Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)
NCT ID: NCT02228148
Last Updated: 2018-01-10
Study Results
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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COMPLETED
NA
48 participants
INTERVENTIONAL
2014-11-30
2017-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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NFS
Cochlear Nucleus Fitting Software
NFS
Cochlear Nucleus Fitting Software
CSS
Cochlear Nucleus Custom SoundTM Suite
CSS
Cochlear Nucleus Custom SoundTM Suite
Interventions
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NFS
Cochlear Nucleus Fitting Software
CSS
Cochlear Nucleus Custom SoundTM Suite
Eligibility Criteria
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Inclusion Criteria
* Post linguistically deafened adults (≥ 18 years)
* Unilaterally implanted
* ≤ 15 years of severe to profound deafness prior to implantation
* Subjects who are capable and willing to participate in speech perception tests in local language
* Subjects who are able to provide feedback in form of a written questionnaire (e.g. Speech Spatial Hearing Qualities questionnaire)
* Subjects willing to give their consent to the study
Exclusion Criteria
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure/fitting method
* Bilateral implantation
* Hybrid-L (not supported by Nucleus Fitting Software)
* Subjects who already have hearing experience with a Cochlear Implant (e.g. reimplantation, contralateral Cochlear Implant)
* Subjects with single-sided deafness
* Known cochlea malformations
* Subjects who lost their hearing due to meningitis
18 Years
ALL
No
Sponsors
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numerics data GmbH
UNKNOWN
Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Bart Volckaerts, PhD
Role: STUDY_DIRECTOR
Cochlear
Locations
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Deutsches HörZentrum Hannover der HNO-Klinik der MHH
Hanover, Lower Saxony, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie
Kiel, Schleswig-Holstein, Germany
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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CEL5332
Identifier Type: -
Identifier Source: org_study_id
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