Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
Hospital Universitario La Paz
1 participants
Jun 27, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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
- Fluctuating hearing loss.
Exclusion Criteria3
- 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
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06039332