The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus.

OBJECTIVES: Chronic subjective tinnitus is a prevalent condition that causes significant distress to millions of Americans. Effective tinnitus treatments are urgently needed, but evaluating them is hampered by the lack of standardized measures that are validated for both intake assessment and evaluation of treatment outcomes. This work was designed to develop a new self-report questionnaire, the Tinnitus Functional Index (TFI), that would have documented validity both for scaling the severity and negative impact of tinnitus for use in intake assessment and for measuring treatment-related changes in tinnitus (responsiveness) and that would provide comprehensive coverage of multiple tinnitus severity domains. DESIGN: To use preexisting knowledge concerning tinnitus-related problems, an Item Selection Panel (17 expert judges) surveyed the content (175 items) of nine widely used tinnitus questionnaires. From those items, the Panel identified 13 separate domains of tinnitus distress and selected 70 items most likely to be responsive to treatment effects. Eliminating redundant items while retaining good content validity and adding new items to achieve the recommended minimum of 3 to 4 items per domain yielded 43 items, which were then used for constructing TFI Prototype 1.Prototype 1 was tested at five clinics. The 326 participants included consecutive patients receiving tinnitus treatment who provided informed consent-constituting a convenience sample. Construct validity of Prototype 1 as an outcome measure was evaluated by measuring responsiveness of the overall scale and its individual items at 3 and 6 mo follow-up with 65 and 42 participants, respectively. Using a predetermined list of criteria, the 30 best-functioning items were selected for constructing TFI Prototype 2.Prototype 2 was tested at four clinics with 347 participants, including 155 and 86 who provided 3 and 6 mo follow-up data, respectively. Analyses were the same as for Prototype 1. Results were used to select the 25 best-functioning items for the final TFI. RESULTS: Both prototypes and the final TFI displayed strong measurement properties, with few missing data, high validity for scaling of tinnitus severity, and good reliability. All TFI versions exhibited the same eight factors characterizing tinnitus severity and negative impact. Responsiveness, evaluated by computing effect sizes for responses at follow-up, was satisfactory in all TFI versions.In the final TFI, Cronbach's alpha was 0.97 and test-retest reliability 0.78. Convergent validity (r = 0.86 with Tinnitus Handicap Inventory [THI]; r = 0.75 with Visual Analog Scale [VAS]) and discriminant validity (r = 0.56 with Beck Depression Inventory-Primary Care [BDI-PC]) were good. The final TFI was successful at detecting improvement from the initial clinic visit to 3 mo with moderate to large effect sizes and from initial to 6 mo with large effect sizes. Effect sizes for the TFI were generally larger than those obtained for the VAS and THI. After careful evaluation, a 13-point reduction was considered a preliminary criterion for meaningful reduction in TFI outcome scores. CONCLUSIONS: The TFI should be useful in both clinical and research settings because of its responsiveness to treatment-related change, validity for scaling the overall severity of tinnitus, and comprehensive coverage of multiple domains of tinnitus severity.

A comparison of benefit and economic value between two sound therapy tinnitus management options.

BACKGROUND: Sound therapy coupled with appropriate counseling has gained widespread acceptance in the audiological management of tinnitus. For many years, ear level sound generators (SGs) have been used to provide masking relief and to promote tinnitus habituation. More recently, an alternative treatment device was introduced, the Neuromonics Tinnitus Treatment (NTT), which employs spectrally-modified music in an acoustic desensitization approach in order to help patients overcome the disturbing consequences of tinnitus. It is unknown, however, if one treatment plan is more efficacious and cost-effective in comparison to the other. In today's economic climate, it has become critical that clinicians justify the value of tinnitus treatment devices in relation to observed benefit. PURPOSE: To determine perceived benefit from, and economic value associated with, two forms of sound therapy, namely, SGs and NTT. RESEARCH DESIGN: Retrospective between-subject clinical study. STUDY SAMPLE: A sample of convenience comprised of 56 patients drawn from the Tinnitus Management Clinic at the Cleveland Clinic participated. Twenty-three patients selected SGs, and 33 patients selected NTT as their preferred sound therapy treatment option. DATA COLLECTION AND ANALYSIS: Sound therapy benefit was quantified using the Tinnitus Handicap Inventory (THI). The questionnaire was administered before and 6 mo after initiation of tinnitus treatment. Prior to device fitting, all patients participated in a 1.5 hr group education session about tinnitus and its management. Economic value comparisons between sound therapy options were made using a cost-effectiveness analysis (CEA) and cost-utility analysis (CUA). RESULTS: THI scores indicated a significant improvement (p < 0.001) in tinnitus reduction for both treatment types between a pre- and 6 mo postfitting interval, yet there were no differences (p > 0.05) between the treatment alternatives at baseline or 6 mo postfitting. The magnitude of improvement for both SGs and NTT was dependent on initial perceived tinnitus handicap. Based on the CEA and CUA economic analyses alone, it appears that the SGs may be the more cost-effective alternative; however, the magnitude of economic value is a function of preexisting perceived tinnitus activity limitation/participation restriction. CONCLUSIONS: Both SGs and NTT provide significant reduction in perceived tinnitus handicap, with benefit being more pronounced for those patients having greater tinnitus problems at the beginning of therapy. Although the economic models favored the SGs over the NTT, there are several other critical factors that clinicians must take into account when recommending a specific sound therapy option. These include initial tinnitus severity complaints and a number of patient preference variables such as sound preference, listening acceptability, and lifestyle.

