ArticlePDF AvailableLiterature Review

Experimental, Controversial, and Futuristic Treatments for Chronic Tinnitus


Abstract and Figures

Background: Because chronic tinnitus is a condition that negatively impacts the quality of life of millions of people worldwide, a safe and effective treatment for tinnitus has been sought for millennia. However, effective treatments for tinnitus are greatly outnumbered by ineffective strategies, medications, devices, and surgeries that continue to be developed and promoted for the condition. Purpose: This article describes and critiques experimental, controversial, and potential treatments for chronic tinnitus. The purpose of this review is to provide information that should help patients and clinicians to select tinnitus treatment and management strategies most likely to be effective for each set of symptoms and circumstances. Research design: PubMed and MEDLINE databases (National Center for Biotechnology Information, U.S. National Library of Medicine) were searched for the term tinnitus in articles published from 1940 to 2012. Other historical documents and publications were also reviewed as needed for particular topics. Study sample: Studies included in this review were selected to represent a sampling of treatment methodologies that have been used for tinnitus. Data collection and analysis: Due to the heterogeneity of the studies reviewed, it was not appropriate to perform a meta-analysis. A selective review of the literature was conducted to summarize and critique published research results. Results: Most invasive treatments for tinnitus should be avoided because (1) at best, there is scant evidence that any of these treatments is effective, and (2) the risk to patients for most invasive procedures is much greater than the risk posed by the tinnitus perception. Effective and noninvasive treatments for tinnitus include acoustic therapy (which includes hearing aids and other types of environmental sound enrichment); cognitive-behavioral therapy; psychological counseling; hypnosis; biofeedback; and relaxation training. Over-the-counter or prescription medications may be used as needed to facilitate sleep and to reduce anxiety, depression, or obsessive-compulsiveness. Conclusions: Patients and clinicians should be especially cautious when considering invasive (and potentially harmful) treatments for tinnitus, which is a non-life-threatening symptom. Unless well-designed clinical trials verify that a tinnitus therapy demonstrates effectiveness above and beyond the placebo effect, consumers should be wary of medications, devices, or procedures promoted as a "cure." Although a true cure for tinnitus has not yet been found, effective and noninvasive tinnitus management strategies are available now. If progress is made to medically (or genetically) treat sensorineural hearing loss in humans, this breakthrough should also help to simultaneously reduce the perception of tinnitus for many patients.
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Experimental, Controversial, and
Futuristic Treatments for Chronic Tinnitus
DOI: 10.3766/jaaa.25.1.7
Robert L. Folmer*
Sarah M. Theodoroff*
William Hal Martin
Yongbing Shi†‡
Background: Because chronic tinnitus is a condition that negatively impacts the quality of life
of millions of people worldwide, a safe and effective treatment for tinnitus has been sought for
millennia. However, effective treatments for tinnitus are greatly outnumbered by ineffective strat-
egies, medications, devices, and surgeries that continue to be developed and promoted for the
Purpose: This article describes and critiques experimental, controversial, and potential treatments for
chronic tinnitus. The purpose of this review is to provide information that should help patients and clini-
cians to select tinnitus treatment and management strategies most likely to be effective for each set of
symptoms and circumstances.
Research Design: PubMed and MEDLINE databases (National Center for Biotechnology Information,
U.S. National Library of Medicine) were searched for the term tinnitus in articles published from 1940 to
2012. Other historical documents and publications were also reviewed as needed for particular topics.
Study Sample: Studies included in this review were selected to represent a sampling of treatment meth-
odologies that have been used for tinnitus.
Data Collection and Analysis: Due to the heterogeneity of the studies reviewed, it was not appropriate
to perform a meta-analysis. A selective review of the literature was conducted to summarize and critique
published research results.
Results: Most invasive treatments for tinnitus should be avoided because (1) at best, there is scant
evidence that any of these treatments is effective, and (2) the risk to patients for most invasive
procedures is much greater than the risk posed by the tinnitus perception. Effective and non-
invasive treatments for tinnitus include acoustic therapy (which includes hearing aids and
other types of environmental sound enrichment); cognitive-behavioral therapy; psychological
counseling; hypnosis; biofeedback; and relaxation training. Over-the-counter or prescription med-
ications may be used as needed to facilitate sleep and to reduce anxiety, depression, or obsessive-
Conclusions: Patients and clinicians should be especially cautious when considering invasive (and
potentially harmful) treatments for tinnitus, which is a non-life-threatening symptom. Unless well-
designed clinical trials verify that a tinnitus therapy demonstrates effectiveness above and beyond
*National Center for Rehabilitative Auditory Research, Portland VA Medical Center, Portland, OR; Department of Otolaryngology, Oregon Health
and Science University, Portland, OR; Currently Metokos LLC, Portland, OR
Robert L. Folmer, Ph.D., National Center for Rehabilitative Auditory Research, Portland VA Medical Center, 3710 SW U.S. Veterans Hospital Road
(NCRAR), Portland, OR 97239; E-mail:
This research was supported by a grant from the U.S. Department of Veterans Affairs Rehabilitation Research and Development (RR&D) Service
(VA RR&D grant #C7448I). Additional support was provided by the National Center for Rehabilitative Auditory Research (funded by VA RR&D grant
#C9230C) at Portland VA Medical Center.
J Am Acad Audiol 25:106–125 (2014)
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the placebo effect, consumers should be wary of medications, devices, or procedures promoted as a
“cure.” Although a true cure for tinnitus has not yet been found, effective and noninvasive tinnitus man-
agement strategies are available now. If progress is made to medically (or genetically) treat sensorineural
hearing loss in humans, this breakthrough should also help to simultaneously reduce the perception of
tinnitus for many patients.
Key Words: Auditory rehabilitation, management, tinnitus, therapy, treatment
Abbreviations: AlstR/AL 5allatostatin receptor/allatostatin; BAHA 5bone-anchored hearing aid;
CBT 5cognitive-behavorial rehabilitation; DBS 5deep brain stimulation; ECT 5electroconvulsive therapy;
FDA 5Food and Drug Administration; GABA 5gamma-aminobutyric acid; LC 5light chain; LTA 5
left temporoparietal area; MVD 5microvascular decompression; RAIC 5rostral agranular insular cortex;
rTMS 5repetitive transcranial magnetic stimulation; tDCS 5transcranial direct current stimulation; THI 5
Tinnitus Handicap Inventory; TMS 5transcranial magnetic stimulation; SSRI 5serotonin-specific
reuptake inhibitor; VAS 5visual analog scale
Because chronic tinnitus is a condition that neg-
atively impacts the quality of life for millions of
people worldwide, a safe and effective treat-
ment for tinnitus has been sought for millennia. For
example, the Ebers Papyrus (an Egyptian medical
document originating in 3000 B.C.E.) recommended
intraural infusions of balanites oil and frankincense
as treatment for a “bewitched ear” (Dietrich, 2004).
Medical practitioners in Assyria (sixth century B.C.E.)
offered this advice: “If the hand of a ghost seizes on a
man and his ears sing, apply herbs, oils and salt
through a hollow reed” (Carey, 1988). The famous
physician Galen of Pergamon (130–200 C.E.) recom-
mended the following for his tinnitus patients: “Dull
the senses with mandrake or opium” (Kraft, 1998). Such
potent substances may or may not affect tinnitus
directly, but they are likely to distract patients’ atten-
tion away from the symptom for a while.
More recent attempts to treat tinnitus have employed
a wide variety of methods, including electrical stimu-
lation of the patient’s head; inserting magnets into the
ear canals; prefrontal leucotomy; and a plethora of
potions and pills that include exotic ingredients such
as lyophilized powder of enzymolyzed honeybee larvae
(Aoki et al, 2012). In spite of these creative approaches,
(damage or degeneration within the auditory system)
remains elusive. This review describes and critiques
some tinnitus treatments that have been developed
or investigated.
Research Design
PubMed and MEDLINE databases (National Center
for Biotechnology Information, U.S. National Library of
Medicine) were searched for the term tinnitus in
articles published from 1940 to 2012. Other historical
documents and publications were also reviewed as
needed for particular topics.
Study Selection
Studies included in this review were selected to rep-
resent a sampling of treatment methodologies that have
been used for tinnitus. The purpose of this manuscript
is not to be an exhaustive review of tinnitus treatments
but, rather, to focus on experimental and controversial
treatments for chronic tinnitus.
Data Collection and Analysis
Due to the heterogeneity of the studies reviewed, it
was not appropriate to perform a meta-analysis. A selec-
tive review of the literature was conducted to summarize
and critique published research results.
Some tinnitus treatment methods show potential to
offer tinnitus relief, while others lack evidence to support
their claims of being beneficial and should therefore be
avoided. This is not meant to be an exhaustive review;
the article reflects the authors’ professional biases and
Acoustic therapy is often a component of effective
tinnitus management. One definition of acoustic
therapy is “using external sounds to provide relief from
tinnitus.” This is not a new concept, as the following
examples (recounted by Stephens, 1987) illustrate:
Alexander of Tralles (525–605 C.E.) suggested that
tinnitus sufferers could obtain relief by walking in
“sondry places.”
“Why is it that buzzing in the ears ceases if one makes
a sound? Is it because a greater sound drives out the
less?” (Salerno School, 12th–13th centuries C.E.)
Johan Jakob Wepfer (1620–1695) gave this account
of one patient’s technique: “He banged two pebbles
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together next to his ear so that the sound made by
these stones would solve his problem.”
Jean Marie Gaspard Itard (1821) wrote the follow-
Producing a roaring fire in the grate considerably
relieves the disturbance resulting from tinnitus
which sounds like the distant murmuring of wind
and a river in flood. The same approach can be adop-
ted with whistling tinnitus by putting green or
slightly damp wood on the fire. When the tinnitus
is like the sound of bells, as long as it is not too loud,
it may be masked by the resonance of a large copper
bowl into which falls a trickle of water from a vase.
Finally, in the case of tinnitus resembling the sound of
a set of wheels turning, one can place alongside the
bed a noisy spring-driven motor adapted to a mechan-
ical organ, or a large watch, of which the movements
are speeded up by removal of the regulator.
During the last two centuries, numerous techniques
and devices have been developed to deliver acoustic
therapy to tinnitus sufferers. Urbantschitsch (1883)
used tuning forks; Wilson (1893) tried a telephone
transducer; Spaulding (1903) played a violin. Porter
and McBride (1916) suggested that tinnitus patients
should place a loud ticking clock near their beds. Saltzman
and Ersner (1947) recommended hearing aids for tinnitus
The rationale for all of these strategies is the same:
increase the level of external sounds in the patient’s
environment in order to decrease the patient’s percep-
tion of tinnitus. Acoustic therapy has been shown to be
an effective method to reduce tinnitus perception or
severity (Folmer and Carroll, 2006; Henry et al,
2008). In a quiet environment, the tinnitus signal is
prominent, and the level of background sound is low.
This phenomenon was demonstrated by Heller and
Bergman’s study published in 1953. They asked 80
adults who had normal hearing and no tinnitus to enter
a sound booth (one at a time) and make note of the
sounds they heard while in the booth. The interior of
the booth had a maximum background sound level
of 18 dB SPL. While they were in the booth, 75 (94%)
of these subjects reported that they heard sounds such
as buzzing, humming, ringing, insects, or pulsations.
Heller and Bergman (1953) concluded, “It appears that
tinnitus is present constantly, but is masked by the
ambient noise which floods our environment. This
ambient noise level for ordinary quiet living conditions
usually exceeds 35 dB SPL and is of sufficient intensity
to mask physiological tinnitus which remains subau-
dible. It would appear, then, that tinnitus will not be
eliminated by any treatment but at best can only
become subaudible.”
