Trial Outcomes & Findings for Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss (NCT NCT02811549)
NCT ID: NCT02811549
Last Updated: 2023-08-21
Results Overview
The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. The intent is to understand the benefit of the implant treatment option and restoration of auditory input results in improved speech understanding.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Baseline and Twelve months
Results posted on
2023-08-21
Participant Flow
Investigators recruited study subjects from their clinical practices. The first patient first visit occurred on November 7, 2016 and last patient last visit occurred on March 25, 2020. Two study sites enrolled a total of 24 subjects in the study. Of the 24 subjects enrolled 15 were deemed eligible to undergo surgical implantation and 14 completed the study. All enrolled subjects provided informed consent.
Per protocol, a subject is considered enrolled upon giving written informed consent. After undergoing the ICF process, subjects completed audiometric testing and speech perception testing to determine eligibility to undergo surgical implantation. Subjects that did not meet the audiometric threshold hearing or speech testing inclusion criteria were discontinued at baseline.
Participant milestones
| Measure |
HiResolution Bionic Cochlear Implant
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
HiResolution Bionic Cochlear Implant
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Subject screen failed
|
4
|
|
Overall Study
Surgery denied by subject's insurance carrier
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HiResolution Bionic Cochlear Implant
n=15 Participants
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=15 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 10.1 • n=15 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
|
Audiometric Threshold Testing
Pre-Implant PTA (Ear to be implanted)
|
92.1 dB HL
STANDARD_DEVIATION 21.1 • n=15 Participants
|
|
Audiometric Threshold Testing
Pre-Implant PTA (Contralateral Ear)
|
26.0 dB HL
STANDARD_DEVIATION 18.5 • n=15 Participants
|
PRIMARY outcome
Timeframe: Baseline and Twelve monthsPopulation: The primary outcome measure used in this clinical feasibility study was monosyllabic word recognition with the ear to be implanted in quiet using the CNC word test. Subjects that achieved a CNC word recognition score ≤ 30% in the implanted ear and \>30% in the contralateral ear. Subjects are tested using their everyday listening condition for each ear.
The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. The intent is to understand the benefit of the implant treatment option and restoration of auditory input results in improved speech understanding.
Outcome measures
| Measure |
HiResolution Bionic Cochlear Implant
n=15 Participants
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
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|---|---|
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Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)
Baseline CNC Score
|
2.13 percentage of recognized words
Standard Deviation 7.453
|
|
Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)
12 Month Post Implant CNC score
|
61.14 percentage of recognized words
Standard Deviation 20.240
|
PRIMARY outcome
Timeframe: Baseline and Twelve monthsPopulation: Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary. • Unaided air conduction thresholds using insert earphones at octave frequencies were measured for non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.
Unaided audiometric thresholds compared to preimplant. Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary. • Unaided air conduction thresholds using insert earphones at octave frequencies were measured for the contralateral, non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.
Outcome measures
| Measure |
HiResolution Bionic Cochlear Implant
n=14 Participants
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
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|---|---|
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Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 250 HZ
|
17.14 change in decibels (db)
Standard Deviation 7.774
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 250 HZ
|
17.14 change in decibels (db)
Standard Deviation 8.254
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 500 HZ
|
17.86 change in decibels (db)
Standard Deviation 14.769
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 500 HZ
|
20.00 change in decibels (db)
Standard Deviation 14.005
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 1000 HZ
|
23.21 change in decibels (db)
Standard Deviation 17.277
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 1000 HZ
|
25.71 change in decibels (db)
Standard Deviation 18.172
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 2000 HZ
|
28.57 change in decibels (db)
Standard Deviation 21.342
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at the 12 Month 2000 HZ
|
28.93 change in decibels (db)
Standard Deviation 20.679
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 4000 HZ
|
35.00 change in decibels (db)
Standard Deviation 29.483
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Earat the 12 Month 4000 HZ
|
37.86 change in decibels (db)
Standard Deviation 31.483
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 8000 HZ
|
34.29 change in decibels (db)
Standard Deviation 31.736
|
|
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 8000 HZ
|
40.36 change in decibels (db)
Standard Deviation 38.203
|
PRIMARY outcome
Timeframe: Baseline and Twelve monthsPopulation: Speech recognition in noise was measured with the AZBio speech perception test presented in a background of noise in which the target remained at 0° and noise was presented from 0° (speech front).
AzBio speech scores in speech front, noise front twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was the primary speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Outcome measures
| Measure |
HiResolution Bionic Cochlear Implant
n=15 Participants
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
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|---|---|
|
Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front
Baseline Pooled AzBio in Noise Data - Speech Front / Noise Front
|
87.39 percentage of recognized words
Standard Deviation 15.382
|
|
Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front
Month 12 Pooled AzBio in Noise Data - Speech Front / Noise Front
|
91.20 percentage of recognized words
Standard Deviation 13.08
|
PRIMARY outcome
Timeframe: Baseline and Twelve monthsPopulation: Lateralization ability was measured as the ability to identify the location of a sound presented from a loudspeaker placed at +/- 45° in front of the subject. Test is performed using the participant's bilateral, everyday listening condition using both ears and reported for all subjects at baseline compared to month12.
