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The first clinical trial to investigate the effect of a standardized physical therapy treatment—directed to the cervical spine—on tinnitus is being conducted by Sarah Michiels, MSc, and colleagues at the University of Antwerp.  The randomized and controlled trial, which began in May, will also seek to identify a subgroup within the tinnitus population that benefits from physical therapy treatment.
The researchers will investigate the effect of a standardized physical therapy treatment protocol on somatic tinnitus with a prospective comparative delayed design and with blinded evaluator for baseline, end of therapy, and 6 and 12 weeks after therapy.
The device is fully implantable and is designed to be used at home.  During the therapy, an individual sits in a comfortable chair and wears headphones. MicroTransponder’s approach to treating tinnitus is based on decades of scientific research. One might ask the question, “How can a nerve in the neck cause changes in the brain?” The vagus nerve is unlike any other nerve in the body. The MicroTransponder team utilizes this natural response system by directly stimulating the vagus nerve while playing a sound, which tells the brain to “pay attention” to that sound. Henry Ford Health System, Detroit, Mich, is one of many institutions around the world seeking participants for two clinical trials investigating tinnitus, a chronic ringing of the ears affecting more than 600 million people worldwide.
Tinnitus affects more than 12% of American troops who have been exposed to acoustic trauma from machinery and explosive devices. Tinnitus in the inner ear is often a consequence of an acoustic trauma, barotrauma, operation on the middle ear, traumatic perforation of the eardrum or middle ear infection. Henry Ford is one of 70 sites worldwide involved in this National Institutes of Health-supported study and it is currently recruiting patients aged 18-75, and have been diagnosed within the past three months or less with acute inner ear tinnitus brought on by acoustic trauma, barotrauma, operation on the middle ear, traumatic perforation of the eardrum or middle ear infection. A second trial will test a new pacemaker-like-device that uses nervous system stimuli to rewire parts of the brain, in hopes of significantly reducing or removing tinnitus.
Eligible participants are ages 22-65, who have been diagnosed with subjective tinnitus due to hearing loss with sensorineural aspects and at least some tonal quality of the tinnitus.
The results from this clinical study strongly support the use of Widex Zen Therapy in tinnitus patient management. Previous reported investigations of hearing aids containing fractal tones1-6 have yielded favorable results in reducing the tinnitus annoyance or handicap for patients with significant tinnitus. Derived from these findings and subsequent research, Widex introduced a new tinnitus management approach called “Widex Zen Therapy” in 2012.7 The overall objective of Widex Zen Therapy (WZT) is to ensure that the tinnitus does not negatively impact the patient’s quality of life.
4) Relaxation strategy program, highlighted by relaxation exercises and sleep management strategies. The appropriate components constituting the therapeutic intervention are tailored for each individual in accordance with the audiologic evaluation and the patient’s reaction to the tinnitus. 2) to investigate how subjects employ the hearing aids and the acoustic (fractal tones or filtered noise) options. Two tinnitus clinics participated in the data collection (Hearing and Tinnitus Center Tinnitus Clinic in New York and Canadian Tinnitus and Hyperacusis Centre in Whitby, Ontario, Canada). Subjects were given a comprehensive audiologic and tinnitus evaluation by trained tinnitus clinicians at the two clinical sites. All subjects had significant tinnitus distress (THI >18) when they enrolled in the clinical study with a mean THI score of 51, ranging from 20 to 96.
Instructional counseling was similar to that provided in Tinnitus Retraining Treatment (TRT)11 directive counseling.
The choice of the particular model (which varied from the high end 440 to the entry level 110) was based on the individual patient’s needs and economic considerations. There are five Zen fractal tone styles available that vary in their tempo, pitch, dynamic range, and chord. Zen Program A utilized the “Aqua” setting that has proven to be the most popular fractal tone style. Subjects were instructed on hearing aid use, including how to access the various Zen programs and how to adjust the volume. The mean TFI baseline score was 53 (range 20 to 82), while the final TFI mean score improved to 25 (range 0 to 62). Individual subject scores for the baseline and 6 months after WZT are shown in Figures 3 (THI) and 4 (TFI). Symbols falling below these diagonal dashed lines reflect clinically significant relief from tinnitus on these two scales. A secondary objective of this study was to ascertain individual preferences and wearing habits for the hearing aids and programs.
The majority (80%) of subjects selected “Aqua style with microphone on” as their Zen A program.
Figure 6 shows the mean percentage of time use for amplification versus the three Zen programs.
Additionally, 74% and 75% of subjects achieved clinically significant changes in their THI and TFI scores, respectively.
