Actively Recruiting
Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
Led by Hospital Universitario La Paz · Updated on 2023-09-15
1
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitario La Paz
Lead Sponsor
M
MED-EL Elektromedizinische Geräte GesmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Unilateral and/or bilateral conductive or mixed hearing loss within the device indication range
- Implanted with a BCI602 device
- Willingness and ability to use the hearing system and perform all study tests
- Signed and dated informed consent before any study procedure
- Native speaker
You will not qualify if you...
- Profound unilateral sensorineural hearing loss (single sided deafness)
- Retrocochlear or central auditory disorders
- Physical, psychological, or emotional disorders interfering with test or rehabilitation
- Fluctuating hearing loss
- Not meeting one or more inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
Research Team
J
Javier Gavilan
CONTACT
M
Miryam Calvino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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