Development and psychometric adequacy of the screening version of the tinnitus handicap inventory.

OBJECTIVE: To develop a screening version of the Tinnitus Handicap Inventory (THI-S) and establish its psychometric characteristics. DESIGN: : Prospective clinical study to analyze 1) the level of predictability between THI and THI-S; 2) test-retest reliability of the THI-S; 3) 95% confidence intervals (critical difference scores) for the THI-S; and 4) a THI-S cutoff score used for referral purposes. SETTING: Head and Neck Institute at the Cleveland Clinic, a tertiary care medical center. PATIENTS: : Thirty-three patients reporting tinnitus as their primary complaint. INTERVENTIONS: There was, on average, a 16-day interval between test-retest administrations of the THI-S. MAIN OUTCOME MEASURE: Comparability of scores between the THI and the THI-S and test-retest reliability of the THI-S was assessed using Pearson product-moment correlations. The level of agreement between the 2 administrations of the THI-S was evaluated using Bland-Altman repeatability plots. RESULTS: Comparability between the THI and THI-S was high (r = 0.90). Test-retest reliability of the THI-S was adequate (r = 0.81), as well as the level of agreement between administrations as demonstrated by the Bland-Altman plot. Based on 95% confidence intervals, pretreatment and posttreatment scores would have to differ by more than 10 points for intervention efforts to be considered significant. A 6-point cutoff score was analyzed as an appropriate fence for referral. CONCLUSION: The THI-S is a psychometrically robust screening measure of activity limitation and participation restriction.

Effects of AUT00063, a Kv3.1 channel modulator, on noise-induced hyperactivity in the dorsal cochlear nucleus.

The purpose of this study was to test whether a Kv3 potassium channel modulator, AUT00063, has therapeutic potential for reversing noise-induced increases in spontaneous neural activity, a state that is widely believed to underlie noise-induced tinnitus. Recordings were conducted in noise exposed and control hamsters from dorsal cochlear nucleus (DCN) fusiform cells before and following intraperitoneal administration of AUT00063 (30 mg/kg). Fusiform cell spontaneous activity was increased in sound-exposed animals, approximating levels that were nearly 50% above those of controls. Administration of AUT00063 resulted in a powerful suppression of this hyperactivity. The first signs of this suppression began 13 min after AUT00063 administration, but activity continued to decline gradually until reaching a floor level which was approximately 60% of pre-drug baseline by 25 min after drug treatment. A similar suppressive effect of AUT00063 was observed in control animals, with onset of suppression first apparent at 13 min post-treatment, but continuing to decline toward a floor level that was 54% of pre-drug baseline and was reached 28 min after drug treatment. In contrast, no suppression of spontaneous activity was observed in animals given similar injections of vehicle (control) solution. The suppressive effect of AUT00063 was achieved without significantly altering heart rate and with minimal effects on response thresholds, supporting the interpretation that the reductions of hyperactivity were not a secondary consequence of a more general physiological suppression of the brain or auditory system. These findings suggest that Kv3 channel modulation may be an effective approach to suppressing spontaneous activity in the auditory system and may provide a future avenue for treatment of tinnitus resulting from exposure to intense sound.

A Speech Perception Test in Simulated Reverberation Conditions.

