A randomized, double-blind, placebo-controlled phase 2 study of intratympanic OTO-313 in patients with moderate to severe subjective tinnitus.

PURPOSE: This was a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the efficacy and safety of intratympanic OTO-313 in patients with subjective unilateral tinnitus. METHODS: Patients with moderate to severe unilateral tinnitus of 2-12 months duration were enrolled. A single intratympanic injection of OTO-313 or placebo was administered to the affected ear and patients were evaluated during a 16-weeks follow-up period. Efficacy was assessed using the Tinnitus Functional Index (TFI), daily ratings of tinnitus loudness and annoyance, and Patient Global Impression of Change (PGIC). RESULTS: Intratympanic administration of OTO-313 and placebo produced reductions in tinnitus with a similar percentage of TFI responders at Weeks 4, 8, 12, and 16. Reductions in daily ratings of tinnitus loudness and annoyance, and PGIC scores were also similar between OTO-313 and placebo groups. No significant differences in mean TFI scores between OTO-313 and placebo were observed for pre-specified strata regarding tinnitus duration (≥ 2 to ≤ 6 months and > 6 to ≤ 12 months) and TFI baseline scores (≥ 32 to ≤ 53 points and ≥ 54 to 100 points), although the results numerically favored OTO-313 in patients in the ≥ 2 to ≤ 6 months strata. These results also demonstrated an unexpectedly high placebo response particularly amongst patients with chronic tinnitus, despite training implemented to mitigate placebo response. OTO-313 was well-tolerated with a similar incidence of adverse events compared to placebo. CONCLUSIONS: OTO-313 did not demonstrate a significant treatment benefit relative to placebo due in part to a high placebo response. OTO-313 was safe and well-tolerated.

A randomized single-blind controlled trial of a prototype digital polytherapeutic for tinnitus.

Objective: This randomized single-blind controlled trial tested the hypothesis that a prototype digital therapeutic developed to provide goal-based counseling with personalized passive and active game-based sound therapy would provide superior tinnitus outcomes, and similar usability, to a popular passive sound therapy app over a 12 week trial period. Methods: The digital therapeutic consisted of an app for iPhone or Android smartphone, Bluetooth bone conduction headphones, neck pillow speaker, and a cloud-based clinician dashboard to enable messaging and app personalization. The control app was a popular self-help passive sound therapy app called White Noise Lite (WN). The primary outcome measure was clinically meaningful change in Tinnitus Functional Index (TFI) between baseline and 12 weeks of therapy. Secondary tinnitus measures were the TFI total score and subscales across sessions, rating scales and the Client Oriented Scale of Improvement in Tinnitus (COSIT). Usability of the US and WN interventions were assessed using the System Usability Scale (SUS) and the mHealth App Usability Questionnaire (MAUQ). Ninety-eight participants who were smartphone app users and had chronic moderate-severe tinnitus (>6 months, TFI score > 40) were enrolled and were randomly allocated to one of the intervention groups. Thirty-one participants in the USL group and 30 in the WN group completed 12 weeks of trial. Results: Mean changes in TFI for the USL group at 6 (16.36, SD 17.96) and 12 weeks (17.83 points, SD 19.87) were clinically meaningful (>13 points reduction), the mean change in WN scores were not clinically meaningful (6 weeks 10.77, SD 18.53; 12 weeks 10.12 points, SD 21.36). A statistically higher proportion of USL participants achieved meaningful TFI change at 6 weeks (55%) and 12 weeks (65%) than the WN group at 6 weeks (33%) and 12 weeks (43%). Mean TFI, rating and COSIT scores favored the US group but were not statistically different from WN. Usability measures were similar for both groups. Conclusions: The USL group demonstrated a higher proportion of responders than the WN group. The usability of the USL therapeutic was similar to the established WN app. The digital polytherapeutic demonstrated significant benefit for tinnitus reduction supporting further development.

A State-of-Art Review of Digital Technologies for the Next Generation of Tinnitus Therapeutics.

