Hearing Loss, Adult-OnsetAUDIOCAP-2NCT07252492
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
A study testing Audiocap connected hearing aid in people with Hearing Loss, Adult-Onset and Hearing Aid, run by Archean Technologies at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Adult-Onset, Hearing Aid
- What is being tested?
- Audiocap connected hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 10 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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).
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- 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.
- Subjects with acute otitis extrema and tympanitis.
- Subjects who are allergic to materials of the device.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Hôpital Edouard Herriot
Lyon, France, 69000
Hung Thai Van, Professor, +33 (0)4 72 11 05 03, hthaivan@gmail.com
Hung Thai Van, Professor
- Not yet recruiting
Clinique de l'Oreille
Paris, France, 75000
Marie-José Estève-Fraysse, Doctor, +33 (0)1 43 35 35 30, frayssemariejose@gmail.com
Marie-José Estève-Fraysse, Doctor
- Not yet recruiting
Hôpital Lariboisière (APHP)
Paris, France, 75000
Charlotte Hautefort, Doctor, +33 (0)1 49 95 80 64, charlotte.hautefort@aphp.fr
Charlotte Hautefort, Doctor
- Recruiting
Clinique Rive-Gauche
Toulouse, France, 31000
Joanna Chaube, +33 (0)5 61 77 47 06, j.chaube@clinique-rivegauche.fr
Bernard Fraysse, Professor
About this study
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
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.
Read more
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
- Being tested
- Audiocap connected hearing aid, Placebo
- Keywords
- Aides auditives, Prothèses auditives, Perte auditive, Appareillage audition, Adulte audition
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiocap connected hearing aidDevice
The hearing aids will be used in a standard mode, that is, without the possibility of remote adjustment (remote interplay path).
PlaceboDevice
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 group | Role | What they receive |
|---|---|---|
| Interventional Arm | Active comparator | First period of one month: Audiocap connected hearing aid in a standard interplay path. Receives: 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. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Mean tonal gain of 10 dB (mean 500 / 1000 / 2000 / 4000 Hz).
- Minimum vocal prosthetic gain of 7 dB (dissyllabic words).
- 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.
Measured: After one month of hearing aid use (Month 1)
Secondary outcomes (8)
Measurement of quality of life using the SSQi15 questionnaire
Quality of life will be assessed using questionnaires SSQi15.
The SSQ-15 (Speech, Spatial, and Qualities of Hearing Scale, 15-item version) is a questionnaire that evaluates real-life hearing situations related to speech understanding, spatial hearing, and perceived qualities of hearing.
Measured: 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
The Client Oriented Scale of Improvement (COSI) is a clinical tool developed by the National Acoustic Laboratories to assess hearing aid outcomes. Patients identify up to five specific listening situations they wish to improve. After a period of use, they rate the perceived improvement and their final ability to hear in each situation.
Measured: After one month of using (Month 1) and at the end of the follow up (Month 3 and Month 4)
Treatment preference (Likert)
The subject will be asked to indicate their preference between not using a hearing aid and using a hearing aid on a scale from 0 to 10.
Measured: 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)
The advantage of the remote interplay path is assessed through:
2.a.1. If necessary for the patient, number of adjustments requested and/or number of positive responses to requests from the application to adjust the setting compared with the standard mode,
2.a.2. The number of adjustments requested in the remote interplay path during the first month is higher than the last month,
2.a.3. Comparison of the time interval between the last setting remote requested and the standard last visit,
2.a.4. Subjects in remote interplay path have an equal or better average wearing time than subject in standard interplay path,
2.a.5. During the last month, subjects in remote interplay path don't use their previous setting and don't request a new one,
2.a.6. During the last month, subjects in remote interplay path don't change significantly the global broadcast level of their hearing aid.
Measured: 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.
Subject empowerment is assessed by the PAM-13 questionnaire.
Measured: After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)
Acceptability assessed by wearing time (data logging)
Acceptability assessed by wearing time (data logging).
Measured: After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)
Usability (Ergonomic questionnaire)
Usability assessed via the ergonomics questionnaire.
The ergonomic questionnaire is specially custom to evaluate the medical device (clear information, typeface, visual presentation, design, use and use of each feature).
Measured: After one month of use (M1) and at the end of the follow up (M3 and M4).
Safety of the device : reporting adverse events, serious adverse events and device deficiencies.
Safety of the device : number of adverse events, serious adverse events and device deficiencies (in the context of CE marking)
Measured: This endpoint is measured at each subject visit in the study (visit 2 (Day 15), visit 3 (Month 1), visit 4 (Day 45), visit 5 (Month 2) and visit 6 (Month 4)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start10 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Adult-OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Archean Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252492
- Sponsor's protocol ID
- 2025-A01026-43
- Acronym
- AUDIOCAP-2
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07252492
- Acronym / sponsor ID
- AUDIOCAP-2 / 2025-A01026-43
- Conditions
- Hearing Loss, Adult-Onset, Hearing Aid
- Keywords
- Aides auditives, Prothèses auditives, Perte auditive, Appareillage audition, Adulte audition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Archean TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Active comparator | Device: Audiocap connected hearing aidFirst period of one month: Audiocap connected hearing aid in a standard interplay path. |
| Control Arm | Placebo comparator | Device: PlaceboFirst 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiocap connected hearing aidThe hearing aids will be used in a standard mode, that is, without the possibility of remote adjustment (remote interplay path). | Device | Interventional Arm |
| PlaceboAudiocap 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 | Control Arm |
Primary outcome
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.
Time frame: After one month of hearing aid use (Month 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: 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.
8 secondary outcomes
Measurement of quality of life using the SSQi15 questionnaire
Time frame: 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
Time frame: After one month of using (Month 1) and at the end of the follow up (Month 3 and Month 4)
Treatment preference (Likert)
Time frame: 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)
Time frame: 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.
Time frame: After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)
Acceptability assessed by wearing time (data logging)
Time frame: After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)
Usability (Ergonomic questionnaire)
Time frame: After one month of use (M1) and at the end of the follow up (M3 and M4).
Safety of the device : reporting adverse events, serious adverse events and device deficiencies.
Time frame: This endpoint is measured at each subject visit in the study (visit 2 (Day 15), visit 3 (Month 1), visit 4 (Day 45), visit 5 (Month 2) and visit 6 (Month 4)).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiocap connected hearing aid in people with Hearing Loss, Adult-Onset and Hearing Aid, run by Archean Technologies at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sixtine Marié (+33 (0)6 23 83 22 81, smarie@archean.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: After one month of hearing aid use (Month 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.