Eur Arch Otorhinolaryngol (2014) 271:1815–1822

DOI 10.1007/s00405-013-2849-6

MISCELLANEOUS

Direct current stimulation of the ear in tinnitus treatment:

a double-blind placebo-controlled study
Marzena Mielczarek • Jurek Olszewski

Received: 29 September 2013 / Accepted: 28 November 2013 / Published online: 13 December 2013
Ó The Author(s) 2013. This article is published with open access at Springerlink.com

Abstract The objectives of the study are assessment of treatment. We did not observe a harmful effect of direct
the influence of direct current electrical stimulations of the current on hearing organ.
ear in tinnitus treatment, comparison of the results with
placebo group and evaluation of hearing after electrical Keywords Tinnitus
Electrical stimulation
Direct
stimulations. The study comprised 120 tinnitus and sen- current
Placebo
sorineural hearing loss patients (n = 184 tinnitus ears). In
group one (n = 119 tinnitus ears) the authors applied a
non-invasive hydrotransmissive electrical stimulation (15) Introduction
of the ear, in group two (n = 65 tinnitus ears)—placebo
electrical stimulation. Direct rectangular, positive polari- Subjective tinnitus is defined as a phantom perception of
zation current was used. The frequency of stimulation was sound with the absence of external stimulation. Regardless
adjusted according to tinnitus frequency. In group two, the tinnitus pattern (acute, chronic, constant, intermittent, pure
authors used similar procedure, but no current was deliv- tone vs noise-like), it can negatively affect the quality of
ered through the active electrode. Evaluation of tinnitus life. Despite intense, advanced research conducted all over
and hearing was conducted. In groups one and two, directly the world, the factor directly responsible for subjective
after the treatment, the number of ears with permanent tinnitus’ perception is still not clear. It is known that it is a
tinnitus decreased considerably. In group one in 40 ears result of a pathological activity in the nervous system,
(33.6 %) tinnitus disappeared; in group two, tinnitus dis- without corresponding mechanical activity in the cochlea
appeared in four ears (6.1 %). After 30 days, statistically [1]. On the basis of functional MRI we know that this
significant changes were observed in group one (p \ 0.05), perception is not only purely auditory phenomenon but also
which were comparable with results returned 90 days later limbic-related central nervous system areas take part [2].
(p [ 0.05). Changes in group two (after 30 and 90 days) According to some research, about 10–20 % of the adult
were not significant (p [ 0.05). The authors recognized population suffers from tinnitus and it probably occurs with
audiometric improvement of hearing (in pure tone audi- similar frequency among children [3]. Since its etiology is
ometry). The application of direct current electrical stim- unclear and taking into account the heterogeneity of the
ulation of the hearing organ, with current frequencies tinnitus patients’ group, there is still no satisfactory method
similar to tinnitus frequencies (selective electrical stimu- of treatment. The most accessible and used as a first-line
lation), was an efficient method in severe tinnitus treatment in outpatient clinics is pharmacotherapy, how-
ever, there is no European Medicines Agency (EMA)- or
Food and Drug Administration (FDA)-approved drug on
the market [4]. Furthermore, cognitive-behavioral therapy
M. Mielczarek (&)
J. Olszewski or different forms of stimulations (acoustic or electrical)
Department of Otolaryngology and Laryngological Oncology,
have most promising effects [5–7]. Numerous hypotheses
Medical University of Lodz, 113 Zeromskiego Street,
90-549 Lodz, Poland on the etiology of tinnitus may suggest that there is no
e-mail: [email protected] single mechanism of its onset. In many cases cochlea is an

