NCT07252492 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
| NCT ID | NCT07252492 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Archean Technologies |
| Condition | Hearing Loss, Adult-Onset |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-09-10 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Subjects 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 with a speech reception threshold (SRT) in quiet exceeding 30dB, corresponding to the minimum speech level required to achieve 50% recognition in silence (HAS eligibility criteria for hearing aid reimbursement), / c. Subject with significant degradation of speech intelligibility in noise, defined as a speech-to-noise ratio (SNR) deviation greater than 3dB compared to normative reference values (HAS eligibility criteria for hearing aid reimbursement), / d.Subject with high-frequency hearing loss greater than 30dB from 2000 Hz onwards, associated with a speech reception threshold exceeding 30dB in quiet and/or a significantly degraded speech intelligibility in noise (HAS eligibility criteria for hearing aid reimbursement). 2. Subjects eligible for first hearing aid. 3. Subjects over 18 years of age. French-speaking subjects. 5\. Subjects affiliated with a social security scheme. 6. Subjects who are not subject to another medical option, without external pathology and excluding implants. 7\. Subjects who have signed an informed consent. 8. Subjects available for the study. Exclusion Criteria: 1. Subject deprived of his/her liberty by a judicial or administrative decision 2. Subject with severe psychiatric disorder 3. Subject admitted to a health or social care establishment 4. Subject not able to give consent 5. Adults under guardianship or trusteeship. 6. Subjects with disabling tinnitus that are not suitable for adaptation (THI\>56). 7. Subjects eligible for a cochlear implant. 8. Subjects not able to participate in the study according to the investigator. 9. Subjects with acute and chronic suppurative otitis media, congenital ear atresia, or any type of ear discharge. 10. Subjects with congenital atresia of external ear or deformity of any part of the ear canal. 11. Subjects with deafness that is unstable and with a degree of hearing loss often fluctuating. 12. Subjects with persistent headaches, dizziness, earaches, or other symptoms that are not suitable for adaptation. 13. Subjects with sudden onset of hearing loss within the past 3 months, rapid progressive deafness, unilateral hearing loss or other acute ear disease. 14. Subjects with effusion (secretions/ discharge) in the ear and/or frequent purulence (pus). 15. Subjects with central deafness (central nervous system) or non-organic deafness. 16. Subjects with acute otitis extrema and tympanitis. 17. Subjects who are allergic to materials of the device.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07252492 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hearing Loss, Adult-Onset. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07252492 currently recruiting?
Yes, NCT07252492 is actively recruiting participants. Contact the research team at smarie@archean.tech for enrollment information.
Where is the NCT07252492 trial being conducted?
This trial is being conducted at Lyon, France, Paris, France, Paris, France, Toulouse, France.
Who is sponsoring the NCT07252492 clinical trial?
NCT07252492 is sponsored by Archean Technologies. The trial plans to enroll 100 participants.