Beltone Tinnitus Breaker Pro: Breaking the tinnitus cycle. Snehal Kulkarni, Au.D. Michael Piskosz, M.S.

Transcription

1 Beltone Tinnitus Breaker Pro: Breaking the tinnitus cycle Snehal Kulkarni, Au.D. Michael Piskosz, M.S.

2 Beltone Tinnitus Breaker Pro: Breaking the tinnitus cycle Beltone Tinnitus Breaker Pro: Breaking the tinnitus cycle Tinnitus is a problem for many people around the world and affects approximately 10% of the overall population. Approximately 3-5% of the population suffers from clinically treatable tinnitus (McFadden, 1982). The vast majority have hearing loss in addition to their tinnitus, and as many as half of patients reporting to a typical clinic have tinnitus complaints (Kochkin & Tyler, 2008). Use of hearing instruments or sound generating devices in tinnitus treatment can improve outcomes (Searchfield et al, 2010; Kochkin & Tyler, 2008), yet very few products have been designed specifically to be components of a tinnitus treatment and counseling support program. Beltone Tinnitus Breaker Pro is an advanced feature included in the Beltone True line of hearing instruments. Since the feature is built into the hearing instrument, it can be used to address tinnitus in patients with and without hearing loss. What is tinnitus, and what causes it? Tinnitus is defined as the sensation of sound without external stimulation by the American National Standards Institute (ANSI, 1969). It is proposed to originate in the head (McFadden, 1982). Although commonly referred to as ringing in the ears," the perception of tinnitus can vary significantly from person to person. Tinnitus sufferers have reported experiencing clicking, chirping, pulsing, and whooshing among other perceptual descriptors. It can be either intermittent or continuous and steady; monaural or binaural. Other than known medical pathologies that may cause tinnitus, the specific mechanism of tinnitus causation is not exactly known. Several different theories and models have been examined. It is important to note that psychological factors play a huge role in tinnitus perception. One well-accepted neurophysiological model of tinnitus discusses the role of cochlear damage in relation to tinnitus causation. It explains that when the outer hair cells (OHC) are damaged, they are no longer able to inhibit the neuronal firings of the inner hair cells (IHC) in the absence of auditory input. When this happens, the IHC spontaneously fire impulses to the brain, which are processed, amplified and recognized as sound even in the absence of auditory input. This sensation of sound in the absence of external stimulation is identified as tinnitus. The severity of an individual s tinnitus depends not only on the extent of cochlear damage, but also on the level of attention that is paid to one s tinnitus. This is called prioritization.' The more focused a person is on their tinnitus (i.e. the greater the priority given to the tinnitus), the more audible it becomes even in the presence of other auditory input, such as background noise or speech. Most people can ignore and habituate to their tinnitus quite easily, allowing it to blend into the background without much further notice. But, for some individuals, this is not the case. When tinnitus becomes the focal point, it can lead to negative emotions such as frustration, anxiety and helplessness. These negative emotions involving the limbic system, can in turn lead to physical changes and reactions in the body, such as stress, which involves the autonomic nervous system (Henry et al, 2002). When a person is stressed by the situation, the tinnitus remains, or can at times get worse, prompting the cycle to repeat itself. This is often referred to as the Vicious Cycle of Tinnitus Tinnitus The Vicious Cycle Physical Reactions: Stress, etc The Vicious Cycle Figure 1. The vicious circle of tinnitus Negative Associations Frustrations Negative Associations Frustrations Tinnitus (Figure 1). Other than tinnitus that is caused by known medical pathologies, most clinicians agree that the goal of tinnitus treatment is to break this vicious cycle and allow the person to be in control of their reactions so they can to habituate to it. Habituation is the process by which one becomes used to the sound. For example, most normal hearing people will hear the air conditioning noise when they walk into a room since the sound is new to the brain. However, they quickly learn to put the noise in the back of their mind, and focus on more important stimuli. When the air conditioning noise is no longer recognized by the individual, habituation to it has occurred. By breaking the vicious circle, the individual becomes accepting of their tinnitus instead of reacting negatively to it. The ultimate goal of tinnitus treatment is to habituate to the tinnitus altogether, although complete habituation may not occur in many individuals. When habituation is complete, the person no longer hears the annoying sound even though it is still present. Tinnitus treatments and counseling methods There are many different types of tinnitus treatments, with the most common one being sound therapy, also known as acoustic therapy. Sound