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How to cite this article Nardo WD, Cianfrone F, Scorpecci A, Cantore I, Giannantonio S, Paludetti G.
Tinnitus is a common symptom which often becomes disabling, affecting the emotional and psychosocial dimensions of life. Tinnitus is a quite common symptom, not infrequently reported by patients as a bothersome and upsetting experience severely affecting the emotional and psychosocial dimensions of life and sometimes impairing the patients' ability to perform daily life activities. As reported by basic and clinical research, lesions are more often localized within the auditory periphery and concern hairy cells. Our methods for patient enrollment, informed consent, psychoacoustic testing, placement of a transtympanic electrode, electrical stimulation, data analysis, and follow-up were reviewed and approved by our institutional review board and are in accordance with the Helsinki Declaration. In our clinic, we enrolled 11 patients (7 women and 4 men) affected by postlingual monaural or binaural profound hearing loss and with severe and disabling tinnitus in the worse ear.
When the hearing loss was gradual in onset, patients underwent auditory brainstem response (ABR) recordings before their deafness became profound, and results were consistent with a peripheral origin of their disease. The stimulation system we used is a Cochlear Promontory Stimulator Z10012 (Cochlear Ltd., Lane Cove, NSW, Australia), an active platinum-iridium needle electrode and a silver surface electrode located on the ipsilateral mastoid region.
Characteristics of the study population, including age, cause of hearing loss, and duration of tinnitus, are shown in Table 1; tinnitus pitch, loudness, and MML as measured immediately before the electrical stimulation session are shown in Table 2. The most effective frequencies of electrical stimulation for tinnitus suppression or reduction were 50 Hz and 100 Hz. Conversely, factors such as tinnitus duration and patient's age appear to be associated with the THI outcome: Four of the six patients having had tinnitus for less than 5 years had a complete or partial benefit from the procedure, whereas only one of five patients with more than 5 years of tinnitus showed a THI score reduction after 1 month.
The effectiveness of electrical stimulation on tinnitus is well-known, thanks to studies on groups of patients affected by bilateral profound sensorineural hearing loss and undergoing cochlear implantation, the majority of whom report suppression or attenuation of tinnitus after device hookup [15-18]. Despite the remarkable amount of evidence pointing to a beneficial and lasting effect of EPS on tinnitus, studies generally describe the clinical effects of the procedure rather than focusing on the mechanisms underlying tinnitus suppression, so that at present there are many questions-and no certainty-as to how EPS should work. Whether EPS can restore some degree of normal firing in the cochlear nerve of humans affected by tinnitus is at present unknown.
Alternatively, suggested mechanisms through which a positive current delivered to the promontory or to the cochlea may work on nerve fibers include hyperpolarization of axons, with subsequent inhibition of spontaneous discharge rates [27], and even a reflex increase in microcirculation in the auditory pathway [21].
A temporary alteration of acoustic nerve firing cannot account for the long-term effect (at least 1 month) of a 60-second promontory stimulation such as the one we administered to our study patients.
Finally, a possible effect of EPS on the cortical reorganization [31-34] underlying tinnitus must be assumed, as a positron emission tomography (PET) study has shown that electrical stimulation delivered to the promontory and round-window region causes activation of the primary auditory cortex and some of the surrounding association areas [35].
As for the tinnitus-associated psychosocial impairment, THI administration allowed us to appreciate a reduction of the THI score in five patients 1 month after transtympanic stimulation, which means most of the negative emotional, affective, and psychosocial impacts of tinnitus abated. Considering our preliminary results, we think more expansive series are necessary to precisely define the features that the electrical stimulation should possess to suppress tinnitus. Aside from the optimal parameters of stimulation, clinical features that predict EPS success should be outlined more precisely for a correct selection of candidates who could derive the utmost benefit from the procedure.
In conclusion, we assume that EPS is to be considered per se a worthwhile attempt at tinnitus suppression, being quite easy to administer and successful in the majority of cases. EPS results could help predict tinnitus response to the positioning of an implantable electrical stimulator: Patients for whom EPS proves to be effective could benefit from the implantation of an intratympanic stimulator that could be controlled by radiofrequencies from the outside.
Patients suffering from chronic tinnitus were analyzed to examine whether tinnitus impairments can be predicted by demographic and socioeconomic factors. In computing canonical correlations, only the level of education served as a significant emotional-cognitive predictor for tinnitus impairment. The results indicated that demographic and socioeconomic variables have no predictive value for tinnitus impairments, with the exception of a person's level of education. Investigations of sociodemographic variables [1, 2] showed that female and male individuals are often affected identically by tinnitus and that tinnitus can begin at any age, although more typically the onset occurs between the ages of 40 and 60 years [3].