PURPOSE: This study developed new test materials by applying various reverberation treatments to sentences having high and low contextual redundancy. METHOD: The Speech Perception in Noise-Revised (SPIN-R; Bilger, Nuetzel, Rabinowitz, & Rzeczkowski, 1984; Kalikow, Stevens, & Elliott, 1977) sentences were modified (SPIN-Reverb) with reverberation times (RT60) from simulated environments: unprocessed, RevCond 1 (RT60 = 600 ms), RevCond 2 (RT60 = 1200 ms), and RevCond 3 (RT60 = 3600 ms). Phase 1 investigated list equivalency among 75 listeners with normal hearing; Phase 2 examined the utility of SPIN-Reverb for 15 cochlear implant (CI) recipients. RESULTS: Equivalent lists within each reverberation condition (unprocessed, RevCond 1, 2, and 3) were identified using nonparametric bootstrapping. Analysis of variance (Phase 1) demonstrated significant differences across conditions for high predictability and total scores. Listening performance decreased for both high and low predictability as RT60 increased for listeners with normal hearing and CI recipients. Unprocessed, RevCond 1, RevCond 2, and RevCond 3 conditions were significantly different from each other. Within RevCond conditions, high- and low-predictability sentences were significantly different from each other. CONCLUSIONS: RevCond 1 and RevCond 2 may be useful supplements to the current CI battery. The SPIN-Reverb has potential as a set of clinically feasible materials that are graded in difficulty and representative of real-life acoustic challenges for the evaluation of sensory devices.

Vestibular nerve sectioning for intractable vertigo: efficacy of simplified retrosigmoid approach.

OBJECTIVE: To determine the surgical efficacy of a simplified retrosigmoid approach for vestibular nerve sectioning. STUDY DESIGN: A retrospective analysis. SETTING: Tertiary academic referral center. PATIENTS: Twenty-eight consecutive patients who underwent vestibular nerve sectioning for intractable peripheral vestibular disorders. INTERVENTION: All patients had a simplified retrosigmoid approach for vestibular nerve sectioning. MAIN OUTCOME MEASURES: Functional outcome after vestibular nerve sectioning was analyzed with respect to improvement in patient disability from vertigo and reduction in the frequency of definitive vertigo attacks. Resolution of lightheadedness provided an additional outcome measure. The incidence of surgical complications, including postoperative headache, was determined, and the operative time was reviewed. RESULTS: Twenty-six patients (92.9%) had an improved functional level postoperatively, 21 (75.0%) had excellent improvement, 4 (14.3%) had significant improvement, 1 (3.6%) had limited improvement, and 2 (7.1%) had no change. No patient was worse postoperatively. Eighteen of 23 Ménière's patients (78.3%) had complete control of definitive vertigo attacks after vestibular nerve sectioning. Improvement in lightheadedness was seen in 23 patients (82.1%), 11 (39.3%) of whom reported complete resolution. Postoperative headache developed in 1 (3.6%) patient. No patients experienced infection, facial weakness, or leakage of cerebrospinal fluid. Mild hearing deterioration was seen in 2 patients (7.1%). The mean operative time was 76.3 minutes. CONCLUSION: With excellent efficacy, short operative time, and a low incidence of postoperative hearing loss or headache, this simplified retrosigmoid technique should be considered for vestibular nerve sectioning in patients with intractable peripheral vestibular disorders.

Hearing loss is often undiscovered, but screening is easy.

Screening for hearing loss should be part of the routine physical examination, but it is often not done because of time constraints. We present a quick and easy office screening test that measures the functional impact of hearing loss. We also review the steps of audiologic management that follow referral by the primary care physician.

Assessing outcomes of tinnitus intervention.

