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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00331539

Enrollment

Registered

2006-05-31

Start date

2006-05-31

Completion date

2008-06-30

Last updated

2006-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

DEVICECochlear Implant

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

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 \-

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Israel

Contacts

Primary ContactMichal Luntz, MD

michal.luntz@b-zion.org.il972-4-8359544

Backup ContactTalma Shpak, MA

thalma@netvision.net.il972-4-8359830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026