Meniett clinical trial: long-term follow-up.

OBJECTIVE To delineate 2-year efficacy of Meniett device therapy in people with classic, unilateral, Ménière's disease unresponsive to traditional medical treatment. DESIGN A 2-year long-term unblinded follow-up after a prior randomized, placebo-controlled, multicenter clinical trial of the Meniett device for Ménière's disease. SETTING Follow-up was performed remotely by using diaries and questionnaires mailed to the data coordinating center by the participants. Those who failed to mail their diaries were interviewed by telephone. PARTICIPANTS Sixty-one study participants agreed to use the Meniett device and report their symptoms for 2 years. All had active, unilateral cochleovestibular disease. Outcomes are available for 58 participants; 2 were unavailable for follow-up and 1 was excluded because of a concurrent condition that precluded Meniett device use. INTERVENTIONS Participants were advised to adhere to a low-sodium diet, use the Meniett device 3 times daily, and maintain a patent tympanostomy tube in the affected ear. Diuretic and vestibular suppressant medications were used as needed. MAIN OUTCOME MEASURES Outcomes were based on the participants' daily diary, questionnaires, and telephone interviews. Three different analyses were prepared: tracking of vertigo frequency throughout the study, comparison of vertigo frequency before and at the end of Meniett device use (American Academy of Otolaryngology-Head and Neck Surgery Foundation reporting guideline), and Kaplan-Meier estimates of vertigo remission and recurrence. RESULTS Vertigo levels gradually improved for most but not all participants. American Academy of Otolaryngology-Head and Neck Surgery Foundation class A (remission) or class B (greatly improved) results occurred in 67% (39/58) of participants, and class F (dropped out to receive surgical therapy) results occurred in 24%. Of the 44 nondropout participants, 39 (89%) had American Academy of Otolaryngology-Head and Neck Surgery Foundation group A or B outcomes. People who went into remission were highly likely (80%) to remain in remission long term; participants who achieved remission (20/43; 47%) did so within the first year of follow-up. CONCLUSIONS Use of the Meniett device was associated with a significant reduction in vertigo frequency in about two thirds of the participants, and this improvement was maintained long term. Therapy with the Meniett device is a safe and effective option for people with substantial vertigo uncontrolled by medical therapy.