Evaluating the Benefits of BONEBRIDGE Hearing System with Different Fitting Strategies
Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
This study is testing which fitting method for the BONEBRIDGE hearing system helps people with conductive hearing loss hear better and feel more satisfied with the device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario La Paz Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06039332 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the audiological performance and subjective satisfaction of patients with conductive hearing loss using the BONEBRIDGE (BCI602) hearing system. Participants will be fitted with the device using two different fitting algorithms, DSL v5 and DSL-BCD, to determine which provides better outcomes. The study will involve both inexperienced and experienced users, with evaluations conducted over a period of 4-6 weeks for new users and a single visit for those already implanted. The design is a prospective two-period crossover, allowing each participant to serve as their own control.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unilateral or bilateral conductive or mixed hearing loss who are implanted with a BCI602 device.
Not a fit: Patients with profound unilateral sensorineural hearing loss or other specific auditory disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance hearing outcomes and quality of life for patients with conductive hearing loss.
How similar studies have performed: While the specific application of the DSL-BCD algorithm with the BONEBRIDGE system is novel, similar studies have shown promising results with different fitting strategies in hearing devices.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madrid
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Javier Gavilan
- Email: javier.gavilan@salud.madrid.org
- Phone: +34917270000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.