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Author: admin | 16.03.2015 | Category: Relieve Tinnitus

This study reports on the long-term benefit of ultra-high-frequency masking with the UltraQuiet device. This study reports on the long-term benefit of ultra-high-frequency masking with the UltraQuiet (UQ) device.
Well accepted is that if maskers overlap in frequency with the tones to be masked, masking is likely to occur, its degree related to masker intensity.
Because tinnitus can usually be masked (at least partially) for some period by a variety of sounds, one commonly used procedure is to assess wide-range masking, termed minimal masking levels (MMLs), using a variety of frequencies, including broad- or narrowband noise [12]. Theoretically, stimulation above the tinnitus frequency may supplement or assist the neurological reprogramming at the cortex and perhaps restore the normal-frequency spatial relationship. The goal of this study was to evaluate the long-term efficacy of using UltraQuiet high-frequency bone-conduction therapy for treating tinnitus, using pre- and postbehavioral assessment of tinnitus loudness, tinnitus anxiety, and tinnitus severity. Fifteen subjects (3 female, 12 male) with subjective idiopathic tinnitus of the severe disabling type participated in the study. The stimulus was produced using Kyma Version 5 software with a Capybara 320 Sound Computation Engine, and it was recorded on a compact disk (CD).
The transducer is a custom-made aluminum ceramic bimorph with a high-frequency limit of some 50 kHz. The UltraQuiet stimulus parameters, or sound features, were chosen to optimize the activation of auditory cortical neurons. Classification of masking curve type according to Feldmann's system was applied to the masking data, and we measured loudness discomfort levels at 250-8,000 Hz.
To assess, in a preliminary fashion, the effects of treatment length, we randomly assigned subjects to one of three groups.
Before each stimulation session, subjects completed three outcome measurements: the tinnitus intensity index, the annoyance index, and the tinnitus severity index [1]. The questionnaire results for measures of tinnitus intensity and annoyance were not significantly different over the course of therapy sessions, although a drop in the mean level for each was noted on the last few trials.
We examined the relationship among high-frequency MMLs, tinnitus pitch, tinnitus intensity, and Feldmann masking curves. The use of high-frequency bone conduction stimulation using the UltraQuiet therapy system resulted in longterm reduction in tinnitus severity during therapy, and that tinnitus relief lasted for at least 2 months after therapy in most subjects in this study. During posttherapy interviewing, we noted partial masking of the tinnitus by the UltraQuiet system throughout the trial in all patients (although not in every session).
Frequency range of stimulation is critical in the auditory cortical reprogramming approach of the UltraQuiet system; however, any reduction in the amount of masking required to eliminate (or partially eliminate) tinnitus also is important. Alternatively, we could argue that the energy around 6 kHz was predominant in our subjects owing to mild to moderate sensorineural hearing loss. RI, which refers to a decrease in the perceived intensity of the tinnitus for a time after the masking stops, was first reported by Feldmann [12]. Because the UltraQuiet stimulus generally overlaps with high-frequency tinnitus and the presentation is just above threshold stimulation (~6 dB SL), inhibition should be facilitated.
Treating tinnitus patients with the UltraQuiet device is more difficult when their tinnitus is of the severe problematic type. Problematic tinnitus is most likely related to changes in the auditory pathway and consequent reactions in various areas of the brain. The authors acknowledge the support of Sound Technique Systems, LLC, in this study and the assistance of Robert Guinta.
Clinical medicine teaches that the key to achieving positive treatment results for any diagnostic category of patient complaints is based on the clinical establishment of an accurate diagnosis.
The definition of tinnitus, originally defined as the perception of a sound unrelated to an external source of sound stimulation (1979), is considered to be dynamic, reflecting advances in what is and is not known of the cochleovestibular system and brain function. A tinnitus-targeted therapy (TTT), a combined treatment of medication and instrumentation focusing on pharmacotherapy, has evolved from an ongoing clinical experience since 1977 (in more than 10,000 patients with SIT 1.
Briefly, the identification of principles of tinnitology for diagnosis and treatment of SIT patients has evolved from our ongoing TTT experience since 1977. At this time, the principles of tinnitology are divided into those for diagnosis (Table 1) and treatment (Table 2).
Our clinical experience with the MATPP has been the development of a rationale for establishing an accuracy in tinnitus diagnosis and attempting tinnitus relief 1,9. Critical for both the SIT patient and tinnitus professionals attempting tinnitus relief is to be aware of the realities of the state of the art of tinnitus diagnosis and treatment at this time. The following definitions are considered significant in reporting results of modalities of tinnitus treatment and relief.
The medical significance of a symptom or disease process in a patient is defined as "a clinical manifestation of abnormal function of a living cell, tissue, organ, or organ system(s)" 4. Treatment of a symptom or disease is "the management or care of a patient or the combating of a disease or disorder.
Tinnitogenesis is a seizure-type activity resulting in the perception of an aberrant auditory stimulus (tinnitus) 12. The sensory component of tinnitus refers to the subjective perception of the sensation of the aberrant auditory stimulus-tinnitus-as described by tinnitus patients. Clinical types of SIT have been identified based upon the clinical history and metabolic and electrophysiological correlates of brain activity and cochleovestibular function. Neurodegeneration, in this report, is a term "reflective of process(es) involved in the progressive damage or death of neurons and reflected clinically in a gradual deterioration and interference in function of the affected neural substrates of the nervous system" 17,18. Neuroprotection refers to "processes involved in the maintenance and repair and restoration of normal neuronal function" 17-19. The final common pathway (FCP) for tinnitus has been hypothesized for all clinical types of tinnitus.
