The American Academy of Audiology Foundation was honored to have James Henry, PhD, as the lecturer for the Topics in Tinnitus Lecture Series at AudiologyNOW! 2017 in Indianapolis, Indiana. Dr. Henry is a research career scientist with the Department of Veterans Affairs (VA) Rehabilitation Research and Development Service (RR&D) National Center for Rehabilitative Auditory Research (NCRAR) in Portland, Oregon.
In addition to his role as a researcher at NCRAR, Dr. Henry is also a research professor in the Department of Otolaryngology/Head and Neck Surgery at the Oregon Health and Science University (OHSU), as well as an adjunct professor in the Department of Audiology at Portland State University. He is a recognized expert on tinnitus research with a focus on clinical aspects of tinnitus management. Dr. Henry was recognized at AudiologyNOW! this year with the James Jerger Career Award for Research in Audiology.
The Topic in Tinnitus Lecture Series is generously sponsored by Widex USA, Inc. and Widex A/S, Denmark. The AAA Foundation appreciates the philanthropic support from Widex and thanks them for their five-year commitment to high-level education on the topic of tinnitus. The 2017 edition of the Topics in Tinnitus Lecture with Dr. Henry is available (free of charge for three months) as a webinar on www.eaudiology.org.
Dr. Robert M. DiSogra, a AAA Foundation trustee, had an opportunity to talk with Dr. Henry about his life’s work in the area of tinnitus.
Robert DiSogra: Dr. Henry, thank you for taking time from your busy schedule to speak with me. Let’s start with how you became interested in the study of tinnitus, your path to the NCRAR, and your current and future research plans.
James Henry: Thanks, Bob, and please call me Jim. It’s certainly a pleasure to be interviewed by someone who has done their own research on over-the-counter (OTC) tinnitus products. I was surprised by how many of these products are marketed to consumers!
That’s correct, Jim. Over 80 products are out there and still counting! None of which, I might add, are FDA approved. Caveat emptor!
I’m happy to hear that you are lecturing on this to our colleagues. They need to know about the safety and efficacy of these products.
Thanks! Let’s talk about how you became interested in tinnitus and your research.
My interest in tinnitus was not by design. After some years out of school pursuing other careers, I moved to Portland in 1984 so that my five-year-old deaf daughter could attend Tucker Maxon School, which specializes in teaching speech and listening skills to deaf children. I had already re-entered college prior to moving here. After getting settled, I visited Portland State University and wound up in the Speech and Hearing Department, where I met with one of the professors, Dr. Joan McMahon. When I left her office, I knew that I wanted to become an audiologist and I enrolled in their program. I completed a master's of science in audiology in 1987, and was hired by Drs. John McDermott and Steve Fausti at their VA auditory research lab in Portland to work as a research audiologist.
I soon realized that I wanted to do my own research, so I enrolled in the behavioral neuroscience doctoral program at OHSU in 1988. My research lab was at the Oregon Hearing Research Center (OHRC), which was run by Dr. Jack Vernon, and my research advisor was Dr. Mary Meikle. Dr. Vernon’s Oregon Tinnitus Clinic was under the same roof. I spent six years in that program, receiving my PhD in 1994. All of my research at OHRC involved the evaluation of different methods of tinnitus measurement. Those six years were invaluable in preparing me to start a career in tinnitus research.
I knew Drs. Vernon and Meikle and I know you were very fortunate to spend all of that time under their tutelage.
I was indeed fortunate and owe a great deal to both of them, as well as to all of the staff who guided me through my doctoral program.
So how did your career in tinnitus research start after you completed your PhD?
During those six years in the doctoral program, I continued to work half-time at the VA in Portland. I assisted Drs. McDermott and Fausti in all aspects of their research, and became more and more involved with scientific writing of research articles and grant proposals. This was another form of mentoring that I received and I am also grateful for that opportunity. Shortly after completing my doctoral program, I went to work writing a grant proposal to study a new technique for tinnitus measurement using computer automation. That proposal was funded in 1995, and that’s when my independent tinnitus research began. By the way, the NCRAR started here in 1997, so I was involved in that whole start-up process.
What, specifically, were you studying in the beginning?
The perception of tinnitus has sound-like qualities. Different procedures had been developed, by Drs. Vernon and Meikle, and by others, and Dr. Fausti had the idea that these procedures could be conducted entirely by a computer. We worked with an engineer to develop such a system, and it worked quite well. The first system obtained tinnitus loudness matches, tinnitus pitch matches, and measures of tinnitus “mask-ability” and residual inhibition.
