Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
NCT02156167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2016-07-21
Summary
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.
Conditions
- Severe to Profound Mixed Hearing Loss
Interventions
- DEVICE
-
CP810 and Codacs™ system test
Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)
Sponsors & Collaborators
-
Cochlear
lead INDUSTRY
Principal Investigators
-
Ernst von Wallenberg, PhD · Cochlear
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- Germany
Study Locations
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