The Role of Audiology in an Evidence-based Tinnitus Program

This text course is an edited transcript of a HyperSound webinar on AudiologyOnline.

Learning Outcomes

After this course learners will be able to:

• Describe the most recent AAO-HNS guidelines and the clinical evidence supporting them.
• Explain how the most recent AAO-HNS tinnitus guidelines can be put into practice by clinical audiologists.
• Explain some non-medical tinnitus management solutions and the evidence supporting their effectiveness.

Introduction and Overview

Brian Taylor: Today’s webinar will focus on the role of audiology in an evidence-based tinnitus management or treatment program. This webinar is intended for audiologists who are thinking about offering tinnitus management services in their practice. It can be a point of differentiation. It can be another revenue stream in your practice. It's a great way to offer services to people that are in need. There is a great demand for tinnitus services that has not been met completely. If you already have a tinnitus program and have been doing it for a while, this course is probably not for you. If you're thinking about getting into it and want to take advantage of the opportunity, we're hopeful that we can provide you with some good information as a starting point.

Definition

If you look at some of the more recent literature, you'll see a definition of tinnitus similar to this: “Tinnitus is a persistent sensation of sound for which no acoustic source for the sound exists outside the head.” Tinnitus sufferers commonly describe it as a ringing, buzzing, cricket-like sound, a hissing or a whistling. That's the classic definition and the typical description of tinnitus in an audiology practice.

Theories

Many theories exist about the cause of tinnitus. At the end of this presentation, I have included useful references to specific articles that provide more in-depth information. Tinnitus usually begins with some damage to the peripheral auditory system, which then cascades into problems with the central auditory system, often described as a decrease in inhibitory (efferent) function. There may be somatosensory involvement. Additionally, the person's reaction to the tinnitus includes an emotional component, which involves the limbic system. It's important to have a few talking points related to how these theories operate, to better explain tinnitus to the patient. Many of these theories are complicated. As a clinical audiologist, we should be familiar with these theories, but we don’t need to inundate our patients with too much information about them.

The Importance of Good Audiology

I also want to stress the importance of good audiology. Those of us (myself included) who have worked in ear, nose and throat (ENT) offices may feel like our skills are taken for granted. However, it's essential to note that good audiology is a vital component within a medical ENT practice. Taking a thorough case history, and conducting a comprehensive audiological evaluation works in tandem with the otologic exam from the ENT. If you are part of a larger practice which includes other subspecialties (e.g., neurology, dentistry, psychology, physical therapy), referrals may be in order. Some practices use a multi-specialty approach to tinnitus management.

Ear Diseases and Associated Conditions

There are a number of ear diseases and other conditions associated with tinnitus.  Baguley, McFerran, and Hall (2013) provide a good summary of these. Everything from rheumatoid arthritis to hypertension to ototoxic medications can be associated with tinnitus. As audiologists, we should be fairly well-versed in some of the neoplasms that can result in tinnitus as a symptom. In addition, we are familiar with the different types of pulsatile tinnitus, which may indicate a potential medical problem requiring further work-up and evaluation. The point is that good audiology is essential to identifying and diagnosing a lot of these conditions that have tinnitus as a symptom.

Research: Prevalence and Treatment Patterns

Bhatt and colleagues (2016) conducted an in-depth analysis of tinnitus prevalence. According to their findings, just under 10% of the population of the U.S. experienced tinnitus within the last year. Of that group of over 20 million individuals, one-fourth had been experiencing tinnitus for longer than 15 years. That would tell us that 25% of that group has chronic tinnitus, and 36% of the group described the tinnitus as nearly constant. Clearly, tinnitus is a substantial problem for a significant number of individuals.

They also looked at the subjective severity of tinnitus symptoms as a function of age. When people reach the fifth, sixth and seventh decade of life, tinnitus becomes more common. In the fifth, sixth and seventh decade of life, more people also report that it's a "moderate problem" to a "big problem."

Of patients with tinnitus, this study found that 7.2% reported it as being a very big or big problem. In other words, on a scale of one to five, they rated their tinnitus as a three, four or five. Slightly over 40% reported that it's a small problem. Just under 50% of the individuals said that they discussed their tinnitus with a physician. Of the patients who talked to their doctor, 45% discussed medications as a possible solution. Just under 10% discussed hearing aids and nutritional supplements. Other treatment options discussed include stress reduction methods, music treatment, and tinnitus retraining therapy. Anyone who has dabbled in tinnitus management services in their clinic knows that there is a plethora of services available. It's probably not too surprising that if you're talking to a physician about what your treatment options are, that medications are going to be the primary treatment option that they discuss. Many medications have been tried, such as diuretics, anticoagulants and dietary supplements. However, as shown in the existing research that we will discuss later, medications are largely ineffective in the treatment of tinnitus.

Joo and colleagues (2015) looked at quality of life in people with tinnitus.  They categorized subjects into three categories: those with hearing loss only, those with tinnitus only, and those who had both hearing loss plus tinnitus. They found that people with both hearing loss and tinnitus consistently reported lower overall quality of life scores. Clearly, there are opportunities for us to manage both the hearing loss and the tinnitus.

