Cover Story
First Evidence-Based Tinnitus
Guideline Shines Light on Treatment
By Janelle Weaver
© Rob Colvin/Stock Illustration Source
I
n the past year, about 10 percent of adults in the United
States have experienced tinnitus lasting at least five
minutes. In severe cases, tinnitus can interfere with work
and sleep, and some patients experience anxiety, de-
pression, and extreme life changes.
Even though tinnitus is relatively common and affects quality
of life, historically some clinicians have thrown up their hands
when confronted with the challenges of treating it. After all, tin-
nitus is not a disease, but rather a symptom that can result from
multiple conditions affecting the auditory system, which in-
cludes the ear, the auditory nerve that connects the inner ear to
the brain, and the parts of the brain that process sound.
To help clinicians determine the most appropriate interven-
tions to improve symptoms and quality of life for people
December 2014 The Hearing Journal 19
with tinnitus, the American Academy of
­Otolaryngology–Head and Neck Surgery
Foundation (AAO-HNSF) published the
first evidence-based clinical practice
guideline for the evaluation and treatment
of chronic tinnitus. The guideline, which
was included as a supplement to the Oc-
tober issue of Otolaryngology–Head and
Neck Surgery, emphasizes interventions
and therapies that are deemed beneficial
and discourages those that are time-­
consuming, costly, and ineffective (2014;
151[suppl 2]:S1-S40).
“Overall, I am impressed with the
guideline,” said James W. Hall III, PhD, a
member of The Hearing Journal’s Edito-
rial Advisory Board and an adjunct pro-
fessor of audiology at Salus University,
who was not an author of the clinical
practice guideline.
“Evidence-based guidelines for tinni-
tus assessment and management are
definitely needed. The authors preparing
the guideline included in the document all
major topics relevant to tinnitus assess-
ment and management.”
AUDIOLOGIC ASSESSMENT
A multidisciplinary team of otolaryngolo-
gists, audiologists, and other healthcare
professionals, as well as consumer advo-
cates, developed the guideline’s 13 rec-
ommendations for the evaluation of adult
patients with persistent, bothersome pri-
mary tinnitus in which the underlying cause is not clear.
The guideline excludes patients with secondary tinnitus,
which is associated with a specific underlying cause other
than sensorineural hearing loss, because these patients are
often excluded from randomized, controlled trials of tinnitus
management. The guideline also excludes patients with tinni-
tus related to complex auditory hallucinations or to hallucina-
tions associated with psychosis or epilepsy, and patients with
pulsatile tinnitus.
The guideline begins with recommendations about patient
examinations. First, clinicians should perform a targeted his-
tory and physical examination at the initial evaluation of a pa-
tient with presumed primary tinnitus to identify conditions
that, if quickly identified and managed, might relieve tinnitus.
Cover Story
Second, clinicians should obtain a prompt, comprehensive
audiologic examination in patients with tinnitus that is unilat-
eral, persistent (present for at least six months), or associated
with hearing difficulties. For patients who present with tinnitus
that does not meet any of these conditions, an initial compre-
hensive audiologic examination was listed as an option.
“Overall, I am impressed
with the guideline. Evidence-
based guidelines for tinnitus
assessment and management
are definitely needed.”
James W.
Hall III, PhD
“There are two action statements that support audiologic as-
sessment for these patients,” said David E. Tunkel, MD, lead
author of the tinnitus clinical practice guideline and chief of pe-
diatric otolaryngology at Johns Hopkins School of Medicine.
“The first just identifies who should have prompt audiologic
assessment, and the second notes that audiologic assess-
ment can be performed for any patient with persistent, bother-
some tinnitus.”
Robert Sweetow, PhD, clinical professor of otolaryngology–
head and neck surgery at the University of California, San
Francisco, who was not involved in developing the guideline,
was disappointed by the lack of a recommendation for routine
audiologic care.
“Without audiologic measures, I don’t think the full range of
opportunities for help can be given,” he said.
