ATRR 2018 Five years later FINAL

ANNUAL
TINNITUS
RESEARCH
REVIEW
2018
FIVE YEARS LATER:
What happened after the James
Lind Alliance Tinnitus Priority
Setting Partnership
Nic Wray
Annual Tinnitus Research Review 2018

Annual Tinnitus Research Review 2018.
Copyright © British Tinnitus Association 2018.
Editors: Deborah Hall & Nic Wray
The editors would like to thank all the contributors
for their support and enthusiasm. We would also
like to thank the copyright owners of the images
and figures reproduced in this publication for
their permission to reproduce them either directly
or via licence. We believe that all such work has
been acknowledged, but please contact Nic Wray
on nic@tinnitus.org.uk if any acknowledgements
have been inadvertently omitted.
British Tinnitus Association
Unit 5 Acorn Business Park
Woodseats Close
Sheffield
S8 0TB
www.tinnitus.org.uk
info@tinnitus.org.uk
0114 250 9933
Registered charity no. 1011145. Company limited
by guarantee no. 2709302, registered in England.

FIVE YEARS LATER:
What happened after the James
Lind Alliance Tinnitus Priority
Setting Partnership
NIC WRAY
Communications Manager
British Tinnitus Association
Nic has been Communications Manager at the
BTA since June 2010. She is responsible for the
BTA’s communications online and in print as well
as being one half of the PR team. In addition to
writing a number of the BTA’s information leaflets,
she also edits the BTA’s journal, Quiet and co-edits
the Annual Tinnitus Research Review. She sees
providing the tinnitus community with information
as a key to helping people live well with tinnitus. A
graduate of the University of Sheffield, she is an
Accredited PR Practitioner and a member of the
Chartered Institute of Public Relations.
ACKNOWLEDGMENTS
During 2016 and 2017, a series of articles rounding
up developments in research appeared in Quiet, the
journal of the British Tinnitus Association. These
were written by Paul Chinnock and were invaluable
in the writing of this review.
Nic Wray
Introduction
The James Lind Alliance (JLA) was established
in 2004 to bring patients, carers and clinicians
together to identify and prioritise the unanswered
questions about treatments that they agree
are most important. These priorities may not
necessarily be the same as those considered
important by researchers and commercial
interests, and so the purpose is to bring the
‘minority’ voice to drive the research agenda.
Priority Setting Partnerships (PSP) work together
to gather uncertainties about the effects of
treatments. The uncertainties are all checked
to ensure they cannot be answered by existing
knowledge, research or sources of information.
The JLA Tinnitus PSP began in October 2011.
The initial founders were the British Tinnitus
Association, the NIHR Nottingham Hearing
Biomedical Research Unit (now the NIHR
Nottingham Biomedical Research Centre) and
the Judi Meadows Memorial Fund, with a wider
working partnership of 56 UK stakeholders
representing professional organisations, charities
and patient support groups.
The priority setting process produced a final top
ten clinical research questions (Table 1, column 1)
[1], which demonstrates the breadth of research
required to develop a better understanding
of tinnitus, the need for a cure as well as the
requirement to better understand and determine
the effectiveness of existing treatments.
Working in consultation with the Professional
Advisers’ Committee of the BTA, the partnership
also published ideas for future research
Annual Tinnitus Research Review 2018

