Dr Magdalena Sereda is a Senior Research Fellow - British Tinnitus Association Head of Research at the NIHR
Nottingham Biomedical Research Centre. Her research focuses on assessing the effectiveness of NHS contracted sound therapy options for tinnitus including hearing aids and combination hearing aids.

Magdalena graduated from Warsaw University in Biology and obtained a PhD in Neuropsychology from theInstitute of Experimental Biology, Warsaw. As a Guest Researcher at Humboldt University, Berlin she was researching animal models of tinnitus. In 2007 she started working as a Career Development Fellow at the MRC Institute of Hearing Research in Nottingham to look at objective characterisation of tinnitus using magnetoencephalography.

Over the years Magdalena's research has concentrated on several aspects of the functioning of the auditory system, including cochlear implant technology and tinnitus. She has 16 years’ experience of working with people with different hearing disorders including tinnitus sufferers, cochlear implant users and deaf adolescents.

The vision of the British Tinnitus Association (BTA) is “A world where no one suffers from tinnitus”
[1], therefore the BTA’s research programme concentrates on the areas leading towards achieving that goal. The BTA is currently supporting 14 active research projects involving 21 researchers from 9 institutes across the country, investing over half of its spending in the last year in research [2]. The BTA supported research concentrates around three main areas:

  • Understanding tinnitus – with the view to facilitate the development of a cure
  • Management - including existing and novel practice and treatment
  • Prevention - use of ear protection by young people

Understanding tinnitus


Although research is ongoing, there is currently no pharmacological treatment that has been approved specifically for tinnitus. The route to developing new treatments is complex and involves extensive pre-clinical work before any testing in humans can begin. That includes developing a thorough understanding of the mechanisms involved in tinnitus generation, identifying therapeutic targets, investigating what effects the drug can have on the organism, checking if the drug is safe, estimating a dose for use in people etc. Usually, both in vitro (studies with microorganisms, cells or molecules outside of the body) and in vivo (studies involving living organisms) are needed before the new treatment can be tested in a series of clinical trials.


Dr Martine Hamann from the University of Leicester is currently conducting an early work that is looking at molecular mechanisms of tinnitus and aims to identify novel genetic targets that can be used in the treatment of hearing loss and tinnitus.

Dr Hamann is investigating the role of microRNAs (recently discovered small molecules present in animal and human cells) in hearing loss and tinnitus. MicroRNAs play an important role in gene regulation. The first part of her work is concentrating on confirming the role of microRNAs in tinnitus in an animal model.


If successful, the next step will be developing a pharmacological treatment that will target levels
of these molecules and might lead to alleviation of tinnitus.

Tinnitus management

Whilst researchers are looking for a cure, there are many different management options that can help reduce the impact of tinnitus on someone experiencing the condition. The BTA is funding research into improving currently available options as well as testing novel treatments and therapies. Other projects in this area are looking at
the current clinical practice and potential areas for improvement as well as developing tools for assessing the efficacy of different management options in clinical trials.


In July 2015, the BTA funded a four year Head of Research post for Dr Magdalena Sereda at the then NIHR Nottingham Hearing Biomedical Research Unit (BRU), now part of the NIHR Nottingham Biomedical Research Centre. Dr Sereda’s research programme focuses on National Health Service (NHS) contracted sound therapy options (i.e. hearing aids and combination hearing aids) for tinnitus. The programme comprises studies to:

  • Identify current clinical practice regarding sound therapy for tinnitus;
  • Define the current state of knowledge and quality of the research evidence behind treatment options with the aim to identify gaps in current knowledge and topics where evidence needs to be provided (scoping and systematic reviews);
  • Address those gaps by designing and conducting high quality clinical trials, including Randomised Controlled Trials;
  • Disseminate results to inform and influence clinical practice and guidelines, and to engage the general public.

The projects within the programme include designing and obtaining funding for a UK-wide clinical trial looking at the effectiveness of hearing aids for people with tinnitus and hearing loss and exploring current UK clinical practice around provision of combination hearing aids (amplification and sound generation within one device).


As a member of the steering committee for the British Society of Audiology (BSA) Tinnitus and Hyperacusis Special Interest Group, Dr Sereda is working towards creating professional tinnitus guidelines including guidelines around candidacy and fitting of combination hearing aids. Additional funding to support that work has been secured from the BSA and information about current UK practice is being gathered via a UK-wide survey. Eighty-nine clinicians have already responded and shared their practices and opinions. The next step will be a consensus exercise that will directly inform the guidelines.

