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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00331539
• Other study ID #: BnaiZionMC-06-ML-002-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: May 30, 2006
• Last updated: October 6, 2006
• Start date: May 2006
• Est. completion date: June 2008

Study information

• Verified date: July 2005
• Source: Bnai Zion Medical Center
• Contact: Michal Luntz, MD
• Phone: 972-4-8359544
• Email: michal.luntz[@]b-zion.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• Cochlear Implant

Locations

Country	Name	City	State
Israel	Bnai Zion MC	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	To find possible changes over time in NRT thresholds (12 months period).
Primary	To find possible changes over time in ESRT thresholds (9 months period) starting 3 months post-op.