RECOMMENDED TREATMENTS
The most important recommendations in the clinical practice
guideline focus on identifying patients in need of clinical man-
agement, thereby limiting unnecessary testing and treatment,
said Pawel J. Jastreboff, PhD, ScD, MBA, professor of otolar-
yngology at Emory University School of Medicine, who was
not a member of the guideline development group.
For example, clinicians are encouraged to distinguish patients
with bothersome tinnitus from patients with non-bothersome tin-
nitus, and further distinguish patients with bothersome tinnitus of
recent onset from those with symptoms lasting at least six months.
The guideline also recommends that clinicians avoid imag-
ing studies of the head and neck unless the tinnitus is local-
ized to one ear, pulsatile, or associated with focal neurological
abnormalities or asymmetric hearing loss.
Moreover, clinicians should not routinely recommend tran-
scranial magnetic stimulation or medications like antidepres-
sants or anticonvulsants because these interventions may not
effectively treat tinnitus and could cause side effects, includ-
ing worse tinnitus.
Similarly, dietary supplements such as ginkgo biloba, mela-
tonin, and zinc are not recommended because they have no
proven efficacy and pose potential harm to patients.
22 The Hearing Journal 
Dr. Jastreboff also agreed with the recommendation that
clinicians educate and counsel patients about management
strategies.
On the other hand, he found controversial the statements
identifying cognitive–behavioral therapy as a recommendation—
a treatment that clinicians should recommend—and sound
therapy as an option—a therapy that clinicians may recom-
mend.
“Sound therapies are unjustly underappreciated, while the
usefulness of cognitive–behavioral therapy in practice is very
limited,” he said. “There are very few therapists who can do it
properly for tinnitus, and it is not addressing hyperacusis and
hearing loss, which sound therapies are doing and which very
frequently accompany tinnitus.
“In my opinion, it is crucial to treat decreased sound
­tolerance—both hyperacusis and misophonia—and hearing
loss together with tinnitus to achieve a high level of suc-
cess.”
Dr. Tunkel, on the other hand, said that cognitive–­behavioral
therapy is one of the best-supported treatment strategies for
tinnitus management, with a number of reviews and trials
­behind it.
“While the availability and use of cognitive–behavioral ther-
apy may be limited, the usefulness may not be,” he said.
Dr. Sweetow also is a proponent of cognitive–behavioral
therapy.
“More and more audiologists, in addition to psychologists,
are being trained to provide this assistance,” he said, adding
that he strongly believes in relaxation training as well.
In addition, he was pleased with the recommendation of a
hearing aid evaluation for patients with hearing loss, which is
frequently associated with tinnitus.
“While the availability and
use of cognitive–behavioral
therapy may be limited, the
usefulness may not be.”
David E.
Tunkel, MD
“I believe that the most important message conveyed in
the guideline is that otolaryngologists should not tell patients
that there is nothing that can be done to help them.”
EVALUATING THE EVIDENCE
Dr. Tunkel noted the high-quality evidence base for the clinical
practice guideline.
“We looked at randomized, controlled trials and systematic
reviews, and also looked at potential sources of bias in the
evidence,” he said.
“A major issue was that some studies of interventions for
tinnitus had methodological flaws that limited our ability
to recommend treatment strategies. These flaws included
December 2014
Cover Story

Summary of Guideline Action Statements

Statement
1. History and physical
exam
2A. P
 rompt audiologic
examination
2B. R
 outine audiologic
examination
3. Imaging studies
4. Bothersome tinnitus
5. Persistent tinnitus
6. Education and
counseling
7. Hearing aid
evaluation
8. Sound therapy
9. Cognitive behavioral
therapy
10. Medical therapy
11. Dietary supplements
12. Acupuncture
13. Transcranial magnetic
stimulation
Action Strength
Clinicians should perform a targeted history and physical Recommendation
examination at the initial evaluation of a patient with
presumed primary tinnitus to identify conditions that if
promptly identified and managed may relieve tinnitus.
Clinicians should obtain a prompt, comprehensive audiologic Recommendation
examination in patients with tinnitus that is unilateral,
persistent (≥ 6 months), or associated with hearing difficulties.
