Meniere's Disease and the Meniett

Presenter: Dr. George A. Gates, M.D. Professor and Director, Virginia Merrill Bloedel Hearing Research Center, University of Washington, Seattle.

Dr. Gates devoted the second half of his presentation to a discussion of Meniere's Disease and a new treatment option called the Meniett.

Meniere's Disease is caused by too much fluid in the inner fluid space of the inner ear, and is characterized by vertigo, ringing, and hearing loss. Treatment typically includes a low sodium diet and diuretics; for 70% of Meniere's patients, that is all that's required. For the other 30%, no medication has been found to be effective, so these folks have no treatment option other than surgery.

It has been known for some time that pressure change can make the ear feel better. Pressure chambers are sometimes used to treat Meniere's in Sweden, but that option is rarely available in the US. So scientists began looking for a different way to get pressure to the ear, and they came up with a device called the Meniett. It requires the insertion of a tube through the eardrum (like that typically used to treat chronic ear infections in kids) as a conduit to administer pressure change.

The Meniett is in clinical study at the University of Washington Medical Center under Dr. Gates. The study is seeking to validate the long-term effectiveness of the Meniett in a randomized, placebo-controlled, double-blind clinical trial in people with classic, active Meniere's disease. People participating in the study are those diagnosed with unilateral (one ear) Meniere's disease and experiencing tinnitus and aural pressure in the same ear. They also have vertigo lasting for at least 20 minutes and at least 2 attacks during the past 2 months, and fluctuating hearing loss. They are between 21-70 years of age with general good health. Current medical therapy has failed to control their vertigo.

The Meniett generates pressure pulses at a rate of six Hz. These pulses are generated for one second, followed by four seconds without pulses. To use the Meniett, a patient inserts a probe into his ear and turns the device on for five minutes. The probe delivers the pressure pulses to the inner ear through the tube. Treatment is required three times a day.

Scientists aren't certain why this treatment works. They speculate that it's either because it causes the inner ear fluid to move, or because it somehow signals the inner ear to "behave". Whatever the exact mechanism, it alters the endolymphatic control mechanism. It takes days or weeks to have an effect, and symptoms return quickly if treatment stops. The results have been very good on patients for whom low sodium diet and diuretics fail to work; over 90% of such patients typically report relief using the Meniett. Some candidates also experience a bit of hearing improvement.

Dr. Gates explained the "treatment ladder" for Meniere's, in the order in which they are typically tried:
- Low sodium diet and diuretics
- Pressure chamber
- Local overpressure
- Endolymphatic sac surgery
- Gentamicin injections
- Inner ear destruction

The cost of the Meniett is $3500. Most insurance companies have no clue about this treatment, but Dr. Gates hopes they will cover it when their study is completed this year. He pointed out that it's a lot cheaper than surgery. He also predicted that it will become the standard intermediate therapy.

Q: Does the Meniett work for people who have vertigo from other causes?
A: No

Q: I can hold my nose and swallow and put presser on the middle ear that way. How is the Meniett different from that?
A: You can't pulse the pressure at the rate of 6 Hz.

Q: You said that the trial is for people with unilateral Meniere's. What about people with bilateral Meniere's?
A: We're excluding them from this trial, because it's a different form of Meniere's. We want to prove the Meniett for one ear first.

Q: What about the micro wick being studied in Florida? How does this compare?
A: This is a treatment of gentamicin injection and it destroys hearing. It won't be needed if the Meniett works.

Contact: Aimee Verrall verrall@u.washington.edu or www.meniettstudy.com