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ignition site of tinnitus. That is why, in patients with tin- were subjected to placebo e.s. The allocation to the groups
nitus and a cochlear hearing loss (tinnitus spectrum often was randomized, done according to the order of admission
overlaps with the area of hearing loss) electrical stimula- to our department. The group one was created by first 80
tion (e.s.) can be applied as a treatment. E.s. gives good patients admitted to our department to diagnose and treat
effects in inflammation, pain or nervous system disorders’ tinnitus. Group two was created by the following 40
treatment, improving the blood flow and tropism of tissues patients. In order to decrease potential heterogeneity of the
[8]. Nevertheless, with reference to the hearing organ, it is groups only the patients with tinnitus duration longer than
used in few clinical centers in the world. According to 1 year, as well as with accompanying hearing loss, were
Latkowski [9], e.s. increases transmission of neurotrans- qualified to present research [19].
mitters in the synapses, as well as it controls their secretion Before the beginning of the therapy, we conducted the
to the synaptic area. Portman et al. [10] state that it mod- ENT examination, hearing tests (pure tone audiometry,
ifies the electrical potentials of the hearing organ. speech audiometry, impedance audiometry, auditory
According to Watanabe et al. [11] e.s. improves the blood brainstem responses, otoacoustic emissions) and radiolog-
flow in the inner ear and synchronizes spontaneous ical diagnostics—if necessary (head and cervical spine
impulses in the auditory nerve fibers. E.s. was primarily computer tomography/nuclear magnetic resonance).
used in the cochlear implantation in The House Ear Pathology in the external and/or the middle ear was an
Institute. excluding criterion. Patients who reported tinnitus in the
A non-invasive hydrotransmissive procedure was used head, not in ears, or their tinnitus lasted less than 1 year (to
by Szymiec et al., Konopka et al., Morawiec-Bajda et al. minimize the potential rate of spontaneous disappearance),
and Mielczarek et al. [12–16]. Szymiec et al. [12] using were also disqualified from the research. The patients
low frequency stimulation (50–1,600 Hz) via electrode completed questionnaires (designed by the authors based
dipped in saline solution in the external auditory meatus, on the Tinnitus Handicap Inventory) involving 20 ques-
with the other placed on the ipsilateral mastoid, observed tions concerning tinnitus. Possible answers were ‘yes’
improvement in 48 % of cases, which was comparable to obtaining two points, ‘sometimes’, one point, and ‘no’, 0
Morawiec-Bajda et al.’s [15] results 46.6 %. Kuk et al. [17] point. The maximum score was 40, which meant that tin-
attempted to reduce tinnitus, stimulating with a ball-elec- nitus is an enormous problem. On the other hand, receiving
trode placed at the tympanic membrane. The authors, using 0 points meant that tinnitus is not a disturbing ailment. The
different parameters of current (square, sine, triangular person conducting hearing evaluation and administering
current, within a range of frequencies 62–8,000 Hz) the questionnaires was unaware of the fact that e.s. or
adapted individually according to patients’ response to placebo e.s. had been provided.
stimulation, obtained improvement in tinnitus in 50 % of E.s. was performed with the use of a custom-made
the cases. Kozlowski et al. [18] using similar method of apparatus supplied with four batteries of 1.5 V. The device
e.s., adapted parameters individually (frequencies within has an on/off button, frequency and current intensity but-
16–8,000 Hz), reported improvement in tinnitus in 44 % of tons. The external ear canal was filled with 0.9 % saline
patients. solution. The active, silver probe was immersed inside
The aim of the study was to assess the influence of direct external ear canal, avoiding contact with the skin of the
current e.s. of the hearing organ in tinnitus treatment canal. The passive electrode was placed on the forehead
adapting the frequency of current according to tinnitus after skin abrasion with a suitable sterile abrasive electrode
frequency and to compare these effects with placebo group, paste and clean gauze. The two electrodes were placed to
as well as to evaluate hearing after e.s. in both groups. obtain the transmission of the current throughout the
hypothetical plane (longitudinal axis) of cochlea. Direct
rectangular, positive polarization current was applied via
Materials and methods the active electrode. The frequency of the current was
equal to the frequency of the rectangular impulse. The
Study design: a double-blind placebo-controlled study. The duration of the rectangular pulse (the period) depended on
study comprised 120 patients suffering from tinnitus and the frequency. For 250 Hz, one period lasted 4 min (2-min
sensorineural hearing loss (n = 184 tinnitus ears) divided pulse and 2-min pause). The voltage was constant and
into two groups. The patients from group one (n = 119 equals 3 V. The intensity ranged from 0.15 to 1.15 mA and
tinnitus ears, 80 tinnitus patients, 38 females and 42 was applied according to patient’s sensation. The stimu-
males), aged 21–74 years (average 53.5 ± 9.31), were lation was started using the maximal intensity of current
treated with e.s. of the hearing organ. Those from group (1.15 mA); if it was well tolerated, stimulation was con-
two (n = 65 tinnitus ears, 40 tinnitus patients, 24 females tinued. However, if the patient reported to feel the pain or
and 16 males), aged 22–76 years (average 56.5 ± 11.2), other unpleasant sensation, the intensity of the current was

