Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies (NCT06039332) | Clinical Trial Compass
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Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
Spain1 participantsStarted 2023-06-27
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Audiological performance with both ways of fitting
Timeframe: 12 weeks
2
Speech performance in quiet with both ways of fitting
Timeframe: 12 weeks
3
Speech performance in noise with both ways of fitting
Timeframe: 12 weeks
4
Subjective satisfaction measured with SSQ12
Timeframe: 12 weeks
5
Subjective satisfaction evaluated by means of APHAB
Timeframe: 12 weeks
6
Subjective satisfaction assessed by a custom made questionnaire