In 2004, Dobie performed a meta-analysis, reviewing several different tinnitus studies. He divided the subjects into two groups: those who reported their tinnitus as bothersome, and those who considered it as non-bothersome. Dobie came to the conclusion that about 80% of individuals who experience tinnitus report is as not bothersome in nature; about 20% perceive it as bothersome. Within that 20%, there is a small subgroup of patients who report their tinnitus as being debilitating (beyond moderate or severe). Of course, those are patients that you are going to refer elsewhere for other types of services. Dobie also emphasizes that there is a difference between bothersome and chronic tinnitus. Just because the tinnitus is chronic, doesn't necessarily mean that it's bothersome.

These studies show that there is an opportunity to raise awareness of tinnitus as a symptom that we can manage and treat as audiologists.  The Dobie study shows that 20% of people who experience tinnitus in daily life are affected to the extent that intervention is warranted (i.e., they have bothersome tinnitus). This is about 6.5 million Americans.  This is roughly the same number of people that have severe to profound hearing loss in at least one ear. Regardless of the size of your community, there are plenty of individuals who can benefit from tinnitus management. Individualized, patient-centered services provided by audiologists and other hearing care professionals are needed to improve quality of life for patients who experience problematic tinnitus.

AAO-HNS Clinical Practice Guidelines for Tinnitus

As practitioners, we need to determine what management approach is most effective. How do we bring these management approaches to life in our own practices? The American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) recognizes untreated and unmanaged tinnitus as a mounting clinical problem. They conducted an evidence-based review, where they evaluated all of the published research on tinnitus management. They graded the overall quality of the evidence, as far as treatment approaches based on randomized controlled trials. From those trials, they came up with some recommendations. I would encourage you to take a look at that paper - you can access it here. As stated in the AAO Guidelines, there is little evidence to support many of the existing common tinnitus treatment approaches. When I say “very little evidence,” it does not that the treatment approaches were necessarily ineffective based on a study; often, it's because there haven’t been any randomized controlled trials that we can look at to see if the treatment is effective.

AAO came up with some clinical practice guidelines for tinnitus. We will look at these in greater detail coming up in the presentation:

1. Targeted history and physical exam to identify potential causes of tinnitus.
2. Comprehensive audiological assessment, if tinnitus is unilateral, chronic (>6 months’ duration) or associated with hearing difficulties.
3. Prioritizing clinical services by distinguishing patients with chronic tinnitus from those with bothersome tinnitus of recent onset.
4. Educating patients with chronic, bothersome tinnitus about intervention options.
5. Hearing aid assessment for those with chronic, bothersome tinnitus and hearing loss.
6. Cognitive behavioral therapy for patients with bothersome, chronic tinnitus.

Some of the options that AAO recommends include a comprehensive audiological assessment for patients that have any form of tinnitus, and also sound therapy.

According to AAO-HNS guidelines, three things that they recommended against were: pharmaceutical intervention, dietary supplements and transcranial magnetic stimulation. In all cases, the randomized controlled trials showed that none of these interventions were supported by the evidence.

Along those lines, there was a recent article that was a randomized control study design conducted at the University of Iowa on Lipoflavonoid (Rojas-Roncancio et al., 2016). This product is a supplement that has been touted as being helpful for ringing in the ears, and other ear-related conditions (e.g. vertigo, ear aches, ear infection and Meniere’s disease). According to this study, they found that Lipoflavonoid was not effective as a tinnitus therapy.  It is helpful to stay current with the literature in tinnitus to determine what is and is not found to be effective in rigorous studies.

Randomized Controlled Trials (RCTs) Involving Tinnitus Therapy

Randomized controlled trials are the gold standard of clinical care and decision-making. Randomization means that you select subjects from a similar demographic (e.g., age), and have a similar ailment (in this case, a similar degree of hearing loss or severity of tinnitus), and randomly put them into two different groups. The treatment is withheld from the control group, and is administered to the other group.

In one particular meta-analysis (Martinez-Devesa, Perera, Theodoulou, & Waddell, 2010), one of the treatments for tinnitus that they did find to be effective was cognitive behavioral therapy (CBT). They found that it improved quality of life and depression. Also, in a study by Hobson and colleagues (2010), they found that sound therapy (i.e., the use of a tinnitus masking device), can be beneficial when it's combined with counseling, but not on its own. Furthermore, in 2014, Hoare and colleagues found that there wasn't enough evidence to support or refute the use of hearing aids as a routine intervention for treatment. However, since 2014, there have been some randomized controlled trials supporting the use of tinnitus sound therapy devices.  

Henry et al. (2016)

A recent randomized controlled study looking at devices was published in the journal Ear and Hearing (Henry et al., 2016). This is a study that came out of the Portland Veterans Administration, and was led by Dr. James Henry, a prolific tinnitus researcher. This study compared four different treatment approaches across four different VA sites using several different audiologists. The four approaches they used were: tinnitus masking, tinnitus retraining therapy, tinnitus education group, and a six-month wait listed control group.

The audiologists who conducted all of the tinnitus therapies received minimal training on how to do tinnitus masking and tinnitus retraining therapy. They randomized about 120 veterans into those four groups. They used the Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996) to evaluate the effectiveness of the treatments. The THI consists of a series of 25 yes/no questions. The higher the score, the more the patient perceives the tinnitus as handicapping.

The study used two long-standing approaches: tinnitus masking (TM) and tinnitus retraining therapy (TRT). In a 2002 article, Henry explains in detail how tinnitus masking and tinnitus retraining therapy differ. Tinnitus Masking involves the use of ear level devices to mask or partially mask tinnitus, to produce a sense of tinnitus relief. Follow up is minimal, mainly to ensure devices are working properly. Tinnitus Retraining Therapy is a neurophysiologic model with the main objective to facilitate habituation to tinnitus. It involves the use of ear level “sound generators.” It requires rigorous follow up over one to two years at specific intervals.

