Back to resultsClinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
Primary Purpose
Severe to Profound Mixed Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CP810 and Codacs™ system test
Sponsored by
About this trial
This is an interventional treatment trial for Severe to Profound Mixed Hearing Loss focused on measuring Otosclerosis, cochlear implant, acoustic stimulation
Eligibility Criteria
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
Sites / Locations
- Hannover Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CP810 and Codacs™Test System
Arm Description
Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)
Outcomes
Primary Outcome Measures
Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test
The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions.
Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02156167
Brief Title
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
Official Title
Clinical Validation of the Nucleus® CP810 Sound Processor for the Codacs™ System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe to Profound Mixed Hearing Loss
Keywords
Otosclerosis, cochlear implant, acoustic stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CP810 and Codacs™Test System
Arm Type
Experimental
Arm Description
Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)
Intervention Type
Device
Intervention Name(s)
CP810 and Codacs™ system test
Intervention Description
Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)
Primary Outcome Measure Information:
Title
Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test
Description
The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions.
Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810).
Time Frame
3 months after initial upgraded fitting
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernst von Wallenberg, PhD
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23921930
Citation
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.
Results Reference
background
PubMed Identifier
24556905
Citation
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.
Results Reference
background
Learn more about this trial
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
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