Trial Outcomes & Findings for Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness (NCT NCT02189798)

Last Updated: 2025-05-08

Results Overview

Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)

Recruitment status

TERMINATED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

Twelve months post device activation

Results posted on

2025-05-08

Participant Flow

Investigators recruited study subjects from their clinical practices. Thirteen study sites enrolled a total of 67 subjects. Of those enrolled, 35 completed the study main phase (month 12). The first patient first visit occurred on June 30, 2014, and last patient last visit occurred on 11/2/2020 for the main phase of the study. Twenty-four of the subjects that completed month 12 volunteered to enroll in the extended use phase. The last visit of the extended use phase was March 29, 2022.

Participant milestones

Participant milestones
Measure	Newly Implanted Group HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor. HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss). EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Existing Implanted Group Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.
Main Phase STARTED	49	18
Main Phase COMPLETED	22	13
Main Phase NOT COMPLETED	27	5
Extended Use Phase STARTED	15	9
Extended Use Phase COMPLETED	0	0
Extended Use Phase NOT COMPLETED	15	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Newly Implanted Group HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor. HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss). EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Existing Implanted Group Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.
Extended Use Phase Withdrawal by Subject	0	4
Extended Use Phase Physician Decision	1	0
Extended Use Phase Desire to explore other commercial technology/Processor Upgrade	11	1
Extended Use Phase Explanted prior to 24 month visit	1	0
Extended Use Phase Travel Issues	2	1
Extended Use Phase No longer perceiving a benefit from acoustic component	0	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Newly Implanted Group n=49 Participants HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor. HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss). EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Existing Implanted Group n=18 Participants Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=49 Participants	0 Participants n=18 Participants	0 Participants n=67 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=49 Participants	12 Participants n=18 Participants	35 Participants n=67 Participants
Age, Categorical >=65 years	26 Participants n=49 Participants	6 Participants n=18 Participants	32 Participants n=67 Participants
Age, Continuous	65 years STANDARD_DEVIATION 13.95 • n=49 Participants	60.3 years STANDARD_DEVIATION 12.37 • n=18 Participants	64 years STANDARD_DEVIATION 14.4 • n=67 Participants
Sex: Female, Male Female	27 Participants n=49 Participants	6 Participants n=18 Participants	33 Participants n=67 Participants
Sex: Female, Male Male	22 Participants n=49 Participants	12 Participants n=18 Participants	34 Participants n=67 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	49 participants n=49 Participants	18 participants n=18 Participants	67 participants n=67 Participants
Unaided low frequency hearing threshold - EAS Baseline	67 Hertz (Hz) STANDARD_DEVIATION 11 • n=15 Participants • Low-frequency pure tone hearing ability (250-1000 Hz) was tested by playing tones and measuring the softest sounds the subject could hear. For EAS eligibility, candidates needed to hear at least one low-frequency tone at 80 dB HL or better after surgery without a hearing aid. Only those who met this criterion, used the investigational device, and completed the main EAS phase were included in the analysis.	72.0 Hertz (Hz) STANDARD_DEVIATION 19.5 • n=10 Participants • Low-frequency pure tone hearing ability (250-1000 Hz) was tested by playing tones and measuring the softest sounds the subject could hear. For EAS eligibility, candidates needed to hear at least one low-frequency tone at 80 dB HL or better after surgery without a hearing aid. Only those who met this criterion, used the investigational device, and completed the main EAS phase were included in the analysis.	69 Hertz (Hz) STANDARD_DEVIATION 14.8 • n=25 Participants • Low-frequency pure tone hearing ability (250-1000 Hz) was tested by playing tones and measuring the softest sounds the subject could hear. For EAS eligibility, candidates needed to hear at least one low-frequency tone at 80 dB HL or better after surgery without a hearing aid. Only those who met this criterion, used the investigational device, and completed the main EAS phase were included in the analysis.

PRIMARY outcome

Timeframe: Twelve months post device activation

Population: Analysis includes only subjects who completed up to month 3 using the EAS processor.

Outcome measures

Outcome measures
Measure	Newly Implanted Subjects n=15 Participants HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, were fitted with the EAS sound processor. HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss). EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Existing Implanted n=10 Participants Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.
Unaided Pure-tone Average (PTA) Hearing Threshold Measurements Baseline PTA	46.7 decibles Standard Deviation 8.7	72.0 decibles Standard Deviation 19.5
Unaided Pure-tone Average (PTA) Hearing Threshold Measurements 3 Month PTA	69.4 decibles Standard Deviation 12.1	71.6 decibles Standard Deviation 20.5
Unaided Pure-tone Average (PTA) Hearing Threshold Measurements 6 Month PTA	67.5 decibles Standard Deviation 12.2	72.6 decibles Standard Deviation 18.9
Unaided Pure-tone Average (PTA) Hearing Threshold Measurements 12 Month PTA	71.6 decibles Standard Deviation 15.6	74.5 decibles Standard Deviation 17.1

PRIMARY outcome

Timeframe: Up to 12 months post device activation

Population: Analysis includes only subjects who completed up to month 12 using the EAS processor.

Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.

Outcome measures

Outcome measures
Measure	Newly Implanted Subjects n=15 Participants HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, were fitted with the EAS sound processor. HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss). EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Existing Implanted n=10 Participants Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet Baseline	19.3 Percent words correct Standard Deviation 13.5	61.5 Percent words correct Standard Deviation 19.5
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet Month 1 Post Device /EAS Activation	31.3 Percent words correct Standard Deviation 25.8	67.1 Percent words correct Standard Deviation 17.8
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet Month 3 Post Device /EAS Activation	50.4 Percent words correct Standard Deviation 28.0	70.5 Percent words correct Standard Deviation 15.9
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet Month 6 Post Device /EAS Activation	50.5 Percent words correct Standard Deviation 25.6	72.7 Percent words correct Standard Deviation 18.3
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet Month 12 Post Device /EAS Activation	51.1 Percent words correct Standard Deviation 25.0	73.3 Percent words correct Standard Deviation 19.2

PRIMARY outcome

Timeframe: up to 12 months post device activation

Population: Analysis includes only subjects who completed the main phase study using the EAS processor.

Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.

Outcome measures

Outcome measures
Measure	Newly Implanted Subjects n=15 Participants HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, were fitted with the EAS sound processor. HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss). EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Existing Implanted n=15 Participants Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.
Speech Perception Testing (AzBio) in Noise. 1 Month Post Device/ EAS Activation	19 Percent words correct Standard Deviation 19.7	55.0 Percent words correct Standard Deviation 27.1
Speech Perception Testing (AzBio) in Noise. Baseline	11.9 Percent words correct Standard Deviation 8.5	46.2 Percent words correct Standard Deviation 22.6
Speech Perception Testing (AzBio) in Noise. 3 Month Post Device/ EAS Activation	42.1 Percent words correct Standard Deviation 28.3	57.7 Percent words correct Standard Deviation 25.8
Speech Perception Testing (AzBio) in Noise. 6 Month Post Device/ EAS Activation	44.4 Percent words correct Standard Deviation 28	62.6 Percent words correct Standard Deviation 27.1
Speech Perception Testing (AzBio) in Noise. 12 Month Post Device/ EAS Activation	46.2 Percent words correct Standard Deviation 26.3	64.1 Percent words correct Standard Deviation 23.2

Adverse Events

Newly Implanted Group

Serious events: 16 serious events

Other events: 24 other events

Deaths: 1 deaths

Existing Implanted Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Extended Use Phase - Newly Implanted Group

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Extended Use Phase - Existing Implanted Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Newly Implanted Group n=49 participants at risk HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor. HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss). EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Existing Implanted Group n=18 participants at risk Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Extended Use Phase - Newly Implanted Group n=15 participants at risk Adults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in the Newly Implanted Group. Enrollment was optional and subject to the willingness of the participant and the discretion of the managing clinician.	Extended Use Phase - Existing Implanted Group n=9 participants at risk Adults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in the Existing Implanted Group. Enrollment was optional and subject to the willingness of the participant and the discretion of the managing clinician
General disorders Severe inflammation from extensive radiation damage	2.0% 1/49 • Number of events 1 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/15 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
General disorders Death	2.0% 1/49 • Number of events 1 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/15 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
Musculoskeletal and connective tissue disorders Fractured left femoral head secondary to fall	2.0% 1/49 • Number of events 1 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/15 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
Musculoskeletal and connective tissue disorders Fractured rib secondary to fall	2.0% 1/49 • Number of events 1 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/15 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
Musculoskeletal and connective tissue disorders Crushed legs secondary to Motor Vehicle Accident	2.0% 1/49 • Number of events 1 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/15 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
General disorders Hospitalization due to Health Setback	2.0% 1/49 • Number of events 1 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/15 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.1% 2/49 • Number of events 2 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/15 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
Ear and labyrinth disorders Complication at Implant Site	0.00% 0/49 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	6.7% 1/15 • Number of events 1 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
Musculoskeletal and connective tissue disorders Torn Shoulder Tendon	2.0% 1/49 • Number of events 1 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/15 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
Ear and labyrinth disorders Postoperative decrease/loss of residual hearing	20.4% 10/49 • Number of events 10 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/18 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/15 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.	0.00% 0/9 • Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation. Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.

Other adverse events

Additional Information

Michelle Caulfield, Senior VP, Global Quality Assurance and Regulatory Affairs

Advanced Bionics

Phone: 6613621400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60