HEaring Aids foR tinnITus and mild hearing loss – HEAR IT
Research type
Research Study
Full 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.
IRAS ID
290270
Contact name
Joanne Goss
Contact email
Sponsor organisation
Betsi Cadwaladr University Health Board
ISRCTN Number
ISRCTN31221437
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Research Summary
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. This study is funded via the Research for Patient and Public Benefit (RfPPB) funding from Health and Care Research Wales.
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 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. 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.
This study commences on the 1st December and will last for 2 years. It is designed as a randomised controlled trial; half of the participants will have a hearing aid with amplification and the other half will have a hearing aid without amplification. Participants will not know which hearing aid they receive. For inclusion into the study participants will have a diagnosis of tinnitus with mild hearing loss in one or both ears, be capable of providing written informed consent and able to communicate in English. 128 participants across three health boards in Wales will be recruited. Participants will be expected to wear the hearing aid/s every day for a 6-month period. They will be asked to complete four questionnaires at the beginning of the trial, at an 8-week follow up and again at 6 months. Participants will also be asked about hearing aid usage.
Summary of Results
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 GP’s 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 funded ended before the trial had finished 6 month follow up data was not collected from a number of participants.
Results from the trial can only be used for descriptive analysis only.
REC name
Wales REC 3
REC reference
21/WA/0038
Date of REC Opinion
11 Mar 2021
REC opinion
Further Information Favourable Opinion