Matches of loudness and pitch attempt to replicate the sound of a person’s tinnitus. Mask-ability is the level at which broadband noise completely covers or “masks,” a person’s tinnitus. Residual inhibition is the common (80–90 percent of patients) effect of reduction in tinnitus loudness following one minute of listening to sound at a level higher than that at which tinnitus is masked.
Where has this research led you and your team?
We have since received four consecutive grants to continue this work of tinnitus measurement. Each grant has resulted in an updated version of the testing system, and we are currently funded through 2018, so the work is ongoing. Our current project is focusing on establishing normative standards for these tinnitus measures, as well as other measures, in a large number of people with tinnitus. The caveat is that these measures have not been particularly useful for clinical purposes, other than to serve as a counseling tool for patients. Our goal is to create a clinically viable system that will obtain these measures rapidly and reliably, and that the measures will have clinical utility with respect to assessment and intervention for tinnitus.
So measuring tinnitus with your research methods, at least currently, has limited value in the clinic. What would you suggest be done to assess the patient who reports tinnitus?
The first thing to be aware of is that the majority of patients complaining of tinnitus also have hearing loss. Therefore, these patients should receive a full hearing evaluation by an audiologist. Patients who are candidates for amplification should receive hearing aids. If the tinnitus is bothersome to the patient, then the hearing aids may be effective both for improving hearing and for mitigating effects of tinnitus. We have recently completed two randomized controlled trials (RCTs) that demonstrated the effectiveness of hearing aids for this purpose.
Can you tell us a little about those studies?
Certainly. The first was funded by Starkey Hearing Technologies (Henry et al, 2015). We recruited 30 hearing aid candidates who also had bothersome tinnitus. All participants wore Starkey’s combination instruments for three months. (Combination instruments are hearing aids that include the option for a noise stimulus to help mitigate the awareness of the tinnitus.) All of the participants had the hearing aids adjusted for optimal hearing based on standard clinical fitting procedures.
Participants were then randomized such that half had the sound generator (noise stimulus) adjusted for maximum tinnitus relief (again based on standard clinical procedures), while the other half did not have the sound generator activated—they simply used the devices to treat the hearing loss. Both groups showed significant improvement overall in their report of tinnitus (decrease), based on the Tinnitus Functional Index (TFI) and there was no significant difference between groups (Meikle et al, 2012). This means that treating the hearing loss not only helped the subjects with their hearing, the amplification helped reduce the effects of the tinnitus!
I’m glad to see this study and the results that you got. We need controlled studies verifying what audiologists already know from experience and that is hearing aids are often effective both for improving hearing and for mitigating effects of tinnitus. What did the second hearing aid study reveal?
The second study was similar to the first, but included a third group. The third group wore deep-fit, extended-wear hearing aids (Lyric). These hearing aids were of particular interest because audiologists fitting them were receiving reports from their patients that they seemed to be particularly effective for providing relief from tinnitus. Such benefit seemed logical because these hearing aids are worn 24/7, thus they can provide “sound enrichment” 24/7.
It is generally thought that sound enrichment from hearing aids is what mitigates reactions to tinnitus; having sound enrichment round-the-clock would seem to optimize this effect. The other two groups in this study again wore combination instruments, i.e., one group had the sound generator (noise stimulus) activated and the other group did not have it activated. This study was funded by Phonak, LLC, and all of the devices were supplied by the company.
What were the results?
The results were similar to the first study—combination instruments with the sound generator activated versus un-activated both provided significant benefit (report of reduced effects of tinnitus), and the benefit was comparable between groups. The deep-fit extended-wear device did equally well, indicating that this type of device can also be helpful for tinnitus.
Now we have two randomized-controlled trials showing that hearing aids and combination devices (with the sound generator) are useful for tinnitus management. Has anyone else done a similar RCT?
To my knowledge, there is only one other such RCT, which was published by dos Santos et al in 2014 (Dos Santos et al, 2014). Their study showed results very similar to our own. So, there are now at least three RCTs demonstrating the effectiveness of combination instruments and of hearing aids for tinnitus.
This is certainly something that audiologists should be aware of. The use of these devices for managing tinnitus would now be considered evidence-based. We were talking about assessment of the tinnitus patient when we got off on this tangent. Can you tell me more about how tinnitus patients should be evaluated?
