Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs

NCT ID: NCT02156167

Last Updated: 2016-07-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech reception threshold in noise, to evaluate the usability of the Codacs™ Fitting Software, to evaluate the quality of life with the Nucleus® CP810 Sound Processor for the Codacs™ system, to collect long term data, to evaluate the acceptance criteria of the postoperative Codacs™ system test and to evaluate the usability of the Codacs™ Test System.

Detailed Description

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Conditions

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Severe to Profound Mixed Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CP810 and Codacs™Test System

Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)

Group Type EXPERIMENTAL

CP810 and Codacs™ system test

Intervention Type DEVICE

Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)

Interventions

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CP810 and Codacs™ system test

Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects implanted with a Cochlear C-DACS investigational device

Exclusion Criteria

* Participation in another medical device study
* Unwillingness or inability of the subject to comply with the study requirements
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ernst von Wallenberg, PhD

Role: STUDY_DIRECTOR

Cochlear

Locations

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Hannover Medical School

Hanover, Lower Saxony, Germany

Site Status

Countries

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Germany

References

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Lenarz T, Zwartenkot JW, Stieger C, Schwab B, Mylanus EA, Caversaccio M, Kompis M, Snik AF, D'hondt C, Mojallal H. Multicenter study with a direct acoustic cochlear implant. Otol Neurotol. 2013 Sep;34(7):1215-25. doi: 10.1097/MAO.0b013e318298aa76.

Reference Type BACKGROUND
PMID: 23921930 (View on PubMed)

Lenarz T, Verhaert N, Desloovere C, Desmet J, D'hondt C, Gonzalez JC, Kludt E, Macias AR, Skarzynski H, Van de Heyning P, Vyncke C, Wasowski A. A comparative study on speech in noise understanding with a direct acoustic cochlear implant in subjects with severe to profound mixed hearing loss. Audiol Neurootol. 2014;19(3):164-74. doi: 10.1159/000358004. Epub 2014 Feb 18.

Reference Type BACKGROUND
PMID: 24556905 (View on PubMed)

Other Identifiers

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CEL5441

Identifier Type: -

Identifier Source: org_study_id

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