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

Comparison of Fitting Methods Using Cochlear Clinical Care Innovation

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: NFS; Device: CSS

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Deutsches HörZentrum Hannover der HNO-Klinik der MHH
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie
• Switzerland
  • Kanton Zurich
    • Zurich, Kanton Zurich, Switzerland, 8091
      • Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NFS; Cochlear Nucleus Fitting Software	Device: NFS; Cochlear Nucleus Fitting Software
Active Comparator: CSS; Cochlear Nucleus Custom SoundTM Suite	Device: CSS; Cochlear Nucleus Custom SoundTM Suite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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)	15 months after implantation
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire	after each fitting (4 weeks after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire	after each fitting (3 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire	after each fitting (6 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire	after each fitting (9 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire	after each fitting (12 months after implantation)

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: numerics data GmbH
• Investigators: Study Director: Bart Volckaerts, PhD, Cochlear

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Post linguistically deafness, severe to profound deafness
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: CEL5332