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decreased to the moment when this feeling stopped. The the maximal in group one—30 years, in group two—
frequency of the current ranged from 250 to 8,000 Hz and 27 years.
was adjusted according to the tinnitus frequency, so that Before the treatment, group one (n = 119 ears) com-
the frequency of the current and the tinnitus frequency prised 106 ears (89.1 %) with permanent and 13 ears
were similar (±1,000 Hz)—selective e.s. Pitch-match fre- (10.9 %) with temporary tinnitus; group two (n = 65 ears),
quency was performed for all patients before the beginning 56 ears (86.1 %) with permanent and 9 ears (13.9 %) with
of the treatment. The comparison sounds were presented to temporary tinnitus. In groups one and two, directly after the
contralateral ear. The patient was asked to identify the treatment, the number of ears with permanent tinnitus
tones at the narrowest noticeable frequency intervals. decreased considerably (p \ 0.05), group one comprised
Single e.s. lasted 4 min. The treatment involved 15 appli- 58 ears (48.8 %) with permanent and 21 ears (17.6 %) with
cations of e.s. administered three or four times a week temporary tinnitus, in 40 ears (33.6 %) tinnitus disap-
(whole treatment lasted approximately 30 days). In group peared; group two 46 ears (70.8 %) with permanent and 15
two, the patients were subjected to similar procedure of e.s. ears (23.1 %) with temporary tinnitus, in four ears (6.1 %)
as patients from group one; however, no current was tinnitus disappeared. After 30 days, statistically significant
delivered through the electrode, dipped in external acoustic changes were observed in group one (p \ 0.05), which
canal. Apart from that, the treatment protocol was the same were comparable with results returned 90 days later
in both—e.s. (1) and placebo e.s. (2) group. Evaluation of (p [ 0.05). Changes in group two (after 30 and 90 days)
tinnitus and hearing (in pure tone audiometry) was con- were not significant (p [ 0.05). When compared, there
ducted before, directly after, 30 and 90 days after 15 were apparent differences between results of the groups
applications of e.s. in groups one and two. Subjective (p \ 0.05) (Table 1).
assessment of the results considered a case history and the Analysis of questionnaires, directly after the treatment,
questionnaire. Change from permanent tinnitus (when in group one showed improvement in 45 ears (37.8 %) and
patient reported to hear it every day, all the day) to tem- in group two, in 20 ears (30.8 %). In group one, 30 days
porary tinnitus (when appeared temporarily or the patient after the last e.s., the statistical analysis showed subsequent
reported to have some periods without tinnitus) was con- improvement (p \ 0.05) to 51.3 %. On comparing results
sidered an improvement. Regarding questionnaires, the to the analysis conducted 90 days after the treatment, there
increase in the total points (by at least 20 %) was consid- were statistically significant differences in groups one and
ered deterioration, whereas their decrease an improvement. two (Table 2).
Statistical testing for dependent (correlated) observa- We recognized subjective and audiometric improve-
tions, we used the Student’s t test for correlated samples ments of hearing (in pure tone audiometry) in group one, at
(in case of both normal distribution samples) or the the end of the control period. After the treatment, patients
Wilcoxon test (when at least one sample had non-normal reported subjectively improved hearing in group one in 36
distribution), for independent (uncorrelated) observations ears (30.2 %), in group two in 14 ears (21.5 %). No dete-
the Mann–Whitney U test (when at least one sample had rioration of hearing was reported. In audiometric evalua-
non-normal distribution). In case of nominal features, we tion after the cycle of e.s. in group one, statistically
used the k2 test (for uncorrelated samples) or the significant improvement of hearing was registered: for
McNemar’s k2 test (for correlated samples). The results of frequencies between 1,000 and 4,000 Hz (by on average
the statistical testing were given as a p value (p \ pmax, 4.35 dB). There was no statistically significant deteriora-
e.g. p \ 0.05 indicated the statistically significant relation tion of hearing in both groups. At the end of the control
on a given level). The p [ 0.05 referred to the non-sig- period, the improvement of hearing remained constant in
nificant relation. group one (Table 3).
The research was approved by institutional review board
of Medical University of Lodz (RNN/251/05/KB). All
patients gave their written, informed consent prior to Discussion
inclusion in the study.
The beginning of e.s. clinical application to the hearing
organ appeared after observation of tinnitus disappearing
Results after the implantation of a single-electrode cochlear
implant. In 1973, House (The House Ear Institute) reported
Average duration of tinnitus was similar in both groups (no total disappearing of tinnitus after the implantation of the
statistically significant differences p [ 0.05)—in group single-electrode cochlear implant (using electrical current
one 4.24 years ± 5.29, in group two 3.98 years ± 4.17. to stimulate auditory nerve). Such an effect was noticed
The minimal tinnitus duration in both groups was 1 year, later by other authors [20]. This fact was a fundamental

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Table 1 The evaluation of the

Group/n (%) ears Permanent Temporary Disappearance p
treatment considering tinnitus
character Group one (n = 119 ears)
Before e.s. 106 (89.1 %) 13 (10.9 %) –
Directly after e.s. 58 (48.8 %) 21 (17.6 %) 40 (33.6 %) \0.05
30 days after e.s. 58 (48.8 %) 40 (33.6 %) 21 (17.6 %) \0.05
90 days after e.s. 58 (48.8 %) 47 (39.4 %) 14 (11.8 %) [0.05
Group two (n = 65 ears)
p \ 0.05, change statistically Before placebo e.s. 56 (86.1 %) 9 (13.9 %) –
significant Directly after placebo e.s. 46 (70.8 %) 15 (23.1 %) 4 (6.1 %) \0.05
p [ 0.05, change statistically 30 days after placebo e.s. 50 (77 %) 12 (18.4 %) 3 (4.6 %) [0.05
not significant
90 days after placebo e.s. 48 (73.9 %) 12 (18.4 %) 5 (7.7 %) [0.05
e.s. electrical stimulation

