RecruitingNAINTERVENTIONAL

Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit

This study is testing a new type of rechargeable hearing device that fits behind the ear for adults experiencing hearing loss. Researchers want to find out if this device helps people hear better in challenging situations, like busy restaurants, and if it makes understanding speech easier when there's background noise. They'll compare how well people hear with the new device versus without it. Participants will use the device for about two weeks, answer questionnaires about their experiences, and do some hearing tests in a lab. The goal is to see if this new technology offers a good and helpful solution for improving hearing.

At a glance

Status

Recruiting

Phase

Sponsor

Sonova AG

Enrolment target

Start

30 Jan 2026

Estimated completion

15 Apr 2026

Hearing Loss

What is this study about?

This research study is about a new rechargeable hearing aid that fits behind your ear. It's being developed by a company called Sonova. The main purpose of the study is to see if this new hearing aid can really help adults who have hearing loss. We want to understand if it makes a difference in everyday situations where hearing can be tough, such as in noisy places or when many people are talking.

To find this out, the researchers will be asking some key questions. First, they want to know if the new hearing aid helps people manage those challenging listening situations they often face, and if users generally find it a good experience. Second, they will test in a controlled setting, like a lab, to see if people understand speech better when there's background noise while using this device.

The researchers will compare how well participants hear with the new device compared to when they're not using any hearing aid at all. They will also ask people who already use hearing aids to compare their experience with their usual device to this new one. This will help them understand how effective and helpful this new rechargeable hearing aid might be for people with hearing loss.

Key takeaways

Tests a new rechargeable behind-the-ear hearing aid.
Aims to improve hearing in challenging and noisy places.
Requires using the device for around two weeks daily.
Involves clinic visits, questionnaires, and lab tests.
Needs participants who already use hearing aids and own a smartphone.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, and already use hearing aids regularly (for at least three months). Your hearing loss must fit within what the new device is designed to help, covering mild to profound hearing loss in both ears. You also need to be able to understand the study rules, use the device, and speak and write English well.

It's important that you're generally healthy and that your ears are clear and healthy enough for the device to fit properly. The study is particularly looking for people who are active socially and often find themselves in noisy places where they might need extra help with their hearing. You'll also need a smartphone to use with the hearing aids.

You wouldn't be able to join if you have serious health problems that might affect the study, if you're allergic to the device materials, or if you have trouble describing your hearing experiences. People with very new ringing in their ears (tinnitus that started less than three months ago) or who can't make it to the study appointments also won't be able to take part.

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 already use hearing aids (for at least 3 months)?
Do you have a smartphone you can use with the hearing aids?
Do you speak, read, and write English well?
Are you able to attend clinic appointments?
Do you go out and socialise often?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will first have an initial visit where the hearing device will be fitted for you. Then, you'll get to use the new rechargeable hearing device for about two weeks in your daily life. During this time, the study asks you to wear the device for at least 6-8 hours each day. You'll also need to have a smartphone to connect with the hearing aids.

Throughout the study, you will complete questionnaires. These will help the researchers understand how you're finding different listening situations and get your feedback on using the devices. At the end of the study period, you'll come back to the clinic for a follow-up visit. This visit will include some lab tests to check how well you understand speech in noisy environments and to get your thoughts on the special features of the device's mobile app. There might be a few other visits if necessary, but the core part of using the device is for two weeks, followed by a final assessment.

Potential risks and benefits

Taking part in a study like this can have potential benefits, such as getting to try a new hearing device before it's widely available and contributing to important research that could help many people with hearing loss in the future. You might also find that the new device helps you hear better in certain situations. As for risks, there's always a small chance of discomfort or irritation from wearing a new device, or a very rare chance of an allergic reaction to the materials, though these devices are generally safe. It's important to remember that you can stop being part of the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

National Hearing Services Inc
Verified postcode
Kitchener, Canada· Recruiting
National Hearing Services Inc
Verified postcode
Mississauga, Canada· Recruiting

Common questions

What kind of hearing device is being tested?

It's a new rechargeable hearing aid that fits behind your ear.

How long do I have to use the device for?

You'll use the device for about two weeks as part of the study.

Do I need a smartphone to participate?

Yes, you'll need a smartphone to connect with the hearing aids during the study.

Will this device totally fix my hearing loss?

This study is designed to see if the device helps improve hearing; it won't necessarily 'fix' hearing loss completely.

What if I don't like the device or want to stop?

You are free to leave the study at any point without any problems.

How to find out more

Study Manager

innovation.toronto@sonova.com 519-895-0100 Official trial record

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