The tinnitus dyssynchrony-synchrony theory is a hypothesis that considers tinnitus to be an abnormal, conscious, auditory percept. We present an update on TTT, a combined treatment of medication and instrumentation focusing on pharmacotherapy 1.
The clinical course of tinnitus, particularly SIT, is highlighted by its individuality and chronicity. To appreciate clinical advances that have been made for tinnitus diagnosis and treatment since 2006, it is necessary to briefly review the past. Clinically, however, tinnitus is still considered by many professionals and patients to be a unitary symptom.
The recent publication of the Tinnitus Research Initiative (TRI) database has recognized the clinical reality that tinnitus is not a unitary symptom 25!
The classic site of lesion audiometric hearing threshold testing of 250 Hz-kHz is recommended in tinnitus patients to be extended to include the ultra-high frequencies of 10 to 20 kHz. For patients with either unilateral or bilateral tinnitus and an asymmetrical sensorineural hearing loss, completion of tests of auditory brainstem response or magnetic resonance imaging (or both) of the brain and internal auditory canals with gadolinium is recommended to identify the presence or absence of acoustic tumor.
The incidence of SEH occurrence in our experience continues to be approximately 35% overall. Evaluating tinnitus includes identifying its psychophysical and psychoacoustical characteristics, cochleovestibular testing, and masking curves 28.
Supplemental testing with auditory brainstem responses, nuclear medicine brain imaging with SPECT and PET, and quantitative electroencephalography (QEEG) are reserved for SIT patients resistant to conventional modalities attempting relief. A special clinical type of a predominantly centraltype SIT has been identified in a cohort of SIT patients with cerebrovascular disease, epilepsy, and memory and cognitive disorders, reflecting neurodegenerative disease 17,18. Masking is a term used to refer to the effect of one tone or one sound on another tone or sound or combinations thereof 35.
Auditory masking, the replacement of one source of acoustic stimulation by another, a "covering up" or "blockage" of one sound by another, is a normal function of the auditory system. Tinnitus treatment recommendations continue to focus on identifying the tinnitus etiology and on the conceptualization of the past that tinnitus is a unitary symptom.
Although no tinnitus cure is available in our experience for patients at this time, protocols of combined treatment modalities that are available attempt to provide accuracy in diagnosis and identifying the medical significance of the tinnitus and tinnitus treatment, relief, and control 9,40. The neuro-otological consultation focus is on the clinical history, clinical course of the complaint, neuro-otological physical examination, and review of past medical records.
Hypotheses of the role of biophysiological mechanisms in producing tinnitus are selected for translation to the attempt to establish accuracy for the tinnitus diagnosis and attempted treatment. The selection of a particular modality of treatment is individualized for each patient and differentiated between the components of the tinnitus (see Figs.
Basic pharmacotherapeutic management principles have been followed since 1979 1 (see Table 6).
Instrumentation is recommended to tinnitus patients resistant to pharmacotherapeutic modalities for attempting tinnitus relief, approximately 10% to 15% since 2000. Step 2: Removal of keratotic debris and cerumen from external canal and tympanic membrane as appropriate. In our experience, a majority of the patients report significant tinnitus relief and control after completing steps 1 to 4 and do not require instrumentation. Innovative receptor-targeted therapies (RTT) based on identification of the underlying neurotransmitter systems 37. Titration of gabapentin should begin at the lowest possible dose: The goal is to do no harm. A psychiatric consultation is recommended for evaluation and treatment of associated anxiety and depression or both and to consider the drug Klonopin if no medical contraindication (see Table 4). Step 6: Tinnitus patients, predominantly central type, resistant to attempts tinnitus relief in steps 1-5 are recommended instrumentation in consultation with audiology.
Transcranial magnetic stimulation (TMS) research protocols have reported significant short-term tinnitus relief 48,49. In general, the results of surgery, both clinical and as research protocols for tinnitus relief, have increased since 2006.
Significant tinnitus relief with intratympanic steroid therapy has been reported for a predominantly cochleartype tinnitus 51,52. We look to the future for advances in the discipline of tinnitology for tinnitus theory, diagnosis, and auditory neuroscience of sensation and brain function to provide translation for development of new and increased efficacy of existing modalities of therapy for all clinical types of tinnitus.
These advances will reinforce the alteration in the paradigm of thinking of tinnitus, as recommended in 1983, from a focus on the ear and the psychoacoustic and psychophysical characteristics of the tinnitus to that of the ear and associated multiple brain functions as reflected clinically in the heterogeneity of tinnitus at this time. In summary, we look forward to the pharmacological evolution of tinnitopharmaco-proteogenomics, defined as pharmacology for tinnitus based on what is known of the genetic diversity and protein functions demonstrated by tinnitus patients with different clinical types of tinnitus. We hypothesize that future identification of epilepsy genes can provide an insight into the molecular basis of neuronal excitability and brain function, which will have application for a particular central-type tinnitus.
