Rehabilitation of Tinnitus Patients Using the Neuromonics Tinnitus Treatment
- Tinnitus, a phantom perception of sound, is a frequent clinical condition that may cause significant debilitation.
- Tinnitus treatments can focus on the condition itself or on patients’ reaction to their tinnitus.
- There is a growing acceptance that sound stimulation incites a neuroplastic change in the auditory pathways.
- Neuromonics utilizes highly tailored music and broad frequency wave sounds, in the context of a structured counseling, support, and monitoring program, with the intention of reversing the neurological, psychological, and audiological processes that caused the disturbance.
- Neuromonics also aims to facilitate a relaxation response and shift of attention, leading to a desensitization effect.
- Clinical trial and private clinic outcomes show that the neuromonics tinnitus treatment can consistently provide clinically significant levels of desensitization to tinnitus perception over a relatively short period of time.
- HL Hearing level
- LDL Loudness discomfort levels
- MML Minimum masking levels
- NTT Neuromonics tinnitus treatment
- RI Residual inhibition
- THQ Tinnitus history questionnaire
- TRQ Tinnitus reaction questionnaire
- TRT Tinnitus retraining therapy
Tyler  categorizes tinnitus treatment in two ways: one focused on tinnitus reduction or elimination (e.g., medications, electrical suppression) and the other focused on a patient’s reaction to the condition. Current thinking on the underlying mechanism of tinnitus emphasizes changes in the auditory and neural systems that can be broadly related to the aspects of perception, attentional, and emotional reaction to tinnitus [1–4]. Recent animal studies have shown that tinnitus may be linked to cortical reorganization . In addition, brain imaging studies have shown altered levels of activation in several areas of the brain in tinnitus sufferers. These areas include, for instance, the left temporal lobe (Brodman areas 21 & 41), left hippocampus and posterior thalamic region , right middle frontal and right middle temporal gyri , amygdala, parahippocampal gyrus and hippocampus , inferior colliculus , subcallosal area , right inferior colliculus in the left hippocampus , and the Heschl’s gyrus .
The neuromonics tinnitus treatment (NTT) is a structured tinnitus rehabilitation program consistent with these current models, incorporating structured counselling and individually customized broad frequency sounds including music for relaxation. The sounds are spectrally shaped to individually correct for each patient’s hearing loss configuration and it aims to address the auditory deprivation element of tinnitus pathogenesis, providing most the broadest stimulation of the auditory pathways. The purpose is to decrease the limbic system/amygdala’s involvement in the patient’s perception and reaction to tinnitus, thus promoting relaxation and relief [13–16]. This article provides an overview of the underlying principles of NTT, describes the standard protocol, and outlines candidacy for NTT in the context of published clinical trial and private practice data. The importance of counselling and the main challenges faced by patients and clinicians will be discussed.
Theoretical Basis for Counseling and Sound Treatment
Most hypotheses about the pathology of tinnitus agree that the abnormal neural activity in the brain that is perceived as a sound is a result of neuroplastic processes (e.g., [17, 5]). There is a general agreement that the limbic system and autonomic nervous system are involved in generating the awareness and annoyance from tinnitus [1–3, 17, 18]. This can explain why an individual’s reaction to tinnitus seems to be linked to the person’s emotional state.
The cognitive and emotional reaction to tinnitus is the target for tinnitus treatment that uses counseling. Some commonly used forms of tinnitus treatment combine counseling with acoustic stimulation: tinnitus retraining therapy and a hearing aid program are among these approaches.
Neuromonic tinnitus treatment is based on correcting the abnormal neural activity that causes tinnitus by inducing neural modification within areas of the brain related to audition, attention, and emotion . NTT involves counseling and sound stimulation consisting of music and broad frequency sound (shower noise-like sound) [13–18].
A unique aspect of neuromonics tinnitus treatment is that the spectrum of the sound is individually modified to account for each patient’s hearing loss; this enables the intensity to be set to a comfortably relaxing level. In a study of 35 patients, the average reduction in loudness of their tinnitus was 16.11 dB in a paired comparison between the original source music and the corresponding customized music, which the patient had set to their minimum masking level (MML) . The mean level of the source music was 72 dBA, which would make sleep onset and concentration difficult. The mean customized signal was 56 dB. This 16 dB difference is quite clinically significant when one recalls that 6 dB constitutes a perceptual halving of loudness. This ability to provide a high degree of relief at a comfortable level tends to greatly facilitate a sense of control over the tinnitus. As a result, it greatly reduces the significance of the tinnitus .
