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Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Existing CI recipients | Experimental | Use of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercially available cochlear implant and AI system | Device | Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month |
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Inclusion Criteria:
Newly implanted and existing recipient Groups (Groups 1 and 2):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Ear Center | Englewood | Colorado | 80113 | United States | ||
| Greater Baltimore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33027199 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Newly Implanted CI Recipients | Newly implanted recipients |
| FG001 | Existing CI Recipients | Existing recipients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 13, 2018 | Sep 4, 2020 |
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| Baltimore |
| Maryland |
| 21204 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48108 | United States |
| Midwest Ear Institute | Kansas City | Missouri | 64111 | United States |
| New York University | New York | New York | 10016 | United States |
| Hearts for Hearing | Oklahoma City | Oklahoma | 73120 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Cochlear Hearing Center Houston | Houston | Texas | 77074 | United States |
| Peak ENT Associates | Provo | Utah | 84604 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Newly implanted recipients |
| BG001 | Group 2 | Existing recipients |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Duration of Hearing Loss | Mean | Full Range | years |
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| Duration of Device Use | Mean | Full Range | months |
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| Ear Tested | Number | participants |
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| Type of Sound Processor | Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants with complete data set | Posted | Mean | Standard Deviation | percentage of correct words | Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month |
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Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Newly implanted recipients | 0 | 31 | 5 | 31 | 17 | 31 |
| EG001 | Group 2 | Existing recipients | 0 | 56 | 1 | 56 | 6 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization secondary to losing consciousness from sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Hospitalization | General disorders | Systematic Assessment |
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| Parkinson's disease diagnosis | Nervous system disorders | Systematic Assessment |
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| Hospitalization for sepsis | Infections and infestations | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| Vertigo and BPPV | Ear and labyrinth disorders | Systematic Assessment |
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| Abnormal heart rhythm requiring placement of pacemaker | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness and imbalance | Ear and labyrinth disorders | Systematic Assessment |
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| Tongue numbness/mouth numbness | Injury, poisoning and procedural complications | Systematic Assessment |
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| Headaches | Nervous system disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Change in taste | Injury, poisoning and procedural complications | Systematic Assessment |
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| Loss of hearing | Ear and labyrinth disorders | Systematic Assessment |
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| MAP too loud, unable to wear within 48hours of activation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Swelling at CI site (Ear not specified) | Ear and labyrinth disorders | Systematic Assessment |
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| Altered taste post-op | Injury, poisoning and procedural complications | Systematic Assessment |
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| Occasional dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| Sinus infection | Infections and infestations | Systematic Assessment |
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| Diffuse photodamage of the skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Jaw soreness | General disorders | Systematic Assessment |
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| Pain behind left ear | Ear and labyrinth disorders | Systematic Assessment |
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| Swelling in face and neck | Injury, poisoning and procedural complications | Systematic Assessment |
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| A window blind fell and hit head causing pain on head and neck | General disorders | Systematic Assessment |
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| Tinnitus began night of surgery after a window blind fell on head | Ear and labyrinth disorders | Systematic Assessment |
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| Tooth Abscess | Infections and infestations | Systematic Assessment |
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| Lip swelling | General disorders | Systematic Assessment |
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| Arthritis of carpometacarpal joint on left thumb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pinched nerve in back causing pain down right leg | Nervous system disorders | Systematic Assessment |
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| Left ear tinnitus following surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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| Increased tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Redness and swelling on implanted ear | Injury, poisoning and procedural complications | Systematic Assessment |
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| Intermittent dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| Right ear pain | Ear and labyrinth disorders | Systematic Assessment |
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| Spitting suture at cochlear implant incision site | Injury, poisoning and procedural complications | Systematic Assessment |
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| Left facial pain | Nervous system disorders | Systematic Assessment |
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| Fatigue post-surgery | General disorders | Systematic Assessment |
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| Tingling, numbing and slight pain at coil/magnet site on head | Ear and labyrinth disorders | Systematic Assessment |
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| Patient experienced uncomfortable loudness | Injury, poisoning and procedural complications | Systematic Assessment |
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| Flinching to high frequency stimulation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Loudness discomfort and increased tinnitus | Injury, poisoning and procedural complications | Systematic Assessment |
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| Right lower abdominal pain | General disorders | Systematic Assessment |
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| Hammer toe surgery left foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| MAP too loud; decreased speech perception in noise | Injury, poisoning and procedural complications | Systematic Assessment |
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The disclosure restriction on the PIs, restricts sites from publishing site data or study data without sponsor review and approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Chenier, Clinical Project Manager | Cochlear Limited | 422-325-4171 | lchenier@cochlear.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2018 | Sep 4, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Right |
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| 6-Month |
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| Visit B (1-Month) |
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