NCT02379273

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2019

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 30, 2021

Completed
Last Updated

November 30, 2021

Status Verified

October 1, 2021

Enrollment Period

4.2 years

First QC Date

January 29, 2015

Results QC Date

April 5, 2021

Last Update Submit

October 31, 2021

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    5 years postactivation.

Study Arms (1)

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

Device: Nucleus Hybrid L24 Implant

Interventions

Nucleus Hybrid L24 ImplantDEVICE

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

Hybrid L24 pivotal study subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Reinhart PN, Parkinson AJ, Dunn CC, Gantz BJ. Factors Affecting Audiometric and Speech Perception Outcomes in Hybrid Cochlear Implant Recipients. Laryngoscope. 2025 Oct 8. doi: 10.1002/lary.70195. Online ahead of print.

    PMID: 41059917DERIVED

  • 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.

    PMID: 29330858DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Aaron J Parkinson, PhD, Principal Clinical Project Manager
Organization
Cochlear Americas
aparkinson@cochlear.com
3035242563

Study Officials

  • Bruce J Gantz, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

March 4, 2015

Study Start

January 14, 2015

Primary Completion

March 18, 2019

Study Completion

March 18, 2019

Last Updated

November 30, 2021

Results First Posted

November 30, 2021

Record last verified: 2021-10