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Clinical Trials/NCT01824563
NCT01824563
Completed
N/A

Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing.

Advanced Bionics AG1 site in 1 country30 target enrollmentJune 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Severe-to-profound Hearing Loss
Sponsor
Advanced Bionics AG
Enrollment
30
Locations
1
Primary Endpoint
CI aided word recognition scores in quiet and noise.
Status
Completed
Last Updated
8 years ago

Overview

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-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode. The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a variety of contemporary surgical techniques that have been shown to enable easy insertion and to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus Mid-Scala has already shown to be a safe electrode and promising post op clinical results in the premarketing study that is now in the final stage.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
August 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Outcomes

Primary Outcomes

CI aided word recognition scores in quiet and noise.

Time Frame: 12 months post activation

CI aided word recognition scores in quiet and noise.

Study Sites (1)

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