I mentioned the TFI (Tinnitus Functional Index), which was used in both of our hearing aid studies. The TFI is a tinnitus outcome instrument that has been shown to be responsive to effects of intervention. Development of the TFI was a rigorous project driven by Dr. Meikle over a four-year period (Meikle et al, 2012). The TFI has been adopted internationally by numerous researchers and clinicians, and is being translated into at least 15 languages.
We need a standard outcome measure and the TFI has the potential to meet this need. One caveat with using the TFI, or any tinnitus questionnaire for that matter, is that some patients who have both hearing loss and tinnitus tend to blame their tinnitus for their hearing difficulties. When this happens, they will respond to questions about how their tinnitus affects them with respect to how they are bothered by their hearing problems. These kinds of responses will result in a questionnaire score that indicates the tinnitus is more of a problem than it really is. It is difficult to determine if these patients need intervention specific to their tinnitus or not.
How do you make this determination?
This was a problem for us in our early days of conducting RCTs. To screen for appropriate research participants, we would ask the questions from a tinnitus questionnaire over the telephone. If the score was high, then we figured they had enough of a problem with their tinnitus to warrant the intervention that was offered. They would then be scheduled for a full assessment, which typically took two hours or more. We had numerous candidates who had a significant hearing problem, but a minimal tinnitus problem, despite their high score on the tinnitus questionnaire. We had to send those people home and tell them to consider getting hearing aids for their hearing loss. This cost us valuable time and we realized we needed to find a way to screen more efficiently over the telephone so that the candidates who showed up in our lab were more likely to qualify as needing intervention for their tinnitus.
Did you find a way to address this problem?
Our solution was to develop a screening questionnaire just for this purpose. The questionnaire needed questions about the effects of tinnitus that would not be confused with hearing problems. Similarly, it needed to have questions about hearing loss that would not be confused with tinnitus. We wrote four items for each, and this has worked remarkably well for our screening procedures. The screening instrument is called the Tinnitus and Hearing Survey, and it has been validated and published (Henry et al, 2015).
Is the Tinnitus and Hearing Survey useful in the clinic?
Yes. We recommend that the basic assessment for the patient with tinnitus is a diagnostic hearing evaluation to include the Tinnitus and Hearing Survey. These procedures will normally provide all of the information necessary to determine the patient’s needs, with respect to both hearing and tinnitus. If the patient is a hearing aid candidate, then that person should receive hearing aids (or combination instruments) and should have the Tinnitus and Hearing Survey re-administered in a few months to determine if the tinnitus has been helped.
If the person still has a tinnitus problem, then the hearing aids have not been sufficient in resolving the problem and tinnitus-specific intervention should be considered. That would be the point at which the TFI, or any tinnitus questionnaire, should be completed. The TFI score will serve as a pre-intervention (for tinnitus) baseline that can be used to assess post-intervention outcomes.
So, you are recommending use of the survey and not a tinnitus questionnaire, such as the TFI, as part of the initial tinnitus assessment, correct?
That’s correct. Only the hearing evaluation and the Tinnitus and Hearing Survey are normally needed for basic assessment of a person complaining of tinnitus.
And you’re saying only use the TFI if the patient will be receiving intervention, which will be the baseline measure against which to measure outcomes?
Okay. If the person needs intervention, what’s the next step?
The decision to receive intervention should really come from the patient. The audiologist facilitates that decision by explaining test results and offering realistic expectations for what type of intervention would be appropriate.
There are many methods of intervention for tinnitus. How do you know which is best for the patient?
I would start by recommending that audiologists become very familiar with the tinnitus practice guideline that was published in 2014 by the American Academy of Otolaryngology/Head and Neck Surgery (Tunkel et al, 2014). I was on the committee that developed these guidelines and I can attest to the rigorous process that was employed in developing them. Their exhaustive review of the literature revealed that Cognitive-Behavioral Therapy (CBT) had the strongest evidence base for tinnitus intervention. They also recognized that sound therapy can be effective, but only suggested sound therapy as an “option” for intervention. This was based on the fact that there was not much evidence in the published literature to support the use of sound therapy. We recently completed four RCTs, each with a sound therapy component, so we have provided evidence for sound therapy that did not exist when the guidelines were being developed.
Did these four studies include the other hearing aid RCTs that you have already described above?
