Status:
COMPLETED
Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing
Lead Sponsor:
Advanced Bionics AG
Conditions:
Severe-to-profound Hearing Loss
Eligibility:
All Genders
18-100 years
Brief Summary
The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Definite Postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education.
- Local language proficiency
- Bilateral, sensorineural hearing loss
Exclusion
- Previous inner ear surgery or active middle ear pathology.
- Cochlear malformation or obstruction
- Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
- Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
- Evidence of central auditory lesion or compromised auditory nerve
- Concurrent participation in other study
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01824563
Start Date
June 1 2013
End Date
August 1 2017
Last Update
January 9 2018
Active Locations (1)
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1
Leiden University Medical Centre
Leiden, Netherlands, 2300 RC