Sensorineural Hearing Loss, BilateralNCT03304106
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
A study testing Commercially available cochlear implant and AI system in people with Sensorineural Hearing Loss, Bilateral and Cochlear Implant, run by Cochlear at 9 sites in United States.
Trial summary
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral, Cochlear Implant
- What is being tested?
- Commercially available cochlear implant and AI system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Oct 2017to 18 Sep 2019
- 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
- Newly implanted and existing recipient Groups (Groups 1 and 2):
- Age 12 and older
- Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
- Group 2: 3 months or greater combined experience with commercially available sound processors
- Fluent spoken English skills
Who cannot join
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations
- Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
- Unwillingness or inability of the subject to comply with all investigational requirements
- Use of an acoustic component in the implanted ear
- Less than 18 active electrodes
- Hybrid L Cochlear Implant
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48108
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Rocky Mountain Ear Center
Englewood, Colorado, 80113
Cochlear Hearing Center Houston
Houston, Texas, 77074
Midwest Ear Institute
Kansas City, Missouri, 64111
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York University
New York, New York, 10016
Hearts for Hearing
Oklahoma City, Oklahoma, 73120
Peak ENT Associates
Provo, Utah, 84604
About this study
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
- Being tested
- Commercially available cochlear implant and AI system
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially available cochlear implant and AI systemDevice
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients
| Study group | Role | What they receive |
|---|---|---|
| Newly Implanted CI Recipients | Experimental | Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients Receives: Device: Commercially available cochlear implant and AI system |
| Existing CI recipients | Experimental | Use of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients Receives: Device: Commercially available cochlear implant and AI system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet
Monosyllabic word recognition was scored in quiet using Consonant-Nucleus-Consonant (CNC) words. Scores are listed as percentage correct thus a higher score (percentage) means a better outcome.Group 1: Preoperative to postoperative percentage performance after 6 months of cochlear implant use. Group 2: Visit A to Visit B after 1 month of cochlear implant use.
Measured: Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start19 Oct 2017
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304106
- Sponsor's protocol ID
- CAM 5417
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2017
- Last updated
- 29 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Zwolan TA, Presley R, Chenier L, Buck B. Investigation of an Outcomes-Driven, Computer-Assisted Approach to CI Fitting in Newly Implanted Patients. Ear Hear. 2021 May/Jun;42(3):558-564. doi: 10.1097/AUD.0000000000000957.
PubMed 33027199
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
- ClinicalTrials.gov ID
- NCT03304106
- Acronym / sponsor ID
- CAM 5417
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Posted 29 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly Implanted CI Recipients | Experimental | Device: Commercially available cochlear implant and AI systemUse of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients |
| Existing CI recipients | Experimental | Device: Commercially available cochlear implant and AI systemUse of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 12 and older
- Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
- Group 2: 3 months or greater combined experience with commercially available sound processors
- Fluent spoken English skills
Key exclusion criteria (6 listed)
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations
- Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
- Unwillingness or inability of the subject to comply with all investigational requirements
- Use of an acoustic component in the implanted ear
- Less than 18 active electrodes
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 |
|---|---|---|
| Commercially available cochlear implant and AI systemUse of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients | Device | Existing CI recipients, Newly Implanted CI Recipients |
Primary outcome
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet
Time frame: Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month
Monosyllabic word recognition was scored in quiet using Consonant-Nucleus-Consonant (CNC) words. Scores are listed as percentage correct thus a higher score (percentage) means a better outcome.Group 1: Preoperative to postoperative percentage performance after 6 months of cochlear implant use. Group 2: Visit A to Visit B after 1 month of cochlear implant use.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33027199Zwolan TA, Presley R, Chenier L, Buck B. Investigation of an Outcomes-Driven, Computer-Assisted Approach to CI Fitting in Newly Implanted Patients. Ear Hear. 2021 May/Jun;42(3):558-564. doi: 10.1097/AUD.0000000000000957.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercially available cochlear implant and AI system in people with Sensorineural Hearing Loss, Bilateral and Cochlear Implant, run by Cochlear at 9 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 6 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 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 29 Oct 2020). 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?
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet (time frame: Pre-operative/Visit A; Group 1: 6 months; Group 2: 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 NCT03304106, which also lists 1 linked publication.
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 29 Oct 2020.