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

Hearing Loss Clinical Trial

Official title:

Comparison of Fitting Methods Using Cochlear Clinical Care Innovation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228148
• Other study ID #: CEL5332
• Status: Completed
• Phase: N/A
• First received: August 27, 2014
• Last updated: January 9, 2018
• Start date: November 2014
• Est. completion date: December 15, 2017

Study information

• Verified date: January 2018
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• NFS
Cochlear Nucleus Fitting Software
• CSS
Cochlear Nucleus Custom SoundTM Suite

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	numerics data GmbH

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)