Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Audiological performance with both ways of fitting
研究概览
简要总结
The Bonebridge (BB) is a partially implantable active transcutaneous bone conduction hearing system manufactured by MED-EL Elektromedizinische Geräte Gesellschaft m.b.H. (MED-EL, Innsbruck, Austria).
The BB augments hearing by providing acoustic input to the inner ear via bone conduction.
In 2017 Hodgetts & Scollie introduced a new fitting algorithm called DSL-BCD. The DSL-BCD algorithm was developed especially for the characteristics of bone conduction devices (BCD). If there is a benefit on the patient level in hearing outcomes when comparing the application of DSL-BCD in comparison to DSL v5 when using the BB, was not yet investigated.
The aim of this clinical study is to show the improvement in audiological performance and subjective satisfaction with the BCI602 and SAMBA 2 audio processor in patients with conductive hearing loss compared to the unaided condition and to evaluate performance differences through application of 2 different fitting algorithms, namely DSL v5 and DSL-BCD.
详细描述
- The objective of this study was to verify the influence of different fitting procedures
- Duration of investigation:
Unexperienced users group: Each subject will be actively involved in the study for a period of 4-6 weeks after the first fitting of the audio-processor, 4 visits in total.
Experienced users group: Each subject implanted for at least 3 months will be asked to be involved in the study the day of their following scheduled fitting, 1 visit in total.
We expect the study to conclude within 3 years for study start. 3. Study design: The study is designed as a prospective two-period crossover, single-subject repeated-measures. It is intended to compare the performance with and without BB system in two fitting-configurations (A: DSL v5, B: DSL-BCD) using audiometric and subjective measures. For evaluation each subject serves as his/her own control. For experienced users only acute tests in condition A and B (order randomised, sequence AB or BA) will take place. For unexperienced users the period with each condition will be 2 to 3 weeks. From the clinical perspective no specific washout period between fitting A and B is needed to avoid a carryover effect. Heterogeneity and variability inherent to the population and their outcome measures will be recognized. By using a single-subject design, the effect of variability is minimized. The use of standardized evaluation methods assures the reliability of the data across investigational center. 4. Randomisation: To eliminate the sequence effect, we performed a block randomisation to ensure that the number of patients in each sequence (fitting with configuration A or B) is similar throughout the study. 5. Inclusion criteria:
- 18 years of age or older
- Unilateral and/or bilateral CHL/MHL in the device indication range
- Implanted with a BCI602 device
- Willingness and ability to use the hearing system and to perform all tests required for the study
- Signed, and dated informed consent before the start of any study specific procedure
- Native speaker 5.1. Exclusion criteria: A patient with/is
- Profound unilateral sensorineural hearing loss, often termed Single Sided deafness (SSD)
- retrocochlear, or central auditory disorders
- any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
- fluctuating hearing loss
- subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study
- Fitting:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Unilateral and/or bilateral conductive or mixed hearing loss (CHL/MHL) in indication range.
- •Implanted with a BCI602 device.
- •Willingness and ability to use the hearing system and to perform all tests required for the study
- •Signed, and dated informed consent before the start of any study specific procedure
- •Native speaker
排除标准
- •Profound unilateral sensorineural hearing loss, often termed Single sided deafness (SSD)
- •Retrocochlear, or central auditory disorders
- •Any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
- •Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study.
- •Fluctuating hearing loss.
结局指标
主要结局
Audiological performance with both ways of fitting
时间窗: 12 weeks
Standard audiometry Sound field testing will be conducted in quiet with the subject sitting one meter from the loudspeakers. The volume control of the device shall be set at the most comfortable level for the sound field tests.
Speech performance in quiet with both ways of fitting
时间窗: 12 weeks
Speech audiometry in quiet The word recognition score will be measured in quiet. The test in quiet shall be conducted with the speaker at 0° azimuth (S0) with 1 meter distance from the center of the subject's head and at ear level. Spanish speech material (recorded): Cardenas and Marrero balanced word list. 100% will be considered as the maximum outcome
Subjective satisfaction measured with SSQ12
时间窗: 12 weeks
Questionnaires A hearing specific questionnaire will be filled out per participant, in 3 conditions, unaided (preoperatively), aided with BB in fitting condition A and aided with Bonebridge in fitting condition B. The Spanish version of Speech, Spatial, and Qualities of Hearing Questionnaire with 12 items (SSQ12) will be used. It is designed to measure self-reported auditory disability across a wide variety of domains, reflecting the reality of hearing in the everyday world. It takes approximately 5 minutes to complete. It consists of 12 questions that the subjects score on a scale from 0 (not at all) to 10 (perfectly). The total score is the sum of all items and can range between 0 and 120. The higher score, the better outcomes.
Subjective satisfaction assessed by a custom made questionnaire
时间窗: 12 weeks
Questionnaires A hearing specific questionnaire will be filled out per participant, in 3 conditions, unaided (preoperatively), aided with BB in fitting condition A and aided with Bonebridge in fitting condition B. A third, custom made questionnaire, will be filled out at two timepoints, after the acute test of condition A \& B in visit 2 and at the last visit. The questionnaire will ask the patient what condition A or B was preferred in visit 2. At the last visit (for the unexperienced users, and in the only visit for the experienced users) the patient will be asked what condition was preferred in several listening scenarios during the trial time.
Speech performance in noise with both ways of fitting
时间窗: 12 weeks
Speech audiometry in noise For measuring speech intelligibility in noise the International Matrix Test is used with fixed noise level at 65 dB SPL and speech level at 65 dB SPL from S0N0 (speech and noise coming from the front). One list comprises 20 sentences with 5 words in each sentence. A negative value means, better performance
Subjective satisfaction evaluated by means of APHAB
时间窗: 12 weeks
Questionnaires A hearing specific questionnaire will be filled out per participant, in 3 conditions, unaided (preoperatively), aided with BB in fitting condition A and aided with Bonebridge in fitting condition B. The Spanish version the Abbreviated Profile of Hearing Aid Benefit (APHAB) will be used. It is a 24-item questionnaire derived from the original 66-item Profile of Hearing Aid Benefit. The self-assessment instrument evaluates hearing impairment in real-life situations with and without hearing aids. Participants have to rate how often a given statement is true in their daily life, based on the following seven response alternatives: always (99%), almost always (87%), generally (75%), half-the-time (50%), occasionally (25%), seldom (12%) and never (1%). In the first three subscales, higher scores suggest less hearing disability, while lower scores indicate less hearing disability in the aversiveness subscale. The APHAB typically requires 10 minutes or less to complete.
次要结局
未报告次要终点
研究者
Miryam Calvino
Investigator, Member of the Research Department
Hospital Universitario La Paz