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

NCT01824563 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2018-01-09

No results posted yet for this study

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.

Conditions

  • Severe-to-profound Hearing Loss

Interventions

OTHER

Observational study

Sponsors & Collaborators

  • Advanced Bionics AG

    lead INDUSTRY

Principal Investigators

  • Johan Frijns, Prof Dr · LUMC - Department of ORL-HNS

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824563 on ClinicalTrials.gov