A recent collaboration between Dr Sereda and the BTA is focusing on mobile applications (apps) for the management of tinnitus. Currently, available tinnitus apps postulate a range of mechanisms by which they might be effective for managing tinnitus including masking, modulation of brain activity, or relaxation. The study will generate the list of apps used by people with tinnitus, and explore and describe the options and management techniques available in each of those apps, their usability, and people’s experiences. The results will inform the choice of apps offered by clinicians to people with tinnitus for aiding the management of tinnitus as well as inform future research directions such as the need for effectiveness assessment.

Psychological therapy is one of the tinnitus management options recommended by the Department of Health Good Practice Guide [3] Amongst different psychological approaches, therapist led Cognitive Behavioural Therapy (CBT) has good evidence for effectiveness in managing tinnitus distress [4].

Another approach is Mindfulness Behavioural Cognitive Therapy (MBCT), which has been successfully applied to manage depression and chronic pain, but up to now, there was no evidence for its effectiveness for tinnitus. MBCT involves teaching meditation techniques – usually in a group format – over a course of eight weeks, paying careful attention to one’s physical, emotional and cognitive experiences. Between 2013 and 2015, Dr Laurence McKenna and Dr Liz Marks from University College London Hospitals (UCLH) conducted a study assessing effectiveness of MBCT for tinnitus and compared it to the Relaxation Therapy (current standard treatment). Seventy-five participants took part and the results have shown that both MBCT and Relaxation Therapy resulted in reductions in tinnitus severity, psychological distress, tinnitus loudness, anxiety and depression. However, for MBCT those positive effects lasted much longer (up to 6 months). The results were presented at the 10th International Tinnitus Research Initiative Conference and a research publication describing the results of the study has been submitted to the medical journal The Lancet. The long term goal is to adopt MBCT more widely as a treatment for tinnitus.

Following on from that project, Dr McKenna and Dr Marks are continuing their research in this area by looking at how CBT can be used to treat tinnitus-related insomnia. About 70% of people with tinnitus complain of sleep disturbance including getting to sleep or staying asleep [5} {6] and poor sleep may contribute to tinnitus distress. Currently, there has been limited research into tinnitus-related insomnia and the most effective management options for it. However, there is evidence that CBT can be effective for insomnia either on its own or co-morbid with other health problems. CBT for insomnia (CBTi) is now part of the NICE guidelines for the management of long term insomnia [7]. The study will assess the effectiveness of CBTi for tinnitus-related insomnia and compare it to the current standard approach of sleep hygiene.

In a BTA-funded PhD project, Lucy Handscomb at the University of Nottingham is assessing a new cognitive model of tinnitus distress and its applications to patient management. Patient reported outcome measures
(questionnaires) were used to assess such elements as tinnitus distress, anxiety, coping, insomnia, depression and general wellbeing and fit to the model will be tested. The ultimate goal of the project is to evaluate the interplay between current practice, patient priorities and components of the model to improve patient care. Several aspects of this work looking at properties of different questionnaire measures used in the study and methods of data collection have been published during the last year [8] [9] [10].

Dr Sally Erskine from the Norfolk and Norwich Teaching Hospitals NHS Foundation Trust is exploring the application of Eye Movement Desensitisation and Reprocessing (EMDR) to treat tinnitus. Eye movement therapies have previously been used for treating phantom sensations, such as phantom limb pain (the sensation of pain in an amputated limb) [11] [12]. Tinnitus may be considered a phantom auditory sensation so EMDR is a plausible treatment to test. The study will provide information on feasibility, acceptability and outcomes of EMDR in patients with tinnitus that will inform the development of a larger study looking at effectiveness of this approach.

Dr Sam Lear from Sheffield Children’s Hospital is exploring the relationship between tinnitus, hyperacusis and anxiety in children aged 8-16 years. The outcome of this study may help clinicians seeing children with tinnitus and/or hyperacusis to decide whether additional treatment for anxiety may be needed.


A questionnaire study by Dr James Jackson from Leeds Trinity University is investigating the association between personality and individual differences on tinnitus distress. Most people habituate to their tinnitus over time, however, many do not. Understanding the relationship between personality and tinnitus distress may contribute to understanding why some treatments and strategies work for some people, but not others.