Lateralization is ability to recognize the location of sound origin compared to preimplantation. The subject was asked to identify if the sentence was heard from the right or left loudspeaker. Scoring was based on the number of sentence locations correctly identified and expressed as a percent average. A higher percent average indicates a better ability to identify sound location.
Outcome measures
| Measure |
HiResolution Bionic Cochlear Implant
n=15 Participants
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
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|---|---|
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Change in Lateralization Ability Testing (Bilateral Listening Condition)
Baseline Pooled Lateralization Ability Data
|
72 percentage of sentences localized
Standard Deviation 21.634
|
|
Change in Lateralization Ability Testing (Bilateral Listening Condition)
Month 12 Pooled Lateralization Ability Data
|
89.10 percentage of sentences localized
Standard Deviation 19.522
|
PRIMARY outcome
Timeframe: Baseline to Twelve MonthsPopulation: Speech recognition in noise was measured with the AZBio Speech test presented with the participant at 0° and noise was presented at either 90° or 270° dependent on the implanted ear side.
AzBio word scores in speech front, noise to implanted ear twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Outcome measures
| Measure |
HiResolution Bionic Cochlear Implant
n=15 Participants
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
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|---|---|
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Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear
Baseline Pooled AzBio in Noise Data - Speech Front / Noise to Implanted Ear
|
92.15 percentage of recognized words
Standard Deviation 15.689
|
|
Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear
Month 12 Pooled AzBio in Noise Data - Speech Front / Noise to Implanted Ear
|
93.01 percentage of recognized words
Standard Deviation 10.165
|
PRIMARY outcome
Timeframe: Baseline to Twelve MonthsPopulation: Speech recognition in noise was measured with the AZBio Speech test presented with the participant at 0° and noise was presented from either 90° or 270° dependent on the contralateral ear side. Higher percentages score represents a better ability to identify speech source location.
AzBio speech scores in speech front, noise to the contralateral ear at 12 months post implantation compared to preimplant bilateral sentence scores. The baseline speech perception testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Outcome measures
| Measure |
HiResolution Bionic Cochlear Implant
n=15 Participants
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
|
|---|---|
|
Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.
Baseline Pooled AzBio in Noise Data - Speech Front / Noise to Contralateral Ear
|
82.24 percentage of recognized words
Standard Deviation 19.318
|
|
Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.
Month 12 Pooled AzBio in Noise Data - Speech Front / Noise to Contralateral Ear
|
89.10 percentage of recognized words
Standard Deviation 19.522
|
Adverse Events
HiResolution Bionic Cochlear Implant
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HiResolution Bionic Cochlear Implant
n=15 participants at risk
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
HiResolution Bionic Cochlear Implant: HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
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|---|---|
|
Surgical and medical procedures
Complication at implant site
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Mild Tinnitus, intermittent - Left Ear
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Moderate Tinnitus, continuous - Right Ear
|
13.3%
2/15 • Number of events 3 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Allergy induced asthma
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Granuloma
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Headache
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Imbalance
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Itching in implanted ear
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Lightheadedness
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Mild ear pressure
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
mild head & neck pain post-surgery
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Numbness, discomfort, or pain at or around the pinna
|
26.7%
4/15 • Number of events 4 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Pain and Anxiety when wearing external device
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Residual hearing loss with a PTA greater than 30dB
|
60.0%
9/15 • Number of events 9 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Infections and infestations
Sinus Infection
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Small scab superior pole of incision line related to the patient's haircut
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Jaw Pain when chewing
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Soreness, Tenderness, or Pain at or around the incision site
|
26.7%
4/15 • Number of events 4 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Tongue Numbness
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Transient Pain
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Unsteady Gait
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Severe Tinnitus - Left Ear
|
13.3%
2/15 • Number of events 2 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Severe Tinnitus - Right ear
|
13.3%
2/15 • Number of events 2 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Taste Disturbance
|
26.7%
4/15 • Number of events 4 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
General disorders
Vertigo or Dizziness
|
46.7%
7/15 • Number of events 7 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Moderate Tinnitus, continuous - Left Ear
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
|
Ear and labyrinth disorders
Aural fullness
|
6.7%
1/15 • Number of events 1 • Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
|
Additional Information
Ankur Kaushal, VP of Global Regulatory Affairs
Advanced Bionics
Phone: 661 362 1400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees to submit any publication to Sponsor at least 30 days before submission. Within 30 days, Sponsor advises PI in writing of any information contained therein which is Confidential Information (other than Study Data) or which may impair availability of patent protection for Inventions. Sponsor has the right to require PI to remove specifically identified CI and/or to delay the publication for an additional 60 days to enable Sponsor to seek patent protection for Inventions.
- Publication restrictions are in place
Restriction type: OTHER