For surgery, we look forward to expansion of intratympanic drug delivery systems, with a focus on hearing conservation, which we predict will result in increasing degrees of reported tinnitus relief.
Alternate therapies will report in the future an increased significance for tinnitus relief with cognitive therapy and acupuncture as an accompaniment of anticipated advances in understanding brain function. The MATPP is presented as a dynamic neurootological-audiological protocol reflecting advances in tinnitology and neuroscience; it provides increased diagnostic accuracy, a monitoring system for all clinical types of tinnitus, and translation for increased efficacy of tinnitus relief. A paradigm switch for clinical thinking of tinnitus is recommended to concentrate on brain function responses to an aberrant dyssynchronous auditory sensory input and in particular consciousness and affect, respecting the psychophysical and psychoacoustic characteristics of the tinnitus. A biochemical marker, the GABA-A receptor, that has been identified provides translation for treatment, called RTT-GABA, of a predominantly central-type tinnitus. A commercial product, UltraQuiet provides a new form of high-frequency bone conduction therapy.
In the case of masking tinnitus by an external noise, this relationship is more the exception than the rule. The masking stimulus is raised in 5-dB steps, and patients are asked whether their tinnitus is still audible.
The stimulation must be very high in spectral content to accomplish this above the tinnitus pitch requirement. Music appears be a more effective tinnitus masker than is noise [19], possibly owing to the involvement of more central and cognitive processes.
The CD recording stimulus consisted of digitally processed music (44.1-kHz sampling rate) with playback in the 10- to 20-kHz range.
Spectrum of the high-frequency bone-conducted stimulation ranges from approximately 6 kHz to 20 kHz. The transducer is coupled to the skin and held in place with a band, much as are traditional clinical boneconduction transducers. Cortical neurons have been shown to be sensitive to frequency edges, temporal patterns, and frequency or intensity transitions [20].
We presented outcome questionnaires to establish a baseline of functioning; these included the tinnitus intensity index, the annoyance index, and the tinnitus severity index [1,21,22]. No one indicated a poorer result, and those four reporting no change in their tinnitus did indicate improvement on measures of tinnitus intensity or severity after therapy treatment. That is, as a group, the patients with problematic tinnitus indicated a significant reduction in severity over the course of the treatment trials. Effects of high-frequency therapy on three outcome measures - tinnitus severity, intensity, and annoyance - as evaluated by questionnaires completed after each therapy session.
For some patients at some frequencies, reductions in MMLs were as high as 25-45 dB in one ear (Fig. Decrease in the minimum masking levels (MMLs) for the six patients who received brain imaging before and after therapy.
Mean minimum masking levels for all subjects when patient and ear data are collapsed reveals a frequency-specific pattern.
Individual variability in this small sample of patients with problematic tinnitus precluded any detailed analysis, but tinnitus intensity ratings exceeding 50 dB were associated with improvement on the overall tinnitus relief questionnaire and were associated with a high-frequency pitch match. Relationship among minimal masking level changes (by frequency), Feldmann masking curve (FMC) types, and pitch and loudness matches in all subjects. Hearing thresholds before and after therapy generally suggest improvement after therapy; however, the pattern was complex and included elevation in some frequencies. Threshold was established before each session but, given the problems in detecting a stimulus in the presence of tinnitus (even in skilled hands), the level of UltraQuiet therapy may have been as little as 2-3 dB SL for some patients in some sessions.
Patients in the 10-session group averaged just above "no change," whereas those in the 12- and 14- session groups averaged above "slight improvement." What must be emphasized is that these patients with problematic tinnitus have had limited therapeutic success with other treatment modalities. The tinnitus relief was inferred from a pattern of lower weekly scores on the tinnitus severity scale and reduction in MMLs. Owing to stringent adherence to the protocol approved by the Western Institutional Review Board, we made no effort to increase the stimulation level in an attempt to produce complete masking. All patients had serviceable hearing to 12 kHz, but hearing improvement may have been related to relative frequency sensitivity of the UltraQuiet stimulus. In an individual with hearing loss and tinnitus, RI may last for a few seconds or minutes but can last days or weeks [2,31].


The acceptance of RI over questionnaire data is understandable in an effort to obtain a more "physiological" metric. What effect the increase in stimulation level from 6 dB SL to 12 dB SL would have on the effect of masking, on further reduction in MMLs, and on increased RI remains to be explored.
When contrasted to normal controls and tinnitus patients who tolerate their tinnitus, patients with problematic tinnitus showed less habituation in middle latency potentials [36]. The emerging picture is that of an initial insult to the ear or brain (or both) followed by an increase in the tinnitus frequency cortical map, which could increase dyssynchrony-synchrony and loudness and reduce habituation. Department of Otolaryngology, State University of New York, Downstate Medical Center, Brooklyn, and Martha Entenmann Tinnitus Research Center, Forest Hills, New York. Background: The completion of a MATPP has been recommended since 1977 for each tinnitus patient in an attempt to establish an accurate diagnosis. The term tinnitus in this article refers to subjective idiopathic tinnitus of the severe disabling type (SIT). Tinnitology is an integrated multidiscipline of basic science, neuroscience, and clinical and nuclear medicine used in an attempt to understand an aberrant auditory phenomenon unrelated to an external source of sound and how it becomes transformed into one of affect. Principles of diagnosis and treatment for SIT have evolved from the TTT experience, which provide a rationale for attempting tinnitus relief. The clinical application is resulting in a significant increase in the efficacy of modalities of therapy available for attempting tinnitus relief for all clinical types of tinnitus.