Although it is not possible to determine the relative contribution of each WZT component to the reduction of tinnitus handicap and quality of life improvement, it is interesting to note that the degree of improvement (in terms of THI and TFI reduction) was slightly greater (though not statistically significant) for the subjects receiving the more comprehensive cognitive behavioral intervention and relaxation exercises. Future clinical studies would be useful to lend support to these findings and to determine the longer-term efficacy of this treatment. The Serenity System® pairs an existing therapy called Vagus Nerve Stimulation (VNS) with listening to tones via headphones.
They listen to tones while receiving small bursts of neurostimulation, which activate the vagus nerve.

It directly connects to the brain and sends important signals to tell the brain what to learn.
This simultaneous pairing of a specific tone with vagus nerve stimulation (VNS) strengthens auditory neurons representing that tone.
It is now the number one disability among women and men in uniform, a growing problem that costs the US roughly $1.7 billion a year to treat.
While the tinnitus often goes away after a short period in these circumstances, it can persist in some cases even after the injury has healed. Henry Ford Health System is one of four sites worldwide recruiting patients for a clinical trial to test the effectiveness and safety of the vagal nerve stimulator, a small, surgically implanted device that uses nervous system stimuli to rewire parts of the brain, for the treatment of tinnitus.
Participants must have experienced tinnitus (unilateral or bilateral) for at least one year. The data revealed substantial positive adjustment to tinnitus, as measured by the TFI and THI, evident within the first 2 months of treatment, with further (albeit not statistically significant) changes occurring through 6 months.
It appears that a combination of fractal tones (generated by hearing aids), amplification, and counseling have great potential for tinnitus patient management. The more severe and negative the tinnitus reaction, the more components listed above will be added in the individualized program. The mean tinnitus loudness was 6 (on a 10-point scale) and the tinnitus pitch was 7 (on a 10-point scale). Subjects participating in the study were patients who visited the clinics to seek tinnitus management.
In addition, adjustment-based cognitive behavioral intervention (explained below) and relaxation exercises were applied for those individuals demonstrating more severe negative reactions to their tinnitus. All subjects received detailed instructional counseling related to the hearing loss and tinnitus.
The objectives were to provide the patient with an understanding of the habituation process and to help the patient reclassify the tinnitus. Because many clinicians feel instructional counseling alone is not adequate to address the emotional consequences of tinnitus, including fear, anxiety, and depression,12 WZT recommends adjustment-based counseling or Cognitive Behavioral Intervention (CBI) to help the patient identify barriers to achieving natural habituation. All subjects were fit bilaterally with Widex Dream hearing aids with True Input Technology that remain undistorted at the input stage with inputs as high as 113 dB SPL.
All of the hearing aids were programmed to have four memories; a “master” (amplification only) program, and three “Zen” programs, as explained below.
The Zen programs use fractal (Zen) tones that are generated by a semi-random recursive algorithm. In addition, fine-tuning adjustments of each style can be made to its pitch, tempo, and volume by the clinicians. They were told that the fractal tones should be audible, but soft enough to not interfere with conversational speech.
The use of relaxation exercises was given to patients to break the vicious cycle of tinnitus and stress. Mean Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI) scores at baseline, 2 and 6 months. Individual subject Tinnitus Handicap Inventory (THI) baseline and 6 months post Widex Zen Therapy scores for 23 subjects (one subject was missing the THI at baseline). Individual subject Tinnitus Functional Index (TFI) baseline and 6 months post Widex Zen Therapy scores for the 24 subjects. Inspection of individual subject data revealed that 74% of subjects obtained a clinically significant change in THI scores, and 75% of the subjects had clinically significant changes in TFI scores. In addition, the degree of improvement (in terms of THI and TFI reduction) was slightly greater (though not statistically significant) for the subjects receiving the more comprehensive cognitive behavioral intervention and relaxation exercises. Choice of styles and microphone settings for Zen A, Zen B, and Zen C programs at the initial fitting. About two-thirds (65%) of the subjects selected “Aqua + microphone off” as their Zen B program. Percentage (time) of use of amplification only (Master program), Zen A, Zen B, and Zen C at the 2 and 6 month visits. The average use of amplification only (the Master program) was 50%, and the average use of the three Zen programs combined was 50% also. The data revealed substantial positive adjustment to tinnitus (as measured by the TFI and THI) evident within the first 2 months of treatment, with further (albeit not statistically significant) changes occurring through 6 months. While other tinnitus treatments have reported similar success,16 the speed in which the WZT treatment achieved these changes is particularly impressive and vital, considering the importance of early success in maintaining motivation for tinnitus patients. It is also relevant to note that WZT is one of the few current tinnitus treatments utilizing amplification in addition to other sound therapy options. In addition, investigations focusing on and delineating the individual components of WZT would help understand how each component contributes to the process. Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. Using this method, the researchers were first able to eliminate the tinnitus precept in a rat model and then adapted the therapy to be used in human trials.