Background: Digital processing has enabled the development of several generations of technology for tinnitus therapy. The first digital generation was comprised of digital Hearing Aids (HAs) and personal digital music players implementing already established sound-based therapies, as well as text based information on the internet. In the second generation Smart-phone applications (apps) alone or in conjunction with HAs resulted in more therapy options for users to select from. The 3rd generation of digital tinnitus technologies began with the emergence of many novel, largely neurophysiologically-inspired, treatment theories that drove development of processing; enabled through HAs, apps, the internet and stand-alone devices. We are now of the cusp of a 4th generation that will incorporate physiological sensors, multiple transducers and AI to personalize therapies. Aim: To review technologies that will enable the next generations of digital therapies for tinnitus. Methods: A "state-of-the-art" review was undertaken to answer the question: what digital technology could be applied to tinnitus therapy in the next 10 years? Google Scholar and PubMed were searched for the 10-year period 2011-2021. The search strategy used the following key words: "tinnitus" and ["HA," "personalized therapy," "AI" (and "methods" or "applications"), "Virtual reality," "Games," "Sensors" and "Transducers"], and "Hearables." Snowballing was used to expand the search from the identified papers. The results of the review were cataloged and organized into themes. Results: This paper identified digital technologies and research on the development of smart therapies for tinnitus. AI methods that could have tinnitus applications are identified and discussed. The potential of personalized treatments and the benefits of being able to gather data in ecologically valid settings are outlined. Conclusions: There is a huge scope for the application of digital technology to tinnitus therapy, but the uncertain mechanisms underpinning tinnitus present a challenge and many posited therapeutic approaches may not be successful. Personalized AI modeling based on biometric measures obtained through various sensor types, and assessments of individual psychology and lifestyles should result in the development of smart therapy platforms for tinnitus.

Behavioral Outcomes and Neural Network Modeling of a Novel, Putative, Recategorization Sound Therapy.

The mechanisms underlying sound's effect on tinnitus perception are unclear. Tinnitus activity appears to conflict with perceptual expectations of "real" sound, resulting in it being a salient signal. Attention diverted towards tinnitus during the later stages of object processing potentially disrupts high-order auditory streaming, and its uncertain nature results in negative psychological responses. This study investigated the benefits and neurophysiological basis of passive perceptual training and informational counseling to recategorize phantom perception as a more real auditory object. Specifically, it examined underlying psychoacoustic correlates of tinnitus and the neural activities associated with tinnitus auditory streaming and how malleable these are to change with targeted intervention. Eighteen participants (8 females, 10 males, mean age = 61.6 years) completed the study. The study consisted of 2 parts: (1) An acute exposure over 30 min to a sound that matched the person's tinnitus (Tinnitus Avatar) that was cross-faded to a selected nature sound (Cicadas, Fan, Water Sound/Rain, Birds, Water and Bird). (2) A chronic exposure for 3 months to the same "morphed" sound. A brain-inspired spiking neural network (SNN) architecture was used to model and compare differences between electroencephalography (EEG) patterns recorded prior to morphing sound presentation, during, after (3-month), and post-follow-up. Results showed that the tinnitus avatar generated was a good match to an individual's tinnitus as rated on likeness scales and was not rated as unpleasant. The five environmental sounds selected for this study were also rated as being appropriate matches to individuals' tinnitus and largely pleasant to listen to. There was a significant reduction in the Tinnitus Functional Index score and subscales of intrusiveness of the tinnitus signal and ability to concentrate with the tinnitus trial end compared to baseline. There was a significant decrease in how strong the tinnitus signal was rated as well as ratings of how easy it was to ignore the tinnitus signal on severity rating scales. Qualitative analysis found that the environmental sound interacted with the tinnitus in a positive way, but participants did not experience change in severity, however, characteristics of tinnitus, including pitch and uniformity of sound, were reported to change. The results indicate the feasibility of the computational SNN method and preliminary evidence that the sound exposure may change activation of neural tinnitus networks and greater bilateral hemispheric involvement as the sound morphs over time into natural environmental sound; particularly relating to attention and discriminatory judgments (dorsal attention network, precentral gyrus, ventral anterior network). This is the first study that attempts to recategorize tinnitus using passive auditory training to a sound that morphs from resembling the person's tinnitus to a natural sound. These findings will be used to design future-controlled trials to elucidate whether the approach used differs in effect and mechanism from conventional Broadband Noise (BBN) sound therapy.

Emerging Topics in the Behavioral Neuroscience of Tinnitus.

