Abstract
BackgroundChronic tinnitus affects millions of people globally and constitutes the most commonly compensated disability among military service members in the United States. Existing treatment options largely surround helping patients cope with their disease as opposed to directly suppressing tinnitus perception. The current study investigated the efficacy of electrical stimulation of the cochlea on chronic disabling tinnitus.MethodsIn this single-arm, open-label clinical trial, 22 adult subjects with severe-range asymmetric or unilateral non-pulsatile tinnitus underwent electrical stimulation of the cochlea through use of an extra-cochlear electrode positioned on the cochlear promontory. Each subject underwent 3 stimulation treatments over 3 weeks at 7-day intervals. Tinnitus severity was determined by Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus Visual Analog Scale (VAS). Inclusion criteria required subjects have no worse than moderate sensorineural hearing loss determined by pre-enrollment audiometric testing. The primary outcome was nadir post-treatment THI scores, obtained at seven timepoints following electrical stimulation, with clinically significant improvement defined as a decrease of ≥ 7.ResultsAll 22 (100%) subjects experienced clinically significant improvement in the THI during the study period with a mean decrease in scores of − 31 (95% CI − 38 to − 25) from a baseline of 48. Twenty (91%) experienced clinically significant improvement detectable on at least two of the three tinnitus survey instruments and 17 (77%) experienced clinically significant improvement detectable on all three survey instruments (i.e., THI, TFI, and VAS). Eight (36%) subjects reported either complete (THI of 0; n = 3) or near-complete (THI 1–4; n = 5) suppression of their tinnitus following a stimulation session. Thirteen (59%) subjects reported a nadir following stimulation at or below the threshold for “no or slight handicap” on the THI (≤ 16). No adverse events were observed.ConclusionsThese findings establish the foundation for the development of an extra-cochlear implantable device that delivers electrical stimulation to the cochlea for the treatment of disabling tinnitus. For patients considering device implantation, trans-tympanic cochlear promontory stimulation can facilitate patient selection.Trial Registration ClinicalTrials.gov Identifier: NCT03759834. URL: https://clinicaltrials.gov/ct2/show/NCT03759834
Highlights
Chronic tinnitus affects millions of people globally and constitutes the most commonly compensated disability among military service members in the United States
Attempting to replicate the electrical stimulation of the cochlea during cochlear implant device use, an open label clinical trial was undertaken to evaluate the utility of trans-tympanic electrical stimulation of the cochlear promontory in adults who suffer from bothersome chronic unilateral or asymmetric tinnitus but do not have hearing loss of sufficient severity to qualify for cochlear implantation
22 subjects underwent promontory stimulation (Table 1); 21 (95%) subjects completed the study, with one subject withdrawing after the first stimulation treatment due to a perceived inability to complete the remaining requirements in the study; their reported data until self-exclusion were included in Demographics Age at enrollment in years Sex Female Male
Summary
Chronic tinnitus affects millions of people globally and constitutes the most commonly compensated disability among military service members in the United States. Analogous to the nerve stimulation treatment of neuropathic pain in peripheral nerve disorders, the therapeutic effect of cochlear implantation on chronic tinnitus appears to be related to electrical stimulation of the cochlea and independent of auditory masking [8]. Attempting to replicate the electrical stimulation of the cochlea during cochlear implant device use, an open label clinical trial was undertaken to evaluate the utility of trans-tympanic electrical stimulation of the cochlear promontory in adults who suffer from bothersome chronic unilateral or asymmetric tinnitus but do not have hearing loss of sufficient severity to qualify for cochlear implantation
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