The purpose of the “shower noise”, combined with music, is to restore normal activation of the auditory system that may have been deprived of stimulation due to hearing loss or other forms of auditory dysfunction. The rationale is this maximizes the efficiency of sound stimulation to induce a neuroplastic change in the auditory pathways . This has been shown in numerous studies by the marked improvement over treatment in neuroplastic-mediated processes that are reflected by MML and loudness discomfort levels (LDL) [13, 14, 16].
Asymmetric hearing loss is compensated for to allow a balanced loudness perception. Consequently, a true stereo sound is afforded by the system’s ability to phase-lock the left and right channels. Considerable peak compression is also applied to fit within the typically narrow dynamic ranges of those with disturbing tinnitus. Further details of the algorithms for the customization of the sound stimuli are described in Hanley and Davis .
If the tinnitus is considered to be important, it will become part of patients’ consciousness and has been hypothesized to trigger a strong negative emotional reaction [19, 20]. In tinnitus retraining therapy (TRT), the use of noise was proposed because it may be considered “neutral” to the limbic system. Some patients may find noise to be unpleasant, thus possibly contributing to reasons why some patients have rejected the use of TRT [21, 22]. Neuromonics tinnitus treatment uses relaxation music as the predominant signal in order to activate the limbic system with positive associations. The sound is presented within the context of a counseling program with a more collaborative, patient-centered orientation.
Music has long been recognized to provide a therapeutic effect and has been empirically used for facilitating a major relaxation response, a welcomed shift of attention . Tyler  suggests the use of music to provide distraction from tinnitus and notes that it has otherwise been highly underutilized. The use of music in NTT enables tinnitus sufferers to have a pleasant and relaxing sound to listen to while being treated. This approach facilitates patients’ compliance to treatment and provides gradual desensitization to the tinnitus signal [13, 18].
In summary, NTT aims to facilitate the process of gradual desensitization of tinnitus disturbance. Together with a structured counselling program, neuromonics tinnitus treatment uses acoustic stimulation in a way that is effective, yet enjoyable (Picture 1).
Picture 1: Summary of how neuromonics tinnitus treatment addresses the various neurological aspects underlying the tinnitus, mechanism
What follows is the standard NTT protocol aiming to assist clinicians in delivering the program to the most highly suitable “Tier 1” patients, who comprise around 43% of a typical tinnitus clinic population .
The Neuromonics Tinnitus Treatment Protocol and Patient Selection
Based on clinical trials [13, 14] and outcomes of the treatment reported by private clinics , the most suitable candidates are as follows:
- Patients with four-frequency average hearing thresholds better than 50 dB in at least one ear
- Clinically significant tinnitus disturbance reported in the tinnitus reaction questionnaire with score of at least 17
- Normal or decreased sound tolerance
- Tinnitus is neither pulsatile nor multi-tone
- Tinnitus is not exacerbated by normal level of acoustic stimulation (i.e., not highly reactive)
- No active Ménière’s disease or other causes of wide fluctuations in hearing levels
- Patient is well protected when exposed to a noisy environment.
A comprehensive tinnitus history questionnaire (THQ) is mailed to the patient prior to his/her first visit to the clinic. The THQ involves data on the nature of the tinnitus, tinnitus history, general hearing difficulties, effect of tinnitus, and general patient’s health. It helps the patient to recall all relevant factors and information relevant to the rehabilitation process. It also helps to determine the cause and influencing/exacerbating factors of the tinnitus and assess the patient’s candidacy . The patient also completes the tinnitus reaction questionnaire (TRQ). The score on the TRQ is used for counseling purposes, rehabilitation planning, and to monitor the patient’s progress throughout treatment . It has five response options that relate to the previous week of treatment, so it is more sensitive than most other tinnitus questionnaires .
