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

NCT ID: NCT01824563

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-08-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

study population

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

Observational study

Intervention Type: OTHER

Interventions

Observational study

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Bionics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johan Frijns, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

LUMC - Department of ORL-HNS

Locations

Leiden University Medical Centre

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

AB-RCA-01-2013

Identifier Type: -

Identifier Source: org_study_id