Taken together, previous studies failed to detect a consistent influence of socioeconomic or demographic variables on tinnitus impairments.
One hundred and fifty-three patients (75 female, 78 male) suffering from chronic tinnitus participated in the present study.
The patients' level of completed education ranged from an elementary school diploma to a university graduate degree. Tinnitus impairment was measured using the Tinnitus Impairment Questionnaire (THI-12) from Greimel et al. Canonical correlations were computed, for which the socioeconomic and demographic variables served as predictors and the emotional-cognitive and the functionalcommunicative scales of the THI were the criterion variables. In analyzing demographic and socioeconomic data as predictors of perceived tinnitus impairment, we could not find any significant overall results for the criterion variables of emotional-cognitive and functionalcommunicative tinnitus impairment. In summary, these data highlight the minor impact of socioeconomic and demographic factors on tinnitus impairments.
Somatic and general complaints as well as physical and social domains of quality of life are shown to be good predictors of functional-communicative tinnitus impairments. There are many reports describing tinnitus suppression or attenuation through electrical stimulation of the ear, provided either by cochlear implants or by transtympanic stimulation. The subsequent change in the acoustic nerve fiber excitation pattern triggers an immediately successive elaboration by neural centers and then, after some time, the priming of neural plasticity phenomena. Many studies have described attempts at suppressing tinnitus by means of electrical stimulation, delivered both transcutaneously [3-9] and transtympanically [10-12]. The anesthetic procedures consisted in careful cleansing of the external auditory canal and local administration of lidocaine to anesthetize the tympanic membrane for 5 minutes. Table 3 lists data concerning the modalities and the effects of EPS, such as pulse rate of the delivered stimulus, threshold, discomfort level, and best tinnitus-suppressing frequencies for each patient. For lower frequencies of stimulation, electrical intensity for tinnitus suppression or attenuation was just above auditory threshold, whereas for high frequencies of stimulation, it was quite near maximum acceptable level in the majority of patients. THI scores obtained immediately before and 1 month after EPS are shown in Table 4, which also provides information about pre- and poststimulation partial scores relative to the three categories (emotional, functional, and catastrophic) comprising the THI. As for patients' age, four of the five subjects reporting longer-lasting benefit from the procedure were younger than 50 years.

Our short-term and long-term results are consistent both with the evidence provided by such studies on cochlear implants and with recent works on transtympanic electrical stimulation [20-22]. The "masking" hypothesis, which was among the earliest proposed [23], has long been considered too simplistic and insufficient, because in some cases tinnitus reduction can be obtained by means of subliminal electrical pulse rates. Very few reports are currently available about a real-time monitoring of nerve fiber activity during and immediately after peripheral electrical stimulation. In fact, the lasting residual inhibition we observed in some of them implies that central stations along the auditory pathway are likely to be involved as well. Other PET studies report that the electrical stimulation produced by a cochlear implant can reduce the signs of abnormal activity supposed to be associated with tinnitus in the primary auditory and associated cortices and in brain areas of the limbic system [36].
This outcome seems to suggest that electrical stimulation also affects the activity of association areas (limbic system) that are notoriously closely intertwined with the neural pathways involved in tinnitus pathogenesis and play a very important role in producing negative emotional correlates of tinnitus, such as anxiety and annoyance. However, even the results on our small series seem to indicate that tinnitus suppression occurs mostly at lower pulse rates (50 and 100 Hz) and at an intensity of stimulation between threshold and minimum discomfort level, although in two of our patients, tinnitus suppression was achieved through subthreshold stimuli. Our results suggest that recent onset of tinnitus and a patient's age can be predictive of tinnitus suppression, although selection criteria deserve deeper investigations in larger series. Considering the recent achievements of cochlear implant "soft surgery," which allows preservation of residual hearing, cochlear implants could definitely be used to suppress intractable tinnitus in patients with unilateral profound hearing loss [38]. For this purpose, subjective tinnitus complaints were measured in 153 patients using the tinnitus impairment questionnaire (THI-12) that distinguishes between emotional-cognitive and functionalcommunicative factors.