These two long-standing approaches were compared to what they classified as Tinnitus Education Group, or TED. This was a more informal approach that used ear-level devices for sound therapy (e.g., a combination device that included a masking or a tinnitus relief program). Along with that, they provided some very generic counseling, such as talking about the explanation of the problem, the audiogram, and some of the possible treatments. They matched the counseling, both in the length and the format, to the other two groups.

Finally, there was a wait list control (WLC) group.  These were people on a wait list who could not receive treatment for six months.  The did complete outcome assessments at 0, 3 and 6 months, and then started treatment at 6 months.

They had the following hypotheses: 

Results

At three months, people who used either the TRT or the TM approach, the more long-standing approaches, had a greater decline in tinnitus handicap as measured on the THI. The TED approach lagged behind. As you move to six months and 12 months, the approaches came closer to yielding similar results. At 12 months, there was very little difference between the reduction in tinnitus handicap across the three approaches. There was no change in the Wait List Control group at 0, 3 and 6 months, as they had not been exposed to any tinnitus treatment.  Across the three approaches, there was not a lot of variability.  For the most part, they were all equally effective by one year.

Here were the findings:

Hypothesis #1 - Partially Supported.  This hypothesis stated: Over the first six months of treatment, TM and TRT will decrease tinnitus severity relative to TED & WLC, and TED will decrease tinnitus severity relative to WLC.  Over the first six months of treatment, TM and TRT did decrease tinnitus severity relative to TED and WLC; but by six months, TED was not too much further behind so this hypothesis is partially supported.

Hypothesis #2 - No Support. This hypothesis stated: Over 18 months of treatment, TM & TRT will decrease tinnitus severity with bothersome tinnitus relative to TED, had no support. At 18 months, they all were working equally effectively so there is no support for this hypothesis.

Hypothesis #3 - Supported.  This hypothesis stated: When TM, TRT and TED are administered by VA audiologists for a period of 18 months, treatment effectiveness will not differ across the 4 sites. Over that 18-month timeframe, there was not much differentiation in effectiveness across the four sites so this hypothesis was supported.

I find this to be an interesting study, because it demonstrates that when you randomize and control the variables, over time, all three approaches can still be clinically effective.

In conclusion, a one-size-fits-all approach is not the most appropriate way to manage patients that are complaining of bothersome tinnitus. These three different approaches all have some merit as viable therapy options in the clinic. If you work in a large audiology practice where there are three or more audiologists, it might be a good idea for each audiologist to specialize in one of the different types of tinnitus management approaches. Furthermore, it was concluded that the “stripped down approach” with less rigorous follow-up (i.e., the TED approach), also proved effective. Basic audiology services combined with provision of hearing aids and educational counseling might sufficiently meet the needs of some patients with bothersome tinnitus. That's an opportunity for audiologists who are not comfortable taking a deep dive into a specific program, to still offer an effective service when it comes to tinnitus management.

Study: Motivational Interviewing

Another study that I wanted to share involved motivational interviewing (Zarenoe, Sőderlund, Andersson, & Ledin, 2016). Motivational interviewing is getting attention in audiology these days, not only for counseling hearing aid users, but also for counseling tinnitus patients. This study used 50 patients who had both hearing loss and tinnitus.  It randomized them into two groups: a standard practice group and a motivational interviewing group. Motivational interviewing consisted of “engaging” “focusing” “evoking” and “planning” discussions around importance of seeking help.  They followed those two groups over four visits and measured outcomes at 3 months post fitting. Both groups derived benefit from their hearing aids and showed significant reduction in annoyance of tinnitus. However, the group that was exposed to motivational interviewing showed greater improvement on the Tinnitus Handicap Inventory scores, relative to the standard practice group. This study demonstrates the effectiveness of motivational interviewing as an approach that can supplement or complement the use of sound therapy.

Summary of Approaches

The following is a summary of the current nonsurgical and nonpharmacological approaches to tinnitus management.

1. Sound Therapy:
   1. Tinnitus Masking (Jack Vernon)
   2. Tinnitus Re-Training Therapy (P. Jastreboff)
   3. Hearing Aids/Combination Devices
   4. Neuromonics/Desynchra/Otoharmonics
   5. Tinnitus Treatment Solutions (Teleaudiology Component)
2. Counseling-based:
   1. Mindfulness Training (Jennifer Gans)
   2. Cognitive Behavioral Therapy (Robert Sweetow)
   3. Motivational Interviewing (Linkoping University, Sweden)
   4. IHS’s Tinnitus Care Provider (Rich Tyler)
3. Comprehensive “Team” Approaches 
   1. Progressive Tinnitus Management (James Henry, Portland VA)
   2. Mayo Clinic, Cleveland Clinic, U of Iowa, other large medical centers

The AAO Guidelines have given us evidence for some of these approaches. Some of the studies that I've discussed here today that were published after the AAO Guidelines have provided evidence for the effectiveness of some device and non-device approaches.  As we obtain more concrete data showing the effectiveness of these programs, then it becomes an opportunity for audiologists to incorporate them into their clinic.