This volume has highlighted the many recent advances in tinnitus theory, models, diagnostics, therapies, and therapeutics. But tinnitus knowledge is far from complete. In this chapter, contributors to the Behavioral Neuroscience of Tinnitus consider emerging topics and areas of research needed in light of recent findings. New research avenues and methods to explore are discussed. Issues pertaining to current assessment, treatment, and research methods are outlined, along with recommendations on new avenues to explore with research.

Prediction of tinnitus masking benefit within a case series using a spiking neural network model.

Masking has been widely used as a tinnitus therapy, with large individual differences in its effectiveness. The basis of this variation is unknown. We examined individual tinnitus and psychological responses to three masking types, energetic masking (bilateral broadband static or rain noise [BBN]), informational masking (BBN with a notch at tinnitus pitch and 3-dimensional cues) and a masker combining both effects (BBN with spatial cues). Eleven participants with chronic tinnitus were followed for 12 months, each person used each masking approach for 3 months with a 1 month washout-baseline. The Tinnitus Functional Index (TFI), Tinnitus Rating Scales, Positive and Negative Affect Scale and Depression Anxiety Stress Scales, were measured every month of treatment. Electroencephalography (EEG) and psychoacoustic assessment was undertaken at baseline and following 3 months of each masking sound. The computational modeling of EEG data was based on the framework of brain-inspired Spiking Neural Network (SNN) architecture called NeuCube, designed for this study for mapping, learning, visualizing and classifying of brain activity patterns. EEG was related to clinically significant change in the TFI using the SNN model. The SNN framework was able to predict sound therapy responders (93% accuracy) from non-responders (100% accuracy) using baseline EEG recordings. The combination of energetic and informational masking was an effective treatment sound in more individuals than the other sounds used. Although the findings are promising, they are preliminary and require confirmation in independent and larger samples.

Tinnitus and tinnitus disorder: Theoretical and operational definitions (an international multidisciplinary proposal).

As for hypertension, chronic pain, epilepsy and other disorders with particular symptoms, a commonly accepted and unambiguous definition provides a common ground for researchers and clinicians to study and treat the problem. The WHO's ICD11 definition only mentions tinnitus as a nonspecific symptom of a hearing disorder, but not as a clinical entity in its own right, and the American Psychiatric Association's DSM-V doesn't mention tinnitus at all. Here we propose that the tinnitus without and with associated suffering should be differentiated by distinct terms: "Tinnitus" for the former and "Tinnitus Disorder" for the latter. The proposed definition then becomes "Tinnitus is the conscious awareness of a tonal or composite noise for which there is no identifiable corresponding external acoustic source, which becomes Tinnitus Disorder "when associated with emotional distress, cognitive dysfunction, and/or autonomic arousal, leading to behavioural changes and functional disability.". In other words "Tinnitus" describes the auditory or sensory component, whereas "Tinnitus Disorder" reflects the auditory component and the associated suffering. Whereas acute tinnitus may be a symptom secondary to a trauma or disease, chronic tinnitus may be considered a primary disorder in its own right. If adopted, this will advance the recognition of tinnitus disorder as a primary health condition in its own right. The capacity to measure the incidence, prevalence, and impact will help in identification of human, financial, and educational needs required to address acute tinnitus as a symptom but chronic tinnitus as a disorder.

Sense and Sensibility: A Review of the Behavioral Neuroscience of Tinnitus Sound Therapy and a New Typology.

Tinnitus Sound Therapy is not a single strategy. It consists of many different sound types, targeting many different mechanisms. Therapies that use sound to cover, reduce attention to, or facilitate habituation of tinnitus are among the most common tinnitus treatment paradigms. Recent history has seen a proliferation of sound therapies, but they have each been criticized for having limited empirical support. In this review, Sound Therapy's modern history will be described, and a typology will be introduced and discussed in light of current behavioral neuroscience research. It will be argued that contributing factors to the limited evidence for the efficacy of Sound Therapy are its diversity, plural modes of action, and absence of a clear typology. Despite gaps in understanding the efficacy of sound's effects on tinnitus, there is compelling evidence for its multiple, but related, neurophysiological mechanisms. Evidence suggests that sound may reduce tinnitus through its presence, context, reaction, and potentially adaptation. This review provides insights into the neurocognitive basis of these tinnitus Sound Therapy modes. It concludes that a unifying classification is needed to secure and advance arguments in favor of Sound Therapy.

Principles and Methods for Psychoacoustic Evaluation of Tinnitus.

