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Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
Sponsor: Hospital Universitario La Paz
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1
Start Date
2023-06-27
Completion Date
2026-06-27
Last Updated
2023-09-15
Healthy Volunteers
Yes
Interventions
Fitting of the audioprocessor with the auditory implant BCI602
to compare the performance with BB system in two fitting-configurations (active comparator: DSL v5, experimental: DSL-BCD) using audiometric and subjective measures
Locations (1)
Hospital Universitario La Paz
Madrid, Spain