Clinicians may obtain an initial comprehensive Option
audiologic examination in patients who present with tinnitus
(regardless of laterality, duration, or perceived hearing status).
Clinicians should not obtain imaging studies of the head and Strong
neck in patients with tinnitus, specifically to evaluate the recommendation
tinnitus, unless they have one or more of the following: tinnitus against
that localizes to one ear, pulsatile tinnitus, focal neurological
abnormalities, or asymmetric hearing loss.
Clinicians must distinguish patients with bothersome tinnitus Strong
from patients with non-bothersome tinnitus. recommendation
Clinicians should distinguish patients with bothersome tinnitus Recommendation
of recent onset from those with persistent symptoms (≥ 6
months) to prioritize intervention and facilitate discussions
about natural history and follow-up care.
Clinicians should educate patients with persistent, bothersome Recommendation
tinnitus about management strategies.
Clinicians should recommend a hearing aid evaluation for Recommendation
patients with hearing loss and persistent, bothersome tinnitus.
Clinicians may recommend sound therapy to patients with Option
persistent, bothersome tinnitus.
Clinicians should recommend cognitive–behavioral therapy to Recommendation
patients with persistent, bothersome tinnitus.
Clinicians should not routinely* recommend antidepressants, Recommendation
anticonvulsants, anxiolytics, or intratympanic medications for a against
primary indication of treating persistent, bothersome tinnitus.
Clinicians should not recommend ginkgo biloba, melatonin, Recommendation
zinc, or other dietary supplements for treating patients with against
persistent, bothersome tinnitus.
No recommendation can be made regarding the effect of No recommendation
acupuncture in patients with persistent, bothersome tinnitus.
Clinicians should not recommend transcranial magnetic Recommendation
stimulation for the routine* treatment of patients with against
persistent, bothersome tinnitus.

*The words routine and routinely are used to avoid setting a legal precedent and to acknowledge that there may be individual circumstances
for which clinicians and patients may wish to deviate from the prescribed action in the statement.
Adapted from: Tunkel DE, Bauer CA, Sun GH, et al. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg 2014;151(suppl 2):
S1-S40. © 2014 by American Academy of Otolaryngology–Head and Neck Surgery Foundation. Reprinted by permission of SAGE Publica-
tions.

problems with randomization, inadequate placebo conditions,
and variation in entry criteria and outcomes measures.”
Dr. Hall agreed that the quality of the evidence base for the
clinical practice guideline generally was good.
“Best practice is, in effect, evidence-based practice,” he
said. “That is, decisions regarding how to evaluate, diagnose,
and manage patients with tinnitus and other problems must
be guided by research findings.
“The guidelines appropriately cite not only the research evi-
dence in support of the recommendations, but also the strength
or quality of the evidence behind each recommendation.”
The guideline is a step in the right direction, Dr. Jastreboff
noted.
“I believe that these guidelines should be helpful, provided
that people take them as suggestions and not strict rules,” he
said. “They should help in avoiding some errors in treatment,

December 2014 The Hearing Journal 23

Cover Story
but they are not sufficient for people who are not familiar with
treating tinnitus patients.”
FURTHER ADVICE
Tinnitus experts had additional suggestions beyond the
guideline recommendations. For example, Dr. Sweetow ad-
vised that patients first see an otolaryngologist for proper
diagnosis, and then see an audiologist trained in tinnitus
management.
“Without audiologic measures,
I don’t think the full range of
opportunities for help can be
given.”
Robert
Sweetow, PhD
“For nonmedical treatment, trained audiologists are the
best professionals for helping patients find relief,” he said.
“Physicians simply don’t have the necessary time to spend
with the patients.”
A challenge moving forward is convincing otolaryngolo-
gists that audiologists can greatly benefit tinnitus patients, he
added.
Dr. Jastreboff sees value in tinnitus retraining therapy
(TRT), which uses a combination of low-level broadband
noise and counseling to achieve the habituation of tinnitus,
such that patients are no longer aware of their tinnitus, except
when they focus their attention on it.