Tinnitus, the perception of sound in the absence of a physical sound in the environment, is highly heterogeneous. It varies in its etiology, characteristics, and impact on an individual's life. The sound is commonly described as "ringing," "buzzing," "crickets," "hissing," "humming." Tinnitus can be acute or chronic, mild or disabling. It can be perceived unilaterally or, more commonly, bilaterally. The sound and its location differ from person to person and fluctuate in the same individual over a certain period of time. This heterogeneity in characterization has important implications for research and clinical practice. Identifying patterns in how tinnitus sounds and its relationship to hearing may aid in identifying different forms of tinnitus and revealing their underlying mechanisms. However, the subjective nature of characterizing tinnitus makes it difficult to reliably define and measure. This chapter will focus on reviewing the psychoacoustic assessment of tinnitus, its relationship to cognitive and behavioral aspects of tinnitus, and its neuropathophysiology. In particular, it will describe the heterogeneity of tinnitus and tinnitus matching, and how individual variability in measures may be used to guide treatment and as a prognostic factor.

Prediction of Acoustic Residual Inhibition of Tinnitus Using a Brain-Inspired Spiking Neural Network Model.

Auditory Residual Inhibition (ARI) is a temporary suppression of tinnitus that occurs in some people following the presentation of masking sounds. Differences in neural response to ARI stimuli may enable classification of tinnitus and a tailored approach to intervention in the future. In an exploratory study, we investigated the use of a brain-inspired artificial neural network to examine the effects of ARI on electroencephalographic function, as well as the predictive ability of the model. Ten tinnitus patients underwent two auditory stimulation conditions (constant and amplitude modulated broadband noise) at two time points and were then characterised as responders or non-responders, based on whether they experienced ARI or not. Using a spiking neural network model, we evaluated concurrent neural patterns generated across space and time from features of electroencephalographic data, capturing the neural dynamic changes before and after stimulation. Results indicated that the model may be used to predict the effect of auditory stimulation on tinnitus on an individual basis. This approach may aid in the development of predictive models for treatment selection.

The Effect of Auditory Residual Inhibition on Tinnitus and the Electroencephalogram.

OBJECTIVES: Tinnitus is the perception of sound in the absence of an external physical sound source, for some people it can severely reduce the quality of life. Acoustic residual inhibition (ARI) is a suppression of tinnitus following the cessation of a sound. The present study investigated the effect of ARI on brain activity measured using EEG. DESIGN: Thirty adult participants (mean age of 58 years) experiencing chronic tinnitus (minimum 2 years) participated. Participants were presented broad band noise at 10 dB above minimum masking level (1 min followed by 4 min of silence, 4 times) counterbalanced with a control treatment of broad band noise at threshold (1 min followed by 4 min of silence, 4 times) while 64-channel EEG was simultaneously recorded. Tinnitus loudness was measured using a 9-point tinnitus loudness rating scale. RESULTS: The ARI stimulation resulted in a self-reported reduction in tinnitus loudness in 17 of the 30 participants. Tinnitus rating reduced following stimulation but gradually returned to near baseline during 4 min of silence post sound exposure; successive sound exposures resulted in lower loudness ratings. No significant reductions in loudness rating were found with the control stimulation. The EEG showed increases in power spectral density, particularly in the alpha and gamma bands, during ARI compared to the control periods. CONCLUSIONS: These results contribute to the understanding of ARI and tinnitus. We recommend that there be a closer examination of the relationship between onset and offset of sound in both tinnitus and nontinnitus control participants to ascertain if EEG changes seen with ARI relate to tinnitus suppression or general postsound activity.

The Neural Bases of Tinnitus: Lessons from Deafness and Cochlear Implants.

