High Frequency Sensorineural Hearing LossHNENCT02379819

Hybrid L24 New Enrollment Post Approval Study

A study testing Nucleus Hybrid L24 Implant in people with High Frequency Sensorineural Hearing Loss, run by Cochlear at 19 sites in United States.

Completed

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

Official record

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Trial summary

This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: High Frequency Sensorineural 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: 52 participants
Where: 19 sitesUnited States
Study dates: Feb 2015to 14 Apr 2022
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

Ear to Be Implanted:
Normal to moderate hearing loss in the low frequencies with severe to profound mid to high frequency hearing loss in the ear to be implanted
CNC word recognition of 10-60% in the ear to be implanted
Contralateral Ear:
Moderately severe to profound mid to high frequency hearing loss in the contralateral ear
CNC word recognition equal to or better than that in the ear to be implanted but not more than 80% correct

Who cannot join

not proficient in English
unwilling and/or unable to comply with the test protocol
deafness due to lesions of the acoustic nerve or central auditory pathway.
active middle-ear disease, with or without tympanic membrane perforation.
absence of cochlear development.
duration of severe to profound hearing loss of 30 years or greater

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado Hospitals
Aurora, Colorado, 80045
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01803
The University of Cincinnati
Cincinnati, Ohio, 45219
Denver Ear Associates
Englewood, Colorado, 80110
Rocky Mountain Ear Center
Englewood, Colorado, 80113
Michigan Ear Institute
Farmington Hills, Michigan, 48334
University of Iowa
Iowa City, Iowa, 52242
Midwest Ear Institute
Kansas City, Missouri, 64111
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NorthShore University Health System
Northbrook, Illinois, 60062
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Arizona Ear Center
Phoenix, Arizona, 85004
Pittsburgh Ear Associates
Pittsburgh, Pennsylvania, 15212
Kaiser Permanente South Sacramento
Sacramento, California, 95823
Ear Institute of Texas
San Antonio, Texas, 78258
Ohio Ear Institute
Westerville, Ohio, 43082

Other trials in United States

About this study

Official title: Nucleus Hybrid L24 Implant System: New Enrollment Study

This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.

Conditions: High Frequency Sensorineural Hearing Loss
Being tested: Nucleus Hybrid L24 Implant

What participants receive

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

Nucleus Hybrid L24 ImplantDevice

Study groups in NCT02379819
Study group	Role	What they receive
Nucleus Hybrid L24 Implant	Experimental	Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Receives: Device: Nucleus Hybrid L24 Implant

What is being measured

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

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
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.
Measured: From pre-operatively through 3 years post-activation of the device
Number of Device or Procedure Related Adverse Events
Measured: Up to 5 years post-activation of the device

Secondary outcomes (1)

Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition
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.
Measured: Pre-operatively, up to 3 years post-activation of the device

Timeline

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

Feb 201514 Apr 2022

First posted5 Mar 2015 (estimated)
Study startFeb 2015
Primary completion14 Apr 2022
Study completion14 Apr 2022

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 High Frequency Sensorineural 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: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02379819
Sponsor's protocol ID: CAM-5573-HYB-PMA
Acronym: HNE
Status last verified: Feb 2023
First submitted: 29 Jan 2015
Last updated: 13 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes
Individual data sharing: No: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

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
Reinhart P, Parkinson A, Gifford RH. Hybrid Cochlear Implant Outcomes and Improving Outcomes With Electric-Acoustic Stimulation. Otol Neurotol. 2024 Dec 1;45(10):e749-e755. doi: 10.1097/MAO.0000000000004305.
PubMed 39514431

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nucleus Hybrid L24 Implant System: New Enrollment Study
ClinicalTrials.gov ID: NCT02379819
Acronym / sponsor ID: HNE / CAM-5573-HYB-PMA
Conditions: High Frequency Sensorineural Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Study start: Feb 2015 (actual)
Primary completion: 14 Apr 2022 (actual)
Study completion: 14 Apr 2022 (actual)
First posted: 5 Mar 2015 (estimated)
Results: Posted 13 Mar 2023

Clinical summary

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

This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.

Study design

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

Arm	Type	Receives
Nucleus Hybrid L24 Implant	Experimental	Device: Nucleus Hybrid L24 ImplantAdults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.

Who may qualify

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

Key inclusion criteria (6 listed)

Normal to moderate hearing loss in the low frequencies with severe to profound mid to high frequency hearing loss in the ear to be implanted
CNC word recognition of 10-60% in the ear to be implanted
Moderately severe to profound mid to high frequency hearing loss in the contralateral ear
CNC word recognition equal to or better than that in the ear to be implanted but not more than 80% correct

Key exclusion criteria (6 listed)

not proficient in English
unwilling and/or unable to comply with the test protocol
deafness due to lesions of the acoustic nerve or central auditory pathway.
active middle-ear disease, with or without tympanic membrane perforation.
absence of cochlear development.

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 Implant	Device	Nucleus Hybrid L24 Implant

Primary outcome

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
Time frame: From pre-operatively through 3 years post-activation of the device
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.
Number of Device or Procedure Related Adverse Events
Time frame: Up to 5 years post-activation of the device

1 secondary outcome

Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition
Time frame: Pre-operatively, up to 3 years post-activation of the device

Results and safety

Results posted to the registry on 13 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nucleus Hybrid L24 Implant	52	38

Primary outcome: 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

Time frame: From pre-operatively through 3 years post-activation of the device. Mean (95% Confidence Interval). Unit: percentage of correct words

Measure	Nucleus Hybrid L24 Implant n = 50
Unilateral condition at 3 months post-activation	31.3 (25.4 to 37.3)
Unilateral condition at 6 months post-activation	35.2 (29.3 to 41.1)
Unilateral condition at 1 year post-activation	35.8 (29.6 to 41.9)
Unilateral condition at 2 years post-activation	35.3 (29.2 to 41.5)
Unilateral condition at 3 years post-activation	36.8 (29.7 to 44.0)
Bilateral condition at 3 months post-activation	26.8 (22.2 to 31.5)
Bilateral condition at 6 months post-activation	29.7 (24.6 to 34.8)
Bilateral condition at 1 year post-activation	31.1 (26.4 to 35.9)

Population analysed: 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.

Primary outcome: Number of Device or Procedure Related Adverse Events

Time frame: Up to 5 years post-activation of the device. Number. Unit: Number of events

Measure	Nucleus Hybrid L24 Implant n = 52
Total number of device or procedure related adverse event	98
Number of serious device or procedure related adverse event	1

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nucleus Hybrid L24 Implant	1 of 52 (1.9%)	35 of 52 (67.3%)	2 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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 39514431Reinhart P, Parkinson A, Gifford RH. Hybrid Cochlear Implant Outcomes and Improving Outcomes With Electric-Acoustic Stimulation. Otol Neurotol. 2024 Dec 1;45(10):e749-e755. doi: 10.1097/MAO.0000000000004305.
Individual participant dataSharing planned: No. Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

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.

Brian Kaplan, MD principal investigator

Greater Baltimore Medical Center

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nucleus Hybrid L24 Implant in people with High Frequency Sensorineural Hearing Loss, run by Cochlear at 19 sites in United States.

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 6 inclusion and 6 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 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 13 Mar 2023). 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?

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 (time frame: From pre-operatively through 3 years post-activation of the device). 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 NCT02379819, 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 13 Mar 2023.