Yes, plus two others that involved Progressive Tinnitus Management, or PTM. All of the research that we have done has culminated in the development of PTM, which is a structured, stepped-care method of tinnitus management.
And can you tell me briefly about the two PTM studies?
Sure. PTM involves five levels of management, and patients progress only to the level that meets their needs.
Level 1: Referral Level—Depending on the patient’s symptoms, they may be referred to audiology, mental health, otolaryngology, or emergency care. As I’ve already mentioned, every patient reporting tinnitus should have a hearing evaluation and tinnitus assessment using the Tinnitus and Hearing Survey, which is part of PTM Level 2: Audiologic Management.
Level 2: Audiologic Management—This also includes hearing aids or combination instruments, if indicated. After completing Level 2, patients requiring tinnitus-specific intervention are offered PTM Level 3: Skills Education.
Level 3: Skills and Education—With this level, our approach is to teach patients the skills they need to self-manage their tinnitus problems. We combine teaching them about different forms of sound therapy (by an audiologist) along with CBT taught by a mental-health provider. As you can see, Level 3 is interdisciplinary. Our studies and clinics that use PTM have shown that most patients who receive Level 3 intervention have their needs met to the degree that they do not desire or need further services.
Those relatively few patients who do need further services are offered the PTM Level 4: Interdisciplinary Evaluation.
Level 4: Interdisciplinary Evaluation—This level involves an in-depth evaluation by both an audiologist and a psychologist. Based on the outcome of this evaluation, it should become clear why the patient is still so bothered by tinnitus and what might be the most appropriate form of intervention. If intervention is still needed, then these patients are offered PTM Level 5: Individualized Support.
Level 5: Individualized Support—This level involves one-on-one services by an audiologist and/or a mental-health provider. The audiologist typically covers sound therapy skills in greater detail, while the mental-health provider typically expands on the CBT that was provided in Level 3. Other forms of tinnitus therapy can also be offered at Level 5.
And what about the two PTM studies?
One was a clinical effectiveness study of PTM that was conducted in two VA audiology clinics—one in Memphis, Tennessee, and one in West Haven, Connecticut. Patients who came to the clinics signed up for the study if they felt that the PTM Level 3 intervention might be helpful for them. Half were enrolled to attend the Level 3: Skills Education classes and half were placed on a six-month wait list. The PTM group showed significantly greater benefit than the wait list group. There were 300 veterans in this study (Henry et al, 2017).
The second PTM study was motivated by the fact that so many VA patients have experienced a traumatic brain injury and many have bothersome tinnitus. We used the counseling from PTM Level 3: Skills and Education, and it was administered to participants over the telephone by both an audiologist and a psychologist. Participants were located all over the United States and they were randomized to either receive the telephone counseling for six months or to be put on a six-month wait list. The Tele-PTM group showed significant improvement (reduction in effects of tinnitus), while the wait list group did not.
Dr. Henry, this has been a most illuminating discussion and we are sure the reader has a much greater appreciation of all of the research and work you and your team have done in the areas of tinnitus evaluation and intervention. Can you provide us with a summary of your recommendations at this point?
We have 10 recommendations based on our work, as follows:
- Clinical services for tinnitus should be progressive. Every patient is different, and the level of care he or she receives for his or her tinnitus should be based on his or her level of need.
- Three disciplines should be involved in tinnitus management: audiology, otolaryngology, and psychology.
- All patients with tinnitus should have their hearing tested by an audiologist.
- Determine if the tinnitus is bothersome or not. If so, then tinnitus-specific intervention should be offered.
- The best way to determine if intervention is needed is to complete the appropriate tinnitus questionnaires.
- Make sure the tinnitus problem is not a hearing problem by using the Tinnitus and Hearing Survey up front.
- The first step in tinnitus management is for patients to be informed and educated. This may include dispelling some myths, particularly with regard to all of those OTC products that purport to “cure” tinnitus. This information is empowering and will enable a person to make informed decisions.
- Patients are best served if they learn coping skills. Just like any other chronic condition, tinnitus needs to be managed and people need to learn what to do to manage their tinnitus.
- People should learn how to use sound effectively to manage tinnitus. There are many ways sound can be used, and as I mentioned earlier, there is no proof that any one method works better than any other.
- Tele-health works, if the provider has the necessary expertise. The beauty of this method is that patients would not have to leave their homes—they just pick up the phone and talk.