NCT00331539

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

October 9, 2006

Status Verified

July 1, 2005

First QC Date

May 30, 2006

Last Update Submit

October 6, 2006

Conditions

Hearing Loss

Keywords

Cochlear implantthreshold (T) measurementcomfort (C) levelprofound hearing lossauditory stimuliprofound hearing loss patients eligible for the study should be capable of providing reliablesubjective counted thresholds and has good NRT recordings, implanted withthe Nucleus Freedom system

Outcome Measures

Primary Outcomes (3)

  • 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.

Interventions

Cochlear ImplantDEVICE

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion MC

Haifa, 31048, Israel

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Officials

  • Michal Luntz, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Luntz, MD

CONTACT

972-4-8359544michal.luntz@b-zion.org.il

Talma Shpak, MA

CONTACT

972-4-8359830thalma@netvision.net.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

May 1, 2006

Study Completion

June 1, 2008

Last Updated

October 9, 2006

Record last verified: 2005-07

Locations

IL(1)