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The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CI532/N7 study group | Experimental | All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CI532 | Device | Cochlear implant |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone | Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores. | Preoperatively and 6 months post sound processor activation |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone | Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores. | Preoperatively and 6 months post sound processor activation |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency Specific Thresholds and Speech Recognition in Noise or Quiet | Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone. | 12 months post-activation |
| Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jillian Crosson, PhD | Senior Manager of Clinical Services | Study Director |
| Megan Mears, AuD | Clinical Project Manager | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Ear Center | Englewood | Colorado | 80113 | United States | ||
| University of Iowa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17647093 | Background | Grutters JP, Joore MA, van der Horst F, Verschuure H, Dreschler WA, Anteunis LJ. Choosing between measures: comparison of EQ-5D, HUI2 and HUI3 in persons with hearing complaints. Qual Life Res. 2007 Oct;16(8):1439-49. doi: 10.1007/s11136-007-9237-x. Epub 2007 Jul 24. | |
| 17178943 | Background | Hiller W, Goebel G. Factors influencing tinnitus loudness and annoyance. Arch Otolaryngol Head Neck Surg. 2006 Dec;132(12):1323-30. doi: 10.1001/archotol.132.12.1323. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CI532/N7 Study Group | All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CI532/N7 Study Group | All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone | Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores. | Posted | Mean | Standard Deviation | percentage of correct words | Preoperatively and 6 months post sound processor activation |
|
12 months
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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 | CI532/N7 Study Group | All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acid Reflux | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cochlear Clinical Studies | Cochlear | (303) 790-9010 | clinicalstudies@cochlear.com |
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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 | Jun 28, 2019 | Oct 18, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 4, 2019 | Oct 18, 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 |
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| Nucleus 7 | Device | Sound processor |
|
|
| Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3) | Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0). | Preoperatively and 6 months post sound processor activaton |
Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise. |
| Following 12-month study visit but prior to 36-month interval. |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48108 | United States |
| The Center for Hearing and Balance Disorders | Chesterfield | Missouri | 63017 | United States |
| Midwest Ear Institute | Kansas City | Missouri | 64111 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| New York University | New York | New York | 10016 | United States |
| The Ohio State University | Columbus | Ohio | 13212 | United States |
| Hearts for Hearing | Oklahoma City | Oklahoma | 73120 | United States |
| Dallas Ear Institute | Dallas | Texas | 75230 | United States |
| Background | Meinert,C(1986).ClinicalTrials:Design,Conduct,andAnalysis.OxfordUniversityPress,NewYork. |
| 15817019 | Background | Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. |
| 14485785 | Background | PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available. |
| 21829134 | Background | Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549. |
| 33161258 | Derived | Kelsall D, Lupo J, Biever A. Longitudinal outcomes of cochlear implantation and bimodal hearing in a large group of adults: A multicenter clinical study. Am J Otolaryngol. 2021 Jan-Feb;42(1):102773. doi: 10.1016/j.amjoto.2020.102773. Epub 2020 Oct 22. |
| 32857114 | Derived | Wick CC, Kallogjeri D, McJunkin JL, Durakovic N, Holden LK, Herzog JA, Firszt JB, Buchman CA; CI532 Study Group. Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older: A Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):925-932. doi: 10.1001/jamaoto.2020.1585. |
| 32857113 | Derived | Buchman CA, Herzog JA, McJunkin JL, Wick CC, Durakovic N, Firszt JB, Kallogjeri D; CI532 Study Group. Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):916-924. doi: 10.1001/jamaoto.2020.1584. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ipsilateral Ear Mean - Duration of Hearing Loss | Mean | Standard Deviation | years |
|
| Contralateral Ear Mean - Duration of Hearing Loss | Mean | Standard Deviation | years |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone | Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores. | Posted | Mean | Standard Deviation | percentage of correct AzBio sentences | Preoperatively and 6 months post sound processor activation |
|
|
|
| Secondary | Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3) | Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0). | Posted | Mean | Standard Deviation | score on a scale | Preoperatively and 6 months post sound processor activaton |
|
|
|
| Other Pre-specified | Frequency Specific Thresholds and Speech Recognition in Noise or Quiet | Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone. | Not Posted | 12 months post-activation | Participants |
| Other Pre-specified | Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming | Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise. | Not Posted | Following 12-month study visit but prior to 36-month interval. | Participants |
| 2 |
| 96 |
| 16 |
| 96 |
| 26 |
| 96 |
| Active Meniere's Disease/Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Atrial Fibrillation requiring Ablation Procedure | Cardiac disorders | Systematic Assessment |
|
| CI Explanted Due to Non-Auditory Stimulation | Product Issues | Systematic Assessment |
|
| Coxsackievirus, subsequent labyrinthitis/vestibular neuritis | Ear and labyrinth disorders | Systematic Assessment |
|
| CVA (cerebrovascular accident) | Vascular disorders | Systematic Assessment |
|
| Cardio-respiratory failure | Cardiac disorders | Systematic Assessment | Death secondary to cardio-respiratory failure, presistent tachycardia secondary to myotonic distrophy, stage Y3 N0 colon carcinoma, sepsis, VRE, acidosis |
|
| Alcoholic cirrhosis of the liver | Hepatobiliary disorders | Systematic Assessment | Death-complications |
|
| Decreased Hearing in Non-Implanted Ear | Ear and labyrinth disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Diagnosed with prostate cancer | Reproductive system and breast disorders | Systematic Assessment |
|
| Electrode Tip Foldover | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Heart Attack | Cardiac disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| TIA/Stroke | Vascular disorders | Systematic Assessment |
|
| Tip Rollover | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |