Title: Feasibility of conducting a multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss
Funder: Department of Health and Social Care

Abstract: Background Tinnitus affects 6 million people in the UK, with over &frac12; million experiencing symptoms that negatively affect quality of life. In most cases tinnitus is associated with hearing loss and is the result of hearing loss related changes in the brain1, 2. The incidence of tinnitus increases with age, peaking in the age group 60 to 69 years3. In the UK the most common management strategy is education and support combined with some form of sound therapy4,5. While education and support is generally provided by all clinics, there is a marked variability in provision of devices (i.e. hearing aids) that depends very much on clinical decisions6. Aims The overall aim of this trial is to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) comparing i) education and support (Treatment as Usual; TAU) with ii) education and support with digital hearing aids, for management of people with tinnitus and hearing loss. The trial objectives are: 1) Recruitment (proportion of patients eligible for the trial, feasibility of randomisation, barriers to screening and recruitment, characteristics of recruited patients, compliance, completeness of the collected data, capture components of TAU, estimate re-referral rates) 2) Outcome assessment (relevance of outcome measuresfor patients, distribution of outcome measures, healthcare resource use) 3) Acceptability (feedback from patients and clinicians regarding experience with the trial). Addressing the above objectives will: (i) determine if it is feasible to conduct a multicentre RCT comparing TAU and TAU with hearing aids, (ii) help us to refine the design of a planned multicentre randomised controlled trial (iii) help us to determine which outcome measures are relevant for patients. Plan The study will run over 25 months: 1. Multicentre open label randomised controlled feasibility trial (Months 1-25) will address abjectives 1 and 2. The randomised trial will allocate participants to treatment for 12 weeks with either: &bull; Treatment as Usual (TAU, education and support); &bull; TAU plus digital hearing aid/s. Five NHS audiology departments will participate representing different types of clinical setting and service size. Multiple self-assessment questionnaires will be administered at baseline and 3-month follow-up. 2. Nested process evaluation will address objectives 2 and 3. More detailed insight about trial acceptability and effects fo the intervention will be generated in a series of semi-structured interviews with non-trial patients, audiologists participants. These will explore: i) experience of participation in the trial from patient and audiologist perspective; ii) outcomes that are relevant to patients; iii) impact of hearing aids on pateint s tinnitus and hearing loss; iv) barriers to screening and enrolment. Approximately one third of trial participants (selected purposively to capture a range of different experiences and outcomes), as well as small number (n Benefit to patients and the NHS The trial will address current inequalities and lack of evidence around provision of hearing aids for people with tinntus and hearing loss within the NHS. A definitive trial comparing the outcomes and costs of digital hearing aids combined with education and support compared with TAU alone is needed. However before this can be performed a feasibility trial is needed to provide data which may inform the design and conduct of a future trial. A future grant application is envisaged to NIHR Health Technology Assessment programme, if feasibility is shown. The findings of the definitive trial will ultimately be used to facilitate evidence-based NHS commissioning and clinical practice, support equity of care in a way that provision of hearing aids for tinnitus will be informed by high-quality research evidence.

Lay abstract: Tinnitus is the awareness of a sound in the ear or head without any outside source. It affects around 15% of people in the UK. About 20% of people with tinnitus experience symptoms that negatively affect their quality of life including sleep disturbances, difficulties with hearing and concentration, social isolation, anxiety, depression, irritation or stress. NHS audiology departments are the main provider of services for people with tinnitus and hearing loss. Audiologists most commonly provide education and support and in some patients discuss whether hearing aids might be beneficial. There is no rigorous research evidence for the benefits of digital hearing aids over education and support for people with tinnitus and hearing loss. There is no standard way to treat patients and the decision to fit hearing aids is left to individual audiologists. High quality evidence is needed in order to decide whether patients should always be offered hearing aids. This can be done in a clinical trial that will compare: -education and support (the usual treatment) -education and support with hearing aids. This trial would be large and therefore some investigations are needed to find out whether it would be possible to run. This application is for feasibility study to assess: a) if clinicians and patients are willing to take part in a trial b) what outcome measures are relevant for patients c) what a large trial should look like. Five audiology departments will take part. We aim to recruit 100 participants over 12 months. We will also talk to participants and clinicians about their experiences with the trial and with hearing aids. People with tinnitus will be involved in the feasibility trial by helping design the research and participant information resources, managing the research, analysing the interview data, contributing to study report and disseminating study results.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: EAR