Subjective tinnitus is the conscious perception of sound in the absence of any acoustic source. The literature suggests various tinnitus mechanisms, most of which invoke changes in spontaneous firing rates of central auditory neurons resulting from modification of neural gain. Here, we present an alternative model based on evidence that tinnitus is: (1) rare in people who are congenitally deaf, (2) common in people with acquired deafness, and (3) potentially suppressed by active cochlear implants used for hearing restoration. We propose that tinnitus can only develop after fast auditory fiber activity has stimulated the synapse formation between fast-spiking parvalbumin positive (PV+) interneurons and projecting neurons in the ascending auditory path and coactivated frontostriatal networks after hearing onset. Thereafter, fast auditory fiber activity promotes feedforward and feedback inhibition mediated by PV+ interneuron activity in auditory-specific circuits. This inhibitory network enables enhanced stimulus resolution, attention-driven contrast improvement, and augmentation of auditory responses in central auditory pathways (neural gain) after damage of slow auditory fibers. When fast auditory fiber activity is lost, tonic PV+ interneuron activity is diminished, resulting in the prolonged response latencies, sudden hyperexcitability, enhanced cortical synchrony, elevated spontaneous γ oscillations, and impaired attention/stress-control that have been described in previous tinnitus models. Moreover, because fast processing is gained through sensory experience, tinnitus would not exist in congenital deafness. Electrical cochlear stimulation may have the potential to reestablish tonic inhibitory networks and thus suppress tinnitus. The proposed framework unites many ideas of tinnitus pathophysiology and may catalyze cooperative efforts to develop tinnitus therapies.

An Evaluation of a Continuing Education Workshop for Audiologists on the Assessment and Management of Tinnitus.

INTRODUCTION: Tinnitus assessment and management is an important component of audiology. The benefits of continuing education (CE) workshops in the field of tinnitus have not been published. This study evaluated the outcomes of a workshop centered around a Sound Therapy and Aural Rehabilitation for Tinnitus (START) framework. Our hypotheses were that a CE workshop would (1) be useful, (2) improve clinician's knowledge and willingness to undertake tinnitus practice, and (3) result in learners using knowledge gained in their practice. METHODS: Twenty-five participants attending a 3-day tinnitus workshop were invited to complete an evaluation immediately and 3 months after the workshop's completion. The workshop consisted of seminars and practical sessions. The pedagogical approaches employed were experiential (theory building, reflection, and testing) and community of practice (shared experiences). RESULTS: Participants reported on a 5-point Likert scale (1 = not useful-5 = excellent) a high level of satisfaction both immediately after the workshop (ratings of usefulness: mean, 4.8; SD, 0.4; willingness to practice: 4.6; SD. 0.6; ability to manage: 4.6; SD, 0.5; all "excellent" ratings) and 3 months later (ratings of usefulness: mean, 4.2; SD, 0.9, "very useful;" willingness to practice: 4.6; SD, 0.6, "excellent;" ability to manage: 4.1; SD. 0.5, "very useful"). Open-ended questions indicated participants made changes in their practice that reflected material provided in the CE. CONCLUSION: The workshop was successful in improving knowledge and confidence of audiologists in undertaking tinnitus assessment and management, but the need for ongoing support and supervision was a common theme.

A proof-of-concept study of the benefits of a single-session of tinnitus instruction and counselling with homework on tinnitus.

Objective: The objective of this study was to provide proof-of-concept of a single session of tinnitus instruction and counselling with and without homework.Design: A mixed-method design using questionnaires and thematic evaluation of qualitative data was implemented.Study sample: Sixteen participants received instruction in a single, one-to-one counselling session; eight participants additionally undertook homework consisting of either positive visualisation augmented by sound or a workbook of written and drawing activities supporting the instruction provided in the counselling session. All participants completed questionnaires just before and 3 weeks after the intervention, half were interviewed 3 weeks following the intervention.Results: Average tinnitus functional index (TFI) scores were 45 (SD 25) before and 29 (SD 23) following counselling, with a change of 4.8 or greater recorded in 75% and change of 13 points or greater in 50% of participants. Both counselling and counselling with homework showed similar changes in the TFI. This finding was supported by the qualitative analysis from which a model consisting of the themes of counselling benefit, content, application and homework benefit was derived.Conclusions: This study provides proof-of-concept of a single tinnitus instruction and counselling session, based on an ecological model of tinnitus.

Changes in tinnitus and physiological biomarkers of stress in response to short-term broadband noise and sounds of nature.

