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

Overview

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.

Full Title of Study: “Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2017

Interventions

  • Other: Observational study

Arms, Groups and Cohorts

  • study population
    • Subjects will need to be standard CI patients acording to national implant criteria and the study criteria.

Clinical Trial Outcome Measures

Primary Measures

  • CI aided word recognition scores in quiet and noise.
    • Time Frame: 12 months post activation
    • CI aided word recognition scores in quiet and noise.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Advanced Bionics AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Johan Frijns, Prof Dr, Principal Investigator, LUMC – Department of ORL-HNS

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