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 - AUDIOCAP-2
Led by Archean Technologies · Updated on 2025-11-26
100
Participants Needed
4
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Placebo hearing aid is a Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid). Participants will be first-time hearing aid users, eligible for hearing aid fitting, and adults according to French legislation (18 years and older).
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Mild to moderate hearing loss (20dB to 50dB average at 500, 1000, 2000, and 4000 Hz) in the better ear or speech reception threshold in quiet greater than 30dB or significant speech intelligibility degradation in noise or high-frequency hearing loss greater than 30dB from 2000 Hz onwards
- Eligible for first hearing aid fitting
- French-speaking
- Affiliated with a social security scheme
- Not subject to another medical option, without external pathology and excluding implants
- Signed informed consent
- Available for the study
You will not qualify if you...
- Subject deprived of liberty by judicial or administrative decision
- Severe psychiatric disorder
- Admitted to a health or social care establishment
- Unable to give consent
- Under guardianship or trusteeship
- Disabling tinnitus not suitable for adaptation (THI>56)
- Eligible for a cochlear implant
- Unable to participate as per investigator
- Acute or chronic suppurative otitis media, congenital ear atresia, or ear discharge
- Congenital atresia or deformity of the ear canal
- Unstable or fluctuating deafness
- Persistent headaches, dizziness, earaches, or other symptoms unsuitable for adaptation
- Sudden hearing loss within past 3 months, rapid progressive or 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
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
CONTACT
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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