Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant

October 6, 2006 updated by: Bnai Zion Medical Center

Cochlear implants require programming on an individual basis to provide appropriate levels of electrical stimulation. This program, or "map", is placed in the speech processor of the cochlear implant. Success of implantation largely depends on the adequacy of this map. Cochlear implant fitting remains a difficult challenge in congenitally or pre-linguistically deafened children. It requires competence of experienced audiologists with expertise in behavioral techniques for hearing function assessment.Our goal is to establish the offset correlation between objective measurements (NRT and ESRT) and the behavioral measurements of T & Cs in different stimulation rates in the Freedom SP System.

Study Overview

Status

Unknown

Conditions

Hearing Loss

Intervention / Treatment

Device: Cochlear Implant

Detailed Description

An open trail. The implantees will go through their routine programming sessions after implantation, the specified data will be collected and analyzed in order to establish the offset correlation which we seek for.

Study Type

Interventional

Enrollment

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Haifa, Israel, 31048
    - Recruiting
    - Bnai zion MC
    - Contact:
      
      Michal Luntz, MD
      
      Phone Number: 972-4-8359544
      
      Email: michal.luntz@b-zion.org.il
    - Principal Investigator:
      
      Michal Luntz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:Patients eligible for the study should be capable of providing reliable subjective counted thresholds (e.g. children older than 12 years of age at CI or adults) and has good NRT recordings, implanted with the Nucleus Freedom system

Exclusion Criteria:Implantees With any other serious illness, Who can not give a reliable subjective counted thresholds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To find possible correlation between behavioral counted T & C levels at different stimulation rates and NRT thresholds using the Auto NRT and ESRT over time, from switch on up to 12 months period.
To find possible changes over time in NRT thresholds (12 months period).
To find possible changes over time in ESRT thresholds (9 months period) starting 3 months post-op.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Investigators

Principal Investigator: Michal Luntz, MD, Head of the E.N.T department head and neck surgery Bnai Zion MC ISRAEL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion

December 7, 2022

Study Completion

June 1, 2008

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (Estimate)

May 31, 2006

Study Record Updates

Last Update Posted (Estimate)

October 9, 2006

Last Update Submitted That Met QC Criteria

October 6, 2006

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BnaiZionMC-06-ML-002-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.