Audiocap connected hearing device to improve audibility in adults with hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique Rive-Gauche
  Toulouse, France, France Recruiting
• 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

Study contacts

• Study coordinator: Sixtine Marié
• Email: smarie@archean.tech
• Phone: +33 (0)6 23 83 22 81

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.