Counseling Combined with Sound Therapy

My recommendation would be to use what I would call a “Quasi-TED” approach. In other words, this approach is a stripped down tinnitus therapy approach with a device component (from the Henry et al. 2016 study). Some of the counseling strategies that we can employ would be to look at a patient's reactions to tinnitus: their thoughts, emotions, hearing and communication, sleep and concentration. With regard to sound therapy, we can use hearing aids and combination devices, table top maskers, and/or the new HyperSound device that will be discussed later in the presentation.

Launching Tinnitus Management Services within Your Practice

Clinicians who are thinking about getting started in tinnitus management services may have some of these questions:

1. How do I identify candidates for tinnitus management services?
2. What aspects of tinnitus do I measure?
3. How do I measure outcomes?

Identifying Tinnitus Patients

There's no shortage of surveys and questionnaires to help identify those who have tinnitus. Specifically, I found the Tinnitus and Hearing Survey (Henry et al., 2015) to be a useful tool, because it helps in triaging or prioritizing which patients need intervention, for both hearing and for tinnitus. Patients can rate how problematic their tinnitus/hearing is on a scale, from zero to four. The higher the number, the more of a red flag there is for a patient to receive intervention, either for tinnitus or for hearing. The authors of this survey suggest using it as a tool to guide a conversation with patients. They don't provide any specific cutoff scores, but the higher the score on the survey, the more leverage you have to talk about either hearing or tinnitus, or perhaps both, as useful intervention strategies.

Measuring Tinnitus

Another component to launching tinnitus management services involves determining what aspects of tinnitus to measure. Historically, audiologists have measured the following characteristics: pitch, loudness, minimal masking level, duration and quality. However, as stated in recent literature, there is not any real clinical value to doing it, other than to be used as a counseling tool to validate to the patient their perception of the tinnitus. Measuring psychological characteristics (e.g., annoyance, habituation, emotions, concentration and sleep patterns) can be useful in determining the patient’s perceived severity of tinnitus. Furthermore, if they find tinnitus highly disruptive, we may need to refer them to other professionals, such as psychiatrists or psychologists.

Henry (2016) outlines how to measure some of these different characteristics. In the interest of time, I won’t get into too many of the details, other than to say it's a good way to validate to the patient and help explain what's going on. It may not have a lot of clinical value based on research. If you're looking for ways to measure tinnitus, I would recommend you review Henry (2016).

The one that does seem to have some real possibilities, would be the measurement of residual inhibition. According to Henry, this is an under-researched area, and there's clearly some potential for this to be used as a therapeutic technique. The idea here is, after the masker is turned off, how long does it take for the patient’s tinnitus to return? We're finding some very interesting things with the HyperSound device that are too early to talk about, but the HyperSound device might have some real value when it comes to providing long-lasting residual inhibition for some individuals. Stay tuned for information to be forthcoming over the next several months.

You could measure the patient's reaction to tinnitus using a scale like the Tinnitus Function Index (TFI, Meikle et al., 2012 ). Another one that I think has a lot of utility is the Iowa Tinnitus Activities Questionnaire (Tyler et al., 2014). It's shorter and it looks at some of the more problematic reactions to tinnitus, like sleep patterns, emotions and concentration. I would encourage you to take a look at some of those questionnaires with an emphasis on that new Iowa survey.

Clinical Applications

Sara Mattson: In our clinic, we use the AAO Guidelines as a way to help triage patients.  All patients who complain of tinnitus, hearing loss or an ear abnormality receive a thorough audiological evaluation.

Targeted Case History and Physical Exam 

It's important that the case history includes details of the symptoms the patient experiences, and the effect that the tinnitus has on their life. In addition, it is important to investigate the characteristics of the tinnitus and determine laterality (i.e., whether or not this is a unilateral problem). Also, we inquire as to whether or not it's pulsatile in nature. We rule out auditory hallucinations; if the patient is hearing voices, we make certain that the appropriate referrals are made to a psychiatrist.

We discuss the possibility of hearing loss, and whether the patient acknowledges that they have a hearing problem. Also, we determine if they have problems with balance or disequilibrium, vertigo or any neurological changes or deficits. Our clinic includes ENTs and audiologists, so we complement each other in regard to history-taking. The audiologists tend to focus on the ear and also on quality of life related to tinnitus. As the patient transitions to the otologist or ENT, they focus on the medical questions.

We also want to make sure that we ask if the patient has had exposure to ototoxic agents. Even over-the-counter medications such as aspirin, if taken in high doses, can cause tinnitus. Be aware that high frequency hearing loss may occur with ototoxic agents such as chemotherapy, aminoglycosides, or high doses of quinine. In a sensitive and respectful manner, determine if the patient may have excessive use of alcohol, tobacco or caffeine. This is important, especially for a patient that has bothersome tinnitus.

Providing good audiology and gathering a thorough case history is critical to understanding if there's a secondary reason for tinnitus. There may be a treatable issue that can be addressed and provide a quick solution to the patient's tinnitus.

The examination by the audiologist should include a thorough otoscopy exam and a comprehensive audiological evaluation. The ENT medical exam is aimed at ruling out serious disease associated with the tinnitus, and any potentially treatable, explainable cause for the tinnitus. A full exam should be completed. If the patient complains of pulsatile tinnitus, we want to refer for investigation of their cardiovascular health, examine their middle ear via otoscopy, and the signs of a vascularized middle ear tumor, like a glomus tumor.

