Usability of the CP950 Sound Processor

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: CP950 Sound Processor; Device: Wireless programming pod

• Registration Number: NCT02727842
• Lead Sponsor: Cochlear

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.

Study Timeline

• Study First Submitted: 2016-03-17
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-05
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2018-07-16
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-14
• Last Update Submitted: 2018-08-14
• Results First Posted: 2018-09-12
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
2. 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
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Ability to use 2 zinc air batteries with their current program (MAP)
5. Willingness to participate in and to comply with all requirements of the protocol for the duration of the trial

Exclusion criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Implant types not currently supported by the CP950 sound processor (i.e.,N22)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	CP950 Sound Processor	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
Treatment group	Wireless programming pod	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

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire	1 month	To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users.; Specifically: 1. Patient Reported Hearing Performance; 2. Retention \& Comfort; 3. Ease of use; 4. Use of remote controls; 5. Look \& feel; 6. Reliability; 7. Maintenance \& use

Trial Locations

Locations (3)

Hearts for Hearing; 🇺🇸 Oklahoma City, Oklahoma, United States

Rocky Mountain Ear Center; 🇺🇸 Englewood, Colorado, United States

NYU; 🇺🇸 New York, New York, United States