Status:
RECRUITING
Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
Lead Sponsor:
Hospital Universitario La Paz
Collaborating Sponsors:
MED-EL Elektromedizinische Geräte GesmbH
Conditions:
Bone Conduction Deafness
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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). ...
Detailed Description
1. The objective of this study was to verify the influence of different fitting procedures 2. Duration of investigation: Unexperienced users group: Each subject will be actively involved in the st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 27 2026
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06039332
Start Date
June 27 2023
End Date
June 27 2026
Last Update
September 15 2023
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Spain, 28046