One of the goals of acoustic therapy is to increase the
level of background sound in order to decrease the
tinnitus signal-to-noise ratio. When background sounds
are increased, the tinnitus signal-to-noise ratio becomes
smaller; therefore, tinnitus will then be less noticeable
and less bothersome or intrusive for most patients. In
this issue of JAAA, the article by Hoare et al (2014)
describes different methods and strategies of acoustic
therapies that can be implemented by clinicians and
patients. Here we describe two controversial methods
of acoustic therapy that have been promoted recently.
1. The “Inhibitor” ultrasonic tinnitus treatment device
(see Fig. 1) is being marketed by the Melmedtronics
Company (Colleyville, TX). This battery-powered
device is held against the patient’s mastoid and
delivers high-frequency stimulation via bone con-
duction. The idea that high-frequency stimulation
(i.e., frequencies near or above the upper range of
human hearing, which has a limit of 20 kHz) might
provide relief to tinnitus patients was pioneered by
the Hearing Innovations company that produced a
multifrequency device called “HiSonic.” Originally,
HiSonic technology was developed to deliver speech
stimuli via ultrasonic bone conduction (Lenhardt
et al, 1991) and was promoted as an alternative to
cochlear implantation. One major problem emerged:
although people with normal hearing or mild-to-
moderate hearing loss could perceive speech signals
through the device, people with severe to profound
hearing loss (the target population) could not. Sub-
sequently, the HiSonic device was promoted as a
form of acoustic therapy for tinnitus. Unfortunately,
the majority of patients who tried the device disliked
the sensations it produced, and they received
no relief from tinnitus. A similar fate befell the
Aurex-3 device (distributed by ADM Tronics, New
Jersey), another version of a high-frequency bone
stimulator that did not survive in the tinnitus treat-
ment marketplace. Promoters of the Inhibitor are
attempting to rekindle interest in ultrasonic bone
conduction for tinnitus, but no well-designed re-
search studies have been conducted to establish
or confirm the Inhibitor’s efficacy. Note: These
descriptions of the Inhibitor, HiSonic, and Aurex-3
are based on the authors’ experiences with the de-
vices (and with patients who tried them) and there-
fore reflect the authors’ opinions.
Figure 1. Image of the Inhibitor device.
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2. A different type of acoustic therapy was described
by Reavis et al (2012), who presented a variety of
amplitude- and frequency-modulated tones for 3 min
at a time to 20 patients with chronic tinnitus. These
sounds, in addition to white noise, were presented
in a random order to all subjects and at intensities
that were just below the tinnitus loudness. The
authors concluded: “Our results suggest that, in
addition to a traditional masking approach using
unmodulated pure-tones and white noise, modulated
sounds should be used for tinnitus suppression
because they may be more effective in reducing
hyperactive neural activities associated with tinni-
tus.” However, the study described 13 of the 20 sub-
jects as “poor responders” who experienced at most
50% suppression of perceived tinnitus loudness after
exposure to any masking sounds. The remaining
seven patients were designated as “good responders”
who reported 70% suppression of their tinnitus after
exposure to masking sounds.
Given these modest results, it is somewhat surprising
that Reavis et al recommend using modulated sounds
for tinnitus suppression. Independent clinical trials
that demonstrate treatment efficacy for this method
would help to dispel concerns of bias, given the financial
interests in the SoundCure Company disclosed by three
of the article’s authors. SoundCure (San Jose, CA) dis-
tributes a handheld device that produces modulated
tones for use by tinnitus patients (see Fig. 2). According
to the company’s Web site (,
The Serenade device consists of a handheld acoustic
stimuli generator, earphones, and pleasant treatment
sounds that are intended to address the underlying
cause of tinnitus. A suite of three different types of
sounds is included, enabling the audiologist to deter-
mine the specific clinical approach that is most likely
to be effective for each patient. Unlike most treatment
methodologies, Serenade is customizable and can be
programmed to meet the unique needs of each patient,
day or night. Studies suggest that S-Tonesämay offer
immediate relief.
Overstatements of a treatment’s efficacy, even in
light of modest research findings, are common in this
field and other clinical fields as well. Ioannidis (2011)
discusses how conflict of interest can influence medical
findings and stresses the importance of validating find-
ings prior to implementing a new treatment. Independ-
ent research studies (i.e., performed by researchers who
are free of conflicts of interest) should be conducted to
validate test results prior to implementing a treatment
in clinical practice. Other examples of product develop-
ment and marketing that occurred before efficacy was
fully documented by research include the “Inhibitor”
device mentioned previously and a vagus nerve stimu-
lator (developed by Microtransponder, Inc.) described
in a later section of this article. Perhaps some of these
products are effective treatments for tinnitus, even in a
subpopulation of patients. However, well-designed, pla-
cebo-controlled clinical trials should be conducted and
analyzed before claims of efficacy are made. In order
to establish whether a treatment is effective, research
must demonstrate that a significant change (clinical or
statistical) has occurred that can be attributed to the
treatment above and beyond the placebo effect. Per-
forming clinically relevant research is part of conduct-
ing evidence-based medicine. By definition, “evidence
based medicine is the conscientious, explicit, and judi-
cious use of current best evidence in making decisions
about the care of individual patients” (Sackett et al,
1996), which leads to an informed decision regarding
the results reported in the literature pertaining to a
specific treatment prior to implementation.
In this issue of JAAA, the article by Cima et al
(2014) describes psychological interventions—such as
cognitive-behavioral therapy (CBT) and acceptance and
commitment therapy (ACT)—that have demonstrated
efficacy for reducing patients’ distress, anxiety, depres-
sion, insomnia, and other negative consequences asso-
ciated with tinnitus perception (Hesser et al, 2011).
Andersson and Lyttkens (1999) performed a meta-
analysis review on psychological treatments (CBT,
relaxation, education, hypnosis, biofeedback, stress
management) and reported that these treatments ben-
efit many tinnitus patients. Here we describe two addi-
tional psychological interventions that have helped
some tinnitus patients.
Figure 2. Image of SoundCure’s Serenade device.
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Reports of using hypnotherapy to help tinnitus
patients began in the 1940s (Pearson and Barnes,
1948) and have been published in every decade since,
including the current one (Yazici et al, 2012). Given
the fact that hypnotherapy can help to promote relaxa-
tion and reduce anxiety (Lee et al, 2007), and might alter
neural connectivity between brain regions (Hoeft et al,
2012), it is not surprising that this technique helps tin-
nitus patients since many studies have established the
correlation between tinnitus severity and anxiety/stress
(e.g., Folmer et al, 2001). Also, hypnotherapy can be used
to augment other behavioral therapies (such as CBT) by
encouraging patients to implement more productive cop-
ing strategies. Self-hypnosis techniques (Attias et al,
1993) might help to instill a “locus of control” for some
tinnitus patients who exhibit a deficiency of this trait.
Is hypnosis more effective than other psychological
interventions for tinnitus? Because no large-scale,
randomized clinical trials of hypnosis have been con-
ducted with tinnitus patients, it is difficult to gauge
the efficacy of the method. Also, different types of hyp-
notherapy exist and have been used with this popula-
tion. However, since the procedure carries minimal
risk for patients and usually promotes self-improvement
and relaxation, hypnotherapy would seem to be more ben-
eficial than harmful in most cases.
Biofeedback provides information to patients about a
physiological measure (such as electroencephalography
or muscle tension) while they engage in activities (such
as relaxation, meditation, or pleasant visualization)
designed to have a positive effect on the physiological
characteristic. Reports of clinicians using biofeedback
techniques with tinnitus patients date to the 1970s
(Grossan, 1976; House, 1978). In the study by House
(1978), 41 tinnitus patients attended 12 1 hr sessions
with a psychologist who provided instruction on relax-
ation techniques and strategies. During these sessions,
patients received constant feedback via electromyogra-
phy (EMG) and skin temperature monitoring devices.
Successful implementation of relaxation techniques
would result in decreased muscle tension and increased
skin temperature. Patients were also encouraged to
practice the techniques at home between formal ses-
sions in the clinic. House reported that 33 of the
patients reported reductions in tinnitus severity imme-
diately after the last therapy session, and 23 patients
sustained some improvement 6 to 12 mo later. A major-
ity of patients also reported improvements in general
well-being and enjoyment of life and less reliance on
anti-anxiety medications. Such positive results are typ-
ical of published studies of biofeedback for tinnitus. In
this study by House, no control group was included (e.g.,
one that received relaxation training but no biofeed-
back). It is likely that 12 1 hr sessions with a psychol-
ogist who provides relaxation training would benefit
most patients who experience tinnitus and/or anxiety.
So we do not know if the biofeedback procedure itself
provided additional benefits for these patients. But
like hypnosis, biofeedback therapy has helped many
patients to increase relaxation and decrease anxiety.
Therefore, the procedure is likely to benefit at least a
subpopulation of patients with bothersome tinnitus.
Additional references on the topic of neurofeedback
for tinnitus include Haller et al (2010) and Crocetti
et al (2011).
Soft Laser
The word soft is used to describe a low-powered laser
that can be focused into the patient’s ear canal. In a
study by Okhovat et al (2011), a 5 mW medical laser
transmitter (Tinnimed, German Medical Laser, Pforzheim,
Germany) was connected by a fiberoptic cable and an
adapter with a soft silicone tip to the patient’s ear.
The laser beam was then directed through the external
ear canal and tympanic membrane into the cochlea
(i.e., transmeatal). Okhovat et al (2011) irradiated
the ear canals of 61 tinnitus patients with a 650 nm,
5 mW soft laser for 20 min per day for 20 consecutive
days. The patients’ sensations of tinnitus were mea-
sured on a visual analog scale (VAS) before and 2 wk
after treatment. The authors reported that the VAS
mean difference before and after the treatment was
statistically significant (p,0.0001), and the best
treatment effect was in the youngest group. Okhovat
et al (2011) admit that “the therapeutic mechanism of
this method is not completely understood” (p. 33).
Siedentopf et al (2007) proposed that laser stimulation
might reduce tinnitus by increasing inner ear cell pro-
liferation, adenosine triphosphate (ATP) and collagen pro-
duction, and secretion of growth factors, and by improving
inner ear blood flow and activating hair cell mitochondria
that stimulate repair mechanisms.
One criticism of the study by Okhovat et al (2011) is
that a placebo control was not part of the research plan.
Cuda and De Caria (2008) did include a control group in
their study involving 46 tinnitus patients: 26 patients
received laser treatment (20 min per day every week
day for 3 mo), and 20 patients were assigned to a placebo
group. The authors reported that Tinnitus Handicap
Inventory (THI) scores improved in the entire sample
after treatment, but they changed more significantly
in the group receiving low-level laser stimulation.
Approximately 61% of irradiated patients had tinnitus
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severity decreased by one class, in comparison to 35% of
the placebo group.
However, other published studies failed to find effi-
cacy of low-level laser stimulation for tinnitus. For
example, Teggi et al (2009) replicated much of the
experimental protocol used by Cuda and De Caria
(2008), which included a treatment group and a placebo
group of patients. Teggi et al reported that no signifi-
cant difference was detected between the groups in
the THI total score (p50.97) and the functional (p5
0.89), emotional (p50.89), and catastrophic ( p5
0.89) subscales. Also,a VAS for tinnitus loudness showed
no difference between the groups (p50.69).
Nakashima et al (2002) conducted a study involving
45 tinnitus patients (n 525 in the treatment group, and
n520 in the placebo group) and used a more powerful
(60 mW) soft laser to irradiate the patients’ ear canals.
