Hearing LossC950NCT02727842

Usability of the CP950 Sound Processor

A study testing CP950 Sound Processor and Wireless programming pod in people with Hearing Loss, run by Cochlear at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients. Read more about this study

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: Hearing Loss
What is being tested?: CP950 Sound Processor and Wireless programming pod
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 3 sitesUnited States
Study dates: Apr 2016to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Rocky Mountain Ear Center
Englewood, Colorado, 80013
NYU
New York, New York, 10523
Hearts for Hearing
Oklahoma City, Oklahoma, 73112

Other trials in United States

About this study

Official title: Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users

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

Read the 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.

Conditions: Hearing Loss
Being tested: CP950 Sound Processor, Wireless programming pod
Keywords: cochlear implant, Sound Processor
Medical subject headings: Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02727842
Study group	Role	What they receive
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 Receives: Device: CP950 Sound Processor; Device: Wireless programming pod

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Dec 2016

First posted5 Apr 2016 (estimated)
Study startApr 2016
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02727842
Sponsor's protocol ID: CAM5657
Acronym: C950
Status last verified: Aug 2018
First submitted: 17 Mar 2016
Last updated: 12 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Hearing Loss, Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness

All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users
ClinicalTrials.gov ID: NCT02727842
Acronym / sponsor ID: C950 / CAM5657
Conditions: Hearing Loss
Keywords: cochlear implant, Sound Processor
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Study start: Apr 2016 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 5 Apr 2016 (estimated)
Results: Posted 12 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment group	Experimental	Device: CP950 Sound Processor, Device: Wireless programming podAll 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

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CP950 Sound ProcessorAn off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor	Device	Treatment group
Wireless programming podThe CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software	Device	Treatment group

Primary outcome

Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire
Time frame: 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

Results and safety

Results posted to the registry on 12 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group	30	30

Primary outcome: Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire

Time frame: 1 month. Count of participants. Unit: Participants

Measure	All Subjects n = 30
Satisfiaction with retention accessory	22
Satisfaction with hearing performance	28
Agreed sound processor is comfortable	27
Agreed sound processor is easy to use	28
Satisfied with look and feel of processor	27
Agreed sound processor was reliable	29
Agreed sound processor is easy to clean	24

Population analysed: All enrolled subjects

Adverse events

Time frame: 1 year. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30

Limitations and caveats (from the sponsor): Short-term usability study, in a small population

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hearing Loss

Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Hearing Loss, Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CP950 Sound Processor and Wireless programming pod in people with Hearing Loss, run by Cochlear at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02727842.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.