Table 2 The evaluation of

Group/n (%) ears Improvement No changes Deterioration p
tinnitus treatment based on the
questionnaires Group one (n = 119 ears)
Directly after e.s. 45 (37.8 %) 65 (54.6 %) 9 (7.6 %) –
30 days after e.s. 61 (51.3 %) 50 (42 %) 8 (6.7 %) \0.05
90 days after e.s. 56 (47.1 %) 49 (41.2 %) 14 (11.7 %) [0.05
p \ 0.05, change statistically Group two (n = 65 ears)
significant Directly after placebo e.s. 20 (30.8 %) 44 (67.7 %) 1 (1.5 %) –
p [ 0.05, change statistically 3,170 days after placebo e.s. 19 (29.2 %) 43 (66.2 %) 3 (4.6 %) \0.05
not significant
90 days after placebo e.s. 17 (26.1 %) 44 (67.7 %) 4 (6.2 %) [0.05
e.s. electrical stimulation

Table 3 The average hearing level (dBHL) in pure tone audiometry

Average hearing level (dBHL) Frequency (Hz)
125 250 500 1,000 2,000 3,000 4,000 6,000 8,000

Group one (n = 119 ears)

Before e.s. 25.6 27 26.4 31.4 35.2 41.1 47.6 56.4 51.6
Directly after e.s. 29.4 28.5 27.5 27.2 30.1 36.5 42.0 53.4 49.6
90 days after e.s. 30.3 29.1 27.3 28.3 31.0 36.9 42.5 53.3 49.4
Group two (n = 65 ears)
Before placebo e.s 30.9 31.4 31.7 33.2 35 39.1 42.0 50.0 49.4
Directly after placebo e.s. 27.9 29.1 31.1 31.5 33.2 35.3 41.5 47.0 45.3
90 days after placebo e.s. 25.6 25.6 27.8 33.3 36.1 35.0 39.5 47.8 47.8
e.s. electrical stimulation

observation which resulted in the idea of suppressing tin- conducted by Bochenek et al. [21]. During e.s. in more than
nitus with electrical current. In this way the idea of the e.s. half of the patients, a sound sensation was observed. The
in tinnitus treatment appeared. Tinnitus suppression was authors suggested that in such cases, clinical diagnosis
obtained when cochlea, round window, promontorium, indicated central VIII-th nerve dysfunction, rather than the
preauricular skin or mastoid was subjected to stimulation. peripheral one. They admitted, however, that some VIII-th
In 1974, House suggested a method of evaluation of the nerve’s fibers, which were not impaired, could have been
hypothetical benefit of the cochlear implantation based on enough to evoke sound.
the transtympanal e.s. of the promontory. In case of a sound Skarzynski et al. [23] and Bochenek et al. [22] proved
sensation (reported by a patient during the stimulation), the usefulness of non-invasive alternative extratympanic
peripheral impairment of the hearing organ (outer, inner ear canal e.s., as a test in prediction of post-operative
hair cells) was considered, whereas when the patient profits before cochlear implantation. The authors observed
reported hearing no noise central. Similar research was reception of the tones as well as speech signal, by some

