Trial Outcomes & Findings for Hybrid L24 New Enrollment Post Approval Study (NCT NCT02379819)

Last Updated: 2023-03-13

Results Overview

The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study. The CNC word test has a score range of 0-100% with higher values indicating better scores.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

From pre-operatively through 3 years post-activation of the device

Results posted on

2023-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Nucleus Hybrid L24 Implant Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant
Overall Study STARTED	52
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Nucleus Hybrid L24 Implant Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant
Overall Study Withdrawal by Subject	10
Overall Study Death	2
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nucleus Hybrid L24 Implant n=52 Participants Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant
Age, Continuous	59.9 years STANDARD_DEVIATION 15.6 • n=52 Participants
Sex: Female, Male Female	27 Participants n=52 Participants
Sex: Female, Male Male	25 Participants n=52 Participants
Region of Enrollment United States	52 participants n=52 Participants

PRIMARY outcome

Timeframe: From pre-operatively through 3 years post-activation of the device

Population: Data was not collected for all 52 participants at all of the time points. At 2 years post-activation, one participant doesn't have a bilateral speech score.

Outcome measures

Outcome measures
Measure	Nucleus Hybrid L24 Implant n=50 Participants Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Unilateral condition at 3 months post-activation	31.3 percentage of correct words Interval 25.4 to 37.3
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Unilateral condition at 6 months post-activation	35.2 percentage of correct words Interval 29.3 to 41.1
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Unilateral condition at 1 year post-activation	35.8 percentage of correct words Interval 29.6 to 41.9
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Unilateral condition at 2 years post-activation	35.3 percentage of correct words Interval 29.2 to 41.5
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Unilateral condition at 3 years post-activation	36.8 percentage of correct words Interval 29.7 to 44.0
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Bilateral condition at 3 months post-activation	26.8 percentage of correct words Interval 22.2 to 31.5
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Bilateral condition at 6 months post-activation	29.7 percentage of correct words Interval 24.6 to 34.8
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Bilateral condition at 1 year post-activation	31.1 percentage of correct words Interval 26.4 to 35.9
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Bilateral condition at 2 years post-activation	32.4 percentage of correct words Interval 26.8 to 38.0
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device Bilateral condition at 3 years post-activation	32.5 percentage of correct words Interval 26.7 to 38.3

PRIMARY outcome

Timeframe: Up to 5 years post-activation of the device

Population: Related AEs were reported up to 3 years with some participants up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. The data include all related AEs reported.

Outcome measures

Outcome measures
Measure	Nucleus Hybrid L24 Implant n=52 Participants Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant
Number of Device or Procedure Related Adverse Events Total number of device or procedure related adverse event	98 Number of events
Number of Device or Procedure Related Adverse Events Number of serious device or procedure related adverse event	1 Number of events

SECONDARY outcome

Timeframe: Pre-operatively, up to 3 years post-activation of the device

Population: Data was not collected for all 52 participants at all of the time points. At 1 year post-activation, one participant completed the testing at +10 dB SNR (decibel signal to noise ratio) instead of +5 dB SNR which is what is reported on.

The AzBio Sentence Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.

Outcome measures

Outcome measures
Measure	Nucleus Hybrid L24 Implant n=50 Participants Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition At 3 months post-activation	18 percentage of correct words Interval 11.5 to 24.6
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition At 6 months post-activation	24.4 percentage of correct words Interval 17.4 to 31.3
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition At 1 year post-activation	21.5 percentage of correct words Interval 15.2 to 27.9
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition At 2 years post-activation	23.7 percentage of correct words Interval 17.4 to 29.9
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition At 3 years post-activation	17.8 percentage of correct words Interval 9.1 to 26.5

Adverse Events

Nucleus Hybrid L24 Implant

Serious events: 1 serious events

Other events: 35 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Nucleus Hybrid L24 Implant n=52 participants at risk Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant
Ear and labyrinth disorders Explantation at patient's request due to sound quality	1.9% 1/52 • Number of events 1 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.

Other adverse events

Other adverse events
Measure	Nucleus Hybrid L24 Implant n=52 participants at risk Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant
Ear and labyrinth disorders Profound hearing loss	38.5% 20/52 • Number of events 20 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
Ear and labyrinth disorders New or worsened tinnitus	15.4% 8/52 • Number of events 8 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
Ear and labyrinth disorders Vertigo/dizziness	34.6% 18/52 • Number of events 20 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
General disorders Skin irritation due to externals	9.6% 5/52 • Number of events 5 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
Ear and labyrinth disorders Pain in implanted ear	7.7% 4/52 • Number of events 5 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
Gastrointestinal disorders Nausea/vomiting	7.7% 4/52 • Number of events 4 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
Product Issues Sound quality issue	5.8% 3/52 • Number of events 3 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
General disorders Taste/Tongue disturbance	5.8% 3/52 • Number of events 4 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
General disorders Ear numbness	5.8% 3/52 • Number of events 3 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
Product Issues Small parts hazard	5.8% 3/52 • Number of events 3 • Up to 5 years Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.

Additional Information

PRS Specialist, Clinical Affairs

Cochlear

Phone: +61 2 9428 6555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The aggregate data resulting from this study will be the proprietary information of the Sponsor and may be made public after all data have been analyzed and the study results are available. None of the data resulting from this study will be allowed to be presented or published in any form, by the Investigator or any other person, without the prior written approval of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER