Neuromonics Tinnitus Treatment: third clinical trial. The influence of training on tinnitus perception: an evaluation 12 months after tinnitus management training. A clinical study of tinnitus maskers. Prospective crossover evaluation of four methods of clinical management of tinnitus.
The Neuromonics Tinnitus Treatment combines the use of a novel approach to acoustic stimulation with a structured program of counseling and support by a clinician specifically trained in tinnitus rehabilitation. The distinctive acoustic component has been designed to provide stimulation to auditory pathways deprived by hearing loss, engage positively with the limbic system, and allow intermittent, momentary tinnitus perception within a pleasant and relaxing stimulus, thereby facilitating desensitization to the tinnitus signal. The purposes of this study were (1) to demonstrate the efficacy of the treatment, when enhanced with various modifications since previously reported trials and (2) to test the relative clinical effectiveness of two variations of the approach. In the first, intermittent tinnitus perception was facilitated throughout treatment through the use of a stimulus in which intensity peaks allowed the patients' tinnitus perception to be completely covered up, whereas in the intensity troughs their tinnitus was briefly discernible. In the second, subjects experienced little tinnitus perception while listening to the treatment for the first 2 mo, then experienced intermittent perception.
                Thirty-five subjects with a predominantly moderate to severe level of tinnitus-related distress before treatment were randomly allocated into one of two treatment groups, corresponding to the two stage-based variations of the Neuromonics Tinnitus Treatment. Participants were provided with a high-fidelity personal sound player with earphones and an acoustic stimulus that had been spectrally modified according to their individual audiometric profile. They were instructed to use the acoustic stimulus for at least 2 hr per day, particularly at those times when their tinnitus was usually disturbing. Each group had equal amounts of clinician time for education, monitoring, and support.
                At 2, 4, 6, and 12 mo after commencing treatment, both groups displayed clinically and statistically significant improvements in tinnitus distress, awareness, and minimum masking levels as well as loudness discomfort levels. Improvements increased with time over the first 6 mo of therapy, at which time 91% of all subjects across the two groups reported an improvement in tinnitus disturbance (as measured by the Tinnitus Reaction Questionnaire) of at least 40%, with a mean improvement of 65%. Also, 80% of subjects at 6 mo reported a level of tinnitus disturbance that was no longer clinically significant. There was some indication of a more consistent benefit over 12 mo for the group that was provided initially with a high level of tinnitus interaction; however, inter-group differences were not statistically significant. A relation between reported treatment usage (hours per day) and clinical outcomes was observed, suggesting that a "dosage effect" may apply with the stimulus provided.
                This study found that the Neuromonics Tinnitus Treatment provides rapid and profound improvements to the severity of tinnitus symptoms and their effect on the subject's quality of life. This was a consistent effect, provided by a treatment that subjects reported as being pleasant to use. Both of the stage-based variations of the treatment that were tested in this study were shown to be successful in achieving these outcomes. Sixty-five subjects were reviewed 12 months after tinnitus management training, which had been comprised variously of information, relaxation training and a therapeutic noise strategy. Seventy-four per cent of subjects reported increased habituation to tinnitus (n = 48), 65% reported reduced tinnitus annoyance (n = 42), and 52% reported an increased ability to cope with tinnitus (n = 34). Twenty-five per cent of subjects reported deterioration in coping ability (n = 16), 23% reported reduced habituation to tinnitus (n = 15) and 8% reported increased tinnitus-related annoyance (n = 5). None of the management strategies were found to be significantly more effective than others in facilitating improved coping or habituation to tinnitus. Subjects who reported reduced coping and habituation to tinnitus experienced greater levels of general life stress than subjects who reported increased habituation and coping ability. The use of relaxation therapies as applied in this study did not appear to influence the level of tinnitus distress or the level of life stress. Thirty-seven per cent of subjects given long-term low-level white noise (LTWN) stimulation reported benefit. However, LTWN stimulation did not significantly alter tinnitus awareness or the minimum masking level (MML) of tinnitus. Long-term low-level white noise stimulation appeared to influence cognitive reaction to tinnitus rather than its physical perception. Subjects who initially had low ability to cope with tinnitus and preferred a more active coping style reported significantly greater benefit from LTWN stimulation than subjects whose primary approach to coping was to regulate the emotional impact of tinnitus. This report describes a three-centre study of the effectiveness of tinnitus maskers, combination instruments (masker plus hearing aid), and hearing aids in the management of tinnitus. Some 472 patients entered the study with 382 reaching the first evaluation session after a minimum period of 6 months from fitting, and 206 reaching the second evaluation not less than 6 months after the first. The study included two control groups, by which to assess the comparative benefit to be derived solely from the investigation and counselling of such patients. The principal results were as follows: thorough investigation and careful counselling do much to help the patient; much further benefit is given by tinnitus masking instruments of various kinds; maskers are more often effective than hearing aids, although the latter are frequently the most appropriate first treatment of those patients who have substantial (but not yet treated or insufficiently treated) hearing difficulties as well; there is no evidence of masking having any harmful effect on hearing. None of the audiometric or tinnitus tests currently employed can be regarded as predictive, either of tinnitus severity, or of the eventual outcome of masking therapy, however certain measurements may help as a guide to patient management. This article summarizes data obtained from 34 tinnitus-afflicted patients who participated in and completed a prospective crossover evaluation of four methods of clinical management of tinnitus. The methods included a 2-week trial with each of the following: a tinnitus masker, a tinnitus instrument (a combination device consisting of a tinnitus masker and a hearing aid), a hearing aid, and conventional environmental controls. The relative effectiveness of each method of treatment was assessed by interview. The data presented summarize respondents' preferences for each method of treatment. Use of a tinnitus masker, tinnitus instrument, and hearing aid is related to stability of auditory thresholds. Comments are made on our experience with clinical management of the patient afflicted with tinnitus, and observations are offered on continued investigation in this area.
The limited data from the included studies failed to show strong evidence of the efficacy of sound therapy in tinnitus management. The absence of conclusive evidence should not be interpreted as evidence of lack of effectiveness. The lack of quality research in this area, in addition to the common use of combined approaches (hearing therapy plus counselling) in the management of tinnitus are, in part, responsible for the lack of conclusive evidence. Other combined forms of management, such as tinnitus retraining therapy, have been subject to a Cochrane Review. Optimal management may involve multiple strategies.