Audiocap connected hearing device to improve audibility in adults with hearing loss
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
This will see if the Audiocap connected hearing aid helps adults with mild-to-moderate hearing loss hear better than a placebo (flat-response) setting after one month.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Archean Technologies Industry-sponsored |
| Locations | 4 sites (Lyon, France and 3 other locations) |
| Trial ID | NCT07252492 on ClinicalTrials.gov |
What this trial studies
The trial compares the Audiocap connected hearing aid to a placebo configuration (Audiocap set to a flat 'NONE' response equivalent to not wearing a hearing aid) to measure audiological gain after one month of use. Participants are adults who are first-time hearing-aid users and meet specific audiological thresholds for mild-to-moderate adult-onset hearing loss. The primary outcome is the change in audibility and speech understanding after one month of device use. The study is being conducted at clinical sites in Lyon and Paris in the context of CE marking for the device.
Who should consider this trial
Good fit: Adults (18+) who are first-time hearing-aid users with mild-to-moderate adult-onset hearing loss meeting the listed audiological thresholds (for example 20–50 dB average or SRT >30 dB) are the intended participants.
Not a fit: People with severe or profound hearing loss, children, current or prior hearing-aid users, or those who do not meet the specified audiological thresholds are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, Audiocap could provide first-time hearing-aid users clearer audibility and improved speech understanding in everyday situations.
How similar studies have performed: Conventional hearing aids and some connected devices have previously improved audibility in similar patients, but device-specific placebo-controlled comparisons for CE marking are relatively uncommon.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lyon, France and 3 other locations
- Hôpital Edouard Herriot — Lyon, France, France (Not_yet_recruiting)
- Clinique de l'Oreille — Paris, France, France (Not_yet_recruiting)
- Hôpital Lariboisière (APHP) — Paris, France, France (Not_yet_recruiting)
- Clinique Rive-Gauche — Toulouse, France, France (Recruiting)
Study contacts
- Study coordinator: Sixtine Marié
- Email: smarie@archean.tech
- Phone: +33 (0)6 23 83 22 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.