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

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.

Study Overview

• Status: Completed
• Conditions: Severe-to-profound Hearing Loss
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands, 2300 RC
    • Leiden University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

individuals with severe-to-profound hearing loss

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study population; Subjects will need to be standard CI patients acording to national implant criteria and the study criteria.	Other: Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CI aided word recognition scores in quiet and noise.	CI aided word recognition scores in quiet and noise.	12 months post activation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the potential of preservation of residual low frequency hearing	Evaluate the difference in Pure tone thresholds pre and post implantation in the low frequencies.	12 months

Collaborators and Investigators

• Sponsor: Advanced Bionics AG
• Investigators: Principal Investigator: Johan Frijns, Prof Dr, LUMC - Department of ORL-HNS

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: March 22, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: AB-RCA-01-2013