RecruitingNAINTERVENTIONAL

Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Rehabilitation Device for Improving Audibility in Hearing-impaired People in the Context of CE Marking - AUDIOCAP-2

This study is looking at a new type of hearing aid called 'Audiocap'. It's designed to help people with hearing loss hear sounds more clearly. The main goal is to find out if using the Audiocap for one month works better than using a dummy hearing aid (which doesn't really help with hearing). Researchers will compare how well people hear with the Audiocap compared to a placebo hearing aid. People taking part will be adults in France, aged 18 or over. They should be getting a hearing aid for the first time and be suitable for one. The study aims to make sure the Audiocap is effective and safe.

At a glance

Status

Recruiting

Phase

Sponsor

Archean Technologies

Enrolment target

100

Start

10 Sep 2025

Estimated completion

01 Sep 2027

Hearing Loss, Adult-Onset Hearing Aid

What is this study about?

This research study is about a new hearing device called 'Audiocap'. It's a special type of hearing aid that connects to other devices, and the study wants to see how well it helps people who have trouble hearing. The main aim is to check if the Audiocap can truly improve how clearly people hear sounds.

To do this, some people in the study will use the Audiocap, while others will use a 'placebo' hearing aid. A placebo hearing aid looks just like the Audiocap but doesn't actually help you hear better – it's like wearing the device without it being switched on. This helps the researchers fairly compare the new device against not using a proper hearing aid at all.

The study will follow participants for one month to see if the Audiocap helps them hear better than the placebo. The results will help decide if the Audiocap can be approved for wider use, which is known as CE marking. This means it could become available to more people who need hearing support.

Key takeaways

Tests a new 'Audiocap' hearing aid for improved hearing.
Compares Audiocap to a dummy ('placebo') hearing aid.
Study lasts one month for hearing aid use.
For adults aged 18+ who are new to hearing aids.
Aims to prove the Audiocap is safe and effective.

Who may be eligible?

This study is looking for adults aged 18 or over who are living in France. To join, you should be trying a hearing aid for the very first time. You also need to have certain levels of hearing loss, which your doctor or an audiologist can check. This could mean you have mild to moderate hearing loss, struggle to understand speech in noisy places, or have difficulty hearing high-pitched sounds.

There are also some reasons why you couldn't join. For example, if you have a severe mental health condition, certain ongoing ear infections, or if your hearing loss means you might need a cochlear implant instead. Also, if you have very severe tinnitus (ringing in the ears) that is disruptive, this study might not be right for you. Your study doctor will help figure out if you're a good fit.

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?
Are you suitable for getting a hearing aid for the first time?
Do you have mild to moderate hearing loss, or difficulty understanding speech?
Do you not have severe ringing in your ears (tinnitus) that affects your daily life?
Do you not have certain ongoing ear infections or conditions?
Are you not considering a cochlear implant?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will use either the Audiocap connected hearing aid or a placebo hearing aid for one month. You won't know which one you are using. During this month, you will have appointments for check-ups and hearing tests. The total duration of your involvement in the study will be confirmed by the research team, but the main testing period for the hearing aid is one month. All appointments and tests will be scheduled at times that work for you as much as possible.

Potential risks and benefits

Taking part in this study might offer you the benefit of trying a new hearing aid that could improve your hearing. However, there's also a chance you might receive a placebo hearing aid, which won't improve your hearing during the study period. As with any device, there could be minor risks, though they are not expected to be significant with a hearing aid. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Hôpital Edouard Herriot
Verified postcode
Lyon, France· Not yet recruiting
Clinique de l'Oreille
Verified postcode
Paris, France· Not yet recruiting
Hôpital Lariboisière (APHP)
Verified postcode
Paris, France· Not yet recruiting
Clinique Rive-Gauche
Verified postcode
Toulouse, France· Recruiting

Common questions

What is the Audiocap connected hearing aid?

It's a new type of hearing device that helps people with hearing loss hear more clearly. It also has features that connect it to other devices.

What is a placebo hearing aid?

It's a device that looks exactly like the Audiocap but doesn't actually help you hear better. It's used to compare the real device against.

How long will I be in the study?

The main part of the study involves using the hearing aid for one month. Your total involvement, including initial checks and follow-up, will be explained by the study team.

Will I know if I'm getting the real hearing aid or the placebo?

No, you won't know which one you are using. This helps to make the study results fair and accurate.

What if I decide I don't want to continue with the study?

You are free to stop participating in the study at any time, for any reason, without needing to explain why. It won't affect your medical care.

How to find out more

Sixtine Marié

smarie@archean.tech +33 (0)6 23 83 22 81 Official trial record

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