Actively Recruiting
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
Led by Archean Technologies · Updated on 2025-11-26
100
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance, clinical benefits, and safety of the Audiocap connected hearing rehabilitation device for adults with hearing loss. The study aims to determine if using the Audiocap hearing aid for one month improves hearing ability more than a placebo hearing aid that delivers no hearing assistance. Participants are first-time hearing aid users, adults eligible for hearing aid fitting, and French-speaking. Participants will use either the Audiocap connected hearing aid in standard mode without remote adjustment or a placebo version with a flat frequency response equivalent to not wearing a hearing aid. The study has a first period lasting one month where participants use one of these devices in a standard care setting. The study evaluates outcomes after this month of use. During the study, participants will undergo assessments including audiological gain measurements, quality of life questionnaires (SSQi15 and COSI), treatment preference surveys, and data logging of device use. Safety monitoring includes reporting any adverse events throughout several visits up to four months. The study also examines usability and participant control over hearing loss management with remote features. Follow-up visits occur up to four months after starting the device use.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Mild to moderate hearing loss between 20dB and 50dB in the better ear
- Speech reception threshold in quiet exceeding 30dB
- Significant speech intelligibility degradation in noise, with SNR deviation over 3dB
- Eligible for first hearing aid fitting
- French-speaking
- Affiliated with a social security scheme
- Not receiving other medical options, no external pathology, no implants
- Signed informed consent
- Available to participate in the study
You will not qualify if you...
- Deprivation of liberty by judicial or administrative decision
- Severe psychiatric disorder
- Admitted to health or social care establishment
- Unable to give informed consent
- Adults under guardianship or trusteeship
- Disabling tinnitus not suitable for adaptation (THI > 56)
- Eligible for cochlear implant
- Unable to participate as judged by investigator
- Acute or chronic suppurative otitis media, congenital ear atresia, or ear discharge
- Congenital atresia or deformity of external ear or ear canal
- Unstable or fluctuating deafness
- Persistent headaches, dizziness, earaches unsuitable for adaptation
- Sudden hearing loss onset within past 3 months, rapid progressive deafness, unilateral hearing loss, or acute ear disease
- Ear effusion or frequent purulence
- Central or non-organic deafness
- Acute otitis extrema or tympanitis
- Allergy to device materials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants use the Audiocap connected hearing aid or a placebo device in standard mode without remote adjustment for one month.
Visits at Day 15 and Month 1 to assess safety and device use
Duration - 3 months
Participants continue to be monitored for device safety, quality of life, usability, and treatment preference after the initial one-month use period.
Visits at Day 45 (Month 1.5), Month 2, and Month 4 for ongoing assessments
Trial Site Locations
Total: 4 locations
1
Hôpital Edouard Herriot
Lyon, France, France, 69000
Not Yet Recruiting
2
Clinique de l'Oreille
Paris, France, France, 75000
Not Yet Recruiting
3
Hôpital Lariboisière (APHP)
Paris, France, France, 75000
Not Yet Recruiting
4
Clinique Rive-Gauche
Toulouse, France, France, 31000
Actively Recruiting
Research Team
S
Sixtine Marié
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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