therapy, as the name suggests, is the use of an external stimulus to help reduce the contrast of the tinnitus against the background. By increasing the level of external stimulus in the person s environment, we aim to decrease the perception of the tinnitus. A common example to illustrate sound therapy is the candle on the table analogy. A lighted candle on a table in a dark room becomes the focal point because it is very easy to detect the light against the dark background. In contrast, the same candle on a table in a lit room with dinnerware and a busy restaurant environment becomes less noticeable against the background (Figure2). Figure 2. Sound therapy analogy the candle intensity is decreased at a busy dinner table as opposed to being isolated in the dark. There are many different tools that can be used in sound therapy. For example, sound pillows generate a noise that can be useful for people who have difficulty sleeping. Common everyday sounds generated by TVs, radios, fans, an open window that allows environmental sounds in, or listening to music can be useful to help drown out the tinnitus, and allow the individual to habituate to it. Hearing instruments and wearable sound generating devices can also be used for sound therapy. Beltone True is a combination device that has both hearing instrument features as well as the Tinnitus Breaker Pro, a feature that can be used to help address tinnitus. The Beltone Tinnitus Breaker Pro can be used in sound therapy to help increase the level of background noise in order to decrease the contrast of the tinnitus. It has unique parameters, such as frequency shaping of the white noise, modulation level, modulation speed, and a volume control which can help customize the Tinnitus Breaker sound and provide more comfort for the tinnitus sufferer. Another well-known and heavily practiced tinnitus treatment approach is Tinnitus Retraining Therapy (TRT), and more recently, Progressive Tinnitus Management (PTM). In TRT and PTM, emphasis is placed on educating patients about their tinnitus. These methods aim to provide the patient with a better understanding of the origin of their tinnitus as well as the reactions produced by their limbic and autonomic nervous systems in response to the tinnitus. Thorough knowledge and understanding of the process allows the patient to have more control over their emotions and reactions to the tinnitus, allowing them to more effectively cope, and ultimately habituate to their tinnitus (Henry et al, 2002). The main difference between the two treatment options is that PTM has a five-tier hierarchical approach, meaning that patients are exposed only to the treatment tier that is relevant for them. Sound therapy is an integrated part of TRT and PTM. For more severe cases of tinnitus, treatment plans including different psychological and psychiatric models have proven quite effective. It is not the intention of this paper to explore these methods, but information can be found explaining these models in greater detail. Depending on a patient s individual needs, sometimes a combined approach of these methods may be utilized. Regardless of what treatment plan is used, the goal is to break the vicious cycle (Figure 3) and allow for habituation. The patient needs to have control of their tinnitus and not vice-versa. Finally monitoring the status of any treatment plan is very important. It is recommended that both standardized and subjective measurements be made throughout the treatment. Standardized measures often used are the Tinnitus Handicap Inventory (THI), Tinnitus Handicap Questionnaire (THQ), and Tinnitus Reaction Questionnaire (TRQ). These questionnaires look at varying aspects of the tinnitus and how they affect the person. 2 3

3 You have control of your tinnitus Your hearing system selectively attends to the tinnitus Your tinnitus starts Figure 3. Breaking the vicious circle - the blue arrows indicate the path of the vicious circle prior to tinnitus treatment, and the black arrows indicate the goal of tinnitus treatment being in control. They can be given at the beginning of therapy as a baseline measure, and again during and after treatment. Subjective measures are typically in the form of patient feedback. Having the patient discuss how the treatment is working for them and how it is affecting their tinnitus can lead to important insights on the part of the clinician as well as the patient. Information from both standardized measures and subjective feedback are important to understand the effectiveness of the treatment plan. Lastly, creating realistic expectations from the start is crucial. Since the tinnitus treatment can take an extended period of time (6mos 2yrs, or longer for some), and complete habituation may not take place for all patients, it is important that the patient s expectations are in line with the treatment objective. Beltone Tinnitus Breaker Pro You become tense and worry about it Beltone Tinnitus Breaker Pro is a flexible and customizable solution to assist in the treatment of tinnitus, helping to provide relief and a better quality of life. It offers unique parameters such as frequency