Repetitive findings both from the clinical history and the MATPP in this combined neuro-otological-audiological approach for SIT are the basis of what we identified initially to be principles of tinnitology 1,4; (see Tables 1 and 2). Anything that lessens tension or strain, or offers a pleasing change as to the mind or eye 10. Its identification provides an objective basis for an innovative anti-seizure medication attempting tinnitus relief for a predominantly central SIT. They are (1) the sensory component (sensory stimulus), (2) the affect component (behavioral response to the sensory stimulus), and (3) the psychomotor component (the motor response to express the behavioral response to the sensation) 13.
The affect component of tinnitus refers to the emotional response of the patient to the sensory component. Tinnitus is believed to originate as an initial dyssynchrony in pre- or postsynaptic neuronal transmission within the peripheral or central nervous system (cortical or subcortical). All have visited the tinnitus clinic at the Downstate Medical Center of the State University of New York (DMC-SUNY) and the Martha Entenmann Tinnitus Research Center, Inc. Our clinical experiences for both tinnitus diagnosis and treatment since 1977 were summarized in 1991 and updated in 2006.
The principles of diagnosis and treatment (see Tables 1 and 2), , and modalities of treatment available at the present time (see Tables 3-5), are presented not as menu-driven recommendations for tinnitus treatment, control, and relief but rather as a selection based on a rationale targeting hypothesized underlying biophysical processes.
A paradigm change is recommended in clinical thinking both for the symptom itself and for the response to treatment. At this time, tinnitus is considered clinically to be a symptom, heterogeneous in its etiology, clinical course, and clinical manifestation as different clinical types.
Algorithm for tinnitus diagnosis and treatment: the medicalaudiological tinnitus patient protocol. The original concept of clinical types of tinnitus (CTT) 23 is considered to be fundamental for translation to any and all attempts for tinnitus relief.
The establishment of this data base will be a significant advance for both diagnosis and translation for an increased efficacy for any and all modalities of therapy attempting tinnitus relief and control.
Tinnitus patients with hearing thresholds within the range of "normal" (250 Hz-8 kHz) have been found to have elevated thresholds in excess of what is expected for their age.
These modalities are used in the attempt to improve the accuracy of the tinnitus diagnosis and provide a monitoring system for evaluating the efficacy of therapeutic modalities aimed at tinnitus, which included control of factors influencing the clinical course of the tinnitus and a previous trial of instrumentation 33,34. Identifying and treating this particular central-type SIT has been accompanied with relief.
Itard 23,35 believed that utilizing external sounds to interfere with the tinnitus was the most effective relief procedure.
Algorithms of the final common pathway (sensory, affect, psychomotor components) and tinnitus treatment. The brain functions associated with each component of the aberrant auditory sensory stimulus (tinnitus) are integrated in each algorithm with the involved neuroanatomical substrates.
The clinical course of SIT, a stressor, becomes clinically manifest with increased severity by a reduction in the inhibitory activity of the GABA-A receptor, which is deficient and cannot inhibit the aberrant auditory signal 7. A menu-driven approach is that of the majority of tinnitus professionals for recommendations of instrumentation, medication, or surgery.
The MATPP has provided our team with a basis for the selection of existing modalities of treatment with resultant increased efficacy of tinnitus treatment, relief, and control, which we have called a tinnitustargeted therapy (TTT) 1, 9. We have focused on masking, glutamate neuroexcitotoxicity theory, inhibition, benzodiazepine deficiency, neurodegeneration, neuroprotection, calpain theory of apoptosis, kindling, long-term potentiation, lateral inhibition, epileptogenesis, stress, neurotransmitter action at synaptic levels of activity and alteration in the homeostasis of function between the fluid compartments of ear and brain 5,12,20-22,37, 41 For the associated compliant of hyperacusis, a plan for sound attenuation utilizing white noise is recommended. The goal is pharmacological short-term tinnitus relief therapy, but planning must be made for long-term benefit.
If the clinical type of tinnitus is a predominantly cochlear type, intratympanic drug therapy with steroids, preceded by computed tomography of the temporal bones is recommended 43. If the clinical type of tinnitus is a predominantly the central type, innovative drug therapies are recommended. There should be some indication of involvement of the CNS before use of an innovative application of AEDs 9,16,33,37.
Tinnitus relief with auditory cortical stimulation has been reported 53 as has the surgical application of a cochlear implant in a tinnitus patient 54. Cortical brain approaches with extra- or intracranial TMS (electrical stimulation), alone or in combination with drug therapies, will offer to patients with predominantly central-type tinnitus an increased degree of efficacy for tinnitus relief.
A "cure" for tinnitus is the ultimate goal of both tinnitus patients and all professionals involved in tinnitology. Tinnitopharmacolgy and tinnitopharmacoproteogenomics is the future for pharmacotherapeutic treatment of different clinical types of tinnitus. Strashun, MD, Director, Nuclear Medicine, and Matthew J Avitable, MD, Director Scientific Computing Center; and the support of Richard Rosenfeld, MD, Prof. Rothschild G, Nelkon I, MizrahiA: Functional organization and population dynamics in the mouse primary auditory cortex.
