N6 Input Processing in Traditional CI Recipients

A study testing Nucleus 6 Sound Processor in people with Hearing Loss, run by Cochlear at 4 sites in United States.

Completed

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

Trial summary

The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Hearing Loss
What is being tested?: Nucleus 6 Sound Processor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 4 sitesUnited States
Study dates: May 2014to Jan 2015
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
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Greater than 12 years
Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
Minimum of 3 months experience with the N5 sound processor
Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
Native English speaker
Willingness to participate in and comply with all requirements of the protocol

Who cannot join

Unrealistic expectations
Unwillingness to comply with investigational requirements of the protocol
Additional handicaps that would prevent or restrict participation in the evaluations

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Center for Hearing and Balance
Chesterfield, Missouri, 63017
Rocky Mountain Ear Center
Englewood, Colorado, 80113
Houston Ear Research Foundation
Houston, Texas, 77074
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Investigation of Nucleus 6 Sound Processor Input Processing in Cochlear Implant Recipients.

Conditions: Hearing Loss
Being tested: Nucleus 6 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.

Nucleus 6 Sound ProcessorDevice

Study groups in NCT02239263
Study group	Role	What they receive
N6 Input Processing Features	Experimental	Not described Receives: Device: Nucleus 6 Sound Processor

What is being measured

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

Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction
Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
Measured: Visit 2, 1 month after baseline testing
Endpoint 2: Evaluation of SCAN
Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
Measured: Visit 2, 1 month after baseline testing

Timeline

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

May 2014Jan 2015

First posted12 Sep 2014 (estimated)
Study startMay 2014
Primary completionNov 2014
Study completionJan 2015

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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02239263
Sponsor's protocol ID: CAM5555
Status last verified: Feb 2021
First submitted: 10 Sep 2014
Last updated: 26 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Enrolling by invitation
Self-monitoring of Hearing Aids Using Artificial Intelligence
Hearing Loss
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus

All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Nucleus 6 Sound Processor Input Processing in Cochlear Implant Recipients.
ClinicalTrials.gov ID: NCT02239263
Acronym / sponsor ID: CAM5555
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Nov 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 12 Sep 2014 (estimated)
Results: Posted 26 Feb 2021

Clinical summary

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

Study design

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

Arm	Type	Receives
N6 Input Processing Features	Experimental	Device: Nucleus 6 Sound Processor

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Greater than 12 years
Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
Minimum of 3 months experience with the N5 sound processor
Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
Native English speaker

Key exclusion criteria (3 listed)

Unrealistic expectations
Unwillingness to comply with investigational requirements of the protocol
Additional handicaps that would prevent or restrict participation in the evaluations

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
Nucleus 6 Sound Processor	Device	N6 Input Processing Features

Primary outcome

Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction
Time frame: Visit 2, 1 month after baseline testing
Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
Endpoint 2: Evaluation of SCAN
Time frame: Visit 2, 1 month after baseline testing
Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.

Results and safety

Results posted to the registry on 26 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
N6 Input Processing Features - SNR-NR & SCAN	40	34

Primary outcome: Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction

Time frame: Visit 2, 1 month after baseline testing. Mean (95% Confidence Interval). Unit: difference in percent correct scores

Measure	N6 Input Processing Features - SNR n = 34
Value	-5.9 (-9.6 to -2.2)

Primary outcome: Endpoint 2: Evaluation of SCAN

Time frame: Visit 2, 1 month after baseline testing. Mean (95% Confidence Interval). Unit: difference in percent correct scores

Measure	N6 Input Processing Features n = 34
Value	-26.9 (-33 to -20.9)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
N6 Input Processing Features - SNR-NR	0 of 40 (0%)	0 of 40 (0%)	Not reported
N6 Input Processing Features - SCAN	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hearing Loss

Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Enrolling by invitation
Self-monitoring of Hearing Aids Using Artificial Intelligence
Hearing Loss
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus

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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Nucleus 6 Sound Processor in people with Hearing Loss, run by Cochlear at 4 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 6 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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 26 Feb 2021). 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?

Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction (time frame: Visit 2, 1 month after baseline testing). The study lists 2 primary outcomes in all. 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 NCT02239263.

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 26 Feb 2021; AzTrials last refreshed its copy on 27 Oct 2026.