Condition category
Ear, Nose and Throat
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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 has 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 consists 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?
Rotherham Community Health Centre (UK)

When is the study starting and how long is it expected to run for?
January 2013 to September 2013

Who is funding the study?
The study does not require any funding as the participants undergo the same interventions currently carried out in clinic.

Who is the main contact?
Peter Byrom

Trial website

Contact information



Primary contact

Dr Nick Thyer


Contact details

School of Healthcare
Faculty of Medicine & Health
Baines Wing
University of Leeds
United Kingdom
+44 (0)113 343 1238

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Does amplification alleviate the distress caused by tinnitus in patients with mild hearing loss?


Study hypothesis

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.

Ethics approval

Leeds West, 05/03/2013, ref: 13/YH/0033

Study design

Single-centre quasi-experimental before and after design

Primary study design


Secondary study design

Non randomised study

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details 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.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Tinnitus Functional Index (TFI) before intervention and 6 weeks post intervention

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion 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

Participant type


Age group




Target number of participants


Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
United Kingdom

Sponsor information


University of Leeds (UK)

Sponsor details

Faculty Research Ethics and Governance Administrator
Faculty Research Office
Room 10.110
Level 10
Worsley Building
Clarendon Way
United Kingdom

Sponsor type




Funder type


Funder name

Investigator initiated and funded (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Publication plans are unknown at this stage.

IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/05/2017: IPD sharing statement added.