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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Active Comparator | First period of one month: Audiocap connected hearing aid in a standard interplay path. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After one month (Month 1) and at the end of follow-up (Month 3 and Month 4) |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sixtine Marié | Contact | +33 (0)6 23 83 22 81 | smarie@archean.tech |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot | Not yet recruiting | Lyon | France | 69000 | France |
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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.
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| 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. |
|
| 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. | 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. | 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. | 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. | 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). | 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). | 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) | 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)). |
| Clinique de l'Oreille | Not yet recruiting | Paris | France | 75000 | France |
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| Hôpital Lariboisière (APHP) | Not yet recruiting | Paris | France | 75000 | France |
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| Clinique Rive-Gauche | Recruiting | Toulouse | France | 31000 | France |
|
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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