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


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


  • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.