Usability of the CP950 Sound Processor

Study Overview
=================
Brief Summary
-----------------
Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.

Detailed Description
-----------------
One month protocol, with 2 study visits. The aim of the study to is to gain patient and audiologist feedback on their experience and usability with the device and wireless programming pod.

Official Title
-----------------
Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: CP950 Sound Processor
* Device: Wireless programming pod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear Subjects age 12 and older who are cognitively and developmentally able to complete all study related questionnaires as deemed by the principal investigator or delegated staff At least 3 months experience with the CP810,CP920 or CP910 sound processor Ability to use 2 zinc air batteries with their current program (MAP) Willingness to participate in and to comply with all requirements of the protocol for the duration of the trial Exclusion criteria: Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device Additional disabilities that would prevent participation in evaluations Implant types not currently supported by the CP950 sound processor (i.e.,N22)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod | Device: CP950 Sound Processor<br>* An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor<br>Device: Wireless programming pod<br>* The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users. Specifically: Patient Reported Hearing Performance Retention & Comfort Ease of use Use of remote controls Look & feel Reliability Maintenance & use | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cochlear implant, Sound Processor