RecruitingNot ApplicableInterventional

Bone conduction devices in minimal air-bone gaps

Are you an adult who uses hearing aids and has some hearing loss? This study wants to find out if a different kind of hearing aid, called a bone conduction device (BCD), could help people like you hear speech more clearly. BCDs send sounds through your skull to your inner ear. Normally, they're used for more severe hearing loss, but this study is testing if they can also help those with a lesser degree of hearing loss. Participants will compare their current hearing aids with a BCD over a short period. The study involves two hospital visits for hearing and listening tests, plus some questionnaires about your experience. It's happening at University College London Hospital and is funded by Cochlear, with sponsorship from the hospital.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

University College London Hospitals NHS Foundation Trust

Enrolment target

Start

24 Jun 2024

Estimated completion

30 Sep 2026

Hearing loss

What is this study about?

This research study is looking into hearing aids that work a bit differently from the ones you might be used to. These are called bone conduction devices (BCDs). Instead of just making sounds louder and sending them through your ear canal, BCDs send tiny vibrations through the bones of your head directly to your inner ear. This method can be really helpful for people who have certain types of hearing loss where the sound can't easily get through the outer or middle ear.

Usually, BCDs are given to people with more significant hearing problems. However, this study wants to explore if they could also benefit people with a smaller amount of hearing loss – what doctors call 'minimal air-bone gaps'. The main goal is to see if these BCDs can help you understand speech better than your current hearing aids. If they can, it could mean more options for people with this type of hearing loss in the future.

By taking part, you would be helping researchers understand more about different ways to improve hearing. Your experiences and the results of the tests will provide important information that could potentially help many other people with hearing loss down the line.

Key takeaways

The study is investigating a different type of hearing aid (bone conduction device).
It aims to see if this device helps people with milder hearing loss hear speech better.
Participation involves two visits to University College London Hospital.
You'll try the new device on a soft headband for two weeks.
There are no major risks, but the device might feel a little uncomfortable.
Your involvement helps improve understanding of hearing loss treatments.

Who may be eligible?

This study is looking for adults aged 18 or older. You need to be currently using a hearing aid or two hearing aids that were fitted or adjusted in the last six months. It's also important that you're able to understand and sign a consent form, and fill out questionnaires on your own. You should be comfortable with English speech tests.

There are also specific requirements about your hearing. You'll have a type of hearing loss where there's a certain difference between how you hear sounds through the air and through your bones. Your bone hearing thresholds also need to be within a specific range.

If you can't wear your current hearing aids regularly, or if your hearing loss changes quickly, this study might not be suitable for you. Also, if you can't do the English listening tests or questionnaires by yourself, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you use at least one hearing aid that was newly fitted or adjusted in the last 6 months?
Are you able to speak and understand English well enough for tests and questionnaires?
Is your hearing loss generally stable, not changing quickly?
Are you able to visit University College London Hospital twice?

Answer every question to see your result.

What does participation involve?

If you decide to join, you'll need to visit University College London Hospital twice. During your first visit, a member of the research team will explain everything and answer your questions. If you're happy to proceed, you'll sign a consent form. You'll then have a hearing test and some listening tests using your current hearing aid(s). You'll also complete some questionnaires about your feelings and how well you hear with your current aids.

After these initial steps, a bone conduction device (BCD) will be fitted to you on a soft headband for you to wear and try out for two weeks. Then, about 2 to 6 weeks later, you'll come back for your second and final hospital visit. During this visit, you'll do more listening tests, this time using the BCD you've been trying. You'll also fill out a few more questionnaires to tell the researchers what it was like listening with the BCD and how it compared to your usual hearing aid(s). The total time you'd be involved in the study from your first visit to your last is typically within one to two months, including the time you try out the device at home.

Potential risks and benefits

During the study, we don't expect any major problems. The bone conduction device you'll try is worn on a soft headband, and while it's designed to be comfortable, some people might find it a little uncomfortable if worn for a long time. There are no direct personal medical benefits guaranteed from taking part; however, your participation will help doctors and researchers learn more about hearing loss and potentially improve future treatments for others. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (7)

Royal National Ent and Eastman Dental Hospitals
Approximate
London, United Kingdom
John Radcliffe Hospital
Approximate
Oxford, United Kingdom
Addenbrookes
Approximate
Cambridge, United Kingdom
Royal Hallamshire Hospital
Approximate
Sheffield, United Kingdom
University Hospital Birmingham
Approximate
Birmingham, United Kingdom
Basingstoke and North Hampshire Hospital
Unverified
Basingstoke, United Kingdom
Lister Hospital
Unverified
Stevenage, United Kingdom

Common questions

What is a bone conduction device?

It's a type of hearing aid that sends sounds through the bones of your head to help you hear, rather than through your ear canal like most regular hearing aids.

Why is this study being done?

Researchers want to see if bone conduction devices can help people with a milder type of hearing loss hear speech better than their usual hearing aids.

Do I have to stop using my regular hearing aid?

No, you'll continue to use your regular hearing aid as normal, and you'll try the bone conduction device for a couple of weeks to compare them.

Will I get to keep the bone conduction device?

The study offers the device for you to try during the research period. It's not guaranteed that you'll keep it afterwards, as it's to gather information for the study.

Who is paying for this study?

Cochlear, a company that makes hearing aids, is providing some funding, but University College London Hospital is fully responsible for running the study.

How to find out more

Fei Long

f.long@ucl.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.