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completely deaf patients in whom e. s. via external auditory is needed in clinical trials for evaluation of treatment, but it
canal (with a ball-shaped electrode dipped in saline solu- requires standardization of techniques.
tion) was conducted. In this way, they claim to stimulate Tyler et al. [6] summarize the state of the art knowledge
the fibers of the auditory nerve, obtaining hearing sensation of extra- and intracochlear e.s. in tinnitus. The authors state
as an evidence. Despite numerous researches on tinnitus that the optimal parameters of stimulation are likely dif-
disappearance after cochlear implantation, its mechanism ferent for different subjects. Offut claims that auditory
seems to remain unexplained conclusively. As many stimulation with specific frequencies within the area of loss
patients benefit from hearing aid (experiencing tinnitus of hearing in pure tone audiometry can reduce tinnitus, by
suppression) we may suspect that the enhancement of the suppressing the inner hair cells [37]. However, Dauman
signal in the auditory pathway is the factor responsible for et al. [38], using cochlear implant for e.s. of hearing organ,
this phenomenon [24]. Sensorineural hearing loss is one of observed that the effectiveness of the stimulation depended
the most apparent risk factor for tinnitus, probably resulting on the stimulating frequency and was optimal using
from maladaptive attempts at cortical reorganization due to 125 Hz. Morawiec-Bajda et al. [15] performed e.s. via
peripheral deafferentation [25]. As in patients with tinnitus external auditory meatus with the active electrode placed
and single-sided deafness (SSD) therapies based on on tympanic membrane and the other on the forehead. The
acoustic input (retraining, masking) are impossible, the improvement was obtained in 46.6 % of cases. Further-
restoration of peripheral sensory input may be a method of more, using for stimulation frequencies close to tinnitus
masking/relieving tinnitus. There are some data showing frequencies, an increase in otoacoustic emission’s ampli-
good effects of binaural integration of acoustic (unilateral tude (more distinct in DPOAE than TEOAE) was obtained,
normal hearing) and electric stimulation (via cochlear as well as increase in amplitude and shortened latencies in
implant), which appeared to be superior to the alternative auditory brainstem responses.
rehabilitation methods of SSD and tinnitus [bone-anchored The theories on the cochlea as an ignition site for tin-
hearing aid (BAHA), contralateral routing of signal nitus, together with hypothesized ways of influencing its
(CROS)] [26]. Although groups of patients implanted with structures by e.s., may indicate the need for individually
tinnitus and SSD were not numerous, there were studies modified parameters of e.s [6]. The promontory stimula-
demonstrating significant improvement reaching 100 % tions were conducted by Aran and Cazals [39] who
[27–29]. In effect, SSD with severe tinnitus is considered a achieved satisfactory effects (complete or partial
new indication for cochlear implantation; however, improvement of tinnitus condition) in 43 % of cases,
appropriate patients selection is required [27, 29, 30]. Arts compared with 60 % of improvement cases when oval
et al. [31] state that cochlear implant should be considered window was stimulated. Ito and Sakakihara [40] via stim-
as a treatment for tinnitus resulting from SSD (from ulation of cochlea directly with cochlear implant received
peripheral-cochlear deafferentation). Furthermore, there better outcomes (77 %) than via stimulation of promontory
may be some predictors of the degree of improvement after (69 %). The results of invasive (direct) transtympanal e.s.
such procedure. Song et al. [32] collecting quantitative are better when compared with that of non-invasive
electroencephalography found positive correlation between methods.
increased activity of auditory posterior cingulate cortex and As far as an improvement is concerned, our outcomes
dorsolateral prefrontal cortex and slight tinnitus reduction are comparable to the results of non-invasive e.s. con-
after cochlear implantation. ducted by other authors. The total number of tinnitus dis-
In the research, the application of the current was based appearance is more apparent in presented research;
on our experience. The intensity of current was applied however, the tendency to decrease with time is observed.
according to patient’s sensation and tolerance, whereas the Application of hydrotransmissive method in our research
frequency according to tinnitus pitch (frequency)—selec- greatly simplifies the technique of e.s. This non-invasive
tive e.s. As in the majority of cases, the cochlea may be a procedure allows the doctor to perform it in any outpatient
trigger or ignition site for subjective tinnitus, authors clinics, and as a result, the patient does not have to stay
adopted the theory that the frequency of tinnitus might be under the medical observation directly after stimulation.
consistent with the area of damaged outer hair cells in the Furthermore, hydrotransmissive stimulation allows appli-
basilar membrane [33, 34]. For that reason those parame- cation of cycle of such stimulations, improving the chances
ters were similar as well as the tinnitus matching (pitch) of relieving tinnitus, as well as helping to boost and
method was used in the research. It was done based on maintain the improvement of hearing. Recently, a range of
‘Adaptive Method’ according to Tyler’s indications [35, device delivering transcutaneous mastoid e.s. has been
36]. Despite the fact that psychoacoustic measurements constructed. The idea was to stimulate in a simple, non-
may not correspond to tinnitus severity, such quantification invasive way, giving the patient possibility to perform

