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

Completed

• Conditions: Severe-to-profound Hearing Loss
• Interventions: Other: Observational study

• Registration Number: NCT01824563
• Lead Sponsor: Advanced Bionics AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Study Start: 2013-06
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study population	Observational study	Subjects will need to be standard CI patients acording to national implant criteria and the study criteria.

Primary Outcome Measures

Name	Time	Method
CI aided word recognition scores in quiet and noise.	12 months post activation	CI aided word recognition scores in quiet and noise.

Trial Locations

Locations (1)

Leiden University Medical Centre; 🇳🇱 Leiden, Netherlands