Hearing LossNCT04237207

Clinical Evaluation of a Cochlear Implant Sound Processor

A study testing Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software and 301-M062 sound processor & software in people with Hearing Loss and Ear Diseases, run by Advanced Bionics at 6 sites in United States.

Completed

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

Official record

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Trial summary

This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hearing Loss, Ear Diseases, Hearing Disorders
What is being tested?: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software and 301-M062 sound processor & software
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 6 sitesUnited States
Study dates: 17 Dec 2019to 15 Oct 2020
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Austin Ear, Nose & Throat Clinic
Austin, Texas, 78731
Midwest Ear Institute/St. Luke's Health System
Kansas City, Missouri, 64111
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Washington University Medical Center
St Louis, Missouri, 63110
Tampa Bay Hearing and Balance Center
Tampa, Florida, 33606

Other trials in United States

About this study

Official title: Evaluation of AutoSense OS on a Cochlear Implant Sound Processor Programmed With Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System

Read the detailed description

The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.

Conditions: Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
Being tested: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software, 301-M062 sound processor & software
Medical subject headings: Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases

What participants receive

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

Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & softwareDevice
Control cochlear implant sound processor
301-M062 sound processor & softwareDevice
New cochlear implant sound processor

Study groups in NCT04237207
Study group	Role	What they receive
Aidable Residual Hearing (ARH) Cohort	Other	Control Device followed by experimental Device. Receives: Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software; Device: 301-M062 sound processor & software
Electric Only (EO) Cohort	Other	Control Device followed by experimental Device. Receives: Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software; Device: 301-M062 sound processor & software

What is being measured

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

Speech Recognition in Quiet
The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Measured: 1 Day

Secondary outcomes (2)

Speech Recognition in Noise
Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Measured: 1 Day
Increased Speech Recognition in Noise
Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Measured: 1 Day

Timeline

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

17 Dec 201915 Oct 2020

First posted23 Jan 2020
Study start17 Dec 2019
Primary completion15 Oct 2020
Study completion15 Oct 2020

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04237207
Sponsor's protocol ID: CR1218
Status last verified: Apr 2022
First submitted: 7 Jan 2020
Last updated: 13 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of AutoSense OS on a Cochlear Implant Sound Processor Programmed With Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System
ClinicalTrials.gov ID: NCT04237207
Acronym / sponsor ID: CR1218
Conditions: Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Advanced BionicsIndustry (pharma, biotech, devices)
Study start: 17 Dec 2019 (actual)
Primary completion: 15 Oct 2020 (actual)
Study completion: 15 Oct 2020 (actual)
First posted: 23 Jan 2020 (actual)
Results: Posted 13 May 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Aidable Residual Hearing (ARH) Cohort	Other	Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software, Device: 301-M062 sound processor & softwareControl Device followed by experimental Device.
Electric Only (EO) Cohort	Other	Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software, Device: 301-M062 sound processor & softwareControl Device followed by experimental Device.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (2 listed)

Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator

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
Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & softwareControl cochlear implant sound processor	Device	Aidable Residual Hearing (ARH) Cohort, Electric Only (EO) Cohort
301-M062 sound processor & softwareNew cochlear implant sound processor	Device	Aidable Residual Hearing (ARH) Cohort, Electric Only (EO) Cohort

Primary outcome

Speech Recognition in Quiet
Time frame: 1 Day
The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.

2 secondary outcomes

Speech Recognition in Noise
Time frame: 1 Day
Increased Speech Recognition in Noise
Time frame: 1 Day

Results and safety

Results posted to the registry on 13 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Electric Only (EO) Cohort	10	10
Aidable Residual Hearing (ARH) Cohort	12	12

Primary outcome: Speech Recognition in Quiet

Time frame: 1 Day. Mean (Standard Deviation). Unit: percentage of correct words

Measure	EO Cohort n = 10	ARH Cohort n = 12
Baseline AutoSound	88.31 (5.817)	89.39 (10.535)
Baseline AutoSense	87.30 (10.214)	88.09 (9.848)

EO Cohort vs ARH Cohort: p = 0.0010, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit. The total period is up to 5 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EO Cohort	0 of 10 (0%)	2 of 10 (20%)	0 of 10
ARH Cohort	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Limitations and caveats (from the sponsor): Due to clinic closures related to the COVID-19 pandemic, total enrollment in the EO Cohort was 10 subjects instead of 12.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

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

Questions about this trial

What is this clinical trial studying?

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 0 inclusion and 2 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 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 13 May 2022). 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?

Speech Recognition in Quiet (time frame: 1 Day). 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 NCT04237207.

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 13 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.