Title: A randomised controlled trial assessing the effectiveness of hearing aids (intervention setting) compared to hearing aids (placebo setting) in reducing tinnitus for adults with mild hearing loss.
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background: Across the United Kingdom (UK), approximately nine million people (1 in 6) live with some level of hearing loss (NHS England, 2017) and it is the fifth leading cause of years lived with disability (Institute of Health and Metrics and Evaluation, 2013). This equates to 575,500 people in Wales who are deaf or have some form of hearing loss (AoHL, 2017). Tinnitus commonly occurs with hearing loss and is a serious health condition in itself with significant impact on quality of life and mental health. It is estimated that 1 in 8 (13.2%) of the UK population experience tinnitus permanently (British Tinnitus Association, 2019). Approximately half of people with tinnitus experience moderate or severe distress with debilitating consequences, including anxiety, depression and other mental health disorders. The prevalence of both tinnitus and hearing loss is expected to increase with an ageing population, leading to increased burden on the NHS and national economy. Many of those with tinnitus also have hearing loss, for which hearing aids are frequently offered as a management option without charge by the NHS; however, there is no evidence base for the use of hearing aids to manage troublesome tinnitus in patients with a mild hearing loss. Aims: This research aims to answer “Are hearing aids effective in reducing tinnitus symptoms for adults with mild hearing loss across Wales?” Plan of investigation: The proposed definitive study will be conducted as a parallel group randomised control trial; comparing a hearing aid with amplification appropriate for the level of hearing loss (intervention settings) to the same hearing aid with amplification only to counteract its presence in the ear (placebo setting). Outcomes will be measured using tinnitus functional index (TFI) primarily and secondarily, Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) to capture changes to mental health status due to reduction in tinnitus distress. Potential benefits to the public and/or to patients and the NHS: The resultant evidence has the potential to influence services widely in supporting people with tinnitus and mild hearing loss by demonstrating clear benefits in a large scale RCT study. The pathway to impact will be immediate for both service users and the NHS. The research findings will be used to support patients making informed decisions for their own care and has the potential to benefit a large population. This prudent and wellbeing focussed approach meets the aims of the Welsh Government’s A Healthier Wales strategy (WG, 2018) and Framework of Action for Wales (WG, 2016). Specifically the latter focuses on the importance of “early intervention to minimise delay and impact on well-being and independence” and specific action to improve tinnitus pathways. Furthermore the National Institute of Clinical Excellence (NICE) draft tinnitus guidelines (NICE, 2019) highlighted the limited evidence base for the use of hearing aids in patients reporting tinnitus and hearing loss. No evidence was found to support the use of amplification for people with tinnitus and a hearing loss that does not cause difficulties. As a result, the recommendations from NICE, that amplification is important for this group of patients, are based on expert opinion alone. New empirical research is therefore key.

Lay abstract: The aim of the research study is to provide information on whether hearing aids help people with both tinnitus and mild hearing loss to manage their tinnitus more effectively. Both hearing loss and tinnitus are very common conditions in the UK. 12% of the public have some level of hearing loss which causes them worry, upset and/or frustration. Tinnitus affects 10-14% of the population. Both are serious health conditions which can have significant impact on quality of life and mental health. Current practice by health professionals in the NHS is to offer hearing aid/s to patients with both hearing loss and tinnitus which is bothersome for them. However, there is no guidance for professionals working with patients with mild hearing loss and tinnitus. There are studies that have been carried out previously which have shown that hearing aids are effective at helping patients with tinnitus and hearing loss. It is hoped that this study will provide information on whether hearing aid/s help people with both mild hearing loss and tinnitus, filling the gap in the evidence and providing a real impact to both the NHS and the patients it serves. This knowledge is important for researchers and clinicians in order to offer the best care to this group of patients. From a public point of view, it is important that this research question is answered, to enable them to make the best evidenced based care choices for themselves.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: EAR