To assess its effectiveness in tinnitus treatment, we selected 15 patients with problematic tinnitus and randomly assigned them to three variations of the medical-audiological tinnitus patient protocol modified for the UltraQuiet study. Logically, high-frequency masking should provide effective relief in persons with severe problematic tinnitus. The UltraQuiet device delivers amplitude-modulated musical-type stimulation in the range of 10-20 kHz suitable for this purpose. We specifically investigated the use of the UltraQuiet device for providing relief, masking, and RI in individuals with problematic tinnitus of the severe disabling type. The stimulus consisted of synthesized music digitally processed and used to modulate a carrier at 16 kHz. The CD was played through a custom-made amplifier into a piezoelectric bone-conduction transducer.
Some energy occurs around 6 kHz, owing to the transducer's fundamental resonance and the high-pass filter slope. In other words, features that are found in speech, music, or amplitudefrequency modulation were incorporated into the stimulus to facilitate auditory cortical activation. Audiological evaluation included pure-tone audiometry, speech audiometry, tinnitus pitch and loudness matching, the measurement of RI, and masking curves to establish MMLs at 250-8,000 Hz using both narrowband and white noise. One week after the last intervention session, we repeated the audiological evaluation and administered the outcome questionnaires to assess any changes. Group 1 received stimulation twice weekly for 2 weeks, stopped the stimulation for 2 weeks, then received stimulation twice weekly for 3 weeks, for a total of 10 sessions. The stimulation lasted 30 minutes for the first session and 1 hour for all succeeding sessions. Some patients indicated more improvement than others, but the trend in all patients was an increase in tinnitus relief. Note the general improvement that lasted for 2 months in approximately one-half of the patients. Tinnitus severity improvement for the group was evident at the second session, gradually increasing through the twelfth session.
Clearly the severity is decreasing, with a trend in that direction for anxiety and loudness. The tinnitus pitch match most frequently occurred in the region of the hearing loss but not necessarily at the frequency with the maximal loss. Dynamic hearing levels appear related to central processes assumed to be active during and after therapy.
Note in Figure 3 that dramatic improvement in tinnitus severity occurs in session 12, as does a modest abatement of tinnitus intensity and annoyance.
Four factors likely contributed to long-term tinnitus relief: ultra-high-frequency masking, RI, neurological reprogramming, and habituation. The strategy of using high frequencies at low levels was designed to potentially provide some partial masking but, more important, was designed to aid in tinnitus neurological reprogramming and habituation. This is suggested by the six cohort patients in whom positron emission tomography scans were obtained.
High-frequency stimulation, both in the high audiofrequencies (UltraQuiet) [2] and in ultrasonic frequencies [11], have resulted in RI.
We observed (by interview at the end of therapy but not by formal testing) RI lasting approximately 5 minutes.
The conclusion of Shulman [15] suggests that a brain-imaging index in conjunction with high-frequency audiometry may be the technique of choice in objectively assessing tinnitus relief from auditory therapy if neurological reprogramming and habituation are the essential processes as hypothesized.
Cortical reprogramming as a consequence of sensorineural hearing loss has been well established [33, 34].
In view of the degree of improvement and results with the limited number of sessions in our study, a reasonable expectation is improved results with an increased level of stimulation (12 dB SL) and an increased number of sessions over time. Additionally, auditory brainstem response differences between tinnitus patients and controls further suggest that auditory path- way transmission may influence abnormal habituation. Such a condition could hyperactivate the medial temporal and prefrontal lobes, resulting in problematic tinnitus characterized by annoyance, and could trigger autonomic reactions.
Ultra-highfrequency acoustic stimulation and tinnitus control: A positron emission tomography study. Functional inactivation of the amygdale before but not after auditory fear conditioning prevents memory formation. Local improvement in auditory frequency discrimination is associated with hearing-loss slope in subjects with cochlear damage. Loudness perception and frequency discrimination in subjects with steeply sloping hearing loss: Possible correlates of neural plasticity.
Test-retest reliability of pure-tone thresholds from 0.5 to 16 kHz using Sennheiser HDA 200 and Etymotic Research ER-2 earphones. High-frequency (8 to 16 kHz) reference thresholds and intrasubject threshold variability relative to ototoxicity criteria using a Sennheiser HDA 200 earphone. Environmental enrichment improves response strength, threshold, selectivity, and latency of auditory cortex neurons.
Abnormal auditory mismatch response in tinnitus sufferers with high frequency hearing loss is associated with subjective distress level.
A tinnitus-targeted therapy (TTT), a combined treatment of medication and instrumentation focusing on pharmacotherapy, has evolved from our ongoing clinical experience since 1977 (now in excess of 10,000 SIT patients) [1-4]. It is believed to originate as an initial dyssynchrony in pre- or postsynaptic neuronal transmission within the peripheral or central nervous system (cortical or subcortical).