Five years later
Uncertainty in the diagnosis,
assessment and treatment of tinnitus
What management strategies are more
effective than a usual model of audiological
care in improving outcomes for people with
tinnitus?
Is Cognitive Behaviour Therapy (CBT), delivered
by audiology professionals, effective for people
with tinnitus? Here comparisons might be with
usual audiological care or CBT delivered by a
psychologist.
What management strategies are more
effective for improving tinnitus-related
insomnia than a usual model of care?
Do any of the various available complementary
therapies provide improved outcome for people
with tinnitus compared with a usual model of
care?
What type of digital hearing aid or amplification
strategy provides the most effective tinnitus
relief?
What is the optimal set of guidelines for
assessing children with tinnitus?
How can tinnitus be effectively managed in
people who are Deaf or who have a profound
hearing loss?
Are there different types of tinnitus and can they
be explained by different mechanisms in the ear
or brain?
Annual Tinnitus Research Review 2018
Suggested research strategy
1. Studies comparing effects of different management strategies in
reducing the functional impact of subjective idiopathic tinnitus and
improving quality of life. Proceeding to:
2. Timely systematic review of the evidence from clinical trials.
1. Studies evaluating CBT and/or other psychological counselling
approaches delivered by appropriately trained audiology professionals.
1. A study comparing the effects of different management strategies
specifically aimed at improving sleep for patients with tinnitus and
insomnia, including CBT as one arm of the research design.
1. Studies comparing different complementary therapies for improving
functional outcomes for people with subjective idiopathic tinnitus and
compared with the usual model of care. Studies should consider those
complementary therapies that have been shown to be beneficial in
treating other chronic health conditions. Proceeding to:
2. Timely systematic review of the evidence from clinical trials.
1. Studies to determine whether digital hearing aids are effective
in reducing the functional impact of subjective idiopathic tinnitus.
Proceeding if necessary to:
2. Parallel activities comprising:
i. Studies evaluating the effects of different amplification strategies
for people with subjective idiopathic tinnitus
ii. Studies evaluating the effects of different hearing aid devices,
including digital combination devices (hearing aid and sound masker) as
one arm of the trial
iii. Timely systematic review of the evidence from clinical trials.
1. Parallel activities comprising:
i. A systematic approach to gain consensus among a multidisciplinary
panel of experts about the most appropriate assessment methods and
diagnostic criteria for children with tinnitus
ii. Development of an evidence-based algorithm/pathway to aid
clinical diagnosis based on existing research
iii. Development of a systematic form of national data collection
from existing services to provide an evidence base that would inform
development of guidelines.
1. Parallel activities comprising:
i. Studies to evaluate the effects of non-audiological tinnitus
interventions in reducing tinnitus symptoms for people with profound
hearing loss and tinnitus
ii. A systematic review of the effects of multichannel intra-cochlear
implants to suppress tinnitus. Proceeding if necessary to:
2. Development of new treatment approaches for people with profound
hearing loss or deafness and tinnitus.
1. Identification of:
i. Meaningful criteria for tinnitus subtyping
ii. The underpinnings of the different tinnitus subtypes in humans in
terms of inner ear pathology and neurobiology and;
iii. Their relevance for response to various treatments. Proceeding if
necessary to:
2. Development of an evidence-based algorithm/pathway to guide
patient assessment, diagnosis and management.

Five years later
Uncertainty in the diagnosis,
assessment and treatment of tinnitus
What is the link between tinnitus and
hyperacusis (over-sensitivity to sounds)?
Which medications have proven to be effective
in tinnitus management compared with
placebo?
Suggested research strategy
1. A systematic review of the association between tinnitus and
hyperacusis, including epidemiological data. Proceeding if necessary to:
2. Understanding the underpinnings of tinnitus and hyperacusis in terms
of inner ear pathology and neurobiology.
1. Systematic reviews of the other classes of drugs that are prescribed to
alleviate tinnitus and/or associated symptoms. Proceeding if necessary
to:
2. Studies of drug treatments for reducing tinnitus symptoms, including
reduced perception of the tinnitus sound.
Table 1:
Top ten research uncertainties and suggestions for research strategies
strategies to address each uncertainty (Table 1,
column 2) [2].
The research community was challenged to take
on these uncertainties and to use the questions
to devise high-quality research projects [1,2].
This article attempts to provide a summary of the
research carried out since the publication of the
top ten uncertainties which addresses each of
the priorities.
What management strategies are more effective
than a usual model of audiological care in
improving outcomes for people with tinnitus?
The usual model of audiological care is to provide
education and support for tinnitus, with the
provision of digital hearing aids for managing
tinnitus with a hearing loss, and other forms of
sound therapy, as required [3].
Research is continuing into modifications of
existing management strategies such as sound
therapies and relaxation techniques. Whilst some
of these studies show that such interventions
are effective [4][5], there has been no strategy
demonstrating a leap forward in effectiveness.
Indeed, some studies have concluded that no
significant improvements occur [6] or that it is
not better than standard care [7].
The possible exception to this mindfulness. A
Mindfulness Based Cognitive Therapy study
led by Dr Laurence McKenna and Dr Liz Marks
has demonstrated that the technique is more
effective – and the results longer lasting – than
relaxation techniques [8]. More details of this
study can be found elsewhere in this review
series.
Studies into transcranial direct current
stimulation (tDCS) have had variable results and
systematic reviews have been contradictory [9]
[10].
People who receive a cochlear implant for hearing
problems often report that their implant has
reduced their tinnitus [11]. Using implants which
provide environment sounds give a similar benefit
to standard implants [12].
Currently in press is a review into tinnitus apps
with the aim of giving users and clinicians a more
informed choice about the best app for tinnitus
management [13].
In addition to clinician-led management, selfhelp
programmes are used by people with
tinnitus to reduce the impact of the condition.
A systematic review [14] identified the selfhelp
techniques used by adults with chronic
tinnitus and assessed their effectiveness. Five
previous studies reported eight self-management
components and behaviour change techniques,
but the effectiveness of these could not be stated
with any certainty.
Annual Tinnitus Research Review 2018

