Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario La Paz
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fitting of the audioprocessor with the auditory implant BCI602
Treatment groups
1 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hospital Universitario La Paz
Lead sponsor
MED-EL Elektromedizinische Geräte GesmbH
Collaborator
Source ClinicalTrials.gov