryngol. Nov 2007;127(11):1136-1141. PMID 17851896
  6. Dornhoffer JL, King D. The effect of the Meniett device in patients with Meniere's disease: long-term results. Otol Neurotol. Sep 2008;29(6):868-874. PMID 18617868
  7. Mattox DE, Reichert M. Meniett device for Meniere's disease: use and compliance at 3 to 5 years. Otol Neurotol. Jan 2008;29(1):29-32. PMID 18199955
  8. Park JJ, Chen YS, Westhofen M. Meniere's disease and middle ear pressure: vestibular function after transtympanic tube placement. Acta Otolaryngol. Dec 2009;129(12):1408-1413. PMID 19922090
  9. van Sonsbeek S, Pullens B, van Benthem PP. Positive pressure therapy for Meniere's disease or syndrome. Cochrane Database Syst Rev. Mar 10 2015;3(3):CD008419. PMID 25756795
  10. Syed MI, Rutka JA, Hendry J, et al. Positive pressure therapy for Meniere's syndrome/disease with a Meniett device: a systematic review of randomised controlled trials. Clin Otolaryngol. Jun 2015;40(3):197-207. PMID 25346252
  11. Gates GA, Green JD, Jr., Tucci DL, et al. The effects of transtympanic micropressure treatment in people with unilateral Meniere's disease. Arch Otolaryngol Head Neck Surg. Jun 2004;130(6):718-725. PMID 15210552
  12. Gates GA, Verrall A, Green JD, Jr., et al. Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg. Dec 2006;132(12):1311-1316. PMID 17178941
  13. Thomsen J, Sass K, Odkvist L, et al. Local overpressure treatment reduces vestibular symptoms in patients with Meniere's disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Otol Neurotol. Jan 2005;26(1):68-73. PMID 15699722
  14. Gurkov R, Filipe Mingas LB, Rader T, et al. Effect of transtympanic low-pressure therapy in patients with unilateral Meniere's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial. J Laryngol Otol. Apr 2012;126(4):356-362. PMID 22365373
  15. Russo FY, Nguyen Y, De Seta D, et al. Meniett device in Meniere disease: Randomized, double-blind, placebo- controlled multicenter trial. Laryngoscope. Feb 2017;127(2):470-475. PMID 27515294
  16. American Academy of Otolaryngology - Head and Neck Surgery. Position statement: micropressure therapy. 2016; http://www.entnet.org/Practice/micropressure.cfm. Accessed November 27, 2019.
  17. National Institute for Health and Care (NICE). Micropressure therapy for refractory Mnire's disease [IPG426]. 2012; http://guidance.nice.org.uk/IPG426/Guidance/pdf/English. Accessed November 27, 2019.

Coding Section

Codes Number Description
ICD-9 Diagnosis   investigational for all diagnoses
  386.00-386.04 Meniere's disease code range
HCPCS A4638 Replacement battery for patient-owned ear generator, each
  E2120 Pulse generator system for tympanic treatment of inner ear endolymphatic fluid
ICD-10-CM (effective 10/01/15)   Investigational for all diagnoses
  H81.01-H81.09 Meniere's disease code range
ICD-10-PCS (effective 10/01/15)   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for the initiation of this therapy.
Type of Service DME   
Place of Service Outpatient   

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

04/01/2021 

Annual review, no change to policy intent. Updating guidelines. No other changes made.

04/01/2020 

Annual review, no change to policy intent. Updating rationale. 

04/01/2019

Annual review, no change to policy intent. Updating rationale. 

04/18/2018 

Annual review, no change to policy intent. Updating background, rationale and references. 

04/03/2017 

Annual review, no change to policy intent. Updating background, description, rationale and references. 

04/07/2016 

Annual review, changing the determination of this service from investigational to not medically necessary. Updating background, description, rationale and references. 

04/13/2015 

Annual review, no change to policy intent. Updated background, description, rationale and references. Added guidelines and coding.

04/01/2014

Annual Review. No changes made.


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