Active or placebo laser treatment was administered trans-
meatally once per week for 6 min; irradiation was per-
formed four times during a 4 wk period. Nakashima
et al (2002) reported that no significant difference was
observed between the active and placebo laser groups
with regard to loudness, duration, quality, and annoy-
ance of tinnitus. In one patient who received active
laser treatment, acute hearing deterioration occurred
after the third irradiation. The authors concluded that
“transmeatal low-power laser irradiation with 60 mW
is not effective for the treatment of tinnitus” (Nakashima
et al, 2002, p. 296).
Why did some studies conclude that soft laser irradi-
ation is an effective treatment for tinnitus, while other
studies found no efficacy for the procedure? The lack of a
placebo control in the study by Okhovat et al (2011) is a
serious experimental design flaw that occurs in many
tinnitus investigations. While Cuda and De Caria
(2008) did include a placebo group in their study, it is
possible that “blinding” of research subjects and clinical
staff was incomplete. The more rigorous placebo-
controlled protocol employed by Teggi et al (2009)
reduced clinician bias and influence on research sub-
jects, resulting in no significant treatment effects for this
type of laser irradiation.
Wearable Magnets
Wearable magnets have been touted as treatments
for a variety of conditions, including arthritis, diabetes,
gout, chronic pain, even cancer (Philpott and Kalita,
2000; Rose, 2001). The devices are available in many
shapes and sizes and can be worn as bracelets or neckla-
ces; also, magnetic applique
´s can be attached to the skin
of the arm, leg, back, or head–wherever relief is desired.
Takeda (1987) inserted small round (4 mm diameter, 2
mm thick) magnets embedded in cotton into the ear
canals of 56 tinnitus patients. After one week, tinnitus
was reduced in 37 patients, did not change in 18
patients, and worsened for one patient. Takeda re-
ported that the beneficial effects lasted at least 3 weeks,
and sometimes longer than 9 weeks.
However, a placebo control was not included in the
experimental design. In 1991, Coles et al conducted a
double-blind, placebo-controlled study of tinnitus patients
using the same types of magnets that Takeda employed.
Magnets or physically similar but nonmagnetic pieces of
metal were mounted on cotton and inserted into the ear
canal of patients on the side where tinnitus perception
was loudest; 26 patients received magnets, and 23 received
nonmagnetic metal “plugs”. Results were obtained after
4 wk (Table 1). Coles et al concluded, “it is self-evident that
this line of treatment is insufficiently effective to be clini-
cally worthwhile, except perhaps as a form of placebo
treatment, and has to join the long list of claimed treat-
ments for tinnitus that have not stood up to clinical trial”
(1991, p. 372).
Transcranial Magnetic Stimulation (TMS)
A much more powerful magnetic field—delivered to
the patient’s head by a technique called transcranial
magnetic stimulation (TMS)—is being assessed for its
potential to reduce tinnitus perception and severity.
TMS involves delivering electromagnetic pulses through
a coil that is in contact with the patient’s scalp (see
Fig. 3). Ultimately, some of this energy is transmitted
through the skull, inducing an electric current that affects
the activity of underlying neural tissue. Low-frequency
repetitive TMS (1 Hz or less) is known to reduce neural
activity in directly stimulated brain regions (Chen et al,
1997; Maeda et al, 2000; Siebner et al, 2003) as well as in
structurally connected remote brain regions (May et al,
2007). For this reason, repetitive TMS (rTMS) has been
investigated as a possible treatment for disorders related
to increased neural activity (Hoffman and Cavus, 2002),
including tinnitus. Several different functional imaging
studies have shown that, compared to control subjects,
people who experience tinnitus have increased activity
in the auditory cortex, even in the absence of external
auditory stimuli (Arnold et al, 1996; Lockwood et al,
1998; Folmer, 2007). Therefore, applying low frequency
TMS to auditory cortex, as well as the dorsolateral pre-
frontal cortex (De Ridder, Song, et al, 2012), may
reduce patients’ perceived severity or loudness of
Table 1. Effect of Wearable Magnets on Tinnitus
(Coles et al, 1991)
Magnet group
(n =26)
Placebo group
(n =23)
Tinnitus improved 7 (27%) 4 (17%)
No change 12 (46%) 16 (70%)
Tinnitus worsened 7 (27%) 3 (13%)
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tinn itus. A recent article by Theodoroff and Folmer
(2013) reviewed many TMS studies that have been con-
ducted for tinnitus. While optimism for the clinical utility
of TMS as an effective treatment for tinnitus remains high
among many researchers, clinicians, and patients, several
key questions and procedural issues remain unresolved.
Additional studies are needed to identify the optimum
parameters for TMS coil placement, stimulation frequency
and intensity, and other basic procedural issues. Advance-
ments of this kind are necessary to improve the effective-
ness of rTMS as a viable method to treat chronic tinnitus.
Transcranial Direct Current Stimulation (tDCS)
Another promising treatment for tinnitus is transcra-
nial direct current stimulation, or tDCS (Vanneste et al,
2013). This procedure involves attaching one end of
electrodes to the patient’s scalp and the other end to
a current source. Application of electrical current then
either increases or decreases the neuronal excitability
or activity beneath the stimulating electrode. In one
of the first published studies of tDCS for tinnitus,
Fregni et al (2006) reported that stimulation of the left
temporoparietal area (LTA) resulted in a significant
reduction of tinnitus, similar to that produced by 10 Hz
TMS. A review of subsequent tDCS studies for tinnitus
(Song et al, 2012) indicated that 39.5% of all patients
responded to active tDCS with a mean reduction in tin-
nitus intensity of 13.5%. Active tDCS was found to be
more effective than sham tDCS for tinnitus intensity
reduction (Hedges’ g 5.77, 95% confidence interval 5
0.23–1.31). Therefore, Song et al concluded that tDCS
may be a promising tool for tinnitus management. To fur-
ther assess the efficacy of the procedure, the authors rec-
ommended implementation of larger randomized clinical
trials (RCTs) as well as a comparison between LTA and
frontal tDCS electrode placement positions.
The article by Shi et al (2014) in this issue of JAAA
describes the role of the physician in tinnitus
management. One of these roles is to prescribe medica-
tions that might help tinnitus patients by alleviating
the severity of associated symptoms such as insomnia,
anxiety, depression, or obsessive-compulsiveness. This
section will provide an overview of over-the-counter,
prescription, and experimental medications that have
been advocated or used for tinnitus.
Over-the-Counter Substances
As stated in the introduction of this article, numerous
substances have been tried—with minimal success—
over the last few millennia by clinicians and patients
seeking a cure or treatment for tinnitus. Today, several
herbal and homeopathic products are marketed as “tin-
nitus remedies.” For example, the t-gone company
(Henderson, NV) distributes a line of ingestible tablets
that are purported to help with tinnitus due to cochlear
(or noise) damage, stress, sinus/allergy problems, and
tinnitus caused by Me
`re’s disease. Ingredients of
the tablets include different combinations of thiosinami-
num, carboneum sulphuratum, chininum sulphuricum,
pulsatilla vulgaris, cinchona officinalis, belladonna, cal-
carea carbonica, phosphorus, silicea, hydrastis and
kalium bichromate. Because such concoctions are not
well regulated by governmental agencies, it is difficult
to confirm the actual ingredients contained in the tablets
and at what dosages. Further, none of these substances
has been demonstrated by research to be an effective
treatment for tinnitus caused by cochlear damage, noise
exposure, stress, Me
`re’s disease, or any other etiology
of the condition. No clinical trials of t-gone have been
published in peer-reviewed literature.
Another company, Arches Natural Products (Salt
Lake City, UT), distributes Tinnitus Formula capsules
that contain zinc, garlic, and ginkgo biloba extract. The
company Web site claims that the capsules were “Spe-
cifically formulated for ringing in the ears with clini-
cally proven ingredients for tinnitus.” Arches claims
that the capsules have been “recommended by thou-
sands of leading ENT specialists for their patients with
tinnitus.” Like the t-gone company Web site, the Arches
Web site contains numerous testimonials from “custom-
ers” reporting that the products helped them greatly by
reducing or eliminating their tinnitus.
Following is a discussion of each of the Tinnitus For-
mula ingredients to determine if any of them are effec-
tive treatments for tinnitus. Several studies assert that
tinnitus patients might have lower-than-recommended
blood levels of zinc (Ochi et al, 2003; Coelho et al, 2007).
However, few placebo-controlled studies of zinc for tin-
nitus have been conducted. One such investigation, by
Paaske et al (1991) concluded that neither zinc supple-
ments nor placebo tablets had any significant effect on
tinnitus for 48 patients in the study. Arda et al (2003)
also performed a placebo-controlled study of zinc for
Figure 3. A transcranial magnetic stimulation (TMS) system.
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tinnitus treatment and did not find any statistically sig-
nificant results for the supplement. Garlic, the second
ingredient in Tinnitus Formula capsules, has not been
investigated in a placebo-controlled study of tinnitus.
Although it is usually a welcome ingredient in spaghetti
sauce, garlic has not been shown to affect cochlear or
neural damage that is the root cause of most cases of
tinnitus. Linde et al (2001) reviewed herbal medicine
used for health-related problems and found insufficient
evidence to draw any conclusion for garlic to be used as
an herbal remedy. Finally, ginkgo biloba has been
touted as an effective treatment for tinnitus and is
included in many over-the-counter “remedies.” How-
ever, in 2001, Drew and Davies (2001) conducted a
double-blind, placebo-controlled trial of ginkgo biloba
involving 1121 tinnitus patients. The authors con-
cluded that 50 mg of ginkgo biloba extract given 3 times
daily for 12 wkwas no more effective than placebo pills in
treating tinnitus. Therefore, none of the ingredients in
Arches Tinnitus Formula capsules has research support
for improving tinnitus symptoms beyond a placebo effect,
although the company Web site (www.tinnitusformula.
com) proclaims that the ingredients are “clinically proven
for tinnitus.”
The placebo effect is an important consideration in
assessing the effectiveness of tinnitus treatments
because this effect is significant in many clinical trials,
especially those involving tinnitus patients (Dobie,
1999). In his review of randomized clinical trials of tin-
nitus treatments, Dobie (1999) concluded that patients
in the placebo group often improved (usually as much as
patients did in the active treatment group) because of
interactions with clinicians and researchers who took
their problems seriously and sought to help them.
Therefore, with the exception of many psychological
interventions, evaluations of tinnitus treatments
should include a placebo group for comparison. As
described above, when carefully conducted, placebo-
controlled studies of over-the-counter tinnitus “rem-
edies” or ingredients have been conducted, the active
ingredients have not performed better than placebos.
Some over-the-counter substances (such as those that
improve sleep, depression, anxiety, or sinus congestion)
might provide some relief or improvement for tinnitus
patients and aggravating or coincident conditions
(Rosenberg et al, 1998; Megwalu et al, 2006). For exam-
ple, a recent study conducted in Japan concluded that
“the lyophilized powder of enzymolyzed honeybee lar-
vae represents an effective complementary medicine
to alleviate depression associated with tinnitus by reg-
ulating the activity of the hypothalamus-pituitary-
adrenal axis” (Aoki et al, 2012). Until independent
studies have been conducted, all of these claims should
be considered with caution. Since the underlying mech-
anism(s) of tinnitus are not completely understood,
it seems unlikely any of these substances—including
enzymolyzed honeybee larvae—will “cure” tinnitus
or facilitate reparation of the underlying causes of the
Prescription Medications
The severity of tinnitus is positively correlated with
depression (Folmer et al, 1999), insomnia (Folmer and
Griest, 2000), anxiety (Folmer et al, 2001), and obsessive-
compulsive behavior (Folmer et al, 2008). Previous
studies demonstrated that effective treatment of these
symptoms can help to reduce the severity of patients’
tinnitus (Folmer, 2002). Because most of these comorbid
conditions are psychological in nature, a combination of
effective psychotherapy and medication can help many
patients to improve (Folmer, 2002). However, most of
the medications used for this purpose are not prescribed
specifically for tinnitus but, instead, for treatment of
associated mental health symptoms. It is important
for patients to work with clinicians who have appropri-
ate training and experience in behavioral health to find
the most appropriate medication and dosage schedule
to effectively treat the conditions listed above. Two
classes of medications, benzodiazepines and seroto-
nin-specific reuptake inhibitors (SSRIs), were investi-
gated specifically for their effects on tinnitus and are
discussed below.
