NCT02228148

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

August 27, 2014

Last Update Submit

January 9, 2018

Conditions

Hearing Loss

Keywords

Post linguistically deafness, severe to profound deafness

Outcome Measures

Primary Outcomes (10)

  • 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%).

    3 months after implantation

  • 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%).

    6 months after implantation

  • 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%).

    9 months after implantation

  • 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%).

    12 months after implantation

  • 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%).

    15 months after implantation

  • 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.

    3 months after implantation

  • 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.

    6 months after implantation

  • 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.

    9 months after implantation

  • 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.

    12 months after implantation

  • 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.

    15 months after implantation

Secondary Outcomes (11)

  • 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)

    before first fitting post-implantation (1 day)

  • 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)

    3 months after implantation

  • 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)

    6 months after implantation

  • 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)

    9 months after implantation

  • 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)

    12 months after implantation

  • +6 more secondary outcomes

Study Arms (2)

NFS

EXPERIMENTAL

Cochlear Nucleus Fitting Software

Device: NFS

CSS

ACTIVE COMPARATOR

Cochlear Nucleus Custom SoundTM Suite

Device: CSS

Interventions

NFSDEVICE

Cochlear Nucleus Fitting Software

NFS
CSSDEVICE

Cochlear Nucleus Custom SoundTM Suite

CSS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Deutsches HörZentrum Hannover der HNO-Klinik der MHH

Hanover, Lower Saxony, 30625, Germany

Location

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

Kiel, Schleswig-Holstein, 24105, Germany

Location

Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bart Volckaerts, PhD

    Cochlear

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 28, 2014

Study Start

November 1, 2014

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

January 10, 2018

Record last verified: 2018-01

Locations

CH(1)DE(2)