Hearing LossHEDNCT02379273
Nucleus Hybrid L24 Extended Duration Post Approval Study
A study testing Nucleus Hybrid L24 Implant in people with Hearing Loss, run by Cochlear.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Iowa, NYU Langone Health, Midwest Ear Institute, University of Cincinnati, Ohio State University, Mayo Clinic, Hearts for Hearing
- Responsible party
- Sponsor
- Investigators
- Bruce J Gantz, MD, Principal investigator, University of Iowa
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 41059917Roland 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