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

Purpose

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.

Condition	Intervention	Phase
Hearing Loss	Device: Cochlear Implant	Phase IV

Genetics Home Reference related topics:

nonsyndromic deafness

MedlinePlus related topics:

Hearing Disorders and Deafness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:

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.

Estimated Enrollment:	20
Study Start Date:	May 2006
Estimated Study Completion Date:	June 2008

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

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

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331539

Contacts


Contact: Michal Luntz, MD	972-4-8359544	michal.luntz@b-zion.org.il

Contact: Talma Shpak, MA	972-4-8359830	thalma@netvision.net.il

Locations


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

Sponsors and Collaborators

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

More Information

Study ID Numbers:	BnaiZionMC-06-ML-002-CTIL
First Received:	May 30, 2006
Last Updated:	October 6, 2006
ClinicalTrials.gov Identifier:	NCT00331539
Health Authority:	Israel: Ministry of Health

Keywords provided by Bnai Zion Medical Center:

Cochlear implant

threshold (T) measurement

comfort (C) level

profound hearing loss

auditory stimuli

profound hearing loss patients eligible for the study should be capable of providing reliable

subjective counted thresholds and has good NRT recordings, implanted with

the Nucleus Freedom system

Study placed in the following topic categories:

Signs and Symptoms

Sensation Disorders

Hearing Disorders

Deafness

Otorhinolaryngologic Diseases

Neurologic Manifestations

Hearing Loss

Ear Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Bnai Zion Medical Center
Information provided by:	Bnai Zion Medical Center
ClinicalTrials.gov Identifier:	NCT00331539