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‘self’-stimulations at home. However, most reports do not revealed the best effect in group one. Although the degree
support efficient success rates. of the hearing improvement seems not to be clinically
Subsequent improvement of the results after a month is a meaningful, the hearing level reminded stable and this
fact worth noticing. The number of stimulation applications measurement was repeatable during control period. This
(15), performed regularly, might have had an influence on might also be the result of disappearance or decreasing
the subsequent improvement together with its stabilization. tinnitus severity, which could have had a masking effect.
In our research, in both treated groups, we observed the Having in mind that sensorineural hearing loss is difficult
change in the nature of tinnitus (permanent to temporary). to treat, especially in chronic course, this improvement
The change was most noticeable in group one (treated with appeared more significant, nevertheless it needs further
e.s.)—the number of cases with permanent tinnitus confirmation in objective measurements. In group one we
decreased by around 50 %, but in both stimulated groups observed a perception of sound in most ears while using
(groups one and two), the improvement was statistically direct positive current, with its frequency adopted accord-
significant (p \ 0.05). As patients referred, the change ing to the tinnitus frequency parameters (selective e.s.). In
from permanent to temporary tinnitus was meaningful for the majority of cases those frequencies corresponded with
them, and it allowed to experience some silent periods impaired frequencies in pure tone audiometry—peripheral
(often after months or years of presence of continuous, cochlear impairment. This observation might be coherent
chronic noise in the ear) again. That is why most of the with a hypothesis that the sound perception during e.s.
patients considered it an apparent improvement. In litera- proves normal functioning of the auditory nerve.
ture, such evaluation of the tinnitus treatment has not been Many authors highlight the need for placebo-controlled
found. studies to assess placebo effect in tinnitus treatment. The
In one of the earliest publications concerning e.s. in the placebo effect is known to cause neurobiological changes
tinnitus treatment, Portman et al. [10] described the comparable to those resulting from pharmacotherapies;
dependence of the result of stimulation on the polarization however, its mechanisms are not fully understood.
of the current. Using direct negative current, a sound sen- According to Benedetti et al. [44] placebo responses can be
sation was evoked, proving that the VIII-th nerve was attributed to the two phenomena: conditioning and expec-
stimulated. In case of positive polarization suppression of tation of therapeutic benefit. The authors state that expec-
tinnitus was observed, but only for the time of stimulation. tation can best stimulate a placebo response. Neuroimaging
After the procedure was finished, tinnitus appeared again [positron emission tomography (PET) and functional
[41]. In our research, in most cases a sound perception was magnetic resonance imaging (fMRI)] and neurotransmitter
observed during stimulation with positive current, so it may release measurement have contributed to explanation of
be possible that the factor responsible for such auditory some placebo underlying mechanisms. The differences of
reception is the condition of the hearing organ rather than the placebo effect in patients may reflect variations in the
current polarization. At early studies conducted by Port- activity in some neurotransmitter systems (dopamine,
mann et al. [41] and Aran et al. [42], direct current serotonin, cholecystokinin, opioid). Neuroimaging of pla-
appeared to be more harmful to the inner ear (than alter- cebo analgesia pointed to decreased activity in thalamus,
nating); however, it was more efficient in suppressing insula and somatosensory cortex [45].
tinnitus. With respect to tinnitus, the placebo effect was mainly
Konopka [43] in his study on the influence of direct assessed in pharmacotherapy (dexamethasone, lidocaine,
current on the hearing organ of guinea pigs demonstrated paroxetine, betahistine, vasodilators, diuretics) and com-
no pathologic effect on auditory pathway based on the plementary medicine therapies (ginko biloba, acupuncture,
evaluation of summation potentials, cochlear microphonics massage, meditation) showing no advantage of therapy
and auditory brainstem potentials. In present research, we over placebo [3]. The comparison of transcutaneous elec-
did not notice any destructive influence of direct current trical stimulation and placebo stimulation resulted in sim-
based on the hearing evaluation, but in the literature there ilar outcomes [46, 47]. Duckert [48] assessed placebo
are some reports on damaging effect of direct current on effect in tinnitus after saline solution injection instead of
the cochlea [41, 42]. Furthermore, in our research, pure lidocain. He obtained improvement in 40 % of tinnitus
tone audiometry revealed statistically significant improve- concluding that each uncontrolled clinical trial may by
ment in hearing threshold (p \ 0.05) in group one, which biased by placebo effect. McFerran and Phillips [3] point to
can mean hypothetically that the function of outer hair cells difficulties in evaluating different tinnitus treatment
improved (but in present study, objective measurements methods as they lack blinding. They cite the Duckert’s
such as otoacoustic emissions or auditory brainstem experiment (aforementioned) stressing that placebo effect
responses were not performed after the treatment). Sub- ‘‘is often regarded pejoratively by practitioners of modern
jective evaluation of hearing in pure tone audiometry medicine, overlooking the fact that a placebo is not the

