Usability of the CP950 Sound Processor

NCT02727842 | Completed Results FDA Device

• 1 other identifier: CAM5657
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hearing Loss

Keywords

cochlear implant; Sound Processor

Outcome Measures

Primary Outcomes (1)

• 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: 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

  1 month

Study Arms (1)

Treatment group

EXPERIMENTAL

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; Device: Wireless programming pod

Interventions

CP950 Sound Processor DEVICE

An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor

Treatment group

Wireless programming pod DEVICE

The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software

Treatment group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cochlear: lead

Study Sites (3)

Rocky Mountain Ear Center

Englewood, Colorado, 80013, United States

Location

NYU

New York, New York, 10523, United States

Location

Hearts for Hearing

Oklahoma City, Oklahoma, 73112, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Short-term usability study, in a small population

Results Point of Contact

• Title: Kimberly Nix, Clinical Project Manager
• Organization: Cochlear Americas

knix@cochlear.com

303-264-2340

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: April 5, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 12, 2018
• Results First Posted: September 12, 2018

Record last verified: 2018-08

Locations

US (3)