Usability of the CP950 Sound Processor

Hearing Loss Clinical Trial

— C950  

Official title:

Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727842
• Other study ID #: CAM5657
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• CP950 Sound Processor
An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor
• Wireless programming pod
The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software

Locations

Country	Name	City	State
United States	Rocky Mountain Ear Center	Englewood	Colorado
United States	NYU	New York	New York
United States	Hearts for Hearing	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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