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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- 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.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Subjects who are not subject to another medical option, without external pathology and excluding implants.
- •7. Subjects who have signed an informed consent.
- •Subjects available for the study.
排除标准
- •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.
- •Subjects with acute otitis extrema and tympanitis.
- •Subjects who are allergic to materials of the device.
结局指标
主要结局
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.
时间窗: 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.
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.
时间窗: 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.
次要结局
- 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))
- 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)(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.(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)).)
- Safety of the device : reporting adverse events, serious adverse events and device deficiencies.(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)).)
- 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))
- 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)(After one month of use (M1) and at the end of the follow up (M3 and M4).)