shaping of the white noise signal, modulation level, modulation speed, and a volume control (both manual and automatic). Because this device can be open fit, it can also allow more natural sound through the ear canal. For individuals with milder hearing losses, simply providing amplification through the open fit hearing instrument is enough sound therapy to help them habituate to their tinnitus, even without the Tinnitus Breaker Pro (Del Bo et al, 2008). Most literature suggests using a broadband stimulus since it activates the most neurons, and is therefore most effective in sound therapy. Therefore, the default noise setting for the Tinnitus Breaker Pro is set to a broadband filter setting, but can be adjusted using the low and high cut controls to meet individual preferences and provide more individualized comfort. The low cut filter can go down to 500 Hz, with the high cut filter reaching 6000 Hz. Another feature, which can be customized for patient comfort, is modulation level. Modulation level is a fluctuation in the level of the noise signal with all spectral components remaining uniform. The modulation level is randomized to avoid audible periodicity, meaning that the amount of attenuation will not always be the same. The modulation level can be configured to a maximum attenuation of 3 options in Beltone s fitting software, Solus Pro: Mild (-4dB) Moderate (-8dB) Strong (-12dB) This means that if a Moderate level is chosen, the white noise energy can fluctuate up to -8dB from the programmed volume of the Tinnitus Breaker Pro. For example, if the programmed volume of the Tinnitus Breaker Pro is 65dB SPL, and a Moderate modulation level is chosen, the volume will randomly fluctuate between 65dB SPL and 57dB SPL. When the modulation level is activated, there is also an option of controlling the speed at which the fluctuations occur. The three options for modulation speed are: Slow (8 sec) Medium (4 sec) Fast (2 sec) The time represents how often a fluctuation will occur in the white noise energy. Modulation level and modulation speed are strictly comfort features, and should be considered on a case-by-case basis. A truly unique feature of the Tinnitus Breaker Pro that can be beneficial in tinnitus treatment is the environmental volume control. The environmental volume control acts as an automatic volume control that adjusts the level of the white noise signal according to the listening environment. Most people typically report their tinnitus to be worse in quiet situations. Therefore, the environmental volume control monitors the input sound to determine what type of acoustic environment the listener is in, and adjusts the Tinnitus Breaker Pro volume accordingly. If the user is in quiet, the volume of the Tinnitus Breaker Pro will be at the programmed setting. When the user is in more sound-rich environments, less noise is needed to decrease the contrast of the tinnitus. As ambient sound levels increase, the Tinnitus Breaker Pro volume will decrease automatically (Figure 4). The environmental volume control serves a number of purposes. Firstly, it can help avoid completely masking the tinnitus for users who are not familiar with a manual volume control or do not fully understand the aim of sound therapy. Completely masking the tinnitus prevents habituation, as one cannot habituate to what is not audible. This can be detrimental to the tinnitus treatment. Level of generated sound Quiet Soft speech Loud noise Figure 4. Volume control - The Tinnitus Breaker Pro volume will automatically adjust according to listening environment. The environmental volume control also ensures that the Tinnitus Breaker Pro signal does not interfere with important speech information. Lastly, not having a manual volume control puts less emphasis on the instrument. For some patients, this may help reduce the focus on the tinnitus, which can occur if they are constantly adjusting the volume control. If the environmental volume control is not preferred, a manual volume control can be activated. For some tinnitus patients, this provides a greater sense of control. Environmental volume control or the manual volume control can be selected in the Volume Control drop-down option in the Solus Pro fitting software. The advantage of having the Tinnitus Breaker Pro as a feature within the hearing instrument is that it provides multiple fitting options. It can be fit as a hearing instrument, as a sound therapy instrument, or as a combination device. Having the flexibility to control how the device is programmed allows the clinician to truly personalize the device to meet the individual needs of the patient. Research Studies using the Tinnitus Breaker Pro Studies A and B were external trials conducted at multiple well-established tinnitus clinics worldwide to evaluate the benefit of the Beltone Tinnitus Breaker Pro feature in regards to tinnitus treatment. The studies also evaluated mixing point information, volume control, modulation level and speed preferences. It is important to note that both trials used some form of counseling and treatment (e.g. TRT) in combination with using the Tinnitus Breaker Pro. Trial design for