Finally, it's important that we inquire as to the patient’s emotional and psychological health. I always ask the patient if their tinnitus bothers them. If they respond in the affirmative, I ask if they have a hard time concentrating or sleeping. Then, in the patient intake form and/or in our questioning, we can find out more about if they have healthy sleep and if they have a history of anxiety or depression. This is critical in making sure that the appropriate referrals are made to take care of those issues. Additionally, it will help us develop a clearer picture as to whether or not this is going to be a patient with bothersome tinnitus, or a patient who is simply curious about why they have ringing or buzzing in their ears.

Comprehensive Audiological Assessment

The assessments we provide in our clinic are extremely thorough. The AAO Guidelines recommend an audiogram for anyone with tinnitus that is unilateral, chronic (i.e., greater than six months in duration), or associated with hearing difficulties. I feel strongly that anyone who reports tinnitus should have an audiological evaluation. If a patient has unilateral hearing loss and other symptoms, we're looking to rule out retrocochlear abnormalities. If a person experiences a sudden onset of these symptoms, an immediate audiological assessment is due in our clinic, as it is deemed an emergency.

When I perform audiograms for patients with tinnitus, I spend a little extra time explaining the process. This is particularly important for the patient with bothersome tinnitus, where you can tell their anxiety level is high. In the sound booth, the patient will hear their tinnitus at a louder level.  In specifically explaning the exam as I go along, I try and relieve any of their fears or anxieties about what is happening. I also explain the findings throughout the exam, to try and reduce their overall stress and anxiety.

I use pulsed tones during pure tone audiology to help the patient better perceive the tones at their threshold, especially at frequencies that are close to the frequency of the tinnitus. Think of yourself as a detective; you're trying to determine why the patient may have tinnitus. Spend that extra time to provide good audiology. SRTs and WRS are important to validate pure tone testing and if a hearing loss is present, to determine how well they understand speech, and to serve as a baseline for future monitoring.  

Immittance testing will help to rule out middle ear issues. Before starting any assessment that will involve higher sound levels, such as acoustic reflex testing or the use of masking, it’s important to ask the patient if they have any loudness tolerance issues. If they do, be sure to very clearly explain the process. If there are tolerance issues, try to use the least amount of masking that's appropriate. Use insert earphones so that you have that increased interaural attenuation, and may not need as much masking. During acoustic reflex and acoustic reflex decay testing, ensure that the patient is comfortable; if they're not, I would discontinue that test.

I typically do DPOAE testing. I frequently see patients with bothersome tinnitus, who have a strong perception and a strong reaction to it. Many have had previous audiological exams elsewhere, where hearing testing was done at the octave frequencies through 8 kHz and they were told they had normal hearing.  They were told that there's no reason that they should have tinnitus. Sometimes it is therapeutic for the patient to understand that there is an underlying condition causing the tinnitus. If you do OAE testing and you see some reduced emmissions, that information can alleviate some patients' concerns.  

OAEs are helpful if you have a patient who has had ototoxicity or ototoxic agent exposure. With anyone who has had ototoxic exposure, we do ultra-high frequency audiometry. I know that all audiometers are not equipped to perform ultra high frequency audiometry but it can be very informative.  Just like the OAE may provide you with information you will not see on a standard audiogram, high frequency audiometry will sometimes show a loss at 9 kHz, 10 kHz, 11 kHZ or 12 kHz, on an audiogram that is normal through 8 kHz.  Again, this can relieve the patient by validating that there is a reason they may have tinnitus.

Ask questions and use questionnaires with patients who have tinnitus. This can be a great way for you to understand what kind of tinnitus-specific interventions are warranted. Furthermore, it can help you to understand the functional and emotional effects that the patient may or may not be feeling; you may determine that they don't need intervention. Finally, we don't routinely do psychoacoustic testing, as these types of tests (loudness matching, pitch matching, minimum masking levels) are not helpful in our diagnostics, in guiding our intervention, or for assessing outcomes. We tend to rely more on questionnaires.

Bothersome v. Non-bothersome Tinnitus

The AAO Guidelines help us understand how to triage the patient with bothersome tinnitus. In the AAO Guidelines, tinnitus is defined as bothersome when it is distressing to the patient, and it affects their quality of life and/or their functional health status. As I mentioned, when gathering the history, it's important to ask if the patient feels bothered by their tinnitus, and if they want to pursue further interventions. It's also significant to know if the tinnitus interferes with communication, concentration, sleep, or enjoyment of life. Furthermore, ask the patient how much time and effort they have put into seeking treatment for tinnitus, as this will help you understand how distraught they may be. Administer at least one of the validated questionnaires, to obtain a baseline on how they're doing if you do choose to treat them, and for use in measuring future outcomes of treatment.

Ask the patient if they have a history of insomnia, anxiety, and/or depression, and if they have ever seen a therapist or mental healthcare professional. If so, obtain the details and ask them if they feel the tinnitus has exacerbated one of these pre-existing conditions. Sometimes people feel that they didn't have any of these problems until they had tinnitus, and that tinnitus is to blame for their anxiety or sleep issues. It's important to ask those questions to develop a clear picture of how they're doing. Typically, a patient with bothersome tinnitus desires management strategies to alleviate their tinnitus. That doesn't mean that the person with non-bothersome tinnitus isn't curious, but they're probably not going to be looking for those management strategies.

