Tara L. Zaugg

Clinical trial to compare tinnitus masking and tinnitus retraining therapy

Conclusion: Both tinnitus masking (TM) and tinnitus retraining therapy (TRT) can be effective therapies for amelioration of tinnitus. TM may be more effective for patients in the short term, but with continued treatment TRT may produce the greatest effects. Objectives: Although TM and TRT have been used for many years, research has not documented definitively the efficacy of these methods. The present study was a controlled clinical trial to prospectively evaluate the clinical efficacy of these two methods for US military veterans with severe tinnitus. Subjects and methods: Over 800 veterans were screened to ensure that enrolled patients had tinnitus of sufficient severity to justify 18 months of individualized treatment. Qualifying patients (n=123) were placed quasi-randomly (alternating placement) into treatment with either TM or TRT. Treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated primarily using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index). Results: Findings are presented from the three written questionnaires with respect to three categories of patients: describing tinnitus as a ‘moderate,’ ‘big,’ and ‘very big’ problem at baseline. Based on effect sizes, both groups showed considerable improvement overall. In general, TM effects remained fairly constant over time while TRT effects improved incrementally. For the patients with a ‘moderate’ and ‘big’ problem, TM provided the greatest benefit at 3 and 6 months; benefit to these TRT patients was slightly greater at 12 months, and much greater at 18 months. For patients with a ‘very big’ problem, TM provided the greatest benefit at 3 months. For these latter patients, results were about the same between groups at 6 months, and improvement for TRT was much greater at 12 months, with further gains at 18 months.

Using Therapeutic Sound With Progressive Audiologic Tinnitus Management

Management of tinnitus generally involves educational counseling, stress reduction, and/or the use of therapeutic sound. This article focuses on therapeutic sound, which can involve three objectives: (a) producing a sense of relief from tinnitus-associated stress (using soothing sound); (b) passively diverting attention away from tinnitus by reducing contrast between tinnitus and the acoustic environment (using background sound); and (c) actively diverting attention away from tinnitus (using interesting sound). Each of these goals can be accomplished using three different types of sound—broadly categorized as environmental sound, music, and speech—resulting in nine combinations of uses of sound and types of sound to manage tinnitus. The authors explain the uses and types of sound, how they can be combined, and how the different combinations are used with Progressive Audiologic Tinnitus Management. They also describe how sound is used with other sound-based methods of tinnitus management (Tinnitus Masking, Tinnitus Retraining Therapy, and Neuromonics).

The Role of Audiologic Evaluation in Progressive Audiologic Tinnitus Management

Progressive Audiologic Tinnitus Management (PATM) is based on the premise that tinnitus is managed most efficiently using a hierarchy of clinical services that address different levels of need. PATM includes five levels of management: (a) triage; (b) audiologic evaluation; (c) group education; (d) tinnitus evaluation; and (e) individualized management. This article provides an overview of PATM and focuses on the procedures that make up the Level 2 Audiologic Evaluation. The evaluation is conducted to assess the potential need for medical, audiologic (hearing loss, tinnitus, hyperacusis), and/or mental health services. The Tinnitus Handicap Inventory, Hearing Handicap Inventory, and Tinnitus and Hearing Survey are used to differentiate effects of tinnitus and hearing loss. If indicated, patients are interviewed with the Tinnitus-Impact Screening Interview. Patients requiring amplification receive hearing aids. Often, management of hearing loss at Level 2 addresses any problems that were attributed to the tinnitus, which obviates further tinnitus-specific intervention.

Auditory Test Result Characteristics of Subjects with and without Tinnitus

Tinnitus is the perception of sound that does not have an acoustic source in the environment. Ascertaining the presence of tinnitus in individuals who claim tinnitus for compensation purposes is very difficult and increasingly becoming a problem. This study examined the potential to observe differences in loudness and pitch matches between individuals who experience tinnitus versus those who do not. This study follows a previous pilot study we completed that included 12 subjects with and 12 subjects without tinnitus. The current study included 36 subjects with and 36 without tinnitus. Results of this study revealed no significant differences between groups with regard to decibel sensation level (SL) loudness matches and within-session loudness-match reliability. Between-group differences revealed that the tinnitus subjects had (1) greater decibel sound pressure level loudness matches, (2) better between-session loudness-match reliability, (3) better pitch-match reliability, and (4) higher frequency pitch matches. These findings support the data from our pilot study with the exception that decibel SL loudness matches were greater for the tinnitus subjects in the pilot study. Tinnitus loudness and pitch matching may have some value in an overall battery of tests for evaluating tinnitus claims.

Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used With Progressive Tinnitus Management

Purpose This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention involved 5 group workshops: 2 led by an audiologist (teaching how to use sound as therapy) and 3 by a psychologist (teaching coping skills derived from cognitive behavioral therapy). It was hypothesized that PTM would be more effective than wait-list control in reducing functional effects of tinnitus and that there would be no differences in effectiveness between sites. Results At both sites, a statistically significant improvement in mean Tinnitus Functional Index scores was seen at 6 months for the PTM group. Combined data across sites revealed a statistically significant improvement in Tinnitus Functional Index relative to wait-list control. The effect size for PTM using the Tinnitus Functional Index was 0.36 (small). Conclusions Results suggest that PTM is effective at reducing tinnitus-related functional distress in clinical settings. Although effect sizes were small, they provide evidence of clinical effectiveness of PTM in the absence of stringent research-related inclusion criteria and with a relatively small number of sessions of cognitive behavioral therapy.

Multisite Randomized Controlled Trial to Compare Two Methods of Tinnitus Intervention to Two Control Conditions.

Objectives: In this four-site clinical trial, we evaluated whether tinnitus masking (TM) and tinnitus retraining therapy (TRT) decreased tinnitus severity more than the two control groups: an attention-control group that received tinnitus educational counseling (and hearing aids if needed; TED), and a 6-month-wait-list control (WLC) group. The authors hypothesized that, over the first 6 months of treatment, TM and TRT would decrease tinnitus severity in Veterans relative to TED and WLC, and that TED would decrease tinnitus severity relative to WLC. The authors also hypothesized that, over 18 months of treatment, TM and TRT would decrease tinnitus severity relative to TED. Treatment effectiveness was hypothesized not to be different across the four sites. Design: Across four Veterans affairs medical center sites, N = 148 qualifying Veterans who experienced sufficiently bothersome tinnitus were randomized into one of the four groups. The 115 Veterans assigned to TM (n = 42), TRT (n = 34), and TED (n = 39) were considered immediate-treatment subjects; they received comparable time and attention from audiologists. The 33 Veterans assigned to WLC were, after 6 months, randomized to receive delayed treatment in TM, TRT, or TED. Assessment of outcomes took place using the Tinnitus Handicap Inventory (THI) at 0, 3, 6, 12, and 18 months. Results: Results of a repeated measures analysis of variance using an intention-to-treat approach showed that the tinnitus severity of Veterans receiving TM, TRT, and TED significantly decreased (p < 0.05) relative to Veterans in the WLC group at 3 months (effect sizes = 0.44, 0.52, and 0.27, respectively) and at 6 months (effect sizes = 0.52, 0.56, and 0.40, respectively). Analyses comparing effectiveness of TM, TRT, and TED over 18 months revealed that the three conditions were not significantly different, but that tinnitus severity in the combined groups significantly decreased (p < 0.01) from baseline to 3 months (5.6 THI points) and from 3 to 6 months (3.7 THI points). With respect to clinically significant change, about half of Veterans who received TM (55%), TRT (59%), or TED (46%) showed strong or modest improvement on the THI by 18 months. Without treatment, the WLC group did not show significant change. Treatment effectiveness did not differ by study site. Conclusions: Audiologists who provided interventions to Veterans with bothersome tinnitus in the regular clinic setting were able to significantly reduce tinnitus severity over 18 months using TM, TRT, and TED approaches. These results suggest that TM, TRT, and TED, when implemented as in this trial, will provide effectiveness that is relatively similar by 6 months and beyond.

