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

Severe to Profound Mixed Hearing Loss Clinical Trial

Official title:

Clinical Validation of the Nucleus® CP810 Sound Processor for the Codacs™ System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156167
• Other study ID #: CEL5441
• Status: Completed
• Phase: N/A
• First received: June 3, 2014
• Last updated: July 20, 2015
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Mixed Conductive-Sensorineural
• Severe to Profound Mixed Hearing Loss

Intervention

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

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Lenarz T, Verhaert N, Desloovere C, Desmet J, D'hondt C, González JC, Kludt E, Macías 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aided speech reception thresholds in noise measured by signal to noise ratio for 50% correct scores with the Oldenburger Sentence test	Description: Noise level is fixed at 65 decibel sound pressure level and speech level is varied adaptively based on number of words the patient understood in previous sentence.	3 months after initial upgraded fitting	No