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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02228148
Date of registration:	27/08/2014
Prospective Registration:	Yes
Primary sponsor:	Cochlear
Public title:	Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)
Scientific title:	Comparison of Fitting Methods Using Cochlear Clinical Care Innovation
Date of first enrolment:	November 2014
Target sample size:	48
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02228148
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Germany	Switzerland

Contacts

Name:	Bart Volckaerts, PhD
Address:
Telephone:
Email:
Affiliation:	Cochlear

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hearing Loss

Intervention(s)

Device: CSS

Device: NFS

Primary Outcome(s)

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds [Time Frame: 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 [Time Frame: 9 months after implantation]

Secondary Outcome(s)

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]

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)]

Secondary ID(s)

CEL5332

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

numerics data GmbH

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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