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same as no effect’’. Kapkin et al. [49] assessed placebo 2. Seydell-Greenwald A, Leaver AM, Turesky TK, Morgan S, Kim
effect in transcutaneous e.s. of preaurical region. The rate HJ, Rauschecker JP (2012) Functional MRI evidence for a role of
ventral prefrontal cortex in tinnitus. Brain Res 16(1485):22–39
of improvement in e.s. group was 42.8 % and in placebo 3. McFerran DJ (2007) Phillips JS Tinnitus. J Laryngol Otol
group 28.5 %. The rate of worsening was respectively: 121:201–208
16.6 and 42.8 %. The authors used lidocain to deliver local 4. Langguth B, Elgoyhen A (2012) Current pharmacological
infiltration anesthesia to the stimulated region of the treatments for tinnitus. Expert Opin Pharmacother 13(17):
2495–2509
preaurical skin to create identical circumstances during e.s. 5. Hesser H, Weise C, Westin VZ, Andersson G (2011) A system-
and placebo e.s. procedure. According to them, substantial atic review and meta-analysis of randomized controlled trials of
difficulty in placebo-controlled study is to establish com- cognitive- behavioral therapy for tinnitus distress. Clin Psychol
parable conditions for treated and placebo group. In case of Rev 31(4):545–553
6. Tyler RS, Rubinstein J, Pan T, Chang SA, Gogel SA, Gehringer
e.s. the patient will feel the electric current. On the basis of A, Coelho C (2008) Electrical stimulation of the cochlea to
our research and previous experiences only 26 % (31 ears) reduce tinnitus. Semin Hear 29(4):326–332
felt electric current during e.s. In those cases patients 7. Searchfield GD, Kaur M, Martin WH (2010) Hearing aids as an
reported sensation of pricking, tingling, warming and pain. adjunct to counseling: tinnitus patients who choose amplification
do better than those that don’t. Int J Audiol 49(8):574–579
All patients were informed that during e.s. they can expe- 8. Fodstad H, Hariz M (2007) Electricity in the treatment of nervous
rience some sensations like above, but not necessarily. system disease. Acta Neurochir Suppl 97(Pt1):11–19
According to Hoare et al. [50] most research on tinnitus 9. Latkowski B (1981) Original improvement of the techinque of
lack blinding, thus those therapeutic methods remain to be implantation of microelectrodes in cochlear deafness. Minerva
Otolaringol 1:69
demonstrated conclusively especially those most com- 10. Portmann M, Cazals Y, Negrevergne M, Aran JM (1979) Tem-
monly used: hearing aids, maskers, tinnitus retraining porary tinnitus suppression in man through electrical stimulation
therapy. On the other hand many patients with ear prob- of the cochlea. Acta Otolaryngol 87:294–299
lems/diseases suffer from tinnitus as well, but only in few 11. Watanabe K, Okawara D, Baba S, Yagi T (1997) Electrococh-
leographic analysis of the suppression of tinnitus by electrical
cases underlying etiology can by clarified. For that reason promontory stimulation. Audiology 36(3):147–154
each therapy, also symptomatic, may be effective espe- 12. Szymiec E, Szyfter W, Karlik M (1997) The possibility of tin-
cially for those with constant, severe tinnitus. nitus suppression by electrical stimulation. Otolaryngol Pol
51(5):487–491
13. Konopka W, Zalewski P, Olszewski J, Olszewska-Ziaber A,
Pietkiewicz P (2001) Tinnitus suppression by electrical prom-
Conclusions
ontory stimulation (EPS) with sensorineural hearing loss. Auris
Nasus Larynx 28:35–40
1. The application of direct current electrical stimulation 14. Konopka W, Mielczarek M, Olszewski J (2008) Electrical stim-
of the hearing organ, with current frequencies similar ulation as an alternative method of tinnitus treatment. Otolaryn-
gol Pol 62(5):601–605
to tinnitus frequencies (selective electrical stimula-
15. Morawiec-Bajda A, Sulkowska J, Gryczynski M (2004) Efficancy
tion), was an efficient method in severe tinnitus of selective therapeutic electrostimulation (SET) in treatment of
treatment. tinnitus patients estimated with objective measurements (BERA,
2. We did not observed a harmful effect of direct current AEMP, TOAE and DPOAE). In: International proceedings 5th
European congress of oto-rhino-laryngology head and neck sur-
on hearing organ.
gery. Rodos, Greece, Sept. 11–16, 2004
16. Mielczarek M, Konopka W, Olszewski J (2013) The application
Acknowledgments This study was funded by the local Medical of direct current electrical stimulation of the ear and cervical
University Grant 502-03/7-061-01/502-54-070. The research was spine kinesitherapy intinnitus treatment. Auris Nasus Larynx
approved by Institutional Review Board of Medical University of 40(1):61–65
Lodz. 17. Kuk FK, Tyler RS, Rustad N, Harker LA, Tye-Murray N (1989)
Alternating current at the eardrum for tinnitus reduction. J Speech
Conflict of interest The authors declare that they have no conflict Hear Res 32(2):393–400
of interest. 18. Kozlowski Z, Jankowski A, Durko M, Modzelewska-Radwan B
(1999) Selective therapeutic electrostimulation in tinnitus treat-
Open Access This article is distributed under the terms of the ment. Otolaryngol Pol 53(Supl 30):520–523
Creative Commons Attribution License which permits any use, dis- 19. Landgrebe M, Azevedo A, Baguley D, Bauer C, Cacace A,
tribution, and reproduction in any medium, provided the original Coelho C, Dornhoffer J, Figueiredo R, Flor H, Hajak G, van de
author(s) and the source are credited. Heyning P, Hiller W, Khedr E, Kleinjung T, Koller M, Lainez
JM, Londero A, Martin WH, Mennemeier M, Piccirillo J, De
Ridder D, Rupprecht R, Searchfield G, Vanneste S, Zeman F,
Langguth B (2012) Methodological aspects of clinical trials in
References tinnitus: a proposal for an international standard. J Psychosom
Res 73(2):112–121
1. Jastreboff JP, Gray WC, Gold SL (1996) Neurophysiological 20. Quaranta N, Wagstaff S, Baguley DM (2004) Tinnitus and
approach to tinnitus patients. Am J Otol 17(2):236–240 cochlear implantation. Int J Audiol 43(5):245–251