In 1993, Johnson and colleagues conducted a study of
the anti-anxiety medication alprazolam, which is in a
class of drugs called benzodiazepines (common brand
names include Xanax, Valium, Klonopin, and Ativan).
The study was undertaken because several patients
seen in the investigators’ clinic (Tinnitus Clinic at
Oregon Health and Science University, Portland, OR)
reported that alprazolam seemed to reduce their per-
ception of tinnitus. In the study by Johnson et al, 17 tin-
nitus patients took increasing dosages of alprazolam for
12 wk to a maximum dosage of 0.5 mg three times daily;
19 tinnitus patients took lactose pills according to the
same schedule for 12 wk. Results indicated a significant
reduction in the matched loudness of tinnitus (dB SL)
for the alprazolam group, with no similar effect for
the placebo group. In fact, the maximum dosage of
alprazolam reduced the matched loudness of tinnitus
for 13 of 17 subjects in the active treatment group. Also,
11 of these 13 alprazolam patients reported improved
sleep patterns, and 10 of these 13 patients experienced
reduced anxiety. The placebo patients did not experi-
ence improvements in tinnitus, sleep, or anxiety. These
findings are not surprising because alprazolam is an
anti-anxiety medication that has a sedating effect for
many patients. It is likely that the medication reduced
patients’ perception of tinnitus via its action as a GABA
(gamma-aminobutyric acid) agonist. GABA is one of the
major inhibitory neurotransmitters in the human cen-
tral nervous system. By activating GABA receptors in
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the patients’ brain, alprazolam suppressed some of the
neural activity responsible for tinnitus perception and
also helped patients to relax and sleep.
This study by Johnson et al had a number of design
flaws and procedural problems, including small sample
size; no measures of tinnitus severity; no formal meas-
ures of anxiety; and no long-term follow-up. Also, it was
easy for subjects to differentiate between alprazolam
and placebo because the lactose pills had no sedating
effects. Although alprazolam exhibited some beneficial
effects for tinnitus patients, we must ask the following:
for which patients do the benefits of taking benzodiaze-
pines (improved sleep; reduced anxiety and tinnitus)
outweigh the risks (dependence on medication and
sedation)? It is possible for patients to receive some ben-
efits from alprazolam even if they do not take the max-
imum dosage (0.5 mg three times daily) achieved by
patients in the study by Johnson et al. Interested
patients should work with their physician to determine
if they are good candidates for this medication, which
can be used occasionally (daily administration is not
required) and in smaller dosages as needed.
A more recent study of alprazolam was conducted
among 36 tinnitus patients by Jalali et al (2009).
Patients with depressive or anxiety disorders were
excluded from the study, as were those who used hear-
ing aids. Results indicated that, compared to placebo,
alprazolam did not result in statistically significantly
changes in THI score or matched tinnitus loudness.
However, there was a significant improvement in
VAS tinnitus loudness score for the alprazolam group
compared with the placebo group ( p,0.001). The fact
that patients with depressive or anxiety disorders were
excluded makes it difficult to compare the findings in
this study to results obtained by Johnson et al.
A different class of prescription medications that has
been investigated for tinnitus is SSRIs—drugs that are
used to treat depression, anxiety, and obsessive-com-
pulsive behavior. Case reports by Shemen (1998) and
Christensen (2001) claimed that use of SSRI medica-
tions fluoxetine and paroxetine resulted in “complete
resolution” of tinnitus in a total of four patients.
Encouraging reports such as these led Robinson et al
(2005) to conduct a study of paroxetine in a population
of 120 tinnitus patients. In this study, 60 patients took
the maximally tolerated dose (up to 50 mg/day) of parox-
etine for 31 days, and 60 patients took placebo pills
according to the same schedule for 31 days. Results
indicated that paroxetine was not statistically superior
to placebo on measures including tinnitus loudness
matching and the Tinnitus Handicap Questionnaire.
Robinson et al concluded, “The majority of individuals
in this study did not benefit from paroxetine in a con-
sistent fashion” (2005, p. 981). This negative result
probably occurred because of the study design: patients
with psychotic or substance use disorders or suicidal
ideation were excluded, as were those using psycho-
active medications. Consequently, only one tinnitus
patient with major depression was included in the study
Benzodiazepines and SSRI medications have helped
to reduce the severity of anxiety and depression for mil-
lions of patients throughout the world. Studies of these
medications that excluded patients with anxiety or
depression (e.g., Robinson et al, 2005; Jalali et al,
2009) concluded that they were not effective treatments
for tinnitus. However, these results should not be inter-
preted to mean that benzodiazepines and SSRIs are not
likely to benefit tinnitus patients. For many patients
who experience anxiety and depression in addition to
tinnitus, medications such as these in conjunction with
effective psychotherapy may help to improve their qual-
ity of life and reduce the severity of tinnitus.
“Off-Label” Use of Prescription Medications
for Tinnitus
In addition to benzodiazepines and SSRIs, many
other prescription medications have been tried by clini-
cians and tinnitus patients. The term off label refers to
using a medication for a purpose other than that orig-
inally approved by the Food and Drug Administration
(FDA). For example, a few studies reported that gaba-
pentin (another GABA agonist that was developed as an
anticonvulsant) is effective for reducing the perception
or severity of tinnitus (Zapp, 2001; Bauer and Brozoski,
2006). However, double-blind randomized controlled
trials of gabapentin conducted by Witsell et al (2007)
and Piccirillo et al (2007) concluded that gabapentin
was not superior to placebo as a tinnitus treatment.
Azevedo and Figueiredo (2005) exhibited creative
thinking when they conducted a clinical trial of acam-
prosate for tinnitus. This study was creative because
acamprosate’s usual application is a treatment for alco-
holism. Specifically, acamprosate helps patients to
abstain from alcohol by functioning as a glutamate
(excitatory neurotransmitter) antagonist and a GABA
agonist in the brain. Because over-activation of gluta-
matergic pathways and underactivation of GABA-ergic
pathways in the central auditory system are thought to
play roles in the generation and perception of tinnitus,
acamprosate would seem to be a logical choice that
might help patients with the condition. In the study
by Azevedo and Figueiredo, 23 tinnitus patients
received acamprosate, and 18 patients received placebo
pills for a period of 3 mo. For an outcome measure,
patients rated how “disturbed” they were by tinnitus
on a 1–10 scale. At 60 and 90 days postbaseline, the
acamprosate group exhibited significant decreases in
this measure compared to the placebo group, which
did not show significant changes in tinnitus distur-
bance. Concerns about this study include a small sample
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size, a single (and simplistic) outcome measure, and
questionable blinding of study participants. A larger,
double-blind, randomized controlled trial of acamprosate
conducted by W.H. Martin, S. Griest, and Y. Shi (unpub-
lished) at Oregon Health and Science University concluded
that the effects of the medication were not significantly
different from placebo pills for tinnitus treatment.
Numerous other prescription medications have been
tried for tinnitus, with limited success (see Salvi et al,
2009; Savage et al, 2009, for reviews). In our opinion,
the medications most likely to help reduce tinnitus-
related distress are those that address comorbid symp-
toms (such as insomnia, anxiety, or depression) when
they are present. Also, patients and clinicians should
not expect a medication alone to effectively treat tinni-
tus or any of its cosymptoms. Because all of these con-
ditions are complex in nature, they require integrated,
multidisciplinary management strategies. For exam-
ple, most tinnitus patients benefit from some sort of
acoustic therapy (see the article by Hoare et al [2014]
in this issue of JAAA) that can include utilization of
hearing aids. Many tinnitus patients also benefit from
CBT or other types of psychological interventions that
help reduce tinnitus-related distress (see the article by
Cima et al [2014] in this issue of JAAA). Prescription
medications can thus be viewed as one category of treat-
ment options that may be used in conjunction with
other management strategies to help tinnitus patients.
In modern times, one of the most controversial and
invasive procedures ever implemented to treat tinni-
tus was frontal leucotomy, also known as lobotomy
(Elithorn, 1953; Beard, 1965). Beard (1965) reported
that he performed 20 leucotomy procedures for tinnitus
between 1948 and 1957. Prior to surgery, 13 of these
patients received electroconvulsive therapy (ECT) for
severe depression and other psychiatric disorders. It
is now known that ECT can initiate tinnitus for a small
percentage of patients who undergo the procedure
(Folmer et al, 2011). The leucotomy operations involved
drilling holes in the top frontal region of the patient’s
skull, then cutting downward through neural tissue,
affecting Brodmann’s areas 9 and 10 of the frontal cor-
tex. Regarding outcomes, Beard wrote the following, “of
the 19 patients who survived the operation, 11 felt that
their head noises were just the same but bothered them
less, and 8 felt that they had improved” (1965, p. 30).
Beard did not explain what happened to the patient
who did not survive surgery, but a 5% mortality rate
seems unjustifiable for tinnitus treatment. The author
followed up with these patients 5 yr postsurgery and
wrote, “only 14 of the 20 patients survived for formal
assessment, and of these 14, 5 were very glad they
had the operation, 7 were definitely glad, and only 1
regretted it. One patient was unable to say” (Beard,
1965, p. 30). Again, Beard did not explain what hap-
pened to the five patients who did not survive 5 yr post-
surgery. Beard reported that 12 of the 14 surviving
patients found their tinnitus less distressing at the 5
yr follow-up, although the pitch and loudness of tinnitus
had not changed for most of them. Beard concluded, “we
found that leucotomy gave good results in people inca-
pacitated by psychiatric symptoms reactive to tinnitus,
though it is likely that some of these patients could now
be helped by drugs not available when these operations
were carried out.” Indeed, since the 1950s, development
of effective medications for depression, anxiety, and
other psychiatric disorders hastened a decline in frontal
leucotomy surgeries. A small number of psychosur-
geries are still performed today to treat cases of severe
mental illness that do not respond to other interven-
tions. These surgeries usually target structures in
the limbic system, such as the amygdala, hippocampus,
certain thalamic and hypothalamic nuclei, prefrontal
and orbitofrontal cortex, and the cingulate gyrus. Func-
tional imaging studies of tinnitus patients have shown
abnormal neural activity in the limbic system, suggest-
ing that some of these structures might be associated
with certain forms of the condition (Lockwood et al,
1998; De Ridder, Fransen, et al, 2006). Fortunately,
we found no additional reports of psychosurgery for tin-
nitus that were published after Beard’s 1965 article.
Below we describe some other invasive treatments that
have been implemented for tinnitus.
Insertion of needles into the patient’s skin to treat
medical conditions has been practiced in China for more
than 3000 yr (Robson, 2004). In Western medicine,
reports of using acupuncture to treat tinnitus date to
the 1960s (Bischko, 1963), and a clinical trial of the pro-
cedure was published in 1982 by Hansen et al. In this
double-blind, placebo-controlled trial, the effect of tradi-
tional Chinese acupuncture was evaluated among 17
patients with chronic (mean disease duration 5.3 yr),
unilateral tinnitus. Each patient received two acupunc-
ture treatments per week for 3 wk. In the last phase of
the study, patients who first received active acupunc-
ture switched to the placebo group, and vice versa. After
15 wk, Hansen et al reported that there was no signifi-
cant difference in tinnitus perception or severity
between traditional Chinese acupuncture and placebo
(Wilcoxon test, P .0.05, one-tailed).
