Acceptance of the CP950 Sound Processor

Study Overview
=================
Brief Summary
-----------------
Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.

Official Title
-----------------
Acceptance of the CP950 Sound Processor With Experienced CP810/CP910/CP920 BTE Sound Processor Users

Conditions
-----------------
Hearing Loss, Sensorineural

Intervention / Treatment
-----------------
* Device: CP950 OTE Sound processor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eighteen years of age or older At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear At least 3 months experience with the CP810,CP920 or CP910 sound processor Native speaker in the language used to assess speech perception performance Willingness to participate in and to comply with all requirements of the protocol Able to score 30% or more at +15 SNR with CI alone 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 Nucleus 22 Implant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Repeated measures, single-subject experiment. Each subject received the same treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear and at least 3 months experience with the CP810,CP920 or CP910 sound processor. | Device: CP950 OTE Sound processor<br>* CP950 is Off The Ear (OTE) Cochlear Implant Sound Processor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score. | Each subject used the Investigational device (CP950) for take home use to obtain subjective ratings. During the take home use, A subjective questionnaire was asked them to recall and rate how their hearing performance with the Investigational device CP950 OTE processor compared to their hearing performance with their own CP810, CP910 or CP920 BTE processor. Likert scale was used for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = much worse; 2 = somewhat worse; 3 = No difference; 4 = somewhat better; 5 = much better. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor . | Signal to noise ratio (measured in decibels) providing 50% speech intelligibility for sentences presented in noise to evaluate the benefit from microphone directionality with the CP950 OTE (Off the ear) sound processor. | in booth testing 1 day. | 
| Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor | Two lists of twenty sentences presented from front speaker with 4 Talker babble noise presented from rear-half speakers. Higher the percentage of correct words means better outcome. | In booth testing 1 day |