All patients visited the tinnitus clinic at the Downstate Medical Center at the State University of New York (DMC-SUNY) and the Martha Entenmann Tinnitus Research Center, Inc. Future advances in tinnitology are expected to add to, subtract from, or modify the principles of tinnitology as set forth in this manuscript. The psychomotor component of the tinnitus refers to a patient's motor response accompanying the emotional and subjective perception of the sensation of the aberrant auditory stimulus (tinnitus). They have been identified as involved in sensory processing underlying cochleovestibular function (peripheral and central) and in the neuroscience of brain function. Since 1979, our team has continued to report the clinical identification of clinical types and subtypes of tinnitus, particularly for a predominantly central-type SIT. These findings provide a basis for understanding the heterogeneity in the quality of the tinnitus as described by tinnitus patients and for the future potential application for attempting tinnitus control.
The ultra-high frequency findings, when positive, have clinical application for both diagnosis and treatment 28,29. These factors include cerumen in the external auditory canal with or without tympanic membrane involvement, fluctuating aeration in middle ears, SEH, noise exposure, stress, metabolic abnormalities in glucose, cholesterol, triglyceride or thyroid function, and hypertension with or without fluctuation and occurring either alone or in combination. Such drugs include the vasodilator papaverine for cerebrovascular insufficiency, clopidogrel bisulfate (Plavix) in transient ischemic attack and poststroke patients, and anti-seizure drugs for epilepsy. The FCP proposes clinical consideration of auditory masking to be predominantly a brain function with peripheral and central components. The reciprocal interacting neuroanatomical substrates of the three components complete a circuit-the final common pathway sensory-affect transformation. All patients are interviewed by telephone prior to receiving the appointment and are requested to have undergone a complete physical examination within 6 months prior to neuro-otologicalaudiometric consultation and to provide past hearing and balance testing, imaging and pharmacological record results, and a short narrative of the clinical course of the tinnitus for review.
The clinical types of tinnitus in this group are predominantly of the middle ear and cochlea, alone or in combination. Ultra-quiet therapy utilizing ultra-high-frequency stimulation has provided tinnitus relief in a particular cohort of SIT patients , however is not available at this time 47. It will come as an accompaniment of advances reported in auditory neuroscience and that of sensation and brain function. Tinnitus dyssynchrony-synchrony theory: A translational concept for diagnosis and treatment and a model for the clinical diagnosis of different clinical type(s) of tinnitus. Central tinnitus-diagnosis and treatment: Observations of simultaneous auditory brainstem responses with monaural stimulation in the tinnitus patient.
Neuroprotective drug therapy: A medical and pharmacological treatment for tinnitus control. Final common pathway for tinnitus: Theoretical and clinical implications of neuroanatomical substrates. The Tinnitus Research Initiative TRI database: A new approach for delineation of tinnitus subtypes and generation of predictors of treatment outcome. Adaptive, behaviorally gated, persistent encoding of task-relevant auditory information in the ferret frontal cortex.


GABA-A- benzodiazepinechloride receptor-targeted therapy for tinnitus control: Preliminary report.
Fluid dynamics vascular theory brain and inner ear function in traumatic brain injury: A translational hypothesis for diagnosis and treatment. Worldwide experience with sequential phase-shift sound cancellation treatment of predominant tone tinnitus. Transcranial magnetic stimulation for the treatment of tinnitus: A new coil positioning method and first results. Transcranial magnetic stimulation: Summary of the Proceedings of the 26th Annual Meeting of the International Tinnitus Forum.
Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. We assessed tinnitus relief by questionnaires directed at weighing patient response to overall effectiveness, tinnitus loudness, tinnitus severity, and tinnitus annoyance. The effect of this expansion on connections to the limbic system and other cortical areas is not known, nor have the tuning characteristics of these "recruited" neurons been measured. Preliminary clinical reports were encouraging [2] and a calibration procedure, anchored to international standards, was followed [18]. The pitch match to the tinnitus for 14 of the 15 subjects was high-pitched, matching to either a pure-tone or a narrowband noise or a combination of both, with frequencies between 3 and 16 kHz; 1 subject had a low-pitched tonal tinnitus at 450 Hz.
Group 2 received stimulation twice weekly for 3 weeks, stopped the stimulation for 2 weeks, then received stimulation twice weekly for 3 weeks, for a total of 12 sessions. Further improvement may be present but is obscured by the duration parameters of the three groups. The mean data are perhaps as revealing; when patient and ear data are collapsed, a high-frequency reduction in masking is observed (Fig. Although we saw an increase in some thresholds in some patients, twice as many thresholds improved as those that decreased. Nonetheless, the frequency range of masking is important in obtaining neurological reprogramming and inhibition [16,18].
Those patients with the best thresholds beyond 10 kHz exhibited the best behavioral and physiological activity [15].
The question of the minimal number of trials needed to note tinnitus relief, given that choices were limited to 10, 12, and 14 sessions, can be answered only by stating that 10 session of therapy (and probably fewer) are not as effective as 12 and 14 sessions, on the basis of questionnaire results after therapy. Patients with problematic tinnitus appear not to exhibit normal habituation, and this can influence their perception of tinnitus loudness.
Although we readily recognize that the neural substrate of problematic tinnitus encompasses much more than the auditory pathway, the role of the auditory pathway in masking, RI, neurological reprogramming, and habituation is significant [37]. In GE Reich, JA Vernon (eds), Proceedings of the Fifth International Tinnitus Seminar 1995. Poster presented at the Twenty-First Annual Meeting of the Association for Research in Otolaryngology, 1999. Presented at the Thirty-First Congress of the Neurootological and Equilibriometric Society, Bad Kissingen, Germany, March 25-27,2004. Principles for SIT treatment have evolved from the TTT experience that provides a rationale for attempting tinnitus relief. It interferes in the excitatory and inhibitory process or processes involved in maintaining homeostasis for brain neurofunction in multiple neural substrates and acts as an aberrant auditory stimulus to express this dysfunction via the auditory system 5. It is expected that these principles will be expanded and modified to reflect future advances in tinnitology.