Finally, there is a small subset of individuals with bothersome tinnitus that may have clinical depression or be suicidal. It's vital that these patients have immediate psychiatric evaluation and treatment. I want to stress the importance of approaching their psychological state head-on. Look the patient in the eye, speak in an empathetic yet clear manner, and make solid recommendations. Have referrals available for psychiatrists and/or psychologists that can help; professionals that you've talked to before, who you can comfortably contact and request their prompt assistance. You can also suggest that the patient goes to the ER if you feel they're going to be harmful to themselves. In a case like this, it is critical to document your work and all the referrals you make, in an effort to reduce your liability.

Educating Patients with Chronic, Bothersome Tinnitus

Questionnaires help us understand patients' reaction to their tinnitus; our questions help us understand their perception.

My favorite part about working with tinnitus patients is providing them with education. As you explain to a patient what tinnitus is and why they have it, and discuss assessment and possible treatments, you see some of their hopelessness and fear dissipate. It doesn't have to be a formal process - we can use the quasi-TED approach. Our goal is to demystify tinnitus. If we can reduce their perceived severity and some of their reactions to tinnitus, we play a part in helping to relieve their distress.

At some point, you may see a patient who has been exposed to negative counseling. If we can help other professionals understand how this has a negative impact on patients, perhaps they can take a different approach. Unfortunately, we can't control what Google says; therefore, it is essential that we demystify any myths that patients may have (e.g., there is no cure for tinnitus; you need to learn to live with it; tinnitus can mean you have a brain tumor). Understandably, their reaction to the tinnitus may become much more heightened and worrisome due to negative counseling and misinformation.

In our clinic, when a patient comes in for an audiogram, we take a thorough history, and we give that to the ENT. The ENT performs a full medical evaluation. By the end of the appointment with both of us, we have a good understanding of whether or not the patient has non-bothersome or bothersome tinnitus. If the patient has non-bothersome tinnitus, we give them information.  If they feel comfortable with everything, we don't need to see them again. If we've found something that we need to work up in terms of medical or audiological findings, we send them for follow up.

With the patient that has bothersome tinnitus, we give them information that they can start working on right away, and we suggest sound therapy to incorporate into their home. Then we offer them an appointment (a two-hour consult); this allows enough time to review the pathophysiology of tinnitus, their particular case, talk about science-supported treatment options, and to come up with a plan. We demystify the tinnitus, and then we talk about their lifestyle. I like to let the patient take their time to explain everything that they can to me about their tinnitus. I feel it's important to understand where they're coming from and it helps them feel validated. They tell me everything that's going on, and I make notes about key things that I want to talk to them about. Of course, we want to address any harmful lifestyle issues, such as poorly managed stress, poor sleep, excessive use of alcohol, excessive use of tobacco or caffeine, lack of exercise, and unhealthy behaviors in general.

Tinnitus education should also include a discussion of hearing loss and the connection it has with tinnitus. I find it helpful to visit the American Tinnitus Association (ATA) website, https://www.ata.org/. They have free printable brochures that you can download or order. They're patient-friendly, informative and unbiased (i.e., they don't cater to one particular manufacturer or one kind of therapy). There are also some great self-help books. If you download the AAO Guidelines, there are references for some of the self-help books. One book that I like is called “How to Manage Your Tinnitus: A Step-By-Step Workbook.” It is geared toward patients, and helps guide them through managing their tinnitus.

Another thing to consider is having good referrals on hand for other professionals. I like the idea of having a dentist or professional that works with TMJ dysfunction. We see some highly stressed, young patients that have a tendency to grind or crunch their teeth at night, which could be exacerbating their tinnitus. Also, investigate whether there is a local tinnitus support group that you can recommend to your patients. Finally, I have a rule that my patients are not allowed to search the Internet in an attempt to doctor themselves, because there's a lot of false or misleading information online which feeds their negative reactions.

When I discuss complementary and alternative medicine (e.g., acupuncture) with my patients, I inform them that there's not strong science to show that they help tinnitus itself. However, they may be useful in reducing tension or pain associated with tinnitus. I don't see a problem with trying them, especially if there's no negative side effects, other than the time and money spent by the patient. We also talk a little bit about drug therapy and how there's no strong evidence that drugs can cure tinnitus. Again, if they have underlying depression, then they should see a mental healthcare provider to obtain any necessary medicine for depression or anxiety.

Hearing Aid Evaluation

A meta-analysis by Cabral et al. (2016) assessed whether hearing aids reduced the emotional or auditory effects of tinnitus.  They found that hearing aids did improve quality of life for tinnitus patients by mitigating the emotional and auditory aspects of tinnitus.  If you can deliver hearing aids, and also provide some education, even if it's in a modified way, you have a chance of helping that patient.

One consideration when fitting a patient with a hearing aid, is that it's good to use a well-ventilated design, with more of an open fit design. This way, the hearing aid can provide not only increased access to softer intensity sounds, but also better access for normal ambient sounds. Those sounds can help reduce the perception of tinnitus.

Another recommendation is to fit your patient bilaterally when at all possible. Consistent use of the hearing aids is key. It is important that the patient uses the devices from the time they get up to the time they go to bed. This way, they receive the full therapeutic effect, and it lessens the times where they're stressed or worried about their tinnitus.

My other consideration for hearing aids is to make sure that you get an instrument that's flexible. I recommend connectivity so that the patient can stream some sort of sound therapy. Another beneficial feature is an onboard sound generator. It doesn't cost much more, and it's a nice option if you need it. Also, I recommend some type of end-user control, whether it's through a smartphone app, a remote control, an onboard memory button or a volume control. 