The following baseline audiological measures are obtained: tympanometry, but no acoustic reflexes in patients with decreased sound tolerance; pure-tone audiometry up to at least 12.5 kHz; tinnitus pitch match; tinnitus loudness balance; MML; LDL at 0.5, 1, and 4 kHz; and residual inhibition (RI).
Practical Use of Neuromonics Tinnitus Treatment
Prior to commencing the treatment, patients are taught how to manage the device, and discussion on the realistic outcomes during the first phase and neural changes related to the desensitization process over the second phase is considered of high priority for NTT. A good understanding of tinnitus and the proposed treatment are likely to make the patient more compliant and positive about the therapy . Patients are provided with take-home reading material about their assessment results, how NTT works, what to expect at each phase of the treatment, advice on factors that can exacerbate tinnitus perception, and a list of suggested activities that can be done while using the device.
The first stage of neuromonics tinnitus treatment lasts for approximately 2 months after the fitting date. Patients are instructed to initially use the device for at least 2–4 h a day, and especially during the times that his/her tinnitus is the most disturbing. Patients are also instructed to set the volume at the beginning of each session to a comfortable level that provides a high level of interaction with his/her tinnitus. The high level of interaction aims to increase the amount of neurostimulation (representing the deprived sounds at the auditory cortex) and to provide maximal relief and relaxation for the tinnitus sufferers. This approach would facilitate the desensitization process of the tinnitus signal at a later stage by enabling them to relax despite their tinnitus and overcome prior problems like concentration disturbance and sleep onset/maintenance . As observed by the authors and other clinicians in private clinics, the patients’ monitoring of their tinnitus is contra-productive, potentially delaying, or even stopping the benefit of the treatment. Therefore, patients are encouraged to undertake another quiet activity while using the customized device to avoid monitoring the music and consequently risk monitoring the tinnitus.
The second phase of the treatment aims to gradually promote desensitization to the tinnitus signal as a more permanent effect. Patients are re-instructed to set the volume to a level that only covers up their tinnitus around half of the time. Hence, the patient will experience an intermittent interaction with their tinnitus, which happens during the intensity troughs of the music. This fleeting exposure to the tinnitus whilst in a relaxed state is intended to help the brain develop a capability of placing the tinnitus in the background.
This phase usually lasts for approximately 4 months, and the progress is reviewed at weeks 16 and 24. The MML and LDL are measured again at 2, 4, and 6 months after beginning the program to evaluate the patient’s progress. The TRQ is also re-administered and the patient needs to estimate how often they have been aware of (and also how often they have been disturbed by) their tinnitus over the past week. The measures are used to determine the current progress and link back toward the stage-specific pretreatment goals.
The patient’s response to the second stage of treatment is checked at the tenth week, as there are a few cases where the patient feels too anxious about not having the extra “shower sound” to fill in the quieter parts of the dynamic signal, and they can worry that their tinnitus is increasing. Few patients may benefit from extra time on phase one. For instance, recent data from the authors suggest that patients with higher levels of hearing loss or protected exposure to noise may benefit from a few extra weeks of high level of interaction .
The clinical trials have shown that once the systematic desensitization starts to occur, patients typically report that their tinnitus annoyance gradually decreases, and often their current data suggest improvement from their TRQ, their audiometric MML, LDL, and even their estimates of the percentage of time they are aware of their tinnitus (e.g., ). Desensitization is deemed to have occurred when the patient reports that they do not need the device to distract them from the tinnitus. That represents the end of the second stage. A few patients will occasionally use the device in certain situations that trigger their tinnitus, for instance, high levels of stress, noise exposure, middle-ear pathology. .
Once tinnitus is no longer a problem, the third phase begins. The patients are encouraged to use the device at least once a week to maintain their improvement because complete withdrawal from treatment may cause re-emergence of tinnitus or decreased sound tolerance. This is consistent with the notion that the subsequent lack of stimulation had caused the auditory deprivation process to reappear. Rebound has not been found to be a factor when patients have kept using their devices, suggesting that the constant tonotopic representation of the hearing loss-frequencies at the cortex has been successful at maintaining their gains .
The first step for adequate counselling is the patient’s understanding of hearing and tinnitus mechanisms . Patient should be aware of the factors or illnesses that influence on the habituation process. They should also be advised about specific habits and behaviors that can interfere with the treatment, such as diet, alcohol, excess caffeine intake, insufficient exercise, noise exposure, stress levels.
