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Tests treatment safety and results for Hearing Loss, Adult-Onset
Official title 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
ClinicalTrials.gov ID: NCT07252492
What this study is testing
- What it's testing
- The goal of this clinical trial is the evaluation of performances, clinical benefits and safety of the 'Audiocap' connected hearing rehabilitation device for improving audibility in hearing-impaired people. The main question it aims to answer is to demonstrate, after one month's use of the Audiocap connected hearing aid, that the audiological gain for the patient is better than with a placebo hearing aid.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people presenting one or more of the following criteria: a.Subject with mild to moderate hearing loss (20dB to 50dB average at 500, 1000, 2000, and...
- people eligible for first hearing aid.
- people over 18 years of age. French-speaking people. 5\. people affiliated with a social security scheme. 6. people who are not subject to another...
You likely can't join if
- Subject deprived of his/her liberty by a judicial or administrative decision
- Subject with severe psychiatric disorder
- Subject admitted to a health or social care establishment
- Subject not able to give consent
- Adults under guardianship or trusteeship.
- people with disabling tinnitus that are not suitable for adaptation (THI\>56).
See the full eligibility criteria
- people presenting one or more of the following criteria: a.Subject with mild to moderate hearing loss (20dB to 50dB average at 500, 1000, 2000, and 4000 Hz) in the better ear according to WHO standards, / b. Subject...
- people eligible for first hearing aid.
- people over 18 years of age. French-speaking people. 5\. people affiliated with a social security scheme. 6. people who are not subject to another medical option, without external pathology and excluding implants. 7\...
- Subject deprived of his/her liberty by a judicial or administrative decision
- Subject with severe psychiatric disorder
- Subject admitted to a health or social care establishment
- Subject not able to give consent
- Adults under guardianship or trusteeship.
- people with disabling tinnitus that are not suitable for adaptation (THI\>56).
- people eligible for a cochlear implant.
- people not able to participate in the study according to the investigator.
- people with acute and chronic suppurative otitis media, congenital ear atresia, or any type of ear discharge.
- people with congenital atresia of external ear or deformity of any part of the ear canal.
- people with deafness that is unstable and with a degree of hearing loss often fluctuating.
- people with persistent headaches, dizziness, earaches, or other symptoms that are not suitable for adaptation.
- people with sudden onset of hearing loss within the past 3 months, rapid progressive deafness, unilateral hearing loss or other acute ear disease.
- people with effusion (secretions/ discharge) in the ear and/or frequent purulence (pus).
- people with central deafness (central nervous system) or non-organic deafness.
- people with acute otitis extrema and tympanitis.
- people who are allergic to materials of the device.
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France, France
- Paris, France, France
- Toulouse, France, France
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France, France; Paris, France, France; Toulouse, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.