Although some recent studies claim that acupuncture
is an effective treatment for tinnitus (Wang et al, 2010;
Rogha et al, 2011; Jeon et al, 2012), a similar number of
reports found no significant treatment effect when
active and placebo acupuncture procedures were com-
pared (Hansen et al, 1982; Axelsson et al, 1994; Vilholm
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et al, 1998; Park et al, 2000). This conundrum seems to
plague other applications of acupuncture, including its
use in pain management. Since the risk of adverse out-
comes (e.g., infection, blood vessel or nerve puncture)
resulting from professionally applied acupuncture is
low, our recommendation to tinnitus patients is this:
try it if you are inclined to do so, but have reasonable
expectations regarding symptomatic improvement.
Surgical severance of the vestibular branch of the
VIIIth cranial nerve is sometimes performed as a treat-
ment for extreme dizziness that does not respond
to other therapies (Colletti et al, 1994; Decat et al,
1997). Unfortunately, tinnitus and hearing loss some-
times result from these procedures (Pappas and
Pappas, 1997; Van de Heyning et al, 1997). By contrast,
Wazen et al (1997) described a cochlear neurectomy pro-
cedure that was performed on two patients who experi-
enced severe tinnitus prior to surgery. Both of these
patients also exhibited unilateral profound sensorineu-
ral hearing loss in the ear that perceived tinnitus.
Because Wazen et al severed the cochlear branch of
the VIIIth cranial nerve and preserved the vestibular
branch, patients reported a reduction of tinnitus but
did not experience dizziness or vertigo. It is important
to note that this surgery is recommended only for
patients who present with profound sensorineural
hearing loss and tinnitus in the same ear. After con-
ducting a retrospective study of surgical procedures
and outcomes involving cranial nerves, Silverstein
et al (1986) concluded, “when useful hearing is present,
a CVN [cochleovestibular neurectomy] is not usually
recommended for relief of tinnitus, since the actual cure
rates are only 35%. When vertigo is not a complaint,
there is currently no surgical procedure known that can
be recommended for the treatment of tinnitus” (p. 438).
Microvascular Decompression
Microvascular decompression is a surgical technique
that is used to move blood vessels away from nerves on
which they are exerting excessive pressure. One of the
most common applications of the procedure is to move
blood vessels away from the trigeminal nerve in order to
relieve symptoms of trigeminal neuralgia (Broggi et al,
2012; Zhang et al, 2012). During the last 30 yr, micro-
vascular decompression of the VIIIth cranial nerve has
been performed occasionally to treat chronic tinnitus (Kudo
and Ito, 1984; Møller et al, 1993; De Ridder, Vanneste,
Adriaenssens, et al, 2010). The majority of published
reports state that the procedure reduces or abolishes
tinnitus for most patients and usually does not result
in adverse effects. However, results from 20 such sur-
geries described by De Ridder, Vanneste, Adriaenssens,
et al (2010) are instructive: the mean preoperative VAS
for tinnitus intensity was 7.8 61.5; the mean postoper-
ativeVASwas6.762.5, which does not represent a
statistically significant change. The mean preopera-
tive Tinnitus Questionnaire (TQ) score was 55.1 6
17; the mean postoperative TQ score was 55.7 614,
which also does not reflect a significant change.
Despite this apparent lack of effectiveness, De Ridder
(2010) and other neurosurgeons continue to promote
microvascular decompression as a viable treatment
option for tinnitus. In fact, auditory nerve compression
is an exceedingly rare cause of tinnitus; therefore,
microvascular decompression surgery for tinnitus
should be undertaken in a similarly miniscule number
of cases (Folmer, 2010). In 2007, De Ridder at al admit-
ted, “The outcome of operations for tinnitus, moving
the blood vessel off the nerve (microvascular decom-
pression operations, MVD) is less successful than
microvascular decompression operations for other
vascular conflict syndromes” (p. 401). Consequently,
clinicians should not recommend MVD procedures for
tinnitus unless there is irrefutable evidence that vascu-
lar compression of the VIIIth cranial nerve is a causa-
tive factor for the symptom.
Implantable Devices
Some implantable devices can improve or partially
restore hearing, thereby improving patients’ communi-
cation abilities and contributing to increased socializa-
tion and quality of life; reduced anxiety, depression, and
tinnitus severity. Other types of implantable devices
that stimulate cranial nerves or specific brain regions
also have the potential to reduce patients’ perception
or severity of tinnitus. This section reviews several dif-
ferent classes of implantable devices that have been or
could be used to treat chronic tinnitus.
Deep Canal Hearing Aids
Any treatment or procedure that improves patients’
hearing sensitivity is likely to reduce their perception of
tinnitus by reducing the tinnitus signal-to-noise ratio.
That is why conventional hearing aids benefit many tin-
nitus patients who also have significant hearing loss:
hearing aids improve patients’ hearing and communica-
tion abilities and simultaneously make tinnitus less
noticeable (Folmer and Carroll, 2006). A recent develop-
ment in hearing aid technology is the “deep canal” or
“implantable” aid distributed by Phonak (Warrenville,
IL). This hearing aid (brand name: Lyric) is placed deep
into the patient’s ear canal (within 4 mm of the tym-
panic membrane) by a clinician and can be left in place
up to 4 mo (see Fig. 4). Advantages of this device include
reduced handling and adjustment; improved sound
localization; and external invisibility. Because the Lyric
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hearing aid remains in the patient’s ear canal, it con-
stantly increases background sound. For this reason,
the device might be of particular benefit to tinnitus
patients who need hearing aids. Although no formal
studies of the effectiveness of this hearing aid for tinni-
tus have yet been published, such studies are likely to
be conducted and published in the near future.
Stapes Prosthesis
Because the cochlea is extremely sensitive to physical
vibrations, the force applied during stapedectomy sur-
gery sometimes transfers unnaturally large and harm-
ful vibrations to the inner ear, resulting in permanent
hearing loss or tinnitus (Causse et al, 1983; Sancipriano
´ndez et al, 1999). Improved surgical techniques
such as lasers have reduced the likelihood of this neg-
ative outcome (Matkovi
c et al, 2003). In fact, successful
stapedectomy surgery can help to reduce the patient’s
perception of tinnitus. A study of 19 patients with pre-
operative severe tinnitus undergoing stapedectomy
resulted in 10 patients with complete remission of tin-
nitus and seven with significant improvement in tinni-
tus severity (Oliveira, 2007). Two patients had no
change, and none reported worsening of tinnitus after
surgery. Dost et al (2005) also reported significant
improvement in hearing status and tinnitus levels for
a majority of 49 otosclerosis patients who underwent
stapes prosthesis surgery.
Cochlear Implant
Numerous publications have reported that cochlear
implantation reduces patients’ perception of tinnitus
(Arts et al, 2012; Kim et al, 2013; Kompis et al,
2012). Yonehara et al (2006) reported on 29 cochlear
implant candidates, 21 of whom experienced tinnitus
before cochlear implantation. When the implant was
activated, seven patients (33%) experienced total sup-
pression of tinnitus, and eight (39%) reported partial
relief. Cochlear implantation usually improves hearing
and tinnitus on the side of implantation in patients with
bilateral deafness, but tinnitus sometimes persists,
becomes noticeable, or worsens on the side contralat-
eral to the implant. Bilateral cochlear implantation
should be considered for some patients who suffer these
Middle Ear Implant
The Vibrant Soundbridge (distributed by Med-El,
Durham, NC) was approved by the FDA for adults
with moderate to severe sensorineural hearing
loss who wanted an alternative to acoustic hearing
aids. Unlike conventional hearing aids, this device
bypasses the ear canal and eardrum by directly
vibrating the small bones in the middle ear. No por-
tion of the device is placed in the ear canal. Biesinger
(2006) studied eight patients with hearing loss and
severe tinnitus who were fitted with a Vibrant Sound-
bridge. He reported that the device improved hearing
and reduced the perception of tinnitus in patients for
whom conventional sound stimulation treatments
were not helpful.
Bone-Anchored Hearing Aid (BAHA)
BAHAs were designed to help people who have
chronic inflammation or infection of the ear canal
and cannot wear conventional hearing aids, those with
conductive hearing loss or with malformed or absent
outer ear and ear canals (as occurs in Treacher-Collins
syndrome or microtia), and those with unilateral deaf-
ness. Holgers and Ha
˚kansson (2002) reported that the
majority of eight patients with significant hearing loss
and tinnitus who received BAHAs stated that sound
amplified by the aid helped to make their tinnitus less
Auditory Brainstem Implant
In the United States, auditory brainstem implants
are approved only for patients who suffer from neuro-
fibromatosis type 2. Soussi and Otto (1994) reported
that six of seven patients with neurofibromatosis type
2 who received an auditory brainstem implant experi-
enced noticeable tinnitus reduction; the seventh patient
reported no effect. Three other patients used the implant
only during laboratory testing; one reported complete
suppression of tinnitus; one described worse tinnitus;
and one reported no effect. More recently, Behr et al
(2007) reported that auditory brainstem implants
Figure 4. Image of deep ear canal insertion for the Lyric hearing
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improved hearing and reduced the perception of tinni-
tus for a majority of neurofibromatosis type 2 patients.
Deep Brain Stimulation (DBS)
DBS involves surgical implantation of long electrodes
into the brain to deliver electrical impulses to specific
regions. A stimulator unit is implanted beneath the
patient’s skin, usually below the clavicle. An external
device is used to control the stimulator, which delivers
electrical current through wires to the electrodes. This
procedure has provided therapeutic benefits for other-
wise treatment-resistant disorders such as chronic
pain, Parkinson’s disease, tremor, and dystonia.
Shi et al (2009) tested four patients who were im-
planted with deep brain electrodes in the ventral in-
termedius nucleus of the thalamus for movement
disorders. All patients experienced chronic tinnitus, and
although the electrodes were not positioned in auditory
regions of the brain, two of these patients reported
reduced tinnitus loudness when deep brain stimulation
was activated. Cheung and Larson (2010) took a more
proactive approach to test the efficacy of deep brain
stimulation for tinnitus. They enlisted six patients with
tinnitus who were scheduled to undergo deep brain
stimulation surgery for Parkinson’s disease and essen-
tial tremor. Although the final target for electrode
implantation was the subthalamic nucleus or the ven-
tral intermediate nucleus, the electrode was paused
during surgery in the caudate region to deliver electri-
cal stimulation there. The electrode tip traversed the
caudate in five patients for whom tinnitus loudness
in both ears was suppressed to a level 2 or lower on a
0–10 rating scale. Tinnitus did not change for one
patient in whom the DBS electrode was outside of
the caudate region.
These reports are encouraging, but it is important
to consider the risks and benefits of this invasive pro-
cedure for a symptom such as tinnitus that is not life-
threatening. If DBS was performed for tinnitus specifi-
cally, how would a target for stimulation in the brain be
selected? Based on their experience, Cheung and Larson
(2010) might argue for the caudate region, but other
candidates could be the auditory cortex (Arnold
et al, 1996; Folmer, 2007; Friedland et al, 2007), the
medial geniculate region of the thalamus (De Ridder,
Vanneste, et al, 2012), the inferior colliculi (Melcher
et al, 2009), or the cochlear nucleus in the brainstem
(De Ridder, Vanneste, et al, 2012). These vital details
need to be investigated and understood before DBS
should be recommended as a tinnitus treatment.