Five years later
Figure 1:
Acupuncture
Is Cognitive Behaviour Therapy (CBT), delivered
by audiology professionals, effective for people
with tinnitus? Here comparisons might be with
usual audiological care or CBT delivered by a
psychologist.
Psychological approaches to tinnitus treatment
are a popular management strategy and subject
for research. A recent review [15] found there
have been over 5,000 studies. Very little of this
research has involved RCTs so the quality of the
evidence available is not high.
A pilot RCT aimed to evaluate the feasibility of
comparing a psychologically informed guidance
manual developed to support audiologist
management of tinnitus with usual treatment
is currently underway. The study will assess the
acceptability of the counselling intervention,
compliance and whether there is sufficient
interest and need for a full RCT [16].
What management strategies are more effective
Annual Tinnitus Research Review 2018
for improving tinnitus-related insomnia than a
usual model of care?
Sleep disturbance affects over one half of
people attending tinnitus clinics [17]. Cognitive
Behavioural Therapy [CBT] has been shown to
help manage insomnia and CBT for insomnia
(CBTi) is now part of the NICE guidelines for the
management of long-term insomnia [18]. In a BTA
-commissioned study, Dr Laurence McKenna and
Dr Liz Marks are investigating the effectiveness of
CBTi as a treatment for tinnitus-related insomnia
[19].
Do any of the various available complementary
therapies provide improved outcome for people
with tinnitus compared with a usual model of
care?
Whilst there have been a number of systematic
reviews into complementary therapies and
dietary supplementation, the number of studies
eligible for consideration is generally small, and
often considered to be of low quality and at risk of
bias [20].
A systematic review into acupuncture for tinnitus
found a total of 18 RCTs, half of them performed

Five years later
in China and half elsewhere [21]. Nearly all the
Chinese studies reported positive results, whilst
most studies from other countries had negative
findings. The reviewers were unable to conclude
whether acupuncture is or is not an effective
treatment for tinnitus.
There is no evidence that electroacupuncture,
in which electrical stimulation is applied via
acupuncture needles, works [22].
Ginkgo biloba has been investigated over many
years for potential benefit in tinnitus. An updated
Cochrane Review in 2013 concluded that the
limited evidence offered did not demonstrate that
Ginkgo biloba is effective for tinnitus where this is
the primary complaint [23].
What type of digital hearing aid or amplification
strategy provides the most effective tinnitus
relief?
Published in 2014, a Cochrane Review [24] to
examine the evidence that already exists about
hearing aid interventions for tinnitus with hearing
loss found only one previous trial. This highlights
the need for further research in this area. Dr
Magdalena Sereda – in a post funded by the
BTA – is researching the clinical efficacy of NHS
contracted sound therapy options for tinnitus
including hearing aids and combination hearing
aids [25]. A Delphi review was conducted as a
pre-cursor to this work, and this suggests a lack
of consensus among clinicians with regard to
fitting hearing aids for patients presenting with
tinnitus and a mild hearing loss [26].
Researchers in Germany fitted patients with
hearing aids which delivered sounds from which
a ‘notch’ of frequency had been removed [27].
This technique was called notched environmental
sound technology [NEST]. A control group
received hearing aids only. Whilst the NEST
group showed more improvement, the difference
between the two groups was not statistically
significant. Similarly, a trial [6] conducted using
notched music without amplification showed
no significant improvement levels in tinnitus
measured by questionnaire.
Figure 2:
Tinnitus activity book for children [32]
Two types of sound were compared in a small
trial [28] in which 17 patients heard conventional
‘technical’ sounds through their hearing aids
and 20 were chosen from a selection of ‘nature
sounds’. They all completed THI questionnaires
before treatment began and after three and
six months. Tinnitus Handicap Inventory (THI)
scores improved after treatment in both groups,
but there was no significant difference between
groups. There was no control group.
What is the optimal set of guidelines for
assessing children with tinnitus?
The Paediatric Audiology Interest Group (PAIG) of
the British Society of Audiology (BSA) formed a
working party of national specialists in paediatric
tinnitus in response to the challenge posed by the
JLA tinnitus PSP. They published the Tinnitus in
Children: Practice Guidance document in March
2015 [29].
Annual Tinnitus Research Review 2018

