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

This project was terminated early due to being unable to recruit participants because of the COVID-19 pandemic

End of project summary

Hearing loss and tinnitus are very common conditions in the UK. Both of which can have significant impact on quality of life and mental health. Current practice by health professionals in the NHS is to offer hearing aids 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. This knowledge is important for clinicians to offer the best care to this group of patients. From a public point of view this knowledge will enable them to make the best evidenced based care choices for themselves.       

The aim of the HEAR IT study was to provide information on whether hearing aids help people with both tinnitus and mild hearing loss to manage their tinnitus more effectively.   

The study was designed as a randomised controlled trial; half of the participants had a hearing aid with amplification and the other half had a hearing aid without amplification. Participants did not know which hearing aid they receive. For inclusion into the study participants had a diagnosis of tinnitus with mild hearing loss in one or both ears, were capable of providing written informed consent and able to communicate in English. It was hoped the study would recruit 128 participants across three health boards in Wales. Participants were expected to wear the hearing aid/s every day for a six-month period. They completed four questionnaires at the beginning of the trial, at an eight-week follow up and again at six months. In addition, participants were asked about hearing aid usage.   

• The COVID-19 pandemic had significant implications on participant recruitment onto the study, and unfortunately only 16 were recruited over an 11-month period. 
• Throughout the lockdowns during the pandemic audiology services across Wales reported reduced patient activity with fewer patients being referred by their GPs and fewer patients wanting to attend outpatient appointments within the hospital settings. 
• Trial clinicians reported that many patients who did access the service reported an increase in mental ill health compared to pre COVID-19 mental health. 
• Staffing was also an issue across the three sites; with some staff being redeployed to positions within their hospital or being affected by COVID-19 themselves. 
• As the funding ended before the trial had finished six month follow up data was not collected from a number of participants. 
• Results from the trial can only be used for descriptive analysis only.