Development and field testing of a smartphone “App” for tinnitus management

Abstract Objective: This study’s objective was to develop and test a smartphone app that supports learning and using coping skills for managing tinnitus. Design: The app’s content was based on coping skills that are taught as a part of progressive tinnitus management (PTM). The study involved three phases: (1) develop a prototype app and conduct usability testing; (2) conduct two focus groups to obtain initial feedback from individuals representing potential users; and (3) conduct a field study to evaluate the app, with three successive groups of participants. Study Sample: Participants were adults with bothersome tinnitus. For Phase 2, two focus groups were attended by a total of 17 participants. Phase 3 involved three consecutive rounds of participants: five from the focus groups followed by two rounds with 10 participants each who had not seen the app previously. Results: In both the focus groups and field studies, participants responded favourably to the content. Certain features, however, were deemed too complex. Conclusion: Completion of this project resulted in the development and testing of the delivery of PTM coping skills via a smartphone app. This new approach has the potential to improve access to coping skills for those with bothersome tinnitus.

Randomized Controlled Trial of a Novel Device for Tinnitus Sound Therapy During Sleep

Purpose The aim of this study was to determine if a customized stimulus from the Otoharmonics Levo System reduces tinnitus perceptions and reactions for people with bothersome tinnitus. Method Sixty participants were randomized to 1 of 3 groups that used sound therapy devices during sleep that differed in their acoustic stimulus: (a) tinnitus-matched (TM), (b) noise stimulus (NS), and (c) bedside sound generator (BSG). Outcome measures were the Tinnitus Functional Index (TFI), numeric rating scale of tinnitus loudness, and tinnitus loudness match. A Bayesian hierarchical model was fit to estimate the differences in treatment efficacy among groups. Results Average tinnitus reactions and perceptions improved across treatment groups. We are at least 87% certain that treatment with TM or NS reduces mean TFI compared to treatment with BSG, with an estimated relative efficacy of 4.5-5 points greater reduction. We are at least 95% certain that treatment with TM results in greater reduction in mean numeric rating scale (NRS) of tinnitus loudness compared to the other groups, with an estimated relative efficacy of about 0.75 points greater reduction. Conclusions This study offers some support for greater average improvement in reactions to tinnitus with TM or NS devices compared to the BSG device. The TM group, compared to the BSG and NS groups, showed a greater reduction in ratings of tinnitus loudness on the NRS on average. Supplemental Material https://doi.org/10.23641/asha.5545759.

A qualitative study of implementation and adaptations to Progressive Tinnitus Management (PTM) delivery

Background Tinnitus is a common condition, especially prevalent among military Veterans. Progressive Tinnitus Management (PTM) is an interdisciplinary, structured, stepped-care approach to providing clinical services, including teaching coping skills, to people bothered by tinnitus. PTM has been shown to be effective at reducing functional distress, but implementation of the intervention outside of a research setting has not been studied, even though dissemination is underway within the Veterans Health Administration (VHA) system in the United States. This study was designed to address a gap in knowledge of PTM clinical implementation to date, with a focus on factors facilitating or hindering implementation in VHA audiology and mental health clinic contexts, and whether implementing sites had developed intervention adaptations. Methods Qualitative interviews were conducted with 21 audiology and mental health clinicians and service chiefs across a regional service network. Interviews were transcribed and coded using a hybrid inductive-deductive analytic approach guided by existing implementation research frameworks and then iteratively developed for emergent themes. Results PTM prioritization was rare overall, with providers across disciplines challenged by lack of capacity for implementation, but with differences by discipline in challenges to prioritization. Where PTM was prioritized and delivered, this was facilitated by perception of unique value, provider’s own experience of tinnitus, observation/experience with PTM delivery, intervention fit with provider’s skills, and an environment with supportive leadership and adaptive reserve. PTM was frequently adapted to local contexts to address delivery challenges and diversify patient options. Adaptations included shifting from group to individual formats, reducing or combining sessions, and employing novel therapeutic approaches. Conclusions Existing adaptations highlight the need to better understand mechanisms underlying PTM’s effectiveness, and research on the impact of adaptations on patient outcomes is an important next step. Prioritization of PTM is a key barrier to the scale up and spread of this evidence-based intervention. Developing clinician champions may facilitate dissemination, especially if accompanied by signals of systemic prioritization. Novel approaches exposing clinicians and administrators to PTM may identify and develop clinical champions. Acknowledging the potential for PTM adaptations may make delivery more feasible in the context of existing system constraints and priorities.