Neuroanatomical substrates that have been identified in brain contribute to an evolving pathophysiology for all clinical types of tinnitus.
According to the definition of tinnitus, the perception of tinnitus is a central function in all CTT . Particularly significant for tinnitus is the finding of a labyrinthine asymmetry that, when correlated with the symptom of ear blockage and a positive Metz test for recruitment, provides the basis for the clinical diagnosis of a secondary endolymphatic hydrops (SEH) 30. Identification, treatment, and maintenance of normal aeration of the middle ears, when identified and treated, have resulted in tinnitus relief and control in approximately 15% of our SIT patients.
For memory and cognition, we recommend the neuroprotective drugs donepezil hydrochloride (Aricept), Cognex (tacrine), memantine hydrochloride, gabapentin, and clonazepam (Klonopin).
The manifestation of the symptom of tinnitus is considered to be a reduction in the normal auditory masking function in the brain: The neuroanatomical substrates are hypothesized to involve the cochlea, the brainstem, the thalamus, and multiple cerebral cortices (Figure 2). Similarly, tinnitus relief, when reported, is clinically considered by our team to reflect a return of adequate masking. Second, drug selection should take into account agents that have a short half-life so as to minimize the incidence and duration of side effects. The dose for the sensory component is based on the tinnitus intensity index (TII) and the tinnitus annoyance index (TAI), both on a scale from 0 to 7. Additionally, we performed audiological measures (including pure-tone and speech audiometry, minimal masking levels, pitch and loudness matching, and residual inhibition). That is, tinnitus masking may be a complicated product of peripheral and central processes, and sounds outside of traditional psychoacoustic ranges can be effective with tinnitus [2], including ultrasound masking delivered through bone conduction [11].
If neural space expansion of the tinnitus frequency (or frequencies) is associated with synchronized activity, ignoring an attentiongenerating tinnitus percept that could readily arise may be impossible. The UltraQuiet system has a maximum output of 53 dB hearing level (HL) when it is massloaded to the artificial mastoid with 5.4 Newtons of force applied. Group 3 received stimulation twice weekly for 4 weeks, stopped the stimulation for 1 week, then received stimulation twice weekly for 3 weeks, for a total of 14 sessions.
The threshold for stimulation was established, and the stimulation was presented 6 dB above threshold or 6-dB sensation level (SL).
That is, for the latter sessions, the number of patients being tested dropped, owing to the session limitations for each of the three treatment groups. No consistent pattern was noted between Feldmann masking curve type and tinnitus pitch match (Fig.
If highfrequency stimulation is essential for auditory cortical reprogramming, the sensitivity to such stimulation should be an essential variable. What should be noted is that the stimulating intensity was only 6 dB SL, and this may not have been sufficient energy to elicit RI in the other patients, a metric to be systematically studied in the future. If the auditory cortex has reprogrammed, stimulation with very high frequencies might stabilize and reverse the process and perhaps restore the normal frequency map. According to these serial measures, therapy of fewer than 12 sessions would not be as satisfactory as therapy lasting 12 and 14 sessions. A plastic auditory pathway treated with a stimulus specifically designed for highpitched tinnitus may, with time, provide long-term relief. Understanding the pathophysiology of this transformation in brain is considered to be fundamental to diagnosing and treating tinnitus of all clinical types.
The CTT are identified by the correlation of the clinical history, physical examination, electrophysiological correlates of cochleovestibular function, and an evaluation of metabolic and electrophysiological activity in brain.
Visual suppression of the vestibuleocular reflex, a sign of cerebellar dysfunction, is significant for the identification of a central component for the tinnitus and involvement of the acousticomotor system 31. These drugs may influence the SIT by improving the underlying neuronal anatomic substrate(s) that may be contributing to SIT 1. The cerebellum, via the acousticomotor system, has reciprocal projections to and from the somatosensory cortex, IC, thalamus, PAC, and parietal lobe [18]. We recommend selection of RTT-GABA for patients with SIT of more than a year's duration and a diagnosis of a predominantly central-type tinnitus based on completion of the MATPP.
In H Feldmann (ed), Proceedings of the Third International Tinnitus Seminar, Munster, 1987. All patients showed some long-term gains, and most exhibited relief in at least one measurement parameter, providing support for the use of high-frequency vibration in the treatment of tinnitus. Growing evidence suggests that high-frequency masking is desirable in cases of high-frequency tinnitus [2,11].
Increased degrees of neural synchronydyssynchrony could activate and continue to stimulate the amygdala, an organ known to be critical in evoking emotional and autonomic nervous responses [17].
Although the stimulus is presented on only one side of the head, it is heard binaurally through bone conduction [23]. The frequency area that exhibited the greatest effect is the octave from 3 to 6 kHz, below the lowest resonance in our transducer (6 kHz).