Five years later
The practice guidance was written using the
available evidence base, and from the clinical
experience and practice of the working party
members.
A number of other resources for professionals
working with children with tinnitus have
subsequently been developed. These include
a training course [30] and award-winning
information [31] and activity booklets for children
[32].
Ms Harriet Smith – in a PhD Studentship funded
by the BTA – is now developing a questionnaire
measure of tinnitus in children.
How can tinnitus be effectively managed in
people who are Deaf or who have a profound
hearing loss?
The BTA commissioned The Ear Foundation to
investigate people’s experiences with tinnitus and
severe/profound hearing loss. Their report [33]
presented the views of over 1,400 people with
varying degrees of hearing loss on the treatment
they received, what was effective, and their hopes
for the future. Forty-four per cent of those with
severe/profound hearing loss classed tinnitus
as a severe problem. This impacted on stress,
relationships, concentration and attention, and
sleep. Those with severe/profound hearing loss
had the greatest impact from tinnitus, but were
less likely to receive help and more likely to be
discharged. For those receiving professional
care, it was reported that professional advice
may be insensitive – for example, suggestions
to use maskers or sound therapy – with the
concentration being on the hearing loss and not
the tinnitus.
Twenty-three people who had received a
cochlear implant for hearing loss in one ear in the
previous three to ten years were interviewed and
completed standard Tinnitus Questionnaires [11]
All patients switched on their implants on waking
and used them throughout the day. Seventy
per cent said that their tinnitus level decreased
within one minute of switching them on. Scores
from the questionnaires showed improvement
Annual Tinnitus Research Review 2018
in tinnitus typically began three months after
implantation and then remained stable. This is
not a rigorous experimental study, but the results
are encouraging.
Several studies have explored the benefit of
cochlear implantation in people with severely
impaired hearing in one ear and moderate
to normal hearing in the other (single-sided
deafness). Arts et al 2016 [12] investigated
whether an implant that was programmed
to deliver tinnitus suppressing sounds would
have greater benefit than a standard algorithm
optimised for speech perception. Tinnitus
reduced in both cases, with no difference
between.
Another type of implant called a percutaneous
osseointegrated auditory implant has also been
investigated [34]. These implants are inserted
through the skin and integrated into bone tissue.
Ten patients with single-sided hearing loss were
given implants in the deaf ear. Most showed an
improvement in their tinnitus, particularly those
with the most profound hearing loss.
Are there different types of tinnitus and can they
be explained by different mechanisms in the ear
or brain?
The heterogeneity of tinnitus – explored by
other articles in this review – is often cited
as a stumbling block for developing effective
treatment approaches. There is no agreed
classification and so perhaps a new approach
is required. Eleni Genitsaridi and Theo Kypraios
present progress on this topic, in thisreview
series.
What is the link between tinnitus and
hyperacusis (over-sensitivity to sounds)?
Between 40 and 60% of patients with tinnitus
report hyperacusis, a decreased tolerance
to sound [17][39][40] although it has been
estimated to be as high as 80% [41]. The frequent
appearance of both these conditions in the same
individual is suggestive of a common mechanism
[42].

