title: Multiple electrostimulation treatments to the promontory for tinnitus.
abstract: OBJECTIVE
  To assess the safety and efficacy of multiple sessions of electrostimulation by a transtympanic needle electrode on the promontory for tinnitus relief.
  
  
  METHODS
  Prospective open, unblinded, uncontrolled clinical trial.
  
  
  METHODS
  Tertiary academic referral center.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Multiple sessions of electrostimulation to the promontory seem to be safe and may be beneficial for some tinnitus patients. Further clinical trials are warranted.
authors.affiliation: *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.
authors.forename: Ronen
authors.initials: R
authors.lastname: Perez
authors.forename: Chanan
authors.initials: C
authors.lastname: Shaul
authors.forename: Michael
authors.initials: M
authors.lastname: Vardi
authors.forename: Nidal
authors.initials: N
authors.lastname: Muhanna
authors.forename: Paul R
authors.initials: PR
authors.lastname: Kileny
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Sichel
mesh_terms: D000328:Adult; D000368:Aged; D001299:Audiometry; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D014012:Tinnitus / Q000175:diagnosis* / Q000628:therapy*; D016896:Treatment Outcome; D064232:Visual Analog Scale