Annoyance and tinnitus intensity seemed to persist in most throughout the sessions, suggesting that the tinnitus, while reduced in severity, was still present. In the normal auditory system, an increase in loudness is related to an increase in neural activity.
The changes in MMLs and auditory thresholds suggest an adaptive central nervous system, responsive to high-frequency sound therapy.
When viewed in terms of sensory processing, the FCP hypothesis is considered to be expanded and broader in its application for all sensations, normal or aberrant 8,20. Critical for attempting tinnitus treatment, control, and relief for any and all clinical types and subtypes of tinnitus is the clinical establishment of accuracy for the tinnitus diagnosis 14,24. Again, the accuracy of the tinnitus diagnosis is the key to selecting modalities of treatment in attempting tinnitus treatment, relief, and control. Hyperpolarization and depolarization of GABA-influenced thalamic neuron activity results in thalamocortical oscillations in a synchronous signal at brain cortex [204,254]. Plans should be made for longterm treatment, particularly for the affective behavioral component. Two problems exist: One is developing an efficient, commercially viable, and calibratable transducer and the other is determining a reliable clinical-use protocol. For many patients, substituting one sound for another is not considered a significant enough improvement; additional relief is desired. Stated another way, the frequencies that required less energy to mask tinnitus were those just below the lowest effective stimulating frequencies in the UltraQuiet system. The UltraQuiet masking mechanism appears to be different when using conventional audiological masking at 250-8,000 Hz than when using ultra-high frequencies.
High-frequency stimulation with the UltraQuiet passband of 10-20 kHz has the added quality of disrupting the tinnitus frequency synchrony and reducing the overrepresentation, which might be verified with cortical potentials.
Patients who do not exhibit normal habituation and who rate their tinnitus as loud may have more active dyssynchronous neurons involved in tinnitus perception than do patients who assess their tinnitus loudness as low. Long-term tinnitus relief cannot be solely defined by one metric as complete masking or RI on the order of hours.
For the future, it is hypothesized, a particular clinical type of a predominantly central tinnitus, now considered to be a symptom, will be identified to be a specific disease entity.
Reciprocal innervation from the thalamus to the medial temporal lobe system (MTLS), including the amygdala (AG), hippocampus (HP), paparahippocampal formation (PH), entorhinal cortex (EC), perirhinal cortex (PC), ACG, and hypothalamus (HYP), comprise an endogenous system of the CNS as hypothesized for sensory processing [53,54]. The main clinical manifestation of tinnitus is that of multifactorial characteristics; therefore, single drugs may have multiple sites of action.
In a preliminary report [2], we found a high-frequency tinnitus device, UltraQuiet, to be efficacious. The masking stimulation, if properly chosen, may have the capacity of changing how the brain processes tinnitus, which could provide long-lasting benefit. These frequencies were on the edge of the patients' audiometric hearing loss, a region often associated with increased discrimination possibly due to neural plasticity [24,25]. With ultra-high frequency, the stimulus is apparently combined with neurological reprogramming and plasticity involving the auditory cortex. Such a situation would be predicted in the tinnitus frequency map expansion in the auditory cortex and would influence both the medial temporal lobe system and other cortical area identified as active in tinnitus [37]. Relief is a complex function of many factors arising both within and outside the auditory system, and successful treatment takes time.
For tinnitus, the endogenous system is hypothesized to result in the establishment of a "paradoxical memory" for the aberrant auditory sensory stimulus (tinnitus) and has a reciprocal interaction with the thalamus [16]. We recommend a combination drug strategy to increase the efficacy of attempts at tinnitus relief. The MML improvement was related to the measured tinnitus pitch in that both were high-frequency (with one pitch match exception). RI increased with masker intensity, but the relationship of RI to tinnitus frequency, masker center frequency, and bandwidth was complex and varied among individuals. Brain imaging and high-frequency audiometries seem to be important indices in quantifying tinnitus relief. The associated brain function processes within the neuroanatomical substrates of the sensory component include memory, stress, masking, fear, reward, and autonomic functions. For the affect component, particular attention is directed with pharmacotherapy to avoid drug tolerance and or habituation. Response to treatment is monitored by telephone communication and follow-up office visits as determined by the clinical course of the SIT 1,37. Often, behavioral measures are contradictory, rendering efficacy determination problematic. Stress is considered to be a modulator of the clinical course of the tinnitus with the accompanying reduction and alteration in auditory masking [2,230-232]. Algorithm 2, Affect (Emotional-Behavioral) Component: The neuroanatomical substrates of the affect (emotional) component are highlighted by the OFC, PFC of the frontal lobe, PAC, MTLS of the temporal lobe, and insula.
Reciprocal innervation is hypothesized to occur between the PAC of the sensory component and the OFC, ACG, PFC, MTLS, and insula. The insula, by its central location, is hypothesized to exert a modulating effect among the sensory, affect, and psychomotor components. The thalamic activity is ongoing with reciprocal projections to the PFC, OFC, and parietal lobe. Algorithm 3, Psychomotor Component: The neuroanatomical substrates of the psychomotor component include the insula, parietal lobe, striatum, and cerebellum.
The thalamic activity is ongoing with reciprocal innervation of the parietal lobe, OFC, and PFC. Significant for the sensory-affect transformation is considered to be the interaction between the striatum, parietal lobe, and OFC via the insula.



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