Motivation and realistic expectations are very important matters for tinnitus treatment, particularly in private practice. Clinicians need to certify that the patient acknowledges the success of the treatment demands their active participation in the rehabilitation program. A number of patients continue to find it hard to understand the difference between tinnitus and tinnitus consequences, and that the neuromonics tinnitus treatment can only work on consequences such as the level of awareness and disturbance. If inadequately prepared, patients can display significant decreases on their TRQ score and percentage of disturbance, but show disappointment because they still have tinnitus and often may need revisiting if the patients begin to “move the goalposts”.
Based on clinical outcomes for the first 400 patients treated with neuromonics tinnitus treatment , patients are assigned to one of three categories: Tier 1 candidacy includes the most suitable patients for NTT; Tier 2 suitability includes patients with TRQ score of less than 17, high psychological disturbance, and four-frequency average hearing thresholds worse than 50 dB; and Tier 3 suitability includes patients with reactive, pulsatile or multi-tone tinnitus, ongoing noise exposure, Ménière’s disease, or hearing loss greater than 50 dB in both ears. The standard (Tier 1) patient group represents the largest cohort in NTT populations found in regular private practice (48%); Tier 2 represents 37% and Tier 3 represents 15%. Whilst Tiers 2 and 3 can still be treated with NTT, they need to understand and acknowledge that their progress may be slower and more modest than usual .
Patients with very decreased sound tolerance (mean LDLs < 85 dBHL) are common, comprising 66% of participants in Trial 3 . These patients were found to respond consistently well to neuromonics tinnitus treatment, with a > 5 dB improvement in LDLs found in 85% of those patients using the two-stage stimuli (mean change was 11 dB). A hyperacusis protocol has been subsequently formulated  (neuromonics, ND). This hyperacusis protocol constitutes a variation on the usual protocol. They are not encouraged to strive for a high level of interaction in the first phase, but instead just keep it as high as it can be whilst remaining comfortable. In case of history of even every day sounds making their tinnitus flare up, they should begin on the second phase of treatment immediately, again emphasizing comfort in setting the device intensity levels.
Patients with significant hearing loss across the speech range should be considered for hearing aid fitting in conjunction with NTT, but only if the patients have sufficient dynamic range to make the hearing aids tolerable. Many hearing impaired patients have tried or are wearing hearing aids, but report that tinnitus is most disturbing during quiet times, mainly when trying to sleep at night . Some may find difficult to tolerate amplified sounds. These patients have found that neuromonics tinnitus treatment can improve their LDLs and reduce their reactivity, so that they become progressively better candidates for amplification .
Patients with high levels of hearing loss are likely to need to be kept in phase one of the treatment longer, as they can progress slower. They should be advised to wear the treatment for longer each day, and that the full program will also be extended for a longer period of time .
Patients with unilateral severe to profound hearing loss and those with asymmetric hearing loss (difference greater than 45 dB between the ears) are still considered candidates for NTT, applying a variation of the standard protocol with contra-lateral stimulation, which has been found to be effective in a cohort of 40 participants with severe unilateral hearing loss . The thresholds of the better ear are used to customize the device, and the stimulation is provided only in that ear.
Patients with a level of tinnitus disturbance that is not having a significant effect on their quality of life (TRQ composite score less than 17)  have been found to be poor responders to NTT , perhaps because there is little central gain to reduce. These patients are more likely to benefit from counseling and an educational training. The clinician should provide information on the hearing and tinnitus mechanism and offer a follow-up appointment if the patient feels it is needed. Patients can still be good candidates for NTT when they have low TRQ, but a high level of specific distress (e.g., major concentration disturbance). As the TRQ is more relevant to tinnitus than hyperacusis, when the hyperacusis is the main problem, the TRQ can be low. However, these patients are in great need of treatment and are usually excellent neuromonics tinnitus treatment candidates.
Finally, patients pursuing compensation related to his/her tinnitus are encouraged to complete the case prior to treatment, given their responses have been found to be reduced and far less consistent . The stress of the legal process and the continual reminders of the significance tends to be very counterproductive to a desensitization program such as neuromonics. However, if they are prepared to pay for the program themselves, it may be an indication that they may have enough intrinsic motivation to start sooner.
