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

Cochlear

Status: Completed

Conditions: Severe to Profound Mixed Hearing Loss

Treatments: Device: CP810 and Codacs™ system test

Study type: Interventional

Funder types: Industry

Identifiers

NCT02156167

CEL5441

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

CP810 and Codacs™Test System

Experimental group

Description:

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

Treatment:

Device: CP810 and Codacs™ system test