Five years later
Researchers used the Tinnitus Research
Initiative (TRI) database to compare clinical
and demographic data of tinnitus patients with
and without tinnitus [40]. Hyperacusis with
tinnitus was associated with younger patients,
higher levels of tinnitus-related, mental and
general distress; higher tinnitus pitch in relation
to measured tinnitus pitch; worse subjective
hearing; greater influence on tinnitus from
external factors; and higher rates of pain
disorders and vertigo, leading the authors to
conclude that there is an over-activation of some
unspecified network in these patients. Based
on animal research; Knipper et al proposed a
putative universal model for the mechanisms
of tinnitus and hyperacusis [43] whilst
acknowledging that there may be a range of
such mechanisms. They suggested that tinnitus
and hyperacusis may be associated with various
degrees of deafferentation (the interruption or
destruction of inward connections of nerve cells);
differences in central gain; or abnormal stress
effects that may act in the cochlear periphery.
Which medications have proven to be effective
in tinnitus management compared with
placebo?
Jufa and Wood carried out a systematic review
to assess the effectiveness of benzodiazepines
against tinnitus [44]. Although the number of
studies was small and some were of poor quality,
the researchers concluded that there is no
evidence to support the use of diazepam, and
only weak evidence for the use of clonazepam.
Ciodaro et al combined gabapentin with
lidocaine injections given just under the skin of
the ear canal [42]. Seventy-two patients were
randomly allocated to receive gabapentin only,
gabapentin plus lidocaine, or placebo treatment.
The improvement in THI scores was significantly
higher in the gabapentin group than in the control
group, and those in the gabapentin plus lidocaine
group did significantly better than those receiving
gabapentin alone. An Iranian study [43] also
showed improvement in tinnitus for patients
given gabapentin compared to a control group
but commented on the ‘remarkable’ placebo
effect.
Kumral et al performed a double-blinded RCT into
trimetazidine dihydrochloride [44] .There were no
significant differences between the treatment
and control groups after treatment, leading to
the conclusion that trimetazidine dihydrochloride
offers no benefits for people with tinnitus.
Zinc is known to play a role in the functioning of
the ear. A Cochrane systematic review of studies
using zinc supplementation [45] found only three
RCTs, only once of which had used a validated
scale for tinnitus. This study found that 5% of the
patients given zinc showed benefit, compared
to 2% of the control group who also improved.
The remaining studies also found no significant
differences between treatment and control
groups.
Intratympanic membrane injections have
been attracting some interest. The steroid
dexamethasone was used on 27 patients,
with 27 others in the control group receiving a
Figure 3:
Medication
Annual Tinnitus Research Review 2018

Five years later
Figure 4:
Tinnitus cure road map
saline injection. There was some improvement
in both groups, but there was no significant
difference between them [46]. An initial safety
study of intratympanic injections of esketamine
hydrochloride (AM-101) showed some limited
promise [57]. A larger multi-centre double-blind
placebo controlled trial however only showed
improvements in patients following noiseinduced
hearing loss or after middle ear infection
[48] and Phase III studies were ended after initial
results showed no significant improvements
between treatment groups and control groups
[49].
Mapping a cure
Whilst the research above is undoubtedly of
value, the overwhelming cry from people living
with tinnitus is that they want a cure. The BTA’s
vision is for ‘a world where no one suffers from
tinnitus’. Pivotal to that aim is working towards
an ultimate cure for tinnitus. As part of that
aspiration, the BTA has instituted a series
Annual Tinnitus Research Review 2018
of strategic work streams, one of which is
specifically aimed at achieving a cure.
The first step in this process has been to take
stock of what has been achieved to date and
what current research is being conducted.
To try and identify areas where gaps in our
knowledge are hampering progress, the BTA has
developed a mind map which synthesises the
position of current tinnitus research [Figure 4]
[50].
It is hoped that by being able to see where our
knowledge is deficient, we can more effectively
apportion research resources. This should also
help to ensure that research funding is not
directed towards areas that have already been
fully explored. This project is an update and
follow-up to the JLA Tinnitus PSP which focused
purely on treatments and outcomes.
The mind map is a complex diagram, reflecting
the complex and heterogeneous nature of

Five years later
tinnitus, and the uncertainties that still exist
about causes, mechanisms and management.
The map is split into five different groups,
representing the big themes that will need to be
addressed before a cure can be declared. These
over-arching themes are then broken down into
general areas of research which are then further
divided into specific research topics, individual
projects and further subdivisions.
Work is still ongoing to further refine the mind
map, with contributions having been sought
from the wider tinnitus community, including
clinicians, patients and researchers.
Conclusion
It is important that more research into tinnitus
is carried out, but it needs to be of good quality.
A systematic review by US researchers [51]
examined aspects of study quality in tinnitus
RCTs and found that in over half of the trials,
researchers had failed to define specifically how
they defined ‘tinnitus’, and only 20% of trials had
a low risk of bias. It is a common theme of the
recent systematic reviews undertaken in the
tinnitus field that there have been insufficient
studies of good enough quality for inclusion.
However, whilst many studies have been
inconclusive, the trend over the last five years
has been for increasing numbers of positive
results from studies. This review has shown
that there is much to be celebrated and much
progress has been made since the publication of
the Top Ten Priorities. From scattered nuggets of
clinical experience have come a whole suite of
resources for those clinicians, parents and young
people dealing with tinnitus in childhood, and an
increased acceptance and interest in paediatric
tinnitus.
There is a real drive to explore and evaluate
existing tinnitus management techniques and
introduce novel technologies and interventions.
It will be interesting to see where the next five
years takes us in addressing the challenges
the JLA Tinnitus PSP threw out to the tinnitus
research community.
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