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

NCT ID: NCT00331539

Last Updated: 2006-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Hearing Loss

Keywords

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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 Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cochlear Implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Michal Luntz, MD

Role: PRINCIPAL_INVESTIGATOR

Head of the E.N.T department head and neck surgery Bnai Zion MC ISRAEL

Locations

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Bnai Zion MC

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Michal Luntz, MD

Role: CONTACT

Phone: 972-4-8359544

Email: [email protected]

Talma Shpak, MA

Role: CONTACT

Phone: 972-4-8359830

Email: [email protected]

Facility Contacts

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Michal Luntz, MD

Role: primary

Other Identifiers

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BnaiZionMC-06-ML-002-CTIL

Identifier Type: -

Identifier Source: org_study_id