Status:
COMPLETED
Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users
Lead Sponsor:
Dominik Riss
Conditions:
Bone Conduction Deafness
Hearing Loss, Conductive
Eligibility:
All Genders
13-99 years
Phase:
NA
Brief Summary
Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria. Patients will be asked to wear an adhesive ...
Detailed Description
Phase 1 Patients will be fitted with an adhesive bone conduction device and asked to fill out two questionnaires. They will then wear the device for 30-60 minutes and decide if they want to wear the d...
Eligibility Criteria
Inclusion
- Patients implanted with a Bonebridge device and are active users
- Unilateral and/or bilateral conductive hearing loss (CHL)
- Subjects aged 13 years or older
- Capable of the German language
- Willingness and ability to perform all tests required for the study
- Signed, and dated informed consent before the start of any study specific procedure
Exclusion
- Pregnancy or breastfeeding
- Patient is intolerant of the materials as described by Manufacturer's IFU
- Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
- Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
- Patient presents with retrocochlear, or central auditory disorder.
- any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03766152
Start Date
November 1 2018
End Date
December 13 2019
Last Update
January 2 2020
Active Locations (1)
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1
MUW, AKH
Vienna, Austria, 1090