title: Long-term evaluation of treatment of chronic, therapeutically refractory tinnitus by neurostimulation.
abstract: OBJECTIVE
  Long-term evaluation of treatment of chronic, therapeutically refractory tinnitus by means of chronic electrical stimulation of the vestibulocochlear nerve.
  
  
  METHODS
  Inclusion criteria were severe, chronic, therapeutically refractory, unilateral tinnitus and severe hearing loss at the ipsilateral site. Out of 6 patients, 4 patients were selected for long-term evaluation. Two patients were not evaluated because of premature dropout.
  
  
  METHODS
  A stimulation electrode was placed around the vestibulocochlear nerve through a retrosigmoid approach and connected to a subcutaneously positioned pulse generator via an extension cable. Follow-up was performed 3 months and 42.5 months after implantation. Three measures for treatment outcome were used. First, effect sizes were determined by means of the total Tinnitus Handicap Inventory (THI) score using Cohen's formula. Second, general and tinnitus-specific audiometric tests were performed in on and off conditions of the neurostimulation system. Third, recordings were noted for tinnitus severity and treatment success on a visual analogue scale.
  
  
  RESULTS
  All 4 patients reported successful treatment with neurostimulation. The effect size after 3 months was 0.7, indicating an average effect, while the effect size measured during long-term follow-up was 1.75, indicating a substantial effect with major clinical implications. No changes in hearing level for both ears were measured. The neurostimulation system did not change the tinnitus pitch in any of the patients, and resulted in a minimal reduction of tinnitus loudness in only 2 patients. In all 4 patients the original tinnitus sound was replaced by another, pleasantly perceived sound. The average VAS score of perceived tinnitus severity was reduced from 8 to 3.25. The average VAS score for treatment success was 7.25.
  
  
  CONCLUSIONS
  The long-term follow-up of neurostimulation treatment for chronic tinnitus shows promising results. Long-term results were better than those determined after a 3-month follow-up. In all patients the tinnitus was replaced by another sound, which was perceived as pleasant. Further studies are needed before accepting neurostimulation as a treatment modality for chronic, therapeutically refractory tinnitus.
authors.affiliation: Department of Otorhinolaryngology, University Medical Center Groningen, Groningen, The Netherlands. h.bartels@kno.umcg.nl
authors.forename: H
authors.initials: H
authors.lastname: Bartels
authors.forename: M J
authors.initials: MJ
authors.lastname: Staal
authors.forename: A F
authors.initials: AF
authors.lastname: Holm
authors.forename: J J A
authors.initials: JJ
authors.lastname: Mooij
authors.forename: F W J
authors.initials: FW
authors.lastname: Albers
mesh_terms: D001921:Brain / Q000502:physiology*; D002908:Chronic Disease; D003056:Cochlear Nerve; D004599:Electric Stimulation Therapy / Q000295:instrumentation / Q000379:methods*; D004566:Electrodes; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D019736:Prostheses and Implants; D012720:Severity of Illness Index; D014012:Tinnitus / Q000503:physiopathology / Q000628:therapy*; D014725:Vestibular Nerve