BACKGROUND: It has been estimated that as many as 50 million Americans do experience or have experienced tinnitus. For approximately 12 million of these individuals, tinnitus makes it impossible for them to carry out normal everyday activities without limitation. These are the patients that present to audiology clinics for assessment and management. The tinnitus evaluation includes the measurement of acoustical characteristics of tinnitus and the impact that this impairment has on health-related quality of life (HRQoL). Tinnitus is a disorder that often occurs as a result of auditory system impairment. The impairment for some can impart an activity limitation and a participation restriction (i.e., tinnitus-related disability or handicap, respectively). The goal of tinnitus management is to reduce, or eliminate, activity limitations and participation restrictions by reducing or eliminating a patient's perception of tinnitus or their reaction to tinnitus. Implicit in this statement is the assumption that there exist standardized measures for quantifying the patient's tinnitus perception and their reaction to it. If there existed stable and responsive standardized tinnitus measures, then it would be possible to compare a patient's tinnitus experience at different time points (e.g., before and after treatment) to assess, for example, treatment efficacy. PURPOSE: The purposes of the current review are to (1) describe psychometric standards used to select outcome measurement tools; (2) discuss available measurement techniques and their application to tinnitus evaluation and treatment-related assessment within the domains established by the World Health Organization's International Classification of Functioning, Disability and Health; (3) list and briefly describe self-report tinnitus questionnaires; (4) describe how valuation of tinnitus treatment can be assessed using economic models of treatment effectiveness; and (5) provide future directions including the development of a tinnitus outcomes test battery and treatment-related study designs. RESEARCH DESIGN: Retrospective literature review CONCLUSIONS: Although psychometrically robust measures of tinnitus HRQoL do exist, there is no unanimity in, for example, what tests should be included in the tinnitus assessment, and how studies of HRQoL should be conducted. The current authors suggest that future studies employ more rigorous designs and contain (minimally) the following characteristics: (1) utilization of randomized control groups and blinding; (2) appropriate statistical testing including "dropouts" that should be used in an "intention to treat" analysis rather than elimination from the final data set; (3) long-term follow-up assessment to evaluate responsiveness; (4) appropriate inclusion criteria to avoid "ceiling" and "floor" effects; and (5) suitable sample sizes based on the application of power analyses.

Induction of enhanced acoustic startle response by noise exposure: dependence on exposure conditions and testing parameters and possible relevance to hyperacusis.

There has been a recent surge of interest in the development of animal models of hyperacusis, a condition in which tolerance to sounds of moderate and high intensities is diminished. The reasons for this decreased tolerance are likely multifactorial, but some major factors that contribute to hyperacusis are increased loudness perception and heightened sensitivity and/or responsiveness to sound. Increased sound sensitivity is a symptom that sometimes develops in human subjects after acoustic insult and has recently been demonstrated in animals as evidenced by enhancement of the acoustic startle reflex following acoustic over-exposure. However, different laboratories have obtained conflicting results in this regard, with some studies reporting enhanced startle, others reporting weakened startle, and still others reporting little, if any, change in the amplitude of the acoustic startle reflex following noise exposure. In an effort to gain insight into these discrepancies, we conducted measures of acoustic startle responses (ASR) in animals exposed to different levels of sound, and repeated such measures on consecutive days using a range of different startle stimuli. Since many studies combine measures of acoustic startle with measures of gap detection, we also tested ASR in two different acoustic contexts, one in which the startle amplitudes were tested in isolation, the other in which startle amplitudes were measured in the context of the gap detection test. The results reveal that the emergence of chronic hyperacusis-like enhancements of startle following noise exposure is highly reproducible but is dependent on the post-exposure thresholds, the time when the measures are performed and the context in which the ASR measures are obtained. These findings could explain many of the discrepancies that exist across studies and suggest guidelines for inducing in animals enhancements of the startle reflex that may be related to hyperacusis.

Evaluation of a customized acoustical stimulus system in the treatment of chronic tinnitus.

OBJECTIVE: The purpose of this study is to evaluate the efficacy of a customized acoustical stimulus (Neuromonics) system in the treatment of chronic tinnitus. STUDY DESIGN: Multi-institutional prospective. SETTING: Nine U.S. Tertiary Otological referral centers; ambulatory. PATIENTS: Fifty-two adults with chronic tinnitus for a minimum of 6 months, with poor or no response to previous treatments, and not undergoing concomitant therapies were enrolled. INTERVENTIONS: Treatment was delivered in 2 stages: Stage 1 consisted of stimulation with the patient-customized musical tracks and white noise masking of the tinnitus for 2 months, 2 to 4 hours a day. Stage 2 consisted of listening to the same tracks, with no tinnitus masking for 4 months. Both phases included education, cognitive therapy, and periodic follow-up. MAIN OUTCOME MEASURES: Treatment response was measured through validated psychometric testing: the Tinnitus Reaction Questionnaire and the Tinnitus Handicap Inventory. Other measures included the Hospital Anxiety Depression Scale and loudness discomfort levels. RESULTS: Patients' responses were recorded from 38 patients at 6 months, 28 patients at 12 months, and 12 patients at 24 months after initiation of treatment. A total of 14 patients withdrew or were lost to follow-up, and the rest had not reached the 12- or 24-month testing interval. The Tinnitus Reaction Questionnaire score was significantly reduced in 74% of patients at 12 months and 84% of patients at 24 months. Tinnitus Handicap Inventory scores were significantly reduced in 77% of patients at 12 months and 50% at 24 months. CONCLUSION: The customized acoustical stimulus system offers a safe and effective means of tinnitus management for patients with chronic tinnitus.