123
1822 Eur Arch Otorhinolaryngol (2014) 271:1815–1822

21. Bochenek Z, Bochenek W, Bieniek J (1977) Electrical stimula- 35. Tyler RS (2000) The psychoacoustical measurements of tinnitus.
tion of the human hearing organ with transtympanal electrode. In: Tyler RS (ed) Tinnitus handbook, Singular Thomson Learn-
Otolaryngol Pol 31(3):225–228 ing, pp 149–180
22. Bochenek W, Chorzempa A, Hazell JW, Kiciak J, Kukwa A 36. Tyler RS, Conrad-Armes D (1983) Tinnitus pitch: a comparison
(1989) Non-invasive electrical stimulation of the ear canal as a of three measurement methods. Br J Audiol 17(2):101–107
communication aid in acquired total deafness. Br J Audiol 37. Offut G (2000) Tinnitus, a new concept and treatment. In:
23(4):285–291 Workshop on inner ear biology, Liege, Belgium, 7.11.2002
23. Skarzynski H, Czyzewski A, Kostek B (1999) Prediction of post- 38. Dauman R, Tyler RS, Aran JM (1993) Intracochlear electrical
operative profits in cochlear implanted patients using the electr- tinnitus reduction. Acta Otolgol 113:291–295
ostimulation procedure. In: Proc. workshop on applications of 39. Aran JM, Cazals Y (1981) Electrical suppression of tinnitus. Ciba
signal to audio and acoustics, New Palts, New York, Oct. Found Symp 85:217–231
17–20,1999 40. Ito J, Sakakihara J (1994) Tinnitus suppression by electrical
24. Surr RK, Montgomery AA, Mueller HG (1985) Effect of stimulation of the cochlear wall and by cochlear implantation.
amplification on tinnitus among new hearing aid users. Ear Hear Laryngoscope 104(6Pt1):752–754
6(2):71–75 41. Portmann M, Nègrevergne M, Aran JM, Cazals Y (1983) Elec-
25. Møller AR (2007) The role of neural plasticity in tinnitus. Prog trical stimulation of the ear: clinical applications. Ann Otol
Brain Res 166:37–45 Rhinol Laryngol 92(6Pt1):621–622
26. Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, 42. Aran JM, Wu ZY, Charlet de Sauvage R, Cazals Y, Portmann M
Ihorst G, Wesarg T (2011) Comparison of pseudobinaural hearing (1983) Electrical stimulation of the ear: experimental studies.
to real binaural hearing rehabilitation after cochlear implantation Ann Otol Rhinol Laryngol 92(6Pt1):614–620
in patients with unilateral deafness and tinnitus. Otol Neurotol 43. Konopka W (1986) The use of electrical stimulation in tinnitus
32(1):39–47 treatment in sensorineural hearing loss. Dissertation, Military
27. Punte AK, Vermeire K, Hofkens A, De Bodt M, De Ridder D, Medical Academy of Lodz
Van de Heyning P (2011) Cochlear implantation as a durable 44. Benedetti F, Amanzio M (2011) The placebo response: how
tinnitus treatment in single-sided deafness. Cochlear Implants Int words and rituals change the patient’s brain. Patient Educ Couns
12(Suppl 1):26–29 84(3):413–419
28. Vermeire K, Van de Heyning P (2009) Binaural hearing after 45. Murray D, Stoessl AJ (2013) Mechanisms and therapeutic
cochlear implantation in subjects with unilateral sensorineural implications of the placebo effect in neurological and psychiatric
deafness and tinnitus. Audiol Neurootol 14(3):163–171 conditions. Pharmacol Ther 140(3):306–318
29. Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, 46. Kapkin O, Satar B, Yetiser S (2008) Transcutaneous electrical
De Ridder D (2008) Incapacitating unilateral tinnitus in single- stimulation of subjective tinnitus. A placebo-controlled, ran-
sided deafness treated by cochlear implantation. Ann Otol Rhinol domized and comparative analysis. ORL J Otorhinolaryngol
Laryngol 117(9):645–652 Relat Spec 70(3):156–161
30. Sampaio AL, Araújo MF, Oliveira CA (2011) New criteria of 47. Dobie RA, Hoberg KE, Rees TS (1986) Electrical tinnitus sup-
indication and selection of patients to cochlear implant. Int J pression: a double-blind crossover study. Otolaryngol Head Neck
Otolaryngol. doi:10.1155/2011/573968 Surg 95(3 Pt 1):319–323
31. Arts RA, George EL, Stokroos RJ, Vermeire K (2012) Review: 48. Duckert LG, Rees TS (1984) Placebo effect in tinnitus manage-
cochlear implants as a treatment of tinnitus in single-sided ment. Otolaryngol Head Neck Surg 92(6):697–699
deafness. Curr Opin Otolaryngol Head Neck Surg 20(5):398–403 49. Kapkin O, Satar B, Yetiser S (2008) Transcutaneous electrical
32. Song JJ, Punte AK, De Ridder D, Vanneste S, Van de Heyning P stimulation of subjective tinnitus. A placebo-controlled, ran-
(2013) Neural substrates predicting improvement of tinnitus after domized and comparative analysis. ORL J Otorhinolaryngol
cochlear implantation in patients with single-sided deafness. Hear Relat Spec 70(3):156–161
Res 299:1–9 50. Hoare DJ, Kowalkowski VL, Kang S, Hall DA (2011) Systematic
33. Hazell JW (1985) Management of tinnitus: discussion paper. J R review and meta-analyses of randomized controlled trials exam-
Soc Med 78(1):56–60 ining tinnitus management. Laryngoscope 121(7):1555–1564
34. Jastreboff JP, Hazell J (1993) A neurophysiological approach to
tinnitus: clinical implications. Br J Audiol 27:7–17

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