BACKGROUND: Tinnitus is the perception of sound when no external sound source is present. In some cases, this perception coincides with, or results in, stress. Tinnitus-related distress has been associated with increased levels of cortisol and elevated levels of sympathetic tone. Our primary hypothesis was that short-term sound exposure would reduce tinnitus perception and various physiological measures of stress. A secondary hypothesis was that a self-selected nature sound would reduce physiological markers of stress more than broadband noise. METHODS: Twenty-one participants with constant bothersome tinnitus underwent an audiological assessment. Measurements of blood pressure, heart rate, salivary cortisol and cortisone concentrations, and tinnitus ratings were carried out three times: prior to and, in a counterbalance order, after 30 min of broadband noise and after 30 min of a self-selected nature sound (from: ocean waves, stream, rain or shower sounds). RESULTS: Findings revealed significant reductions in blood pressure measurements following broadband noise. None of the other stress measures demonstrated a statistically significant change. Both broadband noise and nature sounds elicited significant improvements in ratings of tinnitus. CONCLUSIONS: While both sound types had a positive impact on many dimensions of tinnitus, only the broadband noise was associated with a reduction in blood pressure. These results are consistent with a complex interaction between sound and tinnitus and suggest a multifactorial basis to sound therapy that includes a reduction in arousal.

The short-term effects of recorded ocean sound with and without alpha frequency binaural beats on tinnitus perception.

BACKGROUND: The dichotic presentation of two auditory stimuli with a small frequency difference in each ear produces the perception of a third, fused auditory image called a binaural beat. Neural activity has been found to synchronize with these perceived beats. It is for this reason that binaural beats are often used in an attempt to induce certain psychological states that are associated with particular cortical rhythms. The aim of this proof-of-concept study was to explore the short-term effects of a binaural beat on tinnitus, to ascertain if further trials are justified. METHOD: Twenty adults with constant tinnitus and symmetrical hearing underwent audiological assessment and psychophysical measures of tinnitus. Participants were presented with two auditory stimuli: ocean waves with and without alpha frequency (8 Hz) binaural beats. Arousal and tinnitus perception were measured prior to and following each sound stimuli using the Perceived Arousal Scale and tinnitus rating scales. RESULTS: Small improvements in tinnitus rating scores occurred with sound. Some individuals showed more improvement with the binaural beats than ocean waves alone. CONCLUSION: The addition of binaural beats at 8 Hz to an ocean sound showed no significant group benefits above the ocean sound alone.

Sound therapy and aural rehabilitation for tinnitus: a person centred therapy framework based on an ecological model of tinnitus.

Purpose: Tinnitus is a common oto-neurological complaint often accompanying hearing loss. In this perspective on rehabilitation we describe a framework for sound therapy and aural rehabilitation of tinnitus based on the ecological model of tinnitus. Method: A thematic network analysis-based approach was used to relate aural rehabilitation methods to the ecological model of tinnitus and the client-oriented scale of improvement in tinnitus. Results: Aural rehabilitation methods were mapped to concepts of: (1) Context, (2) presence of sound and (3) reaction to sound. A global theme was: adaptation to sound. The framework is the result of an iterative and cumulative research program exploring tinnitus as the outcome of the relationship between individual psychoacoustics and psychosocial factors including context of perception. Conclusions: The intent of this framework is to help guide audiologists managing tinnitus. The framework has been useful in our clinic as illustrated by a case study. The benefits of this approach relative to standard care needs to be independently ascertained. Implications for Rehabilitation Tinnitus is a common oto-neurological complaint that when severe can be very disabling. Tinnitus is very heterogeneous as a consequence of this no one treatment is suitable for everyone. The sound therapy and aural rehabilitation for tinnitus framework is designed to assist audiologists in clinical planning that addresses individual needs. The framework is the result of an iterative and cumulative research program exploring tinnitus as the outcome of the relationship between individual psychoacoustics and psychosocial factors including context of perception.

Auditory Streaming and Prediction in Tinnitus Sufferers.