“TRT is effective for all types of tinnitus, and its effective-
ness does not depend on tinnitus etiology,” said Dr. Jastreboff,
who pioneered the approach. “I believe it is most effective
and addresses tinnitus, hyperacusis, misophonia, and hearing
loss.”
Cochlear implants are sometimes used in people who have
tinnitus along with severe hearing loss. The device brings in
outside sounds that help mask tinnitus and stimulate change
in neural circuits.
Meanwhile, some patients have turned to acupuncture, but
the poor quality of the data and the limited potential for harm
kept the clinical guideline development group from making a
recommendation about this therapy.
No matter which treatment is used, the evaluation of its
effectiveness should involve the assessment of tinnitus se-
verity and changes in the impact of tinnitus on a patient’s life,
Dr. Jastreboff said.
To a large extent, success in tinnitus management depends
on aligning the treatment approach with the disorder and re-
lated underlying problems for a specific patient, according to
Dr. Hall.
“One management approach doesn’t work for all patients
because tinnitus is not a unitary disorder, but rather a symp-
tom of many potential disorders,” he said.
24 The Hearing Journal 
CHALLENGES AHEAD
Various companies are now investigating drugs for the future
treatment of tinnitus. For example, Autifony Therapeutics an-
nounced in June that the United Kingdom’s innovation agency—
the Technology Strategy Board, which is now called Innovate
UK—had awarded the company £2.2 million for a Phase 2a
clinical trial in tinnitus patients with its lead compound,
AUT00063. (To find out more about investigational treatments
targeting audiological conditions, read the article on page 14 of
the September issue of The Hearing Journal, available at bit.ly/
HJ-Investigational.)
AUT00063 is a first-in-class Kv3 potassium channel modu-
lator targeting the brain regions that process sound.
Meanwhile, Otologic Pharmaceuticals is investigating
whether its antioxidant-based product, NHPN-1010, will re-
duce the onset of noise-induced tinnitus.
In addition, Auris Medical is developing AM-101 for the treat-
ment of acute inner ear tinnitus following traumatic cochlear injury
or middle ear infection. This gel contains an ­N-methyl-D-aspartate
(NMDA) receptor antagonist called esketamine hydrochloride.
Similarly, Otonomy is developing a tinnitus treatment called
OTO-311—a sustained-exposure formulation of the NMDA
receptor antagonist gacyclidine.
“Medication continues to be explored, but there is no
magic bullet yet,” Dr. Sweetow said.
Dr. Jastreboff also expressed skepticism.
“I have seen many claims of ‘highly effective treatment’
over the last 30 years, which turned out to be not true when
investigated by independent investigators,” he said.
“I do not believe the cure for tinnitus is possible in any reason-
able time, if at all. Our current knowledge of the function of the
auditory system and the brain makes a cure extremely unlikely.”
Moving forward, it will be important to better understand
the mechanisms responsible for tinnitus being bothersome
and to investigate the mechanisms involved in brain plasticity,
Dr. Jastreboff said. The American Tinnitus Association is fund-
ing research to explore the relationship between tinnitus and
tonotopic remapping in auditory regions of the brain.
In the meantime, obstacles remain in the treatment of tin-
nitus. One of the biggest challenges is “the attitude that
nothing can be done for primary tinnitus, so clinicians are not
engaged in finding appropriate management strategies,”
Dr. Tunkel said.
On a related note, Dr. Jastreboff noted the lack of financial
incentives to work with tinnitus patients.
“It takes time and knowledge, and it is not covered by in-
surance plans,” he said. “One needs to be very passionate to
keep working with these patients, or to have other sources of
support of the work than patients’ payments.”
Despite these challenges, Dr. Hall remains optimistic.
“Clinicians managing tinnitus now can turn to rather sub-
stantial peer-reviewed published research for guidance in
how to evaluate and manage their patients,” he said. “There is
ample evidence that tinnitus can be accurately diagnosed
and, in most cases, effectively managed.
“All patients with tinnitus can be helped, and, with appro-
priate management, the vast majority of patients with bother-
some tinnitus can regain their former quality of life.” 
December 2014