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Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)

Primary Purpose

Hearing Loss

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

NFS

CSS

Sponsored by

Cochlear

About this trial

This is an interventional supportive care trial for Hearing Loss focused on measuring Post linguistically deafness, severe to profound deafness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Deutsches HörZentrum Hannover der HNO-Klinik der MHH
Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NFS

CSS

Arm Description

Cochlear Nucleus Fitting Software

Cochlear Nucleus Custom SoundTM Suite

Outcomes

Primary Outcome Measures

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Secondary Outcome Measures

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Full Information

NCT ID

First Posted

August 27, 2014

Last Updated

January 9, 2018

Sponsor

Cochlear

Collaborators

numerics data GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02228148

Brief Title

Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)

Official Title

Comparison of Fitting Methods Using Cochlear Clinical Care Innovation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

December 15, 2017 (Actual)

Study Completion Date

December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cochlear

Collaborators

numerics data GmbH

4. Oversight

Data Monitoring Committee

No

5. Study Description

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) provides Cochlear Implants Recipients with the same hearing outcome as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles adjustments, operations which are familiar to anyone who has used an audio player.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss

Keywords

Post linguistically deafness, severe to profound deafness

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NFS

Arm Type

Experimental

Arm Description

Cochlear Nucleus Fitting Software

Arm Title

CSS

Arm Type

Active Comparator

Arm Description

Cochlear Nucleus Custom SoundTM Suite

Intervention Type

Device

Intervention Name(s)

NFS

Intervention Description

Cochlear Nucleus Fitting Software

Intervention Type

Device

Intervention Name(s)

CSS

Intervention Description

Cochlear Nucleus Custom SoundTM Suite

Primary Outcome Measure Information:

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Description

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time Frame

3 months after implantation

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Description

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time Frame

6 months after implantation

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Description

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time Frame

9 months after implantation

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Description

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time Frame

12 months after implantation

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Description

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time Frame

15 months after implantation

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Description

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Time Frame

3 months after implantation

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Description

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Time Frame

6 months after implantation

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Description

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Time Frame

9 months after implantation

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Description

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Time Frame

12 months after implantation

Title

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests

Description

Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.

Time Frame

15 months after implantation

Secondary Outcome Measure Information:

Title

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Time Frame

before first fitting post-implantation (1 day)

Title

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Time Frame

3 months after implantation

Title

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Time Frame

6 months after implantation

Title

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Time Frame

9 months after implantation

Title

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Time Frame

12 months after implantation

Title

Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)

Time Frame

15 months after implantation

Title

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Time Frame

after each fitting (4 weeks after implantation)

Title

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Time Frame

after each fitting (3 months after implantation)

Title

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Time Frame

after each fitting (6 months after implantation)

Title

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Time Frame

after each fitting (9 months after implantation)

Title

Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire

Time Frame

after each fitting (12 months after implantation)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bart Volckaerts, PhD

Organizational Affiliation

Cochlear

Official's Role

Study Director

Facility Information:

Facility Name

Deutsches HörZentrum Hannover der HNO-Klinik der MHH

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital

City

Zurich

State/Province

Kanton Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)

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