Treatment of tinnitus with a customized, dynamic acoustic neural stimulus: clinical outcomes in general private practice.

OBJECTIVES: We evaluate the relative effectiveness of a newly available tinnitus treatment approach for different categories of patients in general private practice. METHODS: This was a cohort study, sponsored by Neuromonics, involving the first 470 patients to undertake the Neuromonics Tinnitus Treatment in 7 Neuromonics tinnitus clinics. All patients were provided with a dynamic acoustic neural stimulus, customized to each patient's audiometric profile, for daily use as part of a structured rehabilitation program. Tinnitus disturbance was assessed before, during, and after treatment with the Tinnitus Reaction Questionnaire. RESULTS: The outcomes displayed a relation with patients' suitability according to predefined criteria: among the most suitable patients (tier 1 cohort), 92% exceeded the threshold for success (defined as a reduction in tinnitus-related disturbance of at least 40%), and the mean improvement in tinnitus disturbance was 72%; the discontinuance rate was 4%. For other suitability categories, the success rates and mean improvements were somewhat lower, and the discontinuance rates higher (tier 2: 60%, 49%, and 16%, respectively; tier 3: 39%, 32%, and 17%, respectively). CONCLUSIONS: The results showed that the treatment is effective for suitable patients in the private practice setting, and they provide health-care professionals with guidance as to what patients might expect from treatment, depending on their degree of suitability.

Treatment of tinnitus with a customized, dynamic acoustic neural stimulus: underlying principles and clinical efficacy.

Tinnitus has been challenging to treat with consistently positive results. The Neuromonics Tinnitus Treatment is a newly available approach to the treatment of clinically significant, problematic tinnitus (and reduced sound tolerance) that was developed with the intention of simultaneously addressing the auditory, attentional, and emotional processes underlying the condition. It uses a prescribed acoustic stimulus, customized for each patient's individual audiometric profile, which provides a broad frequency stimulus to address the effects of auditory deprivation, promotes relief and relaxation with the intention of reducing engagement of the limbic system/amygdala and autonomic nervous system, and applies the principles of systematic desensitization to address the attentional processes. This article describes the underlying principles behind this approach. It also summarizes evidence for clinical efficacy from controlled clinical studies and from a private practice clinical setting, where it has been shown to provide consistently positive outcomes for patients meeting suitability criteria.

Treatment of tinnitus with a customized acoustic neural stimulus: a controlled clinical study.

In patients with tinnitus, achieving consistently positive treatment results is a challenge. We conducted a controlled clinical study of a new treatment approach (Neuromonics Tinnitus Treatment) that involves the use of a customized neural stimulus. This stimulus is delivered to the patient in the form of a pleasant acoustic sensation that is spectrally modified according to each patient's individual audiometric profile. This treatment approach is provided as part of a structured rehabilitation program. In our study, patients who received the customized stimulus (Neuromonics group) reported significantly greater and more consistent alleviation of tinnitus symptoms than did patients who participated in a counseling and support program with and without delivery of a broadband noise stimulus (Noise+Counseling group and Counseling-Only group, respectively). After 6 months of treatment, 86% of the Neuromonics patients met the minimum criterion for clinical success, defined as an alleviation of tinnitus disturbance of at least 40% (as determined by the Tinnitus Reaction Questionnaire score). By contrast, only 47 and 23% of the Noise+Counseling and Counseling-Only groups, respectively, reported a successful result according to this criterion. Mean improvements in tinnitus disturbance scores in the Neuromonics, Noise+Counseling, and Counseling-Only groups were 66, 22, and 15%, respectively. The differences between the Neuromonics group and the control groups were statistically significant. Significant differences were observed in other clinical outcomes. Patient reports of user acceptability were more consistently positive in the Neuromonics group.

Neuromonics Tinnitus Treatment: third clinical trial.

OBJECTIVES: 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. DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Multiple-channel non-linear power hearing instruments for children with severe hearing impairment: long-term follow-up.

The long-term benefits of multiple-channel non-linear technology for children with severe hearing impairment have yet to be fully investigated over the longer term. Twenty-one children with severe hearing loss participated in a study comparing performance on measures of audibility, speech understanding (in quiet and noise) and listening situations between the children's current analog hearing aids and a test hearing aid with multiple-channel non-linear compression (DigiFocus II Compact Power). Results were obtained from the children at 2 weeks, 8 weeks, 6 months and 12 months following the fitting of a multiple-channel non-linear hearing instrument. Compared with the children's own hearing instruments, the test instruments provided improved audibility, improvement in speech understanding in quiet and noise, and an improvement in listening skills The gains in speech understanding were greater in noise than in quiet, suggesting that the test hearing instrument provided greatest improvement when listening to speech in noise. While performance increased over time, there was no statistically significant evidence to support continued acclimatization.