Study A: This study involved 30 tinnitus patients falling within Jastreboff s tinnitus category 1 and 2 (Henry et al. 2002). Subjects presented with mild-to-moderate bilateral hearing losses. All had suffered from tinnitus for at least 6 months and patients with Menière s Disease and middle or external ear disease were excluded. After fitting Beltone True receiver-in-the-ear instruments with Tinnitus Breaker Pro, Tinnitus Retraining Therapy (TRT) was administered for 6 months. The effect of the treatment was evaluated using the Structured Interview (Jastreboff & Jastreboff 2000), TRI Tinnitus Patient Assessment and Outcome Measurement (Langguth et. al 2007), and THI self-administered questionnaire (Newmann et al. 1996). Trial design for Study B: Twenty four subjects with varying perceptions of tinnitus were recruited for this trial. Thirteen of the test subjects had varying degrees of sensorineural hearing loss with thresholds falling within the mild-to-moderate range, and eleven of them had no significant hearing loss. The subjects were fit with Beltone True receiver-in-the-ear devices with the Tinnitus Breaker Pro. Twenty-two subjects were fit binaurally and two subjects were fit monaurally. They were seen over a period of approximately 6 months for 5 visits. The Tinnitus Handicap Inventory (THI) and Tinnitus Handicap Questionnaire (THQ) were administered at the initial, mid and final visits to evaluate how the subjects perceived their tinnitus following the fitting. Half the test subjects were fitted with the environmental volume control enabled at the first visit, and the other half with the manual volume control enabled. Approximately four weeks after visit one, the sound level adjustment (i.e. environmental volume control and manual VC) was switched to the opposite of what they were initially fitted with. The test subjects then rated their preferences on a take-home questionnaire. Modulation level was evaluated by initially giving all subjects two programs - one with modulation and one without. Approximately 2 weeks after visit one, all subjects were asked how they perceived the modulation and then chose one Tinnitus Breaker Pro program, either with or without modulation. This Tinnitus Breaker Pro program was adjusted based on their preferences. Results for Trial A: Assessment results were collected at the initial fitting, and again after 3 months and 6 months. Figures 5 and 6 show the development in the 6 months time frame of THI score and structured Interview VAS score regarding annoyance,' intensity and tinnitus effects on patients life. After 6 months all differences were significant (THI: p=0.001; annoyance and intensity: p<0.001; life effect: p=0.002), (Carraba et. al 2008). 4 5

4 THI self-administered questionnaire (Newmann et al. 1996) Initial Figure 5. Pre- and post THI questionnaire results Structured Interview (Jastreboff et al. 2002) Initial Figure 6. Pre- and post Structured Interview results Results for Trial B: 3 months 3 months 6 months 6 months Annoyance(VAS) Intensity (VAS) Life effect (VAS) Twenty of the twenty-four subjects answered the THQ and sixteen answered the THI. The subjects demonstrated a significant subjective improvement in their tinnitus over a period of 3 to 6 months as evidenced by an improvement in their THQ and THI scores. On average, their THQ scores dropped from 50.8 at the beginning of the trial to 33.0 at the end of six months (P<0.05), and the THI scores also improved from 58.4 at the start to 29.9 at the end of 6 months (P<0.05). Regarding the features of the Tinnitus Breaker Pro, 68% of the subjects preferred the manual volume control over the environmental volume control and 73% preferred continuous noise over modulated noise. Approximately 82% of the subjects preferred broadband noise, while 18% preferred more narrow-band filter settings. In conclusion, the trials revealed the Beltone Tinnitus Breaker Pro to provide significant benefit in improving the patient s perception of their tinnitus in combination with therapy. The various parameter options make the Tinnitus Breaker Pro a very flexible feature, allowing the professional to personalize the fit according to patient preference. Fitting the Beltone Tinnitus Breaker Pro To program the Tinnitus Breaker Pro, the Beltone Solus Pro fitting software (version 1.2 or later) is needed. Tinnitus Breaker Pro is activated by choosing it from the navigation menu on the left-hand side of the screen. The default settings of the Tinnitus Breaker Pro include a broadband frequency response, Modulation Level set to mild." Modulation Speed set to medium," and Volume Control set to off (Figure 8). If the hearing instrument microphone is on, amplification will be provided. However, hearing instrument features which work against Tinnitus Breaker Pro such as Sound Cleaner Pro and Silencer are deactivated. Figure 8. Beltone True Tinnitus Breaker Pro program in Solus Pro. The red curve shows the patient s hearing threshold levels (right ear) while the black curve shows the spectral shape and level of the Tinnitus Breaker Pro sound. This gives the fitter an indication of the audibility of the Tinnitus Breaker