Nucleus Hybrid L24 Extended Duration Post Approval Study

A study testing Nucleus Hybrid L24 Implant in people with Hearing Loss, run by Cochlear.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hearing Loss
What is being tested?: Nucleus Hybrid L24 Implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: No sites listed yet
Study dates: 14 Jan 2015to 18 Mar 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study

Who cannot join

Recipients who withdrew or were terminated from the L24 pivotal IDE study
Recipients who were re-implanted and no longer have a Nucleus Hybrid L24 implant

About this study

Official title: The Nucleus Hybrid L24 Implant System: Extended Duration Post Approval Study

This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.

Read the detailed description

The Hybrid L24 Implant System (P130016) was the subject of a pivotal clinical trial (IDE G070191) from 2007 through 2012. Data on the 50 subjects enrolled in the study, in support of safety and efficacy of the device, was submitted in June 2013 as part of Premarket Approval (PMA) #130016. As a condition of approval, March 20, 2014, a Post-Approval Study was designed to monitor the long-term (5 years postactivation for each subject) safety and effectiveness of the device in this existing cohort of implanted subjects was designed.

Conditions: Hearing Loss
Being tested: Nucleus Hybrid L24 Implant
Medical subject headings: Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nucleus Hybrid L24 ImplantDevice
Subjects have already been implanted with the Nucleus Hybrid L24 implant.

Study groups in NCT02379273
Study group	Role	What they receive
Hybrid L24 pivotal study subjects	Experimental	Subjects implanted with the Nucleus Hybrid L24 Implant as part of the pivotal IDE study and who still have the device implanted will continue to be followed for 5 years post activation Receives: Device: Nucleus Hybrid L24 Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized.
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in compact disk format. For this study, two lists were administered in quiet at a level equal to 60 dBA (decibels A-weighted) in the sound field and scored as total number of words correct, which will be expressed as a percentage correct. Minimum score is 0/100 words or 0% (worse), maximum score is 100/100 or 100% (best possible).
Measured: 5 years postactivation.
AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized.
The AzBio Sentence Test 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 towards the overall score. Minimum score is 0 out the total number of words in a given list (varies list to list, with an average length of 141 words) words or 0% (worse), maximum score is all words correctly repeated or 100% (best possible).
Measured: 5 years postactivation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 201518 Mar 2019

First posted4 Mar 2015 (estimated)
Study start14 Jan 2015
Primary completion18 Mar 2019
Study completion18 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02379273
Sponsor's protocol ID: CAM-5563-HYB-PMA
Acronym: HED
Status last verified: Oct 2026
First submitted: 29 Jan 2015
Last updated: 21 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Reinhart PN, Parkinson AJ, Dunn CC, Gantz BJ. Factors Affecting Audiometric and Speech Perception Outcomes in Hybrid Cochlear Implant Recipients. Laryngoscope. 2026 Mar;136(3):1475-1486. doi: 10.1002/lary.70195. Epub 2025 Oct 8.
PubMed 41059917
Roland JT Jr, Gantz BJ, Waltzman SB, Parkinson AJ. Long-term outcomes of cochlear implantation in patients with high-frequency hearing loss. Laryngoscope. 2018 Aug;128(8):1939-1945. doi: 10.1002/lary.27073. Epub 2018 Jan 13.
PubMed 29330858

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
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Enrolling by invitationObservational study
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Conductive Hearing Loss, Mixed Hearing Loss
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
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RecruitingObservational study
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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Nucleus Hybrid L24 Implant System: Extended Duration Post Approval Study
ClinicalTrials.gov ID: NCT02379273
Acronym / sponsor ID: HED / CAM-5563-HYB-PMA
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Collaborators: University of Iowa, NYU Langone Health, Midwest Ear Institute, University of Cincinnati, Ohio State University, Mayo Clinic, Hearts for Hearing
Study start: 14 Jan 2015 (actual)
Primary completion: 18 Mar 2019 (actual)
Study completion: 18 Mar 2019 (actual)
First posted: 4 Mar 2015 (estimated)
Results: Posted 30 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Hybrid L24 pivotal study subjects	Experimental	Device: Nucleus Hybrid L24 ImplantSubjects implanted with the Nucleus Hybrid L24 Implant as part of the pivotal IDE study and who still have the device implanted will continue to be followed for 5 years post activation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study