For example, when someone is exposed to a stressful event, a hormone called epinephrine is released into the bloodstream, which activates the vagus nerve.

Consistently pairing VNS with all other tones except the tinnitus tone, reduces the expanded representation of the tinnitus tone.
Investigators are seeking to determine the drug’s safety and effectiveness in lessening the excessive signaling to the brain that occurs with acute inner ear tinnitus, most often caused by noise trauma or infection.
The average (mean) reduction in THI scores was 30 points (23 points after only 2 months) and was 28 points in TFI scores (25.5 points after only 2 months).
A total of 32 subjects were initially enrolled, but only 24 subjects completed the data collection. Only 6 of the subjects indicated having received previous tinnitus management such as counseling, chiropractic adjustment, medication, dental treatment, Neuromonics,10 and hearing aids. The initial Widex Intake Questionnaire, THI, TFI measures, and the clinician’s observation of the subjects were used to determine which components of Widex Zen Therapy were utilized during the treatment. Table 2 shows the number of subjects receiving the various WZT components in the clinical trial. In addition, the relationship between impaired hearing and tinnitus perception, as well as the reasons why there is commonly an emotional connection established in the brain between the limbic system, autonomic nervous system, and the auditory cortex, was explained.
This intervention utilizes segments of the programs and tools used by psychologists and clinicians who provide comprehensive Cognitive Behavioral Therapy.
These instruments have wide dynamic range compression (WDRC) with compression thresholds as low as 0 dB HL, adaptive multichannel directional microphones, noise reduction, active feedback cancellation, inter-ear communication, and data logging. The four normal-hearing subjects had their hearing aids programmed as if they had a 15 dB hearing loss in order to ensure audibility of the Zen programs. The fractal tones are harmonically related but vary in tonality, intensity, or tempo over time. Each Zen setting was programmed in accordance with the hearing loss (based on the Sensogram) to assure audibility of the tones. They were further advised to avoid frequent volume changes and to use the Zen programs as much as needed for tinnitus and relaxation management and to avoid silence when possible. Tinnitus measures and hearing aid data logging information were collected at baseline, 2 and 6 months. The solid line represents equivalent baseline vs final (post treatment) scores while the dashed line represents the 20-point benefit score considered clinically significant.
The solid line represents equivalent baseline vs final (post treatment) scores while the dashed line represents the 13-point benefit score required for clinical efforts to be considered clinically significant. Given the high prevalence of hearing loss (often too mild to clearly warrant the necessity for hearing aids), the benefit of using amplification is an added value. The Tinnitus Functional Index: Development of a new clinical measure for chronic, intrusive tinnitus. Treatment of tinnitus with a customized acoustic neural stimulus: a controlled clinical study. A critical analysis of the directive counseling as a component of tinnitus retraining therapy.
The vagus nerve then sends a signal to the brain to release the neurotransmitter norepinephrine in a region called the amygdala, which strengthens memory storage for the emotional feelings during that specific time.  This is why people often vividly remember traumatic events in great detail.
AM-101 inhibits certain receptors in the inner ear that are thought to play a key role in the development of tinnitus. The other 8 subjects kept the hearing aids but were excluded from the final data analysis because they did not return for the 6-month follow-up. Twenty of the 24 subjects reported having had tinnitus for more than 1 year, and 18 reported having bilateral tinnitus. However, CBI does not require the same intensive therapeutic approach, which would be beyond the expertise of many hearing care professionals and would require a greater time commitment than can be reasonably expected.
Subjects with hearing loss were instructed to use the devices during waking hours where hearing and communication were essential. The tones (which sound somewhat like wind chimes) are generated while incorporating the properties of music that are proven to be most relaxing.1,2,7 Thus, they are meant to be pleasant and are not associated with music that the listener may hold in memory.
Zen Programs B and C were only recommended if the subjects experienced periods where the tinnitus was very bothersome.
In addition, data logging revealed that the Zen A and Zen C programs were used more frequently than the Zen B program. Pairing several of these tones (except the tinnitus tone) helped subdue the abnormal hyperactivity and restored the auditory cortex activity back to normal in a rat model of tinnitus. During this phase, the clinicians help the patient identify the unwanted thoughts and behaviors hindering natural habituation, challenge their validity, and help the patient replace them with alternative and logical thoughts and behaviors.13 Basically, the intervention’s objective is to help the patient recognize that it is not the tinnitus itself that produces these beliefs, it is the patient’s reaction to tinnitus. The duration of tinnitus, location, and quality reported by the subjects are shown in Table 1.

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