Shared Decision Making (SDM) is a process by which clinicians and patients are involved in decisions about their care and treatment. Despite SDM being a principle of healthcare provision highlighted by the NHS mandate [13], it is still not common in tinnitus services. In many cases, the treatments offered are those that the clinician prefers, without taking the patient’s preferences and desired outcomes into account. This results in high levels of dissatisfaction with the management options. Dr Helen Pryce from Aston University is currently developing an ‘Option Grid’ that will provide a tool for clinicians and patients to communicate the choices in a standardised way and facilitate the decision making process. Option Grids are one-page evidence-based summaries of available options, including trade-offs and frequently asked questions [14]. Firstly, the researchers will find out how decisions are made in the clinic. Secondly, they will ask people with tinnitus what they need to know to be able to make decisions about their care. The final step will be designing a randomised controlled trial to check whether the grids work.

Appropriate outcome measures are of major importance in conducting clinical trials. However, there is a considerable variability in outcome measures (usually questionnaires) used in tinnitus research. In 2014 a European research network (TINNET) was funded by the COST programme, with a working group looking at development of standards for outcome measurements in clinical trials. Within that working group, a pan-European initiative called Core Outcome Measures in Tinnitus (COMiT) emerged with the aim to develop a core outcome set to be used in tinnitus trials worldwide. This initiative is led by NIHR Nottingham Hearing BRU. Dr Adele Horobin received funding from the BTA which will allow the incorporation of the patients’ voice in agreeing which aspects of tinnitus are important to measure. The study is using a Delphi review - an established method for gaining agreement between different people - and will result in the development of a ‘core outcome set’ (i.e. a list of things that should always be measured) for tinnitus. So far, patients have contributed to the project by creating plain English definitions and information sheets that will be used throughout the study.

Tinnitus-specific questionnaires are an essential component of tinnitus assessment. They can be used to measure a variety of tinnitus-related symptoms and to estimate the effect of different treatments. More than 10 clinical questionnaires exist for use with adults, but there are currently none in existence or appropriate for use with children. The aim of a three-year PhD project at NIHR Nottingham Hearing BRC supervised by Dr Derek Hoare is to create a questionnaire that will reliably measure tinnitus-related quality of life in children. Researchers will be following a careful and tested research approach to define why tinnitus is a problem to children. They will gather perspectives from children who have tinnitus, their parents, and the clinicians who look after them. The project will bring together a multi-disciplinary team with combined expertise in tinnitus, clinical questionnaires, and child health.

Dr James Jackson from Leeds Trinity University conducted a preliminary study looking at the potential of the Cortisol Awakening Response (CAR) as a biomarker of distress in tinnitus sufferers. Cortisol is a stress hormone that regulates the release of sugars into the blood stream. CAR is a well described and consistent phenomenon and any deviation from the usual profile may indicate that the body is under stress. Dr Jackson’s study investigated CAR in 30 participants with tinnitus and found that distressed tinnitus sufferers have low cortisol levels, which may be connected to the feelings of lack of control over tinnitus, an inability to relax and emotional distress caused by tinnitus. Currently, tinnitus-related distress is measured using subjective measures such as questionnaires. CAR can provide a measure of stress and anxiety and offers a potential way to objectively measure tinnitus and the effectiveness of any tinnitus interventions. The results of the study were presented at the BTA Conference in September 2016. A larger-scale study is now needed to test whether effectiveness of tinnitus treatments can be measured using CAR.

Tinnitus prevention

It has been well documented that exposure to loud noise is associated with a greater risk of tinnitus and hearing problems [15] [16]. Despite that, the majority of young people do not do anything to protect their hearing [17] [18]. The BTA’s prevention campaign “Plug’em” aims to encourage wearing earplugs at gigs, festivals, clubs and other places where one can be exposed to high levels of noise [11]. Dr Abby Hunter from the then NIHR Nottingham Hearing BRU, now the NIHR Nottingham Biomedical Research Centre, conducted a series of focus groups and interviews with young adults to explore their attitudes to loud music, knowledge, perception of risk, and protective behaviours. The study found that people display different behaviours despite recognising that their hearing problems have been caused by noise exposure. Whilst some people had difficulty coping with their tinnitus and avoided loud places, others would carry on as normal and did not protect their ears. Only some made a positive change and decided to wear earplugs in noisy places. Dr Hunter postulated that the different behaviours can be linked to different personality types. The results of the study will aid and inform prevention campaigns and hearing education programmes that aim to raise awareness, but will also be used to motivate young adults to take preventive measures. Findings will help to design and tailor online/app-based material to address all the above issues and ultimately reduce the incidence of tinnitus and hearing loss in this population.