Clinical Trials of neuromonics tinnitus treatment
NTT been the subject of three major clinical trials. The first clinical trial strongly supported the idea that customization of music according to a patient’s hearing profile is clinically more effective in tinnitus masking than customized noise . The second clinical trial was a randomized controlled study of 50 tinnitus patients . The exclusion criteria for this study were severe hearing loss in the better ear (four-frequency average hearing threshold greater than 70 dB), tinnitusrelated compensation claim, ongoing noise exposure, major psychological disturbance (such as depression or psychosis), cognitive impairment, TRQ score of less than 17, and another simultaneous tinnitus treatment.
The second clinical trial compared clinical outcomes obtained with neuromonics tinnitus treatment, counseling alone, and counseling plus broadband noise set at the TRT mixing point. All groups had equal amounts of clinician time, and the in-depth counseling was reinforced by use of the selfhelp book, “Living with Tinnitus” . Patients were evaluated at 3, 6, and 12 months after commencing treatment. They were asked to report their current tinnitus disturbance using TRQ. After 6 months of treatment, the results demonstrated that NTT was significantly more effective in improving tinnitus symptoms than the two reference groups. Patients receiving NTT presented a mean TRQ improvement of 66%, compared with mean of 22% for patients receiving noise plus counseling, and a mean of 15% for those receiving only counseling . By 12 months, the mean gains of the neuromonics group had improved significantly more, but not for the other two groups. In terms of mechanisms, the study demonstrated that counseling was helpful (at a similar level to other studies), and the use of one-size-fits-all-type noise made a further improvement, but the highly tailored intermittent acoustic stimulation was far more effective. In terms of consistency of response, the proportion of patients who had a clinically significant improvement (TRQ improvement > 40%) was 86% of the neuromonics group, 47% of the noise and counseling group, and 23% of the counseling alone group.
The third clinical trial included 35 individuals with clinically significant tinnitus distress . Participants were randomly allocated into two groups: the first group, called the one-stage group, received intermittent tinnitus interaction throughout the 6-months program, while the second group, or two-stage group, received high interaction for 2 months. Then it moved to intermittent interaction for the last 4 months. Both groups had the same structured support program and followed the suitability criteria discussed earlier in this chapter.
All the audiometric and psychometric measures were performed at pretreatment, 2, 4, and 6 months after commencing the program. The results suggested that patients from both groups improved significantly, both statistically and clinically. At the conclusion of the 6-month program, the TRQ scores showed that 91% of the participants displayed an improvement of their tinnitus disturbance greater than 40%, with a mean improvement of 65%. The two-stage group was found to have a faster response to treatment. In a questionnaire administered after 12 months of commencing the treatment, more than three-quarters of the patients reported that the treatment had provided relief and increased their general well-being by a moderate or large amount . This Ear and Hearing article compared the neuromonics results to a similarly randomized and controlled trial of TRT and masking . It found that at 6 months, the neuromonics group had a higher proportion of patients having a clinically significant response (91%) compared to the TRT group (29%); it took the TRT group 18 months to achieve a more comparable outcome of 74%. Similarly, the TRT group required 15 h of clinician time per patient, whilst the neuromonics group required less than half the total amount of clinician’s time per patient.
A team of tinnitus specialists over eight centers across the US, led by the Cleveland clinic, has recently reported the 6-month post-therapy preliminary results of their study of the effectiveness of neuromonics tinnitus treatment . Their dataset of 45 patients displayed clinically significant improvements of a very similar magnitude (88% of patients displayed this level of improvement of their tinnitus disturbance) to the prior Australian clinical trials and private practice results , and independently replicated those results. Another independent study reported on the long-term outcome of NTT . The results of this report revealed that more than 85% of tinnitus patients treated with NTT sustained the full benefits of treatment 6–24 months after concluding the program.
Based on results from the clinical trials and outcomes showed by the private clinics, neuromonics tinnitus treatment (NTT) can promote a major desensitization of tinnitus perception in a high proportion of patients. Among its advantages are that it is non-invasive, easy and pleasant to use, suitable for patients with a wide range of hearing and tinnitus characteristics, and it is not relatively time consuming for the clinician.
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