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OpenTrials
Completed

NCT Number: NCT01824563

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.

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Key information

Conditions

Severe-to-profound Hearing Loss

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden University Medical Centre

Leiden, 2300 RC, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

Primary outcomes

  1. CI aided word recognition scores in quiet and noise.

    Time frame: 12 months post activation

    CI aided word recognition scores in quiet and noise.

Other outcomes

  1. Evaluate the potential of preservation of residual low frequency hearing

    Time frame: 12 months

    Evaluate the difference in Pure tone thresholds pre and post implantation in the low frequencies.

Sponsors and collaborators

Lead sponsor

Advanced Bionics AG

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2013
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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