Simply improving hearing can reduce the brain's need to strain to hear. If we can reduce the brain's straining to hear, we may be able to reduce the tinnitus, and also reduce fatigue. In addition, when we improve hearing, we can reduce the patient's daily stress; stress that may be associated with their difficulty communicating at work or with family members. In California, we have a 45 day trial period by law.  I do encourage you to try hearing aids and/or sound therapy with your tinnitus patients who are candidates.

To encourage my patients to use some sort of sound therapy, I compare their tinnitus to a candle in a dark room. If you're most bothered by your tinnitus when you're in absolute quiet, it's similar to a candle in the dark. The candle in the dark is very bright when it is the only light source; similarly, the patient’s tinnitus in quiet is extremely noticeable. However, if you open the blinds and let in some more light, the candle's not so bright anymore. Along the same lines, if you can allow a little bit of natural sound in, then maybe that tinnitus won't be so “bright.” I find that patients easily understand that example of how sound therapy can be beneficial, simply by reducing their perception of tinnitus.

Sound therapy can be incorporated into an ear level hearing aid quite easily. You can also use desktop sound generators. There are many options, from cheap ones to expensive ones, some with white noise, or nature sounds. Sometimes my patients dislike white noise, so I suggest sounds that are more benign, like turning on a fan, or a fish tank with a bubbling filter. They also make little tabletop water fountains. Consider those kinds of more benign, everyday sounds that could create a little extra ambient noise. If we can provide some sort of tool to help the patient feel like they have control, that can go a long way to alleviating some of their distress associated with the tinnitus. Furthermore, using these types of sound therapy has no side effects, as compared to medications and some other therapies. There are no real disadvantages.

Cognitive Behavioral Therapy

I'm not a psychologist, so I don't offer cognitive behavioral therapy, but we do recommend it to our patients.  It has been shown to have some benefit for tinnitus patients. You may want to find a mental health professional in your area, and add them to your list of referrals. I tend to suggest this to my patients who are excessively distressed, have high anxiety, or strong feelings of hopelessness related to their tinnitus. The idea is that it helps the patient manage their emotions and feelings related to their tinnitus, by helping them change the way they process their emotions, thoughts and behaviors. For example, an individual with tinnitus may avoid social gatherings, because they are unable to hear over their tinnitus; the resulting behavior is that they don’t attend events or parties. Then, they feel sad because their friends went without them. The way cognitive behavioral therapy works, is a therapist would encourage the individual to modify their thought process. Instead of avoiding social situations, the person might say to themselves, “I may not be able to hear as well as I want to, but I still might enjoy the food and the atmosphere.” Then, they change their behavior and go to the party and see if maybe they will enjoy themselves. The alternate outcome or feeling may be that they enjoyed the food and appreciated not sitting at home alone. In the AAO Guidelines, there are some ways of addressing negative behaviors and pessimistic attitudes related to the patient’s tinnitus.

HyperSound Clear^TM 500P – New Tinnitus Add-on Feature

Brian Taylor: HyperSound Clear 500P is a television listening device. In short, it uses ultrasonic energy to create or turn air into sound. If you're watching television and sitting front of the emitters (similar to speakers), you can be several feet away and it sounds like you're wearing headphones, but you have absolutely nothing in your ear or around your neck. There are no ear-level devices or headsets that you wear.

We recently received FDA clearance to offer a tinnitus add-on feature that has nine different masking sounds: Stream, Rain, Wind, Fan, Shower, Forest, Waves, White Noise and Brown Noise. That feature is customizable by the audiologist using the patient's audiogram and also their masking preferences. 

As presented today, there is clear evidence to support the effectiveness of sound therapy devices for patients with tinnitus. Historically, these have been ear-level devices, usually in the form of a hearing aid, or some type of a tabletop unit. Now, we have the HyperSound Clear 500P that requires nothing to be worn around the ear that you can add to your portfolio of sound therapy devices. It may especially be attractive to people who aren't ready to wear hearing aids or who don't need hearing aids, because they have relatively good hearing.

A tinnitus management approach that combines sound therapy, an explanation of tinnitus, and some form of counseling, relaxation and/or coping strategies to address the reaction to tinnitus, is a standard service package that any audiologist with a little training could offer.  And, the HyperSound Clear 500P with the tinnitus add-on fits nicely into this approach in the sound therapy portfolio.  

FDA Trial Data

Sara Mattson: We completed a pilot study on 11 subjects who all had chronic, persistent, and bothersome tinnitus, accompanied by hearing loss. We wanted to assess whether HyperSound, which uses ultrasound technology to deliver a customizable direct audio signal to the end user, would reduce perceived tinnitus loudness and perceived tinnitus annoyance. My perception, from the moment I first heard this product, is that it gives the end user a very clear, amazing audio experience.  When you use HyperSound Clear, you feel as if you are immersed in sound, while you are sitting comfortably in your home without being required to wear headphones.

In our early studies, we looked at clarity of speech. This HyperSound product was able to give a very clear signal to hearing impaired patients, so much so that their speech perception abilities drastically improved while using it. Part of our hypothesis is that this directed, tunable signal, where we can convey quite a bit of high frequency information, could give our tinnitus patients relief. Our pilot study looked at that.

