Trial Name: 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 (HUSH)
Chief Investigator: Magdalena Sereda, National Institute for Health Research, Nottingham Biomedical Reserach Centre
Trial description: Tinnitus is a major problem affecting 10-30% of adult population. About 20% of people with tinnitus experience symptoms that negatively affect quality of life (including sleep disturbances, hearing difficulties, difficulties with concentration, social isolation and emotional difficulties including anxiety, depression, irritation or stress) and require clinical intervention. It is estimated that tinnitus prevalence in people with hearing loss is as high as 70-85%. The incidence of clinically bothersome tinnitus increases with increasing age. In the UK the most common managment strategy for tinnitus is education and support combined with some form of sound therapy. Treatment is however variable between clinics. While all clinics tend to provide education and support, the additional management strategies (i.e provision of devices) depends very much on individual clinical decisions.
Although hearing aids are prescribed primarily to overcome hearing loss, they may also be effective for tinnitus. Hearing aids can amplify environmental sounds and mask or provide distraction from tinnitus. They can reduce listening effort and improve communication which can reduce stress and anxiety, commonly associated with tinnitus.
A definitive trial comparing the outcomes and costs of digital hearing aids combined with education and support without hearing aid is needed. However before this can be performed a feasbility trial is needed to provide data which may inform the design and conduct of a future trial.
The findings of this definitive trial will ultimately be used to facilitate evidence-based NHS commissioning, facilitate evidence-based clinical practice in audiology and support equity of care in a way that provision of hearing aids for tinnitus will be informed by high-quality research evidence.
The HUSH trial opened to recruitment in October 2018 in five trusts across England and Wales. Participants were recruited for 12 months, and followed up for 3 months. Final report is due April 2020.
Contact: Jennifer White
Funding: NIHR Research for Patient Benefit (RFPB)
Status: Analysis and reporting