References

[1] British Tinnitus Association. Our Mission [Online]. Available from: www.tinnitus.org.uk/our-mission (last accessed 21/05/2017)
[2] British Tinnitus Association. Annual Review 2016 [Online]. Available from: www.tinnitus.org.uk/blog/annual-review-2016 (last accessed 21/05/2017)
[3] Department of Health. Provision of Services for Adults with Tinnitus: A Good Practice Guide, 2009. [Online]. Available from: http://webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh.gov.uk/prod_consum_ dh/groups/dh_digitalassets/documents/digitalasset/dh_093810.pdf (last accessed 21/05/2017)
[4] Martinez-Devesa P, Perera R, Theodoulou M, Waddell A. Cognitive behavioural therapy for tinnitus. Cochrane Database of Systematic Reviews 2010 Sep 8, (9):CD005233. doi: 10.1002/14651858.CD005233.pub3.
[5] Crönlein T, Langguth B, Pregler M, Kreuzer P, Wetter T, Schecklmann M. Insomnia in patients with chronic tinnitus: Cognitive and emotional distress and as moderator variables. Journal of Psychosomatic Research, 2016. 83: 65-68.
[6] Langguth B. A review of tinnitus symptoms beyond ‘ringing in the ears’: a call to action. Current Medical Research and Opinion. 2011, 27(8), 1635-43.
[7] National Institute for Health and Care Excellence. Clinical Knowledge Summaries: Insomnia. Scenario: Managing
long-term insomnia (>4 weeks) [online] Available from: https://cks.nice.org.uk/insomnia#!scenariorecommendation:4 (last accessed 05/06/2017)
[8] Handscomb L, Hall DA, Shorter GW, Hoare DJ. Online Data Collection to Evaluate a Theoretical Cognitive Model of Tinnitus. American Journal of Audiology. 2016, 25(3S):313-317.
[9] Handscomb L, Hall DA, Hoare DJ, Shorter GW. Confirmatory factor analysis of Clinical Outcomes in Routine Evaluation (CORE-OM) used as a measure of emotional distress in people with tinnitus. Health and Quality of Life Outcomes. 2016, 14(1):124.
[10] Handscomb LE, Hall DA, Shorter GW, Hoare DJ. Positive and Negative Thinking in Tinnitus: Factor Structure of the Tinnitus Cognitions Questionnaire. Ear Hear. 2017, 38(1):126-132.

[11] Schneider J, Hofmann A, Rost C, Shapiro F. EMDR in the treatment of chronic phantom limb pain. Pain Medicine, 2008, 9(1): 76-82.
[12] Silver S., Rogers S. Russell M. Eye movement desensitization and reprocessing (EMDR) in the treatment of war veterans. Journal of Clinical Psychology. 2008, 64(8): 947-57.
[13] The Department of Health. The Government’s mandate to NHS England for 2017-2018 [online]. Available from https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/601188/NHS_Mandate_2017-18_A.pdf (last accessed 05/06/2017)
[14] EBSCO Health Option Grid™ decision aids. Available from https://health.ebsco.com/products/option-grid (last accessed 05/06/2017)
[15] Potier M, Hoquet C, Lloyd R, Nicolas-Puel C, Uziel A and Puel JL. The risks of amplified music for disc-jockeys working in nightclubs. Ear and hearing, 2009, 30: 291-3.
[16] Serra MR, Biassoni EC, Richter U, Minoldo G, Franco G, Abraham S, Carignani JA, Joakes S and Yacci MT. Recreational noise exposure and its effects on the hearing of adolescents. Part I: An interdisciplinary long-term study. International Journal of Audiology, 2005, 44: 65-73.
[17] Bogoch II, House RA and Kudla I. Perceptions about hearing protection and noise-induced hearing loss of attendees of rock concerts. Canadian Journal of Public Health, 2005, 96: 69- 72.
[18] Crandell C, Mills TL and Gauthier R. Knowledge, behaviors, and attitudes about hearing loss and hearing protection among racial/ethnically diverse young adults. Journal of the National Medical Association, 2004, 96: 176.
[19] British Tinnitus Association. Plug’em [Online]. Available from: www.plugem.co.uk (last accessed 21/05/2017)

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The views expressed in this publication are those of the author(s) and not necessarily those of the National Institutes of Health, the National Institute for Health Research, or the Department of Health.

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