Each subject had the HyperSound system tuned specifically to their hearing loss. They were able to choose from nine soothing sounds (e.g., either broadband noises, such as pink, white or brown noise; or nature sounds, like wind, rain, or ocean). They would indicate on a visual analog 100-point scale their perceived tinnitus loudness and then their perceived tinnitus annoyance prior to being exposed to the soothing sound via HyperSound. They sat in a reclining chair and they sat in the HyperSound beam listening to their tuned sound for one hour. Following the exposure, they indicated, again, their perceived tinnitus loudness and annoyance while in the beam.

The results were encouraging. They showed impressive reductions in both loudness and annoyance. On average, there was a 61% reduction in the patient's perceived tinnitus loudness, and a 54% reduction in the patient's perceived tinnitus annoyance. It's exciting and it's very easy to use. Every patient that had the opportunity to experience HyperSound was impressed by how much of a reduction in the perception of tinnitus they experienced while they were in the HyperSound beam. More details can be found at https://hypersoundhearing.com/tinnitus/.  

We're currently looking at three of these subjects in a longer term study, evaluating some different ways to use HyperSound in the home. We are also hoping to improve sleep disturbances related to tinnitus and to evaluate the potential for long term benefit. There are some other studies that are underway, results of which will be forthcoming soon.  HyperSound Clear 500P with the tinnitus add-on feature is an FDA-approved product, available for in-home use to provide relief of tinnitus. You can use it with your patients that have hearing loss or that don't have hearing loss. 

References

Baguley, D., McFerran, D., & Hall, D. (2013). Tinnitus.  Lancet, 382(9904). doi: 10.1016/S0140-6736(13)60142-7

Bhatt, J.M., Bhattacharyya, N., & Lin, H.W. (2016, June). Relationships between tinnitus and the prevalence of anxiety and depression.  Laryngoscope (Epub ahead of print). doi: 10.1002/lary.26107

Cabral, J., Tonocchi, R., Ribas, A., Almeida, G., Rosa, M., Massi, G., & Berberian, A.P. (2016). The efficacy of hearing aids for emotional and auditory tinnitus issues.  Int Tinnitus Journal, 20(1), 54-8. doi: 10.5935/0946-5448.20160010

Dobie, R. (2004). Overview: Suffering from tinnitus. In J.B. Snow (Ed.), Tinnitus: Theory and management (pp. 1–7). Shelton, CT: PMPH-USA.

Henry, J.A. (2016) “Measurement” of tinnitus. Otology & Neurotology, 37(8), e276-e285.

Henry, J.A., Griest, S., Zaugg, T.L., Theilman, E., Kaelin, C., Galvez, G., & Carlson, K.F. Tinnitus and hearing survey: a screening tool to differentiate bothersome tinnitus from hearing difficulties. Am J Audiol., 24(1), 66-77. doi: 10.1044/2014_AJA-14-0042.

Henry, J.A., Stewart, B.J., Griest, S., Kaelin, C. Zaugg, T.L., & Carlson, K. (2016).  Multisite randomized controlled trial to compare two methods of tinnitus intervention to two control conditions. Ear & Hearing, 37(6), e346-e359.

Hoare, D.J., Edmondson-Jones, M., Sereda, M., Akeroyd, M.A., & Hall, D. (2014). Amplification with hearing aids for patients with tinnitus  & co-existing hearing loss. Cochrane Database Systematic Review, 1, CD010151. doi: 10.1002/14651858.CD010151.pub2

Hobson, J., Chisholm, E., & El Refaie, A. (2010). Sound therapy (masking) in the management of tinnitus in adults. Cochrane Database of Systematic Reviews, 12, CD006371. DOI: 10.1002/14651858.CD006371.pub2

Joo, Y.H, Han, K.D., & Park, K.H. (2015).  Association of hearing loss and tinnitus with health-related quality of life: The Korea National Health and Nutrition Examination Survey. PLoS One, 10(6), e0131247. doi: 10.1371/journal.pone.0131247

Martinez-Devesa, P., Perera, R., Theodoulou, M., & Waddell, A. (2010). Cognitive behavioural therapy for tinnitus.  Cochrane Database of Systematic Reviews, 9, CD005233. doi: 10.1002/14651858.CD005233.pub3

Meikle, M.B., Henry, J.A., Griest, S.E., Stewart, B.J., Abrams, H.B., McArdle, R,...Vernon, J.A. (2012) The Tinnitus Functional Index: Development of a new clinical measure for chronic, intrusive Tinnitus. Ear Hear 33(2), 153–176.

Newman, C.W., Jacobson, G.P., & Spitzer, J.B. (1996) . Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg, 122,143-148. 

Rojas-Ronacancio, E., Tyler, R., Jun, H.J., Wang, T.C., Ji, H., Coelho, C.,...Gantz, B.J. (2016). Manganese and Lipoflavonoid Plus to treat tinnitus: A randomized controlled trial. JAAA, 27(8), 661-8. doi: 10.3766/jaaa.15106

Tyler, R., Haihong, J., Perreau, A., Witt, S., Noble, W., & Coelho, C. (2014). Development and validation of the Tinnitus Primary Function Questionnaire. American Journal of Audiology, 23, 260-272. doi:10.1044/2014_AJA-13-0014

Zarenoe, R., Sőderlund, L., Andersson, G., & Ledin, T. (2016) Motivational interviewing as an adjunct to hearing rehabilitation for patients with tinnitus: a randomized controlled pilot trial. JAAA, 27(8), 669-676.

More references are listed in the course handout.