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

NCT07252492 | Recruiting

• 1 other identifier: 2025-A01026-43
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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).

Conditions

Hearing Loss, Adult-Onset; Hearing Aid

Keywords

Aides auditives; Prothèses auditives; Perte auditive; Appareillage audition; Adulte audition

Outcome Measures

Primary Outcomes (1)

• The effectiveness of the Audiocap connected hearing aid will be measured by the improvement of at least one of the following three audiological gain criteria.

  The effectiveness of the Audiocap connected hearing aid will be measured by the improvement of at least one of the following three audiological gain criteria: 1. Mean tonal gain of 10 dB (mean 500 / 1000 / 2000 / 4000 Hz). 2. Minimum vocal prosthetic gain of 7 dB (dissyllabic words). 3. Improvement in speech in noise of at least 2 dB SNR (FrMatrix test). Clarification: The primary endpoint measures the audiological gain in decibels (dB) through standard audiometric tests. Three non-cumulative possibilities (i.e., at least one of the three improvements) are defined: depending on the patient's hearing loss, the improvement is not expressed in the same way.

  After one month of hearing aid use (Month 1)

Secondary Outcomes (8)

• Measurement of quality of life using the SSQi15 questionnaire

  After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)

• Measurement of quality of life using the COSI questionnaire

  After one month of using (Month 1) and at the end of the follow up (Month 3 and Month 4)

• Treatment preference (Likert)

  After one month (Month 1) and at the end of the patient's follow-up (Month 3 and Month 4)

• Reduction of the time required to attain adaptation to the hearing aid (remote interplay path)

  After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)

• Remote interplay path empowers the subject to take control of and better manage their hearing loss.

  After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)

Study Arms (2)

Interventional Arm

ACTIVE COMPARATOR

First period of one month: Audiocap connected hearing aid in a standard interplay path.

Device: Audiocap connected hearing aid

Control Arm

PLACEBO COMPARATOR

First period of one month: Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid) in a standard interplay path.

Device: Placebo

Interventions

Audiocap connected hearing aid DEVICE

The hearing aids will be used in a standard mode, that is, without the possibility of remote adjustment (remote interplay path).

Interventional Arm

Placebo DEVICE

Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid) in a standard interplay path.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Subjects eligible for first hearing aid.
• Subjects over 18 years of age. French-speaking subjects.
• \. Subjects affiliated with a social security scheme. 6. Subjects who are not subject to another medical option, without external pathology and excluding implants.
• \. Subjects who have signed an informed consent. 8. Subjects available for the study.

You may not qualify if:

• Subject deprived of his/her liberty by a judicial or administrative decision
• Subject with severe psychiatric disorder
• Subject admitted to a health or social care establishment
• Subject not able to give consent
• Adults under guardianship or trusteeship.
• Subjects with disabling tinnitus that are not suitable for adaptation (THI\>56).
• Subjects eligible for a cochlear implant.
• Subjects not able to participate in the study according to the investigator.
• Subjects with acute and chronic suppurative otitis media, congenital ear atresia, or any type of ear discharge.
• Subjects with congenital atresia of external ear or deformity of any part of the ear canal.
• Subjects with deafness that is unstable and with a degree of hearing loss often fluctuating.
• Subjects with persistent headaches, dizziness, earaches, or other symptoms that are not suitable for adaptation.
• Subjects with sudden onset of hearing loss within the past 3 months, rapid progressive deafness, unilateral hearing loss or other acute ear disease.
• Subjects with effusion (secretions/ discharge) in the ear and/or frequent purulence (pus).
• Subjects with central deafness (central nervous system) or non-organic deafness.

Sponsors & Collaborators

• Archean Technologies: lead

Study Sites (4)

Hôpital Edouard Herriot

Lyon, France, 69000, France

NOT YET RECRUITING

Clinique de l'Oreille

Paris, France, 75000, France

NOT YET RECRUITING

Hôpital Lariboisière (APHP)

Paris, France, 75000, France

NOT YET RECRUITING

Clinique Rive-Gauche

Toulouse, France, 31000, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sixtine Marié

CONTACT

+33 (0)6 23 83 22 81; smarie@archean.tech

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First period of one month: Double blinded randomized placebo-controlled trial (Placebo/group A versus Audiocap standard mode/ group B). Interventional Arm: Audiocap connected hearing aid in a standard interplay path. Control Arm: Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid) in a standard interplay path.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: November 26, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)