Brain Surface Implants/Stimulation
Electrode arrays near the surface of the brain also
can be used to affect specific neural regions. Subdural
electrodes, for example, have been implanted in
patients to reduce epileptic seizures or neuropathic
pain. De Ridder, Vanneste, van der Loo, et al (2010)
implanted an array of extradural electrodes over secon-
dary auditory cortex in five patients with chronic tinni-
tus (see Fig. 5). The patients were asked to rate their
tinnitus distress and loudness on a VAS before and after
40 Hz tonic and 40 Hz burst (5 pulses at 500 Hz) stimula-
tion. Patients reported significantly better suppression for
narrowband noise tinnitus with burst stimulation com-
pared with tonic stimulation. No difference was found
between tonic and burst stimulation for pure-tone tinnitus.
Friedland et al (2007) implanted epidural electrodes over
auditory cortex in eight tinnitus patients. Two patients had
persistent reduction of pure-tone tinnitus, and six patients
had short periods of total tinnitus suppression with contin-
uous stimulation. Significant improvements in the Beck
Depression Inventory and tinnitus questionnaires (Tinnitus
Reaction Questionnaire and Tinnitus Handicap Ques-
tionnaire) were also reported, although more objective
measures of tinnitus loudness remained fairly stable.
Since neurosurgery carries significant risks, is implan-
tation of brain surface electrodes a viable treatment for
tinnitus? Many questions need to be addressed, for exam-
ple, Which side of the patient’s brain should receive the
implant? De Ridder, DeMulder, et al (2006) claimed that
unilateral tinnitus is generated by contralateral auditory
cortex, so his team surgically implanted stimulating elec-
trodes over this area in attempts to suppress tinnitus.
However, neural imaging studies by Arnold et al (1996),
Folmer (2007), and other researchers demonstrated that
the perception of tinnitus is sometimes associated with
activity in ipsilateral auditory cortex. Therefore, the opti-
mal location for cortical stimulation remains uncertain.
Figure 5. Diagram of a brain stimulation system.
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Vagus Nerve Stimulation
The FDA approved the use of vagus nerve stimula-
tion as an adjunctive therapy for partial-onset epilepsy
in 1997 and for treatment-resistant depression in 2005.
Researchers associated with MicroTransponder Inc. in
Dallas, TX, recently published a study stating that elec-
trical stimulation of the vagus nerve “completely elim-
inated the physiological and behavioural correlates of
tinnitus in noise-exposed rats” (Engineer et al, 2011,
p. 101). This publication and subsequent media reports
generated a great deal of interest in vagus nerve stim-
ulation among clinicians, researchers, and tinnitus
patients, but we must remember that the original
experiments were conducted on rats. It seems reason-
able to question whether the rats truly experienced tin-
nitus and what effect vagus nerve stimulation had on
their supposed tinnitus.
Engineer et al (2011) hypothesized that vagus nerve
stimulation eliminated the perception of tinnitus in rats,
but they do not know if stimulation directly affects the
perception of tinnitus at all. Because the vagus nerve
has such wide-ranging roles and paths of innervation
in the body (human and rat), stimulating it will produce
a variety of effects. Some of the efferent effects (broncho-
constriction, reduced heart rate, and increased gastroin-
testinal tract activity) are predictable, and might affect
the ways in which patients perceive or react to tinnitus.
The afferent effects of vagus nerve stimulation on central
nervous system activity are less well known but could
affect patients’ mood, disposition, motivation, and, indi-
rectly, ways in which they perceive or react to tinnitus.
Although the FDA approved vagus nerve stimulation
for treatment-resistant depression, a randomized con-
trolled trial of 235 patients by Rush et al (2005) con-
cluded that no definitive evidence of efficacy for the
method was apparent. In light of this finding, we should
be wary of initial reports that proclaim the efficacy of
vagus nerve stimulation for tinnitus. Of note, these
reports were generated by scientists employed by a
company that is developing devices for commercial
distribution. The article by Engineer et al (2011,
online, under “Competing financial interests”) states,
“[Author] N.D.E. is a full-time employee of MicroTrans-
ponder Inc (Austin, Texas), which develops therapies
using neurostimulation. [Author] M.P.K. is a consul-
tant and shareholder of MicroTransponder Inc.” On
the day Nature published the online letter by Engineer
et al, MicroTransponder Inc. released a media announce-
ment titled, “Nature Study Shows That Nerve Stimula-
tion Therapy Can Eliminate Tinnitus in an Animal
Model.” The company Web site also states that Micro-
Transponder is developing an implantable system
“for a pipeline of additional indications based on Vagus
Nerve Stimulation, including stroke rehabilitation,
tinnitus, and anxiety.” Companies disseminating media
releases or developing new products is standard practice.
However, it is essential that independent research is con-
ducted prior to corporations (or their employees) making
claims as to benefits of their products.
One problem is inherent with all implanted electronic
devices: they do not last forever. Eventually, the device will
stop functioning because of aging components, failing elec-
tronics, or encroachment of the patient’s tissues/fluids,
sometimes necessitating device replacement or removal.
Researchers, clinicians, and medical device companies con-
tinue to develop and test various types of implants that
strive to improve hearing and reduce the perception of tin-
nitus, but patients should thoroughly explore noninvasive
strategies for tinnitus relief before undergoing surgery,
which includes a hospital stay and associated expenses,
especially for implantation of experimental devices. We
all look forward to technological advances, but we should
not allow patients’ zeal for a quick fix to put them at risk for
unproven and potentially harmful procedures.
As we stated earlier, any treatment or procedure
that improves patients’ hearing sensitivity is
likely to reduce their perception of tinnitus by reducing
the tinnitus signal-to-noise ratio. A current line of
investigation that aims to restore sensorineural hear-
ing loss is “hair cell regeneration.” Usually, hair cells
in the mammalian cochlea do not regenerate if they
have been lost due to aging or disease processes or
are irreparably damaged by exposure to ototoxic sub-
stances or excessively loud sounds. In the 1980s, Cotanche
(1987) and Cruz et al (1987,) among others, demonstra-
ted that elements of hair cells in the cochleae of some
birds can regenerate after severe damage by ototoxic
compounds and loud sound exposure. During the last
25 yr, laboratories around the world have studied this
phenomenon in birds (see Ryals et al, 2013, for a recent
review), and several investigators have attempted to
induce regeneration of hair cells or auditory neurons
in the mammalian cochlea. For example, in China,
Yang et al (2012) used a viral vector to deliver Atoh1
(a gene critical for hair cell differentiation) into the
cochleae of guinea pigs that were exposed to loud
sounds. Scanning electron microscopy revealed that
damaged/lost stereocilia bundles were repaired or re-
generated after Atoh1 treatment. In England, Chen
et al (2012) implanted human embryonic stem cells into
the cochleae of gerbils that served as models for audi-
tory neuropathy. The investigators reported that stem
cells were able to differentiate into hair-cell-like cells
and auditory neurons that displayed expected electro-
physiological properties. Moreover, transplantation of
stem cells resulted in significant improvements in the
gerbils’ auditory-evoked response thresholds. If any
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of the various methods now being studied eventually
succeeds in restoring functional hair cells (and hearing)
in humans, the treatment should also help to reduce the
perception of tinnitus for many individuals who experi-
ence this symptom in conjunction with hearing loss.
In addition to treatments designed to restore senso-
rineural hearing loss, several other procedures are being
investigated that might someday be used to reduce
patients’ perception of tinnitus.
Genetic Therapy: Viral Vector Inhibition
of Neural Activity
Because the generation and perception of tinnitus is
often associated with superfluous neural activity, pro-
cedures that can suppress such activity in narrowly tar-
geted regions of the central auditory system have the
potential to be effective treatments for tinnitus. One
such procedure used a viral vector to deliver the gene
for the light chain (LC) fragment of tetanus toxin (that
induces synaptic inhibition by preventing the release of
synaptic vesicles) to discreet regions of the midbrain in
rats (Zhao et al, 2006). Expression of the LC gene
inhibited the increase in startle amplitude seen with
the control viral infection, and blocked context-dependent
potentiation of startle induced by fear conditioning in
treated rats. A different research group (Nielsen et al,
2012) used a viral vector to deliver an allatostatin recep-
tor/allatostatin (AlstR/AL) system (which has previously
been shown to induce inactivation of neurons in vivo) to
a region of visual cortex in macaque monkeys. Expression
of the AlstR/AL system resulted in suppression of a visual
detection task by treated monkeys.
Jasmin et al (2003) described yet another mode of
genetic therapy that affects neural activity: locally
increasing GABA by using an enzyme inhibitor or gene
transfer mediated by a viral vector inhibited activity in
the rostral agranular insular cortex (RAIC) of rats.
Selectively manipulating GABA(B)-receptor-bearing
RAIC neurons produced hyperalgesia or analgesia
through projections to the amygdala, a brain region
involved in pain and fear.
Taken together, these genetic therapy methods have
the potential to help tinnitus patients by (1) reducing
neural activity responsible for tinnitus generation
and perception and (2) reducing patients’ negative reac-
tion to tinnitus (including fear and anxiety). Of course,
many years of additional research are required before
these techniques can be applied in human populations.
Kokaia and Sørensen (2011) described optogenetics
as a new method of controlling neural activity by deliv-
ering light impulses to specific brain regions. Derived
from microbial organisms, opsin genes (encoding
light-activated ion channels and pumps) can be genet-
ically targeted into specific neural populations using
viral vectors. When exposed to light with the appropri-
ate wavelength, action potentials can be triggered in
specific populations of neurons, and inhibition of action
potentials can be induced in other neuronal populations,
thus allowing for powerful control of neural activity.
Restoration of dopamine-related movement dysfunction
in Parkinson’s disease, amelioration of blindness, and sup-
pression of neural activity associated with tinnitus are but
a few potential applications for this new procedure.
Targeted Drug Delivery
GABA agonists, such as benzodiazepine medications
or gabapentin, help some patients by reducing the per-
ception or severity of tinnitus. Lidocaine has also pro-
vided relief for tinnitus patients (Marzo et al, 2004;
Kallio et al, 2008), although its intravenous delivery
and relatively short duration of action limit its practical
use. Another problem that plagues medications for tin-
nitus is their lack of specificity for particular neural tar-
gets. In fact, medications such as benzodiazepines,
gabapentin, and lidocaine have effects—including un-
wanted side effects—throughout the patient’s brain
and body. Jain (2012) describes a potential solution:
nanoparticle-based methods that could enhance and
improve drug delivery to the brain. When perfected,
these methods could enable delivery of effective medica-
tion to specific brain sites to reduce the perception and
severity of tinnitus. At the same time, negative side
effects and effective dosages of beneficial medications
could be reduced.
Fortunately, most people who perceive chronic tinni-
tus do not require any treatment interventions for
the condition. However, effective and noninvasive man-
agement strategies are now available for patients who
require them (Andersson and Lyttkens, 1999; Henry
et al, 2008, 2009; Hesser et al, 2011; Cima et al, 2014;
Hoare et al, 2014) even though a true “cure” for tinnitus
has not yet emerged. Duckro etal (1984) stated, “As with
chronic pain, the treatment of chronic tinnitus is more
accurately describedin terms of management rather than
cure” (p. 460). This is an important concept for patients
and clinicians to understand because most cases of
chronic tinnitus (which areassociated with sensorineural
hearing loss) are likely to persist. Our goal should be to
help patients obtainrelief from thecondition so theirqual-
ity of life improves and is not affected by the symptom.
