CClinicalTrials.gg
Status unknownNCT00331539Updated Oct 9, 2006

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

A Phase 4 interventional study of Cochlear Implant in Hearing Loss, sponsored by Bnai Zion Medical Center. Status unknown at 1 site in Israel. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-10-09.

Sponsored by Bnai Zion Medical Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hearing Loss

Keywords

  • 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
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Bnai Zion Medical Center is the lead sponsor of 102 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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

-

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

-

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants

Interventions

  • DeviceCochlear Implant
06

What researchers measure

Primary outcomes

  1. 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.

  2. To find possible changes over time in NRT thresholds (12 months period).

  3. To find possible changes over time in ESRT thresholds (9 months period) starting 3 months post-op.

07

Study locations

1 of 1 sites recruiting
  • Bnai Zion MC
    Haifa, 31048, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00331539
Lead sponsor
Bnai Zion Medical Center
First posted
May 31, 2006
Start date
May 2006
Completion
Jun 2008
Last update
Oct 9, 2006

Study contacts

Michal Luntz, MD
Contact
michal.luntz@b-zion.org.il
972-4-8359544
Talma Shpak, MA
Contact
thalma@netvision.net.il
972-4-8359830
Michal Luntz, MD
principal investigator · Head of the E.N.T department head and neck surgery Bnai Zion MC ISRAEL
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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