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The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients.
The Fundamental Asynchronous Stimulus Timing (FAST) strategy offers excellent potential as a low power alternative coding strategy to the current default strategy in Nucleus® cochlear implants, Advanced Combination Encoder (ACE). Additionally, FAST offers potential bilateral benefits - localization and listening in spatially separated noise - because it has been shown in acute, controlled studies to provide more access to interaural timing difference (ITD) cues (Smith, 2010).Previous research with experienced cochlear-implant recipients has shown issues with conversion from ACE to FAST. The FAST strategy typically sounds very different in quality, and acclimatization can be lengthy. This extended adaptation time makes it difficult to show conclusively that FAST is non-inferior to ACE for speech understanding. A potential barrier to evaluating performance with FAST in current cochlear-implant recipients is the extensive amount of prior experience that many recipients have using ACE. Hence, there is a distinct need to evaluate FAST in newly implanted recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy. |
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| Group 2 | Experimental | All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental sound coding strategy (FAST) | Device | Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Open Set Monosyllabic Word Recognition Score | Open Set Monosyllabic Word Recognition is a test of 50 words each consisting of 3 individual speech sounds. The subject repeats the word s/he hears to the audiologist. The score is based on the percentage of words correct. The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for word recognition in quiet with percentage of words correct. | Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months) |
| Change in Signal-to-Noise Ratio (SRT) | The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for BKB sentences in noise with mean signal-to-noise ratio (SRT) where participants could understand 50% of sentences in noise using ACE and FAST. Lower SRT values indicate better performance. SRT measures are obtained using two types of background noise. One is "Speech-Shaped Noise" which is white noise or tones made to mimic speech. The other is "Four-Talker Noise" which is multiple talkers made to mimic background conversation. | Visit 5 (3 Months) and Visit 8 (6 months) |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Daneman , M., & Carpenter, P.A. (1980). Individual differences in working memory and reading. Journal of Verbal Learning andVerbal Behavior, 19, 450-466. | ||
| 23651462 | Background | Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: the SSQ12. Int J Audiol. 2013 Jun;52(6):409-12. doi: 10.3109/14992027.2013.781278. | |
| 486816 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: FAST First, Then ACE Sound Coding Strategy | All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy. Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy |
| FG001 | Group 2: ACE First, Then FAST Sound Processng Strategy | All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation. Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Months) |
| |||||||||||||
| Second Intervention (3 Months) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: FAST First, Then ACE Sound Processing Strategy | All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy. Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy |
| 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 in Open Set Monosyllabic Word Recognition Score | Open Set Monosyllabic Word Recognition is a test of 50 words each consisting of 3 individual speech sounds. The subject repeats the word s/he hears to the audiologist. The score is based on the percentage of words correct. The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for word recognition in quiet with percentage of words correct. | Group 1 were analysed at Visit 5 for FAST sound coding strategy and at Visit 8 for ACE sound coding strategy. Group 2 were analysed at Visit 5 for ACE sound coding strategy and at Visit 8 for FAST sound coding strategy. | Posted | Mean | Full Range | percentage of words correct | Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months) |
|
6 months
Adverse events are categorized by the intervention used at the time of adverse event onset. All subjects received a commercially available cochlear implant and then took a resting period of approximately two weeks prior to starting ACE or FAST sound coding strategies. It is common for all cochlear implant recipients to experience adverse events during or after surgery. Adverse events which occur prior to starting a sound coding strategy are listed under "No Sound Coding Strategy".
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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 | No Sound Coding Strategy | Healing period after surgery. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo/dizziness | Ear and labyrinth disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| "Whooziness" | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naomi Croghan | Cochlear | +13032642131 | ncroghan@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2017 | Apr 12, 2019 | Prot_SAP_000.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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| Commercially available ACE sound coding strategy | Device | Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy |
|
| Background |
| Bench J, Kowal A, Bamford J. The BKB (Bamford-Kowal-Bench) sentence lists for partially-hearing children. Br J Audiol. 1979 Aug;13(3):108-12. doi: 10.3109/03005367909078884. |
| 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. |
| Background | Smith, Z. M. (2010). Improved sensitivity to interaural time differences with the FAST coding strategy. Presented at the 11th International Conference on Cochlear Implants and Other Implantable Auditory Technologies, Stockholm, Sweden. |
| NOT COMPLETED |
|
|
| BG001 | Group 2: ACE First, Then FAST Sound Processing Strategy | All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation. Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy.
Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy
Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy
| OG001 | Group 2: ACE First, Then FAST Sound Processing Strategy | All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation. Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy |
|
|
| Primary | Change in Signal-to-Noise Ratio (SRT) | The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for BKB sentences in noise with mean signal-to-noise ratio (SRT) where participants could understand 50% of sentences in noise using ACE and FAST. Lower SRT values indicate better performance. SRT measures are obtained using two types of background noise. One is "Speech-Shaped Noise" which is white noise or tones made to mimic speech. The other is "Four-Talker Noise" which is multiple talkers made to mimic background conversation. | Group 1 were analysed at Visit 5 for FAST sound coding strategy and at Visit 8 for ACE sound coding strategy. Group 2 were analysed at Visit 5 for ACE sound coding strategy and at Visit 8 for FAST sound coding strategy. | Posted | Mean | Full Range | signal-to-noise ratio | Visit 5 (3 Months) and Visit 8 (6 months) |
|
|
|
| 11 |
| 1 |
| 11 |
| 5 |
| 11 |
| EG001 | FAST Sound Coding Strategy | Participants utilising the FAST Sound Coding Strategy. Group 1 utilises in first 3 months, Group 2 utilises in second 3 months. | 0 | 11 | 0 | 11 | 5 | 11 |
| EG002 | ACE Sound Coding Strategy | Participants utilising the ACE Sound Coding Strategy. Group 1 utilises in second 3 months, Group 2 utilises in first 3 months. | 0 | 11 | 0 | 11 | 4 | 11 |
| Ear canal scaly and slightly swollen | Ear and labyrinth disorders | Systematic Assessment |
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| Profound hearing loss | Ear and labyrinth disorders | Systematic Assessment | Sudden hearing threshold shift |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Unsteadiness | Ear and labyrinth disorders | Systematic Assessment |
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| Disabled E12 | Product Issues | Systematic Assessment | Poor sound quality and perception |
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| Cerebrospinal fluid release | Injury, poisoning and procedural complications | Systematic Assessment | Resolved during surgery |
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| Vertigo and dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| Sinus infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Intermittent non-auditory stimulation | Product Issues | Systematic Assessment |
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| Non-auditory stimulator | Product Issues | Systematic Assessment | Disabled electrode |
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| Change in sound quality | Product Issues | Systematic Assessment |
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| Impedance spiked | Product Issues | Systematic Assessment |
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| Change in audibility | Product Issues | Systematic Assessment |
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| Tenderness around device | Product Issues | Systematic Assessment |
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| Non-auditory sensation/pain | Product Issues | Systematic Assessment | Disabled electrode |
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| Disabled electrode 14 following pitch ranking | Product Issues | Systematic Assessment |
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| Intermittent sound | Product Issues | Systematic Assessment |
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| Disabled E22 | Product Issues | Systematic Assessment | Sound quality and significantly higher threshold and comfort levels |
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| Redness and Indentation at magnet site | Product Issues | Systematic Assessment |
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| Significant increase in impedances | Product Issues | Systematic Assessment |
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| Worsening sinus symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Short circuit electrode(s) | Product Issues | Systematic Assessment |
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| Electrode tip roll/fold-over | Injury, poisoning and procedural complications | Systematic Assessment |
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| Swelling and slight soreness/sensitivity around internal device | Product Issues | Systematic Assessment |
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| Lethargic | General disorders | Systematic Assessment |
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| Soreness on posterior border of implant | Product Issues | Systematic Assessment |
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| Low-grade headache | Nervous system 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 |
| Visit 5 - FAST (Four-Talker Noise) |
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| Visit 5 - ACE(Speech-Shaped Noise) |
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| Visit 5 - ACE (Four-Talker Noise) |
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| Visit 8 - FAST (Speech-Shaped Noise) |
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| Visit 8 - FAST (Four-Talker Noise) |
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| Visit 8 - ACE(Speech-Shaped Noise) |
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| Visit 8 - ACE (Four-Talker Noise) |
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