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

Phase 4

• Conditions: Hearing Loss

• Registration Number: NCT00331539
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

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.

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 Timeline

• Status Verified: 2005-07
• Study Start: 2006-05
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Last Update Submitted: 2006-10-06
• Last Update Posted: 2006-10-09
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Bnai Zion MC; 🇮🇱 Haifa, Israel