Effective tinnitus management strategies described
in this issue of JAAA and elsewhere can help patients
to reduce their negative reaction to tinnitus; reduce the
percentage of time they are aware of or bothered by
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tinnitus; gain more control over their tinnitus; reduce
anxiety, depression, and insomnia; and reduce tinnitus
severity and its negative impact on their lives. Regard-
ing new treatments for tinnitus that will continue to
appear in news articles and other media: let the patient
beware, because if it seems too good to be true, it prob-
ably is. Invasive treatments—especially surgical proce-
dures—should be considered with extreme caution, and
a risk/benefit assessment should be conducted before
clinicians and patients decide to implement such proce-
dures. When possible, studies of tinnitus treatments
should adhere to the requirements of randomized clin-
ical trials (Dobie, 1999) and should include a well-
designed control condition to distinguish treatment
effects from placebo effects. The great majority of clin-
ical trials that have been conducted for tinnitus treat-
ments suffer from several experimental design flaws,
including lack of appropriate controls; lack of adequate
sample size; absence of valid outcomes measures; lack of
monitoring participant compliance during the study; and
inadequate inclusion/exclusion criteria for participants.
Recently, an international consortium of researchers
made the following recommendations to facilitate
improvement and standardization of tinnitus clinical
trials (Landgrebe et al, 2012, p. 119, table 2):
Trial planning
Clear formulation of the research question
Choice of adequate trial design
Definition of one or more main outcome measure(s)
(i.e., a validated tinnitus questionnaire)
THI should be included in every trial at least as
secondary outcome to improve interstudy compa-
Sample size estimation based on power calculations
(e.g., based on data from pilot studies)
Ethical approval
Informed consent
Establishment of a statistical analysis plan
Registration in a clinical trials registry
Study performance
The clinical trial should be performed according
to good clinical practice (GCP) and CONSORT
Reporting of results
All clinical trials should be published
Results should be reported according to CONSORT
Because of the heterogeneity exhibited by tinnitus
patients and their symptoms, tinnitus treatment stud-
ies should include as many participants as possible to
allow meaningful analyses of subgroups that do or do
not respond favorably to specific treatment methods.
Due to the variability seen in the tinnitus population,
it is important to perform statistical analyses to detect
such subgroups and to evaluate how they affect outcomes
or respond toa particular treatment. Also, greater stand-
ardization of tinnitus outcome measures would facili-
tate more meaningful comparisons of treatments for
the condition.
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Experimental and Controversial Treatments/Folmer et al
... [8] Most tinnitus management options are poorly researched and might be considered experimental or even controversial. [9] No effective treatment of tinnitus that provides complete symptom relief has been found. [10] Therefore, finding new strategies for the treatment of tinnitus is going on. ...
... Moreover, treatment with SSRIs has been shown to improve the quality of life in some tinnitus patients and might influence the perception of tinnitus loudness [31], but such conclusions lack extensive clinical validation. Clinical trials that have been conducted in tinnitus patients carry methodological limitations [62,63]. A downregulated serotoninergic system is in line with the gating dysfunction theory of tinnitus. ...
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Tinnitus is the phantom perception of a sound, often accompanied by increased anxiety and depressive symptoms. Degenerative or inflammatory processes, as well as changes in monoaminergic systems, have been suggested as potential underlying mechanisms. Herein, we conducted the first post-mortem histopathological assessment to reveal detailed structural changes in tinnitus patients’ auditory and non-auditory brain regions. Tissue blocks containing the medial geniculate body (MGB), thalamic reticular nucleus (TRN), central part of the inferior colliculus (CIC), and dorsal and obscurus raphe nuclei (DRN and ROb) were obtained from tinnitus patients and matched controls. Cell density and size were assessed in Nissl-stained sections. Astrocytes and microglia were assessed using immunohistochemistry. The DRN was stained using antibodies raised against phenylalanine hydroxylase-8 (PH8) and tyrosine-hydroxylase (TH) to visualize serotonergic and dopaminergic cells, respectively. Cell density in the MGB and CIC of tinnitus patients was reduced, accompanied by a reduction in the number of astrocytes in the CIC only. Quantification of cell surface size did not reveal any significant difference in any of the investigated brain regions between groups. The number of PH8-positive cells was reduced in the DRN and ROb of tinnitus patients compared to controls, while the number of TH-positive cells remained unchanged in the DRN. These findings suggest that both neurodegenerative and inflammatory processes in the MGB and CIC underlie the neuropathology of tinnitus. Moreover, the reduced number of serotonergic cell bodies in tinnitus cases points toward a potential role of the raphe serotonergic system in tinnitus.
... The relationship between tinnitus and comorbid conditions is known to be reciprocal (Carlson et al., 2019;Folmer et al., 2001;Prewitt et al., 2021;Trevis et al., 2018). As the severity of tinnitus increases, the condition is associated with serious cosymptoms, including depression, anxiety, insomnia, and reduced quality of life (Folmer, 2006(Folmer, , 2012Folmer & Griest, 2000, 2003Folmer et al., 1999Folmer et al., , 2004Folmer et al., , 2008Folmer et al., , 2014. Likewise, the severity of cosymptoms can exacerbate tinnitus effects and its intrusiveness (Folmer, 2002). ...
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Purpose Tinnitus is a highly prevalent condition that can severely reduce health functioning. In spite of extant clinical practice guidelines (CPGs), implementation of these CPGs is relatively uncommon. As a result, patients seeking professional services for tinnitus often have no assurance of receiving evidence-based care. The purpose of this tutorial was to clarify the evidence for sound therapy so that it may be included in future CPGs for tinnitus. Method “Best clinical evidence” is obtained from high-quality systematic reviews, which are generally considered the highest level of evidence. Our review of recent, comprehensive, high-quality systematic reviews of interventions for tinnitus concludes that cognitive behavioral therapy is the only effective intervention, though the strength of evidence was generally rated as low in these reviews. Although trials of sound therapy for tinnitus have been included in these reviews, they have been rated as having high risk of bias (RoB) and not included in syntheses or rated as insufficient strength of evidence. Results Conclusions from these and other reviews have influenced recommendations made in CPGs for tinnitus. These conclusions, however, can make it appear that an intervention for tinnitus is not effective, even if the opposite is true. We contend that the strict inclusion criteria for these reviews are counterproductive and have the effect of obscuring decades of evidence demonstrating the clinical effectiveness of sound therapies for tinnitus. Ultimately, this process has resulted in many patients not receiving sound therapy, despite what should be sufficient evidence that this is an effective form of intervention. Conclusion If we rely on systematic reviews using contemporary RoB assessment criteria for studies published prior to these reporting guidelines, then we risk excluding important conclusions regarding interventions that could help patients in need.
... Tinnitus itself is a very common audiological symptom frequently correlated with older age and hearing loss, although only between 1 and 3% of the population of people with tinnitus suffers from it severely (Davis & El Refaie 2000;Kim et al. 2015). Although there are a large variety of intervention options; psychological, sound, electrical and electromagnetic stimulation, tinnitus has no reliable cure (Folmer et al. 2014). Accumulating evidence from randomized controlled trials (RCTs) and meta-analyses suggests that cognitive behavioral therapy (CBT) is an efficacious intervention in alleviating tinnitus-related distress (Fuller et al. 2020;Landry et al. 2020). ...
Objectives: Tinnitus is the perception of sound without an external source, affecting quality of life that can cause severe distress in approximately 1 to 3% of the population of people with tinnitus. Randomized controlled trials of cognitive behavioral therapy for tinnitus have demonstrated its effectiveness in improving quality of life, but the effects of their implementation on a large scale in routine practice remains unknown. Therefore, the main purpose of this study was to examine the effects of stepped-care cognitive behavioral therapy for tinnitus delivered in a tertiary audiological center of a regional hospital. Second, we wished to examine predictors of favorable outcome. Design: Four hundred three adults with chronic tinnitus were enrolled in this prospective observational study (at 3 months, N=334, 8 months, N=261; 12 months, N=214). The primary outcome was health-related quality of life as measured by the Health Utilities Index III (HUI-III) at 12 months. Secondary outcomes were self-reported levels of tinnitus-related distress, disability, affective distress and tinnitus-related negative beliefs and fear. Measures were completed pre-intervention at 3 months, 8 months, and 12 months. Multilevel modeling was used to examine effects and their predictors. Results: Younger participants with lower levels of tinnitus distress were more likely to dropout while those with higher tinnitus distress at baseline and quality of life were more likely to receive step 2 of treatment. MLM analyses revealed, with one exception, no relation between any baseline variable and outcome change over time. Most participants' improvement exceeded minimally clinical important difference criteria for quality of life, tinnitus-related handicap, and tinnitus distress. Conclusions: Results from this large pragmatic study complements those from randomized controlled trials of cognitive behavioral therapy for chronic tinnitus distress and supports its implementation under "real-world" conditions.
... However, these approaches are often overlooked in studies of tinnitus interventions. The placebo effect can be as high as 40% in some interventions (Dobie, 1999;Folmer, Theodoroff, Martin, & Shi, 2014), and between 20% and 40% of those who received a placebo injection of saline reported a change in the psychological reaction of tinnitus (Duckert & Rees, 1983, 1984. Sound maskers themselves appear to have a placebo effect. ...
Tinnitus, the perception of sound in the absence of an external source, has been noted for millennia in historical medical and other texts. It affects between 10% and 15% of adults in the general population. Tinnitus can be considered to be both the perceived sound itself and the psychological reaction to it. Variability in both these factors drives the heterogeneity seen in the patient population. Here, we consider what occurs after the onset of chronic, continuous tinnitus, which lacks a cure, focusing primarily on the psychological impact on the individual. The great majority of those with chronic tinnitus learn to habituate to it, possibly exerting greater cognitive control of their emotional processing, whereas a minority report bothersome symptoms associated with their tinnitus. These symptoms include difficulties with sleeping, challenges with communication and concentration, and associated anxiety and depression. Although there have been several influential models of tinnitus generation, few have considered the process of habituation and the attendant neuroplasticity of long-term chronic tinnitus. As data accumulate from cross-sectional behavioral and brain imaging studies, the neural bases of successful habituation are becoming clearer, pointing to interconnected neural networks mediating cognition and emotion and, only secondarily, audition. What remains unclear are the longitudinal changes in these networks culminating in successful habituation, with or without an intervention. Greater knowledge of these changes will allow us to unravel the mystery of not only tinnitus but also how sound itself is consciously perceived.
... Targeted neuromodulation and ABS may re-stabilize neural function for tinnitus sufferers 14 . 17 . Alprazolam, an anti-anxiety medication, is associated with reductions in the perceived volume of tinnitus; however, many patients reported a sedating effect. ...
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Objective: The purpose of this chart review was to assess the response of veterans suffering from tinnitus to Magnetic EEG/EKGguided resonance therapy and Alpha Burst Stimulation (ABS), while also investigating the safety profile of this therapy combination. EEG/EKG-guided Repetitive Transcranial Magnetic Stimulation (rTMS) delivers high-energy electromagnetic pulses to induce current flow in the neocortex. ABS provides rTMS pulses in short, high-frequency bursts. Materials and methods: All equipment used to evaluate and treat participants are either FDA-cleared or are exempt from clearance and listed with the United States FDA. Stimulation was delivered with a MagPro R30 and an MCF-B65 butterfly coil. Charts were reviewed from patients who had received a combination of EEG/EKG-guided rTMS and ABS therapy to relieve symptoms of tinnitus. Paired samples t-tests were performed on the Tinnitus Functional Index (TFI) and Neurobehavioral Symptom Inventory (NSI) scales. Treatment logs and therapy notes were reviewed for safety data. Adverse events or side effects were extracted from therapy notes. Linear regression was used to analyze the relationship between number of therapy sessions, and reported patient symptoms. Results: Eighteen of the 23 patients reported significant improvements in tinnitus symptoms. For patients reporting improvements, there was an average 44% reduction in tinnitus symptoms and a 60% reduction in NSI scores following intervention. No patients experienced adverse side effects. The most common side effects were headache and fatigue. Conclusion: Based on the results from this study, noninvasive neuromodulation holds promise as a potential treatment for tinnitus. Additional investigation in controlled studies may be warranted.
