Plain English Summary
Background and study aims
Hearing aid technology has changed dramatically over the last decade with the use of miniaturised computer chips and improved plastics engineering. Both the structural design and the sound processing have seen major changes. It is suggested that the rules previously used to guide the selection of hearing aids for hearing losses and the minimum hearing loss are not relevant when considering the modern hearing instrument. In particular, for those patients with a mild hearing loss and also suffering from tinnitus (the perception of noise in one ear, both ears or the head), new open fit digital hearing aids are thought to be helpful with mild hearing losses where traditional hearing aids would not have been fitted. The aim of this study is to inform the clinical practice of audiologists who see patients with distressing tinnitus associated with a mild hearing loss; in particular whether these patients should be offered amplification with digital hearing instruments using open fit technology. A secondary aim would be to stimulate further research on a larger scale, possibly using multiple centres. A larger scale, longer term and more robust study with higher numbers of patients involved would serve to support the findings of this smaller study.
Who can participate?
Patients with tinnitus aged between 18 and 80.
What does the study involve?
Each participant will have their tinnitus severity measured before treatment and six weeks after treatment to measure any changes. The measurement tool to be used is the Tinnitus Functional Index, which is sensitive to change over time. Treatment will consist of an open-fit hearing aid fitting verified by Real Ear Measurement.
What are the possible benefits and risks of participating?
The possible benefits of participating are a reduction of tinnitus distress and improved hearing. There are no risks to the participants. The proposed treatment is identical to current clinical practice over the past 3 years.
Where is the study run from?
The study is run from Rotherham Community Health Centre (UK).
When is the study starting and how long is it expected to run for?
The study is due to start in Janury 2013 and finish in September 2013.
Who is funding the study?
The study does not require any funding as the participants will be undergoing the same interventions currently carried out in clinic.
Who is the main contact?
Dr Nick Thyer
School of Healthcare
Faculty of Medicine & Health
University of Leeds
+44 (0)113 343 1238
Does amplification alleviate the distress caused by tinnitus in patients with mild hearing loss?
Amplification provided by digital hearing instruments using open fit technology combined with counselling, giving advice and information alleviates the tinnitus distress measured by the Tinnitus Mini Questionnaire in patients with a mild hearing loss.
Leeds West, 05/03/2013, ref: 13/YH/0033
Single-centre quasi-experimental before and after design
Primary study design
Secondary study design
Non randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Tinnitus/mild hearing loss
Before and after - no control
Prior to treatment, the Tinnitus Functional Index (TFI) is completed by each participant. They are then fitted with 'open-fit' hearing aids using real ear measurements as a verification to National Acoustic Laboratories - Non Linear 2 (NAL-NL2) algorithm. After 6 weeks the TFI is completed again to measure relief from tinnitus provided by the hearing aids.
Primary outcome measures
Tinnitus Functional Index (TFI) before intervention and 6 weeks post intervention.
TFI 100% = tinnitus as severe as it can be
TFI 1% = no tinnitus
Secondary outcome measures
No secondary outcome measures
Overall trial start date
Overall trial end date
Participant inclusion criteria
Eligible patients must fulfill the following criteria:
1. Referred to Audiology for tinnitus management by general practitioner (GP), audiologist or ENT
2. A Tinnitus Functional Index higher than 24
3. Any hearing threshold >20dB in either ear
4. Aged between 18 and 80 years, either sex
5. Voluntary informed consent given
6. Psychosocially, mentally and physically able to fully comply with the protocol including adhering to follow-up schedules and requirements and filling out forms
Target number of participants
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
School of Healthcare, Faculty of Medicine & Health
University of Leeds (UK)
Faculty Research Ethics and Governance Administrator
Faculty Research Office
Investigator initiated and funded (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting