Ronen Perez1, Chanan Shaul, Michael Vardi, Nidal Muhanna, Paul R Kileny, Jean-Yves Sichel. 1. *Department of Otolaryngology-Head and Neck Surgery, Shaare Zedek Medical Center affiliated with the Hebrew University Medical School, Jerusalem; †EStimME, Tel-Aviv, Israel; and ‡University of Michigan Health System, Otolaryngology-Head and Neck Surgery, Ann Arbor, Michigan, U.S.A.
Abstract
OBJECTIVES: To assess the safety and efficacy of multiple sessions of electrostimulation by a transtympanic needle electrode on the promontory for tinnitus relief. STUDY DESIGN: Prospective open, unblinded, uncontrolled clinical trial. SETTING: Tertiary academic referral center. PATIENTS: Ten patients (8 male and 2 female subjects), mean age 50.1 ± 12 years (range, 34-67) with severe unilateral tinnitus completed all stages of the study. Patients with tinnitus duration between 6 months to 3 years were included. INTERVENTION: The patients underwent 3 consecutive 30-minute sessions, every other day, of biphasic, charge balanced electrostimulation pulses to the promontory delivered by a transtympanic needle electrode. MAIN OUTCOME MEASURES: 1) Tinnitus loudness reported by visual analog scale (VAS) between 1 and 10, at baseline, before and after each treatment, and 1, 2, 3, and 4 weeks after the last treatment. 2) Tinnitus Handicap Inventory (THI) questionnaire at baseline and 4 weeks after treatment. 3) Basic audiometry and tinnitus specific tests such as minimum masking level, tinnitus loudness, and pitch. RESULTS: No long-term adverse safety outcomes were noted in physical examination or audiologic evaluation. VAS levels decreased by ≥2 levels in 5 patients (50%) and returned to baseline 4 weeks after treatment. The VAS decrease was found significant (p = 0.048) in those patients. A statistically significant decrease in THI score was noted 4 weeks after treatment. Tinnitus specific tests at that time were unchanged from baseline. CONCLUSION: Multiple sessions of electrostimulation to the promontory seem to be safe and may be beneficial for some tinnitus patients. Further clinical trials are warranted.
OBJECTIVES: To assess the safety and efficacy of multiple sessions of electrostimulation by a transtympanic needle electrode on the promontory for tinnitus relief. STUDY DESIGN: Prospective open, unblinded, uncontrolled clinical trial. SETTING: Tertiary academic referral center. PATIENTS: Ten patients (8 male and 2 female subjects), mean age 50.1 ± 12 years (range, 34-67) with severe unilateral tinnitus completed all stages of the study. Patients with tinnitus duration between 6 months to 3 years were included. INTERVENTION: The patients underwent 3 consecutive 30-minute sessions, every other day, of biphasic, charge balanced electrostimulation pulses to the promontory delivered by a transtympanic needle electrode. MAIN OUTCOME MEASURES: 1) Tinnitus loudness reported by visual analog scale (VAS) between 1 and 10, at baseline, before and after each treatment, and 1, 2, 3, and 4 weeks after the last treatment. 2) Tinnitus Handicap Inventory (THI) questionnaire at baseline and 4 weeks after treatment. 3) Basic audiometry and tinnitus specific tests such as minimum masking level, tinnitus loudness, and pitch. RESULTS: No long-term adverse safety outcomes were noted in physical examination or audiologic evaluation. VAS levels decreased by ≥2 levels in 5 patients (50%) and returned to baseline 4 weeks after treatment. The VAS decrease was found significant (p = 0.048) in those patients. A statistically significant decrease in THI score was noted 4 weeks after treatment. Tinnitus specific tests at that time were unchanged from baseline. CONCLUSION: Multiple sessions of electrostimulation to the promontory seem to be safe and may be beneficial for some tinnituspatients. Further clinical trials are warranted.