Pro sound. The graph can be viewed on a db HL or db SPL scale. When setting the combination device for a first fit, a number of different approaches can be successful for tinnitus therapy. One approach is using the mixing point method, which is well-known and commonly used by professionals in tinnitus treatment. The mixing point is where the tinnitus and Tinnitus Breaker Pro stimulus start to blend together. Often, as the mixing point is approached, the patient may perceive a change in the tinnitus. To use this method, it is suggested that the threshold of the Tinnitus Breaker Pro stimulus be established. From this level, slowly increase the volume in 1-2dB steps to find the mixing point. Finally, reduce the volume of the Tinnitus Breaker Pro 1 to 4dB below the mixing point level. The true mixing point level can often be too loud for the tinnitus patient. Over time, the patient may prefer a lower sound level. This can be related to gradual habituation to the tinnitus. The threshold of audibility method is another approach, which tends to be easier in terms of instruction to the patient. With this approach, the level of the Tinnitus Breaker Pro stimulus is set 5-10dB above the threshold of for this sound. Although simpler than the mixing point method, this approach typically results in a lower setting than the mixing point approach. Thus it offers less opportunity to observe mitigation of tinnitus as reflected in the patient preferring a lower sound level over time. It can also be useful to establish the minimum masking level (MML). This is the level at which the Tinnitus Breaker Pro sound just begins to mask the tinnitus. Comparing the MML to the threshold of the Tinnitus Breaker Pro sound gives a range between the level that is barely audible and the level where masking is too much for successful tinnitus treatment. The actual volume setting should be in between these two points. Regardless of the method chosen for setting the Tinnitus Breaker Pro level, complete masking of the tinnitus should be avoided, as this will not allow for habituation to occur. Although the user may experience immediate relief from the tinnitus if it is completely masked, this will not allow the brain to adjust and habituate to the tinnitus. When the device is removed, the tinnitus will most likely be perceived as it always was, and could potentially be even more negative. The methods described are intended as starting points to help with initial programming. Questionnaires, as mentioned previously, can be used to monitor the effectiveness of the approach chosen. Individual differences and user comfort should always be considered on a case-by-case basis with regards to tinnitus, as tinnitus can vary greatly between individuals. The Beltone fitting guide should be reviewed for more detailed instructions on setting the device in Solus Pro. In conclusion, the Tinnitus Breaker Pro is a unique stateof-the-art feature that has been added to the Beltone True hearing instrument line. It will provide the clinician with the flexibility to address patient needs, for both hearing loss and tinnitus. References American National Standards Institute (1969). Specifications for Audiometers. pp. S3.6 New York: ANSI Carraba, L., Coad, G., Costantini, M., Del Bo, L., Dyrlund, O., Forti, S., Searchfield, G. (2008). Combination open ear instrument for tinnitus sound treatment. Del Bo, L. Jastreboff, M., Parazzini, M., Ravazzani, P. (2008). Open Ear Amplification in Tinnitus Therapy: An Efficiency Comparison with Custom Sound Generators. Henry, James A, Jastreboff, Margaret M, Jastreboff, Pawel J, Schechter, Martin A, Fausti, Stephen A. (2002). Assessment of Patients for Treatment with Tinnitus Retraining Therapy. J Am Acad Audiol 13: Jastreboff PJ, Jastreboff MM. (2000). Tinnitus Retraining Therapy (TRT) as a method for treatment of tinnitus and hyperacusis patients. J Am Acad Audiol 11: Jastreboff PJ, Hazell JWP. (1993). A neurophysiological approach to tinnitus : clinical implications. Br J Audiol 27 : Kochkin S, Tyler R. (2008) Tinnitus treatment and the effectiveness of hearing aids: Hearing care professional perceptions. Hearing Review 15(13): Langguth, B., Goodey, R., Azevedo, A., Bjorne, A., Cacace, A., Crocetti, A., Del Bo, L., De Ridder, D., Diges, I., Elbert, T., Flor, H., Herraiz. C., Ganz Sanchez, T., Eichhammer, P., Figueiredo, R., Hajak, G., Kleinjung, T., Landgrebe, M., Londero, A., Lainez, M.J.A et al.(2007). Consensus for tinnitus patient assessment and treatment outcome measurement: Progress in Brain Research 16: McFadden, D. (1982). Tinnitus: facts, theories, and treatments. Report of Working Group 89, Committee on Hearing Bioacoustics and Biomechanics, Washington, DC: National Academy Press. Newman, CW, Sandridge SA, Jacobson GP. (1998). Psychometric adequacy of the Tinnitus Handicap Inventory (THI) for evaluating treatment outcome. J Am Acad Audiol 9: Searchfield G, Kaur M, Martin WH. (2010). Hearing aids as an adjunct to counseling: Tinnitus patients who choose amplification do better than those that don t. IJA 49:

5 Worldwide Headquarters Beltone A/S Lautrupbjerg 7 DK-2750 Ballerup Denmark Tel.: Fax: M GB Rev.A