In tinnitus retraining therapy (TRT) for the treatment of tinnitus associated with unilateral hearing loss, sound input into the affected or unaffected ear is provided with the use of a sound generator (SG) or hearing aids. In patients with profound unilateral hearing loss of 90dB or over, the use of hearing aids is considered as being ineffective; therefore, contralateral routing of signals (CROS) has been proposed as a means of providing hearing support. A CROS hearing aid is worn on the affected ear as a transmitter and transmits sounds around the affected ear to a hearing aid in the unaffected ear. A total of 104 patients with tinnitus (62 men and 45 women) visited the Tinnitus and Hearing Loss Clinic of the Shin-Yurigaoka General Hospital during the 1-year period from January 2018 to December 2018. A total of 92 patients (54 men and 38 women) received TRT with a hearing aid. We encountered 2 patients who developed tinnitus after sudden hearing loss, in whom the distress caused by the tinnitus and the hearing loss was alleviated by implementation of TRT with a CROS hearing aid. Both the patients had profound severe hearing loss in the affected ear. One patient received treatment with a CROS hearing aid from the beginning, with improvement. In the other patient, a conventional hearing aid was changed to a CROS hearing aid after the patient showed no improvement with the conventional air conduction hearing aid worn in the affected ear. After the switch to a CROS hearing aid, the patient reported a sense of improvement. We also encountered 1 other patient with profound severe hearing loss who did not use a CROS hearing aid. We evaluated the cases, speculate that? the sounds around the affected ear caught by the CROS in the unaffected ear gave sufficient input of external sounds to both ears, which may have contributed to the alleviation of the patients' tinnitus.
Purpose This systematic review aimed to analyze the effects of low-level laser therapy (LLLT) on the severity of tinnitus when compared to no therapy or other modalities of therapies. Method A systematic review protocol was registered at the International Prospective Register of Systematic Reviews (PROSPERO) under the Registration Number CRD42019119376. A search was performed in each of the following databases: EMBASE, LILACS, PubMed, Science Direct, Scopus, Web of Science, Google Scholar, and ProQuest. The inclusion criteria consisted of studies in adults over 16 years of age, randomized clinical trials in which subjects presented chronic (≥ 6 months) and subjective tinnitus (unilateral or bilateral) as well as with or without bilateral sensorineural hearing loss, and studies that used only LLLT for treatment of tinnitus compared to no-therapy group or other modalities of therapy. No language or time restrictions were stipulated. The references were managed by Endnote Web and Rayyan QCRI. Results After the screening process, seven studies remained that attained the eligibility criteria. Regarding the risk of bias, only one study was categorized as low risk of bias; the six remaining studies were classified as moderate risk of bias. The seven included studies mainly assessed the LLLT effects on tinnitus by Visual Analogue Scale, Tinnitus Handicap Inventory, pitch and loudness matching, minimum masking level, and pure-tone audiometry. All the seven selected studies found different degrees of significant results regarding tinnitus severity; however, there was no consensus among the results. Conclusion Even though the LLLT showed positive effects in the tinnitus severity in some studies, it is not possible yet to make any recommendation over its uses for the treatment of tinnitus severity.
Background: Up to now, tinnitus has been an almost non-treatable symptom affecting more than 18% of the population in industrialized countries. So far, there are only a few studies evaluating the effectiveness of acupuncture in tinnitus treatment, none of which include acute tinnitus ( Patients and methods: After randomization patients of the control group received usual care (n = 23), and patients of the intervention group (n = 25) received 4 additional acupuncture treatments in a 4- to 6-week period. Tinnitus severity was assessed by means of a visual analogue scale as well as standardized and validated tinnitus questionnaires (Tinnitus Functional Index and 12-item Mini Tinnitus Questionnaire) at baseline and 6 weeks after. These subjective parameters were completed by tone audiometry. Comparisons of the groups were carried out using the Wilcoxon-Mann-Whitney test. Results: Both groups were comparable without significant differences in baseline values. All outcomes, except for the overall well-being, showed better improvements in the intervention group with clinically significant differences from baseline to end point. However, among the outcomes only the subjective change in tinnitus severity showed a significant group difference. No serious side effects were observed. Conclusion: The design of our pilot study was feasible in terms of recruitment, although patient adherence to treatment remained challenging. However, considering the small intergroup differences, procedures regarding the numbers of acupuncture sessions and the total period of the acupuncture treatment should be reconsidered. The results of this pilot study provide a good basis for future confirmatory trials.
Riassunto Gli acufeni soggettivi sono delle percezioni uditive che non rispondono a una stimolazione sonora registrabile. Sono generalmente sintomatici di una lesione attiva o sequenziale del sistema uditivo periferico. Tuttavia, i meccanismi fisiopatologici multipli e intricati che spiegano sia la loro emergenza che la loro connotazione spiacevole, persino insopportabile, implicano più probabilmente delle disfunzioni centrali. Ciò rifletterebbe un’anomala di plasticità cerebrale generalmente indotta dalla perdita dell’udito. Un’analisi clinica rigorosa che evidenzia i fattori organici e psicologici coinvolti, nonché ulteriori esami prescritti in modo ragionato, consentono di orientare e guidare efficacemente i pazienti. Allo stato attuale delle conoscenze, non esiste un trattamento curativo, in particolare un trattamento farmacologico, sistematicamente applicabile a tutti i pazienti. Tuttavia, varie terapie palliative volte a migliorare la tolleranza del sintomo si sono dimostrate efficaci: come le terapie cognitivo- comportamentali e diversi metodi di rieducazione sonora. Questo vale anche per gli interventi di riabilitazione dell’udito con apparecchi acustici o impianti cocleari. La prospettiva di un ripristino ad integrum della funzione cocleare, grazie agli strumenti emergenti della farmacologia intracocleare e della terapia genica, nonché alle tecniche innovative per la modulazione dell’attività cerebrale costituiscono una speranza per tutti i pazienti che soffrono di acufeni.
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For some patients suffering from tinnitus, an external sound stimulator can offer some mitigation. Based on our positive experience with the bone-anchored hearing aid (BAHA), it seems possible to transmit a masking or habituating sound via bone conduction. A potential advantage of bone-conducted sound is that it is transmitted to the cochlea without affecting the normal hearing via the external and middle ear. The present pilot study, on patients who use a conventional BAHA and who experience mild-to-moderate tinnitus, shows that bone-conducted sound has the potential to relieve tinnitus in the same way as air-conducted sound. It was also found that these patients, having a significant conduction hearing loss, required conventional sound amplification via a BAHA simultaneously with the stimulus provided by the bone-anchored sound stimulator (BASS). Further studies on patients with more severe tinnitus must be conducted in order to justify the use of a BASS for tinnitus relief.
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Background: The authors reviewed practicable options of sound therapy for tinnitus, the evidence base for each option, and the implications of each option for the patient and for clinical practice. Purpose: To provide a general guide to selecting sound therapy options in clinical practice. Intervention: Practicable sound therapy options. Data collection and analysis: Where available, peer-reviewed empirical studies, conference proceedings, and review studies were examined. Material relevant to the purpose was summarized in a narrative. Results: The number of peer-reviewed publications pertaining to each sound therapy option reviewed varied significantly (from none to over 10). Overall there is currently insufficient evidence to support or refute the routine use of individual sound therapy options. It is likely, however, that sound therapy combined with education and counseling is generally helpful to patients. Conclusions: Clinicians need to be guided by the patient's point of care, patient motivation and expectations of sound therapy, and the acceptability of the intervention both in terms of the sound stimuli they are to use and whether they are willing to use sound extensively or intermittently. Clinicians should also clarify to patients the role sound therapy is expected to play in the management plan.
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Background: Tinnitus can be defined as the perception of an auditory sensation, perceivable without the presence of an external sound. Purpose: The aim of this article is to systematically review the peer-reviewed literature on treatment approaches for tinnitus based on cognitive-behavioral therapy (CBT) and to provide a historical overview of developments within these approaches. Research design: Experimental studies, (randomized) trials, follow-up assessments, and reviews assessing educational, counseling, psychological, and CBT treatment approaches were identified as a result of an electronic database metasearch. Results: A total of 31 (of the initial 75 studies) were included in the review. Results confirm that CBT treatment for tinnitus management is the most evidence-based treatment option so far. Though studied protocols are diverse and are usually a combination of different treatment elements, and tinnitus diagnostics and outcome assessments vary over investigations, a common ground of therapeutic elements was established, and evidence was found to be robust enough to guide clinical practice. Conclusions: Treatment strategy might best be CBT-based, moving toward a more multidisciplinary approach. There is room for the involvement of different disciplines, using a stepped-care approach. This may provide brief and effective treatment for a larger group of tinnitus patients, and additional treatment steps can be provided for those suffering on a more severe level.
On the basis of the promising results in CI patients provided with the high rate CIS strategy the ENT and Neurosurgical Clinic of the University of Würzburg started an ABI program in 1997. The 12 channel Med-El device Combi 40/40+ was used and a special electrode for insertion into the lateral recess of the 4th ventricle was developed. The surgical procedure is performed by a team of ENT-neurosurgeons and audiologists. The retrosigmoid approach in a semi-sitting position of the patient is used. Sixteen probes in 15 patients were implanted, one successfully revised due to probe dislocation. In one additional patient hearing was preserved who is now provided with a conventional hearing aid. In another patient the 8th nerve was anatomically preserved due to the retrosigmoid approach and a CI could be implanted after positive promontory test. The same situation occurred in a recent patient who will be examined in the near future by a promontory test. In case of positive results a CI will be implanted. In one patient the planned implantation was not possible due to a vascular abnormality in the lateral recess. One patient of the 15 implanted patients is a non user, the others use the implant on a daily basis. They have tonotopy, sound discrimination and are able to perceive daily life and warning sounds. The average increase of lip reading is 30%. More than 50% have open speech understanding at different performance levels. Complications attributed to ABI implantation are mainly CSF leakage. In summary, ABI implantation is a reliable and safe method for hearing rehabilitation and restoration in NF-2 patients.
Tinnitus is a common auditory complaint that can be caused by many auditory as well as nonauditory systems diseases. Comorbidities including insomnia, anxiety, and depression are common in severe tinnitus. Other factors such as personality characteristics and socioeconomic difficulties can also contribute to tinnitus distress. Management of tinnitus therefore requires diagnosis and treatment expertise by physicians to adequately address existing etiologies and comorbidities, as well as relevant expertise by nonphysician specialists such as audiologists and psychologists. In assessing the efficacy of tinnitus treatments, nonspecific effects such as placebo effects must be taken into consideration. Management of complex tinnitus cases often requires a multidisciplinary team approach. Physicians and nonphysician specialists need to promptly refer patients to relevant specialist colleagues for adequate evaluation and treatment when such needs are present.
We used PET to map brain regions responding to changes in tinnitus loudness in four patients who could alter tinnitus loudness by performing voluntary oral facial movements (OFMs). Cerebral blood flow was measured in four patients and six controls at rest, during the OFM, and during stimulation with pure tones. OFM-induced loudness changes affected the auditory cortex contralateral to the ear in which tinnitus was perceived, whereas unilateral cochlear stimulation caused bilateral effects, suggesting a retrocochlear origin for their tinnitus. Patients, compared with controls, showed evidence for more widespread activation by the tones and aberrant links between the limbic and auditory systems. These abnormal patterns provide evidence for cortical plasticity that may account for tinnitus and associated symptoms. Although audiologic symptoms and examinations of these patients were typical, the unusual ability to modulate tinnitus loudness with an OFM suggests some caution may be warranted in generalizing these findings.