Tinnitus: patients do not have to 'just live with it'.

Tinnitus is distressing and affects the quality of life for many patients. Because primary care physicians may be the entry point for patients seeking help for tinnitus, we urge them to acknowledge this symptom and its potential negative impact on the patient's health and quality of life. Physicians should actively listen to the patient and provide hope and encouragement, but also provide realistic expectations about the course of treatment. The patient must also understand that there may be no singular "cure" for tinnitus and that management may involve multidisciplinary assessment and treatment.

Longitudinal benefit from and satisfaction with the Baha system for patients with acquired unilateral sensorineural hearing loss.

OBJECTIVE: To analyze the short-, medium-, and long-term benefits from and satisfaction with the Baha for patients with profound unilateral sensorineural hearing loss (SNHL). DESIGN: Prospective clinical study. SETTING: Head and Neck Institute at the Cleveland Clinic. PATIENTS: Eight patients with acquired profound unilateral SNHL. INTERVENTIONS: Patients underwent unaided baseline testing and aided Baha testing using laboratory and self-report measures at 6 postfitting intervals. MAIN OUTCOME MEASURES: Laboratory measures included the revised Speech Perception in Noise test, Hearing in Noise Test, and localization testing. Disease-specific self-report measures included the Abbreviated Profile of Hearing Aid Benefit, Hearing Handicap Inventory for Adults, and Single-Sided Deafness Questionnaire. The Medical Outcomes Study SF-36 Health Survey was used to assess health-related quality of life. RESULTS: Based on 95% confidence intervals for unaided testing, significant improvements on aided revised Speech Perception in Noise, Abbreviated Profile of Hearing Aid Benefit, and Hearing Handicap Inventory for Adults scores were sustained during the 18-month test interval. Variable performance was observed for the Hearing in Noise Test over time and patients. No acclimatization effects were shown for localization testing or the generic health-related quality-of-life measure. Patients reported satisfaction in a variety of situations as quantified by the Single-Sided Deafness Questionnaire in the long-term. CONCLUSION: The Baha is effective in reducing psychosocial consequences of unilateral profound SNHL for the long-term. Improvement in speech understanding occurred when the primary signal was spatially separated from background noise. Localization performance did not improve with Baha use. Overall, patients were satisfied with their Baha and would still elect to have this procedure if given a second chance.

Benefit From, Satisfaction With, and Cost-Effectiveness of Three Different Hearing Aid Technologies.

Clinical decision-making has become more complex as newer, more costly, hearing aid (HA) technologies become available. The expanding array of more expensive HAs demands that clinical researchers continue to justify the value of these instruments relative to the substantial increase in cost to both the provider and consumer.In the present report, 25 current conventional HA users with adult onset of sensorineural hearing loss were fitted with: (a) a one-channel linear HA; (b) a two-channel, nonlinear HA; and (c) a seven-band, two-channel digital signal processing (DSP) HA. All instruments were mini behind-the-ear units with identifying information removed from the cases. Subjects wore each HA for at least a 1-month period.A set of laboratory (Speech Perception in Noise [SPIN] test; audibility index calculated from real-ear measurements) and self-report (Abbreviated Profile of Hearing Aid Benefit; Hearing Handicap Inventory for the Elderly/Adults; Knowles Hearing Aid Satisfaction Survey; preference ratings) outcome measures were used to evaluate the benefit from, satisfaction with, and cost-effectiveness of each test HA. As expected, there were statistically significant differences between unaided and aided conditions across HAs.Although the DSP instrument yielded significantly higher word recognition scores on the SPIN test, no differences were observed among the test HAs for the standardized self-report measures. In contrast, however, more than 75% of the subjects preferred the "higher end" instruments. Yet, 33% of the subjects changed their preference for the "higher end" instruments after being informed of costs. A cost-effectiveness model for evaluating the relationship between HA retail purchase price and improvements in performance/benefit is presented.