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

NCT01824563 | Completed DMC

• 1 other identifier: AB-RCA-01-2013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• CI aided word recognition scores in quiet and noise.

  CI aided word recognition scores in quiet and noise.

  12 months post activation

Other Outcomes (1)

• Evaluate the potential of preservation of residual low frequency hearing

  12 months

Study Arms (1)

study population

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

Other: Observational study

Interventions

Observational study OTHER

study population

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

individuals with severe-to-profound hearing loss

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Bionics AG: lead

Study Sites (1)

Leiden University Medical Centre

Leiden, 2300 RC, Netherlands

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Johan Frijns, Prof Dr

  LUMC - Department of ORL-HNS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: April 5, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

NL (1)