Status:
COMPLETED
Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)
Lead Sponsor:
Cochlear
Collaborating Sponsors:
numerics data GmbH
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation)...
Eligibility Criteria
Inclusion
- Newly implanted subjects with available Nucleus Cochlear Implants compatible with CP900 series sound processors (excluding Cochlear Nucleus Hybrid)
- 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
- Additional handicaps that would prevent participation in evaluations (e.g. visual impairment, blindness)
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02228148
Start Date
November 1 2014
End Date
December 15 2017
Last Update
January 10 2018
Active Locations (3)
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1
Deutsches HörZentrum Hannover der HNO-Klinik der MHH
Hanover, Lower Saxony, Germany, 30625
2
Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie
Kiel, Schleswig-Holstein, Germany, 24105
3
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
Zurich, Canton of Zurich, Switzerland, 8091