OBJECTIVES: The aim of this study was to determine whether auditory streaming (segregation of incoming sounds into separate sound sources) and the ability to anticipate future auditory events are affected in tinnitus sufferers compared with nontinnitus controls with matched levels of hearing. It was hypothesized that tinnitus would result in abnormal electroencephalography responses to tone deviants and tone omissions compared to controls for frequencies near the pitch of tinnitus, and this should correspond with increased levels of cortical γ and θ oscillatory rhythms. DESIGN: Sixteen individuals with tinnitus (10 men and 6 women; age, 53.44; SD, 12.92 years) and 14 control participants (8 men and 6 women; age, 50.25; SD, 18.54 years) took part in the study. A modified version of the ABA streaming paradigm, with repeating triplet pattern of two frequencies (A and B) presented as A-B-A, was used to examine deviant-related prediction error. Omission-related prediction errors were examined using a modified version of a tone-omission paradigm. Regions of interest were frontocentral, left frontal, right frontal, and temporal lobes. RESULTS: A larger N1c waveform was elicited in the absence of any tone deviation within the left primary auditory cortex of tinnitus participants. No differences were present between groups for omissions. The only difference in oscillatory band activity between the two groups in this study was in response to tones 7 semitones different from tinnitus pitch, with significantly lower ß-2 band activity present for the tinnitus group, correlating most with activity within the right inferior occipital gyrus. CONCLUSIONS: The findings from this study imply that cortical-level auditory stream segregation is altered among individuals with tinnitus.

A Client Oriented Scale of Improvement in Tinnitus for Therapy Goal Planning and Assessing Outcomes.

BACKGROUND: There is a need to develop methods to help clinicians work with clients to select and personalize tinnitus therapies. The use of validated measures to determine treatment success is also essential for research and clinical practice. A goal planning method widely used in audiologic rehabilitation is the client oriented scale of improvement (COSI). A modified version of the COSI has been used to identify tinnitus treatment goals and outcomes (client oriented scale of improvement in tinnitus [COSIT]). PURPOSE: The aims of this study were to identify treatment goals in a clinic sample and ascertain the convergent validity of the COSIT to three widely used standardized questionnaires. RESEARCH DESIGN: A retrospective evaluation of client treatment goals using thematic analysis and correlational analysis of secondary research data comparing the COSIT to tinnitus handicap questionnaire (THQ), tinnitus handicap inventory (THI), and tinnitus functional index (TFI). STUDY SAMPLE: One hundred and twenty-two adult patients and research participants attending the University of Auckland Hearing and Tinnitus Clinic. RESULTS: Specific treatment goals were categorized into 11 themes. The most common treatment goals (>10% of responses) were: (1) Reducing tinnitus' effects on Hearing. (2) Improved wellbeing and being less depressed. (3) Coping with or controlling the tinnitus. (4) Managing the effect of the environment (context) on tinnitus. (5) Improving sleep. (6) Understanding tinnitus. Individuals differed in their complaints and priorities for treatment. The COSIT showed moderate convergent validity with the THQ, THI, and TFI indicating that the total scores measured similar constructs. CONCLUSIONS: The COSIT is a pragmatic method for determining tinnitus treatment goals and priorities in a format that should be familiar to audiologists.

Psychometric Validity, Reliability, and Responsiveness of the Tinnitus Functional Index.

BACKGROUND: The effects of treatments on tinnitus have been difficult to quantify. The Tinnitus Functional Index (TFI) has been proposed as a standard questionnaire for measurement of tinnitus treatment outcomes. For a questionnaire to achieve wide acceptance, its psychometric properties need to be confirmed in different populations. OBJECTIVE: To determine if the TFI is a reliable and valid measure of tinnitus, and if its psychometric properties are suitable for use as an outcome measure. RESEARCH DESIGN: A psychometric evaluation of the TFI from secondary data obtained from a cross-sectional clinic survey and a clinical trial undertaken in New Zealand. STUDY SAMPLE: Confirmatory factor analysis and evaluation of internal consistency reliability were undertaken on a sample of 318 patients with the primary complaint of tinnitus. In a separate sample of 40 research volunteers, test-retest reliability, convergent and divergent validity were evaluated. Both samples consisted of predominantly older Caucasian male patients with tinnitus. RESULTS: The internal structure of the original US TFI was confirmed. The Cronbach's Alpha and Intraclass correlation coefficients were >0.7 for the TFI overall and each of its subscales, indicating high internal consistency and test-retest reliability. Strong Pearson correlations with the Tinnitus Handicap Questionnaire and tinnitus numerical rating scales indicated excellent convergent validity, and a moderate correlation with the Hearing Handicap Inventory, indicated moderate divergent validity. Evaluation of the clinical trial showed good test-retest reliability and agreement between no-treatment baselines with a smallest detectable change of 4.8 points. CONCLUSIONS: The TFI is a reliable and valid measure of tinnitus severity in the population tested and is responsive to treatment-related change. Further research as to the TFI's responsiveness to treatment is needed across different populations.