Trial Outcomes & Findings for Fundamental Asynchronous Stimulus Timing Sound Coding Study (NCT NCT02698787)
NCT ID: NCT02698787
Last Updated: 2021-02-02
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
11 participants
Primary outcome timeframe
Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months)
Results posted on
2021-02-02
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
First Intervention (3 Months)
STARTED
|
6
|
5
|
|
First Intervention (3 Months)
COMPLETED
|
6
|
5
|
|
First Intervention (3 Months)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3 Months)
STARTED
|
6
|
5
|
|
Second Intervention (3 Months)
COMPLETED
|
6
|
4
|
|
Second Intervention (3 Months)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Second Intervention (3 Months)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1: FAST First, Then ACE Sound Processing Strategy
n=6 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
|
Group 2: ACE First, Then FAST Sound Processing Strategy
n=5 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 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
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
n=6 Participants
|
54.36 years
n=5 Participants
|
60.9 years
n=11 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
5 participants
n=5 Participants
|
11 participants
n=11 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months)Population: 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.
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.
Outcome measures
| Measure |
Group 1: FAST First, Then ACE Sound Processing Strategy
n=6 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
|
Group 2: ACE First, Then FAST Sound Processing Strategy
n=5 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 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
|
|---|---|---|
|
Change in Open Set Monosyllabic Word Recognition Score
Visit 1 (Candidacy) - Implated Ear
|
5 percentage of words correct
Interval 0.0 to 17.0
|
11.8 percentage of words correct
Interval 0.0 to 27.0
|
|
Change in Open Set Monosyllabic Word Recognition Score
Visit 1 (Candidacy) - Contralateral Ear
|
20.2 percentage of words correct
Interval 1.0 to 55.0
|
21.4 percentage of words correct
Interval 2.0 to 38.0
|
|
Change in Open Set Monosyllabic Word Recognition Score
Visit 5 (3 Months) - FAST
|
45 percentage of words correct
Interval 9.0 to 69.0
|
—
|
|
Change in Open Set Monosyllabic Word Recognition Score
Visit 5 (3 Month) - ACE
|
—
|
59.4 percentage of words correct
Interval 39.0 to 85.0
|
|
Change in Open Set Monosyllabic Word Recognition Score
Visit 8 (6 Month) - ACE
|
49.5 percentage of words correct
Interval 15.0 to 79.0
|
—
|
|
Change in Open Set Monosyllabic Word Recognition Score
Visit 8 (6 Month) - FAST
|
—
|
54 percentage of words correct
Interval 27.0 to 76.0
|
PRIMARY outcome
Timeframe: Visit 5 (3 Months) and Visit 8 (6 months)Population: 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.
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.
Outcome measures
| Measure |
Group 1: FAST First, Then ACE Sound Processing Strategy
n=6 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
|
Group 2: ACE First, Then FAST Sound Processing Strategy
n=5 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 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
|
|---|---|---|
|
Change in Signal-to-Noise Ratio (SRT)
Visit 5 - FAST (Speech-Shaped Noise)
|
16.3 signal-to-noise ratio
Interval 9.1 to 32.6
|
—
|
|
Change in Signal-to-Noise Ratio (SRT)
Visit 5 - FAST (Four-Talker Noise)
|
16.3 signal-to-noise ratio
Interval 7.8 to 30.5
|
—
|
|
Change in Signal-to-Noise Ratio (SRT)
Visit 5 - ACE(Speech-Shaped Noise)
|
—
|
11.2 signal-to-noise ratio
Interval 4.9 to 21.6
|
|
Change in Signal-to-Noise Ratio (SRT)
Visit 5 - ACE (Four-Talker Noise)
|
—
|
10.1 signal-to-noise ratio
Interval 4.1 to 23.0
|
|
Change in Signal-to-Noise Ratio (SRT)
Visit 8 - FAST (Speech-Shaped Noise)
|
—
|
13.1 signal-to-noise ratio
Interval 5.8 to 28.0
|
|
Change in Signal-to-Noise Ratio (SRT)
Visit 8 - FAST (Four-Talker Noise)
|
—
|
12.4 signal-to-noise ratio
Interval 7.0 to 26.0
|
|
Change in Signal-to-Noise Ratio (SRT)
Visit 8 - ACE(Speech-Shaped Noise)
|
9.9 signal-to-noise ratio
Interval 6.1 to 14.8
|
—
|
|
Change in Signal-to-Noise Ratio (SRT)
Visit 8 - ACE (Four-Talker Noise)
|
9.1 signal-to-noise ratio
Interval 6.0 to 15.9
|
—
|
Adverse Events
No Sound Coding Strategy
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
FAST Sound Coding Strategy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ACE Sound Coding Strategy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Sound Coding Strategy
n=11 participants at risk
Healing period after surgery.
|
FAST Sound Coding Strategy
n=11 participants at risk
Participants utilising the FAST Sound Coding Strategy. Group 1 utilises in first 3 months, Group 2 utilises in second 3 months.
|
ACE Sound Coding Strategy
n=11 participants at risk
Participants utilising the ACE Sound Coding Strategy. Group 1 utilises in second 3 months, Group 2 utilises in first 3 months.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo/dizziness
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
Other adverse events
| Measure |
No Sound Coding Strategy
n=11 participants at risk
Healing period after surgery.
|
FAST Sound Coding Strategy
n=11 participants at risk
Participants utilising the FAST Sound Coding Strategy. Group 1 utilises in first 3 months, Group 2 utilises in second 3 months.
|
ACE Sound Coding Strategy
n=11 participants at risk
Participants utilising the ACE Sound Coding Strategy. Group 1 utilises in second 3 months, Group 2 utilises in first 3 months.
|
|---|---|---|---|
|
Ear and labyrinth disorders
"Whooziness"
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
|
Ear and labyrinth disorders
Ear canal scaly and slightly swollen
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Ear and labyrinth disorders
Profound hearing loss
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
|
Ear and labyrinth disorders
Tinnitus
|
27.3%
3/11 • Number of events 3 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Ear and labyrinth disorders
Unsteadiness
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Disabled E12
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Injury, poisoning and procedural complications
Cerebrospinal fluid release
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
|
Ear and labyrinth disorders
Vertigo and dizziness
|
9.1%
1/11 • Number of events 1 • 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".
|
18.2%
2/11 • Number of events 2 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Intermittent non-auditory stimulation
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Non-auditory stimulator
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Change in sound quality
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Impedance spiked
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Change in audibility
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Tenderness around device
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Non-auditory sensation/pain
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Disabled electrode 14 following pitch ranking
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Intermittent sound
|
0.00%
0/11 • 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".
|
18.2%
2/11 • Number of events 2 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Disabled E22
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Redness and Indentation at magnet site
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
|
Product Issues
Significant increase in impedances
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
|
Respiratory, thoracic and mediastinal disorders
Worsening sinus symptoms
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Short circuit electrode(s)
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
|
Injury, poisoning and procedural complications
Electrode tip roll/fold-over
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Swelling and slight soreness/sensitivity around internal device
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
|
General disorders
Lethargic
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
|
Product Issues
Soreness on posterior border of implant
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
9.1%
1/11 • Number of events 1 • 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".
|
|
Nervous system disorders
Low-grade headache
|
9.1%
1/11 • Number of events 1 • 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".
|
0.00%
0/11 • 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".
|
0.00%
0/11 • 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".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place