Patients with lower education demonstrated impairments in the emotional-cognitive domain that were more marked than those in higher-educated people. Because of the epidemiological nature of these studies, correlations between the severity of the tinnitus impairment and the various examined factors could not be computed. The aim of our investigation was to analyze demographic and socioeconomic factors-age, gender, level of education, and marital status-as predictor variables for tinnitus impairment. Patients were divided according to two independent variables, level of education and marital status. The evaluation of level of education showed significant differences between highly educated and less-educated people, such that less-educated patients exhibited higher values on the emotional-cognitive tinnitus impairment assessment. A comparison of these studies reveals that psychological variables provide better predictive functions than do socioeconomic and demographic data in this regard. Our study project aims to assess the effects of electrical promontory stimulation (EPS) on persistent disabling tinnitus.We enrolled 11 patients affected by postlingual monoaural or binaural profound hearing loss and disabling tinnitus in the worse ear. Therefore, tinnitus could be due to central nervous system reorganization as a long-term consequence of a peripheral alteration [1,2].
Recently, attempts have been made at relieving chronic intractable tinnitus by delivering electrical stimuli directly to the auditory cortex [13,14]. Furthermore, to exclude the most common central causes of tinnitus (acoustic neuroma, vascular lesion, neurovascular conflict), all patients underwent brain magnetic resonance imaging with gadolinium.
The questionnaire was introduced into the tinnitus assessment battery in order to give the clinician a quick and effective tool for evaluating tinnitus and for classifying patients clinically [19]. We performed transtympanic electrical stimulation with direct continuous positive current at levels ranging from 0 to 500 µA.
No association was found among tinnitus pitch and loudness, MML, and effect of electrical stimulation.
Finally, there seemed to be no association between the cause of hearing loss and the benefits derived from EPS. The dorsal cochlear nucleus (DCN) and the inferior colliculus (IC) could be plausible candidates, given the amount of evidence pointing to them as tinnitus generators [28,29], although there is currently a paucity of direct evidence of their role in humans [30]. To confirm this, functional brain imaging should be improved so as to reliably identify central areas of tinnitus-related activity.
In particular, the issue of using subthreshold or suprathreshold electrical stimulation should be addressed with special attention in future studies: Subthreshold stimulation would be better, avoiding replacement of tinnitus with an unpleasant and intrusive sound, just as often happens with maskers.
Specific features, such as recent onset of tinnitus and patients' young age, appear to be associated with a better outcome and should therefore be considered as major factors for patient selection. Expanding the biological basis of tinnitus: Cross-modal origins and the role of neuroplasticity. Treatment of tinnitus with transcutaneous electrical nerve stimulation improves patients' quality of life. Tinnitus suppression by electrical promontory stimulation (EPS) in patients with sensorineural hearing loss.
Response of the auditory nerve to sinusoidal electrical stimulation: Effects of high-rate pulse trains. Improved temporal coding of sinusoids in electric stimulation of the auditory nerve using desynchronizing pulse trains. Electrocochleographic analysis of the suppression of tinnitus by electrical promontory stimulation.
Summary of evidence pointing to a role of the dorsal cochlear nucleus in the etiology of tinnitus.
Lateralized tinnitus studied with functional magnetic resonance imaging: Abnormal inferior colliculus activation. Functional MR imaging of the auditory cortex with electrical stimulation of the promontory in 35 deaf patients before cochlea implantation.
Quantitative electroencephalography power analysis in subjective idiopathic tinnitus patients: A clinical paradigm shift in the understanding of tinnitus, an electrophysiological correlate. Age, gender, marital status, and education levels were assessed and treated as predictive variables. Patients were recruited from the outpatient clinic of the general hospital in Salzburg and from a head and neck practice in Traunstein, Germany.
In the emotional-cognitive domain, the level of education reached a significant value (p = .017), indicating that people with a higher level of education are suffering less from tinnitus than are less-educated patients.
These results underscore the results of studies by Hallberg and Carlsson [15] and Hallberg et al.

Self-reported disability and handicap in the population in relation to puretone threshold; age, sex and type of hearing loss.
Hearing impairment, coping and perceived hearing handicap in middle-aged subjects with acquired hearing loss.
Structure of perceived handicap in middle-aged males with noiseinduced hearing loss, with and without tinnitus. EPS was performed with direct continuous positive current delivered by an active platinum-iridium needle electrode connected to a promontory stimulator device. Nonetheless, given the invasiveness of cortical stimulation and the uncertainty of its beneficial effect on tinnitus, and also considering the as-yet-undefined criteria of patient selection for such a treatment option, we believe that electrical promontory stimulation (EPS) still deserves attention on account of its good rate of success and of its low invasiveness. We obtained from each patient a complete history and ear, nose, and throat physical examination.
On the whole, 9 of the 11 patients (81.8%) had immediate benefit from EPS relative to their tinnitus. In vivo monitoring of electrical activity in these centers during and after electrical stimulation delivered to the promontory or to the cochlea would be an optimal method to ascertain whether changes occur in the DCN and IC in response to EPS.
No other reports address the central effects of electrical stimulation on tinnitus in humans , though other noninvasive, promising techniques, such as quantitative electroencephalography, could well serve the purpose of a precise monitoring of EPS brain effects as long as they become more reliable in defining central correlates of tinnitus [37]. This instrument consists of 12 items (THI total score) and includes two subscales: emotional-cognitive and functionalcommunicative. Tables 1 and 2 present an overview of the Student's t-test statistics, level of significance, means, and standard deviations. Those authors showed that depression, physical and social domains of quality of life, and subjective experienced somatic and general complaints are appropriate predictors of tinnitus impairments for computing canonical correlations [see also ref. The short-term effect on tinnitus was assessed during and immediately after the stimulation. Furthermore, the assumption that peripheral stimulation can effectively achieve tinnitus suppression is strengthened by the common observation that sensorineurally deaf patients undergoing cochlear implantation often experience reduction or even utter suppression of their tinnitus [15-18].
We started by delivering current at the lowest pulse rate (50 Hz) and proceeded to increase the pulse rate.
However, these authors could not find any impact of social support on the severity of tinnitus, an outcome that contrasts with earlier findings of Tylor and Baker [4].
Subjects with low education scored significantly higher on assessment of perceived handicap than did subjects with higher education.
The subjects gave their consent to participation in the study according to the regulations specified in the Declaration of Helsinki. This finding was attributed to low self-esteem, diminished cognitive capacity, and a sense of lost control over the situation.
Longterm effects were estimated after one month by comparing pre- and post-EPS Tinnitus Handicap Inventory (THI) scores. Our study project aims to assess the effectiveness of EPS as a treatment of persistent tinnitus induced by cochlear lesions and to try to define the most effective electrostimulation type. Eventually, each patient was asked about tinnitus or hearing loss (or both) in his or her family.
For each presented frequency of stimulation, current intensity was slowly increased to find threshold first and then the discomfort level, and we asked patients about the effect of stimulation on tinnitus. Patient 3 reported suppression of both tinnitus components, whereas patients 4 and 8 said that only one of the components had been reduced or suppressed, the other one remaining unchanged (see Table 3). So, even if a role for masking cannot be completely ruled out, it appears that other mechanisms play a role.
Prior studies about gender differences in the severity of tinnitus are inconsistent [5-7], and gender-specific differences or the relationship of age to tinnitus impairments (or both) could not be determined in the later literature [8-12].
The investigators related these results to ineffective coping strategies of individuals with less education, a limitation accompanied by lower selfesteem, less cognitive capacity, and a sense of lost control over a situation. Increased severity of tinnitus impairment could also be associated with lower socioeconomic status, as less-educated people, as compared with higher-educated individuals, are exposed more frequently to noise in industrial jobs and suffer greater associated high-frequency hearing loss (which is related to tinnitus) [18,19].
We performed a complete audiological assessment (pure-tone audiometry, speech audiometry, and transitory evoked otoacoustic emissions) and a study of tinnitus pitch, loudness, and minimum masking level (MML) on the day of the EPS session. Having learned from the patients the frequency causing the best tinnitus suppression, we delivered continuous stimulation at that frequency for at least 60 seconds. After 1 month, among the eight patients who had benefited from EPS, five (45.4%) said their tinnitus was still present but that its intensity was much lower than before. One of the theories about peripheral tinnitus suggests that its origin lies in an alteration of spontaneous firing by acoustic nerve fibers. In couples in which one partner suffered from tinnitus, Sullivan et al.[13] detected less role dysfunction among those who sought more social support.
At the end of the procedure, we asked patients whether tinnitus was still present or had abated or disappeared. The remaining six patients (54.6%) reported that tinnitus was unchanged or had progressively returned to its former loudness.
In a number of animal studies, this abnormal activity was brought back to a spontaneous-type nerve firing by application of an electrical stimulus [24,25]. In the patient-rated set among such couples, lower marital cohesion was associated with greater tinnitus-related role dysfunction, whereas in the spouse-rated set, punishing responses to subject illness behavior correlated more directly with greater tinnitus-related role dysfunction.
The beneficial effects of EPS on tinnitus might be explained by interference with tinnitus generating circuits such as the dorsal cochlear nucleus and the inferior colliculus and by modification of cortical activity.
EPS is to be considered a worthwhile attempt at tinnitus suppression, and could help select candidates for the positioning of an implantable electrical stimulator that might provide longer-term beneficial effect on tinnitus.

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