Key exclusion criteria (2 listed)

Recipients who withdrew or were terminated from the L24 pivotal IDE study
Recipients who were re-implanted and no longer have a Nucleus Hybrid L24 implant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nucleus Hybrid L24 ImplantSubjects have already been implanted with the Nucleus Hybrid L24 implant.	Device	Hybrid L24 pivotal study subjects

Primary outcome

Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized.
Time frame: 5 years postactivation.
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in compact disk format. For this study, two lists were administered in quiet at a level equal to 60 dBA (decibels A-weighted) in the sound field and scored as total number of words correct, which will be expressed as a percentage correct. Minimum score is 0/100 words or 0% (worse), maximum score is 100/100 or 100% (best possible).
AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized.
Time frame: 5 years postactivation.
The AzBio Sentence Test 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 towards the overall score. Minimum score is 0 out the total number of words in a given list (varies list to list, with an average length of 141 words) words or 0% (worse), maximum score is all words correctly repeated or 100% (best possible).

Results and safety

Results posted to the registry on 30 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hybrid L24 Pivotal Study Subjects.	35	35

Primary outcome: Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized.

Time frame: 5 years postactivation.. Mean (Standard Deviation). Unit: percentage of total words correct

Measure	Hybrid L24 Pivotal Study Subjects. n = 35
Implanted Ear	71.2 (20.4)
Bilateral Condition	81 (12.7)

Hybrid L24 Pivotal Study Subjects.: p <0.001, ANOVA
Hybrid L24 Pivotal Study Subjects.: p <0.001, ANOVA

Population analysed: All subjects completing the 5-year postactivation evaluation interval.

Primary outcome: AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized.

Time frame: 5 years postactivation.. Mean (Standard Deviation). Unit: percentage of total words correct

Measure	Hybrid L24 Pivotal Study Subjects. n = 35
Implanted Ear	49.6 (27.5)
Bilateral Condition	61.4 (24.5)

Hybrid L24 Pivotal Study Subjects.: p <0.001, ANOVA
Hybrid L24 Pivotal Study Subjects.: p <0.001, ANOVA

Population analysed: All subjects completing the 5-year postactivation evaluation interval.

Adverse events

Time frame: Adverse event (AE) data were captured from baseline for this study through 5 years postactivation. Since subjects were recruited following their completion of the pivotal study baseline was anywhere from 2 years through 5 years postactivation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hybrid L24 Pivotal Study Subjects.	3 of 35 (8.6%)	4 of 35 (11.4%)	0 of 35

Limitations and caveats (from the sponsor): The non-study group presents a potential bias because it was comprised of a number who experienced significant changes in low-frequency acoustic hearing during the pivotal study and their outcomes beyond the pivotal study were not followed. Prior to the beginning of the post-approval study, 13 of the 18 subjects experienced profound/total loss of hearing between surgery and 18 months postactivation, compared with 9 of the 35 subjects who proceeded into the post-approval study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41059917Reinhart PN, Parkinson AJ, Dunn CC, Gantz BJ. Factors Affecting Audiometric and Speech Perception Outcomes in Hybrid Cochlear Implant Recipients. Laryngoscope. 2026 Mar;136(3):1475-1486. doi: 10.1002/lary.70195. Epub 2025 Oct 8.
Derived from this study: PubMed 29330858Roland JT Jr, Gantz BJ, Waltzman SB, Parkinson AJ. Long-term outcomes of cochlear implantation in patients with high-frequency hearing loss. Laryngoscope. 2018 Aug;128(8):1939-1945. doi: 10.1002/lary.27073. Epub 2018 Jan 13.

Related trials for Hearing Loss

Not yet recruiting
Automated Text Message Reminders to Promote Hearing Aid Adoption
Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
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RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce J Gantz, MD principal investigator

University of Iowa

Questions about this trial

What is this clinical trial studying?

A study testing Nucleus Hybrid L24 Implant in people with Hearing Loss, run by Cochlear.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized. (time frame: 5 years postactivation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379273, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.