AzTrials
AzTrials

Hearing Loss, SensorineuralSMENCT03007472

Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

A study testing CI532 and Nucleus 7 in people with Hearing Loss, Sensorineural, run by Cochlear at 10 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor Read more about this study

Who is it for?
Any age
Conditions the study is for
Hearing Loss, Sensorineural
What is being tested?
CI532 and Nucleus 7
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
10 sitesUnited States
Study dates
15 Feb 2017to 6 Mar 2020
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
  • Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level.
  • Bilateral moderate sloping to profound hearing loss
  • Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method
  • Proficient in English
  • Ability to complete testing -

Who cannot join

  • Previous cochlear implantation
  • Pre-linguistically deafened (onset of hearing loss at less than two years of age)
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Duration of severe to profound hearing loss greater than 20 years
  • Diagnosis of retro-cochlear pathology
  • Diagnosis of auditory neuropathy
Show all 9Show fewer
  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
  • Unwillingness or inability to comply with all investigational requirements
  • Additional cognitive, medical or social handicaps that would prevent completion of all study requirements-

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Michigan

    Ann Arbor, Michigan, 48108

  • The Center for Hearing and Balance Disorders

    Chesterfield, Missouri, 63017

  • The Ohio State University

    Columbus, Ohio, 13212

  • Dallas Ear Institute

    Dallas, Texas, 75230

  • Rocky Mountain Ear Center

    Englewood, Colorado, 80113

  • University of Iowa

    Iowa City, Iowa, 52242

  • Midwest Ear Institute

    Kansas City, Missouri, 64111

  • New York University

    New York, New York, 10016

  • Hearts for Hearing

    Oklahoma City, Oklahoma, 73120

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

Read the detailed description

Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.

Being tested
CI532, Nucleus 7
Keywords
cochlear implant, sound processor
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

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

  • CI532Device

    Also called Slim Modiolar Electrode, 532

    Cochlear implant

  • Nucleus 7Device

    Also called N7, CP1000

    Sound processor

Study groups in NCT03007472
Study groupRoleWhat they receive
CI532/N7 study groupExperimentalAll subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor
Receives: Device: CI532; Device: Nucleus 7

What is being measured

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

  1. Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone

    Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.

    Measured: Preoperatively and 6 months post sound processor activation

Secondary outcomes (2)

  1. Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone

    Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.

    Measured: Preoperatively and 6 months post sound processor activation

  2. Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)

    Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).

    Measured: Preoperatively and 6 months post sound processor activaton

Timeline

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

  1. First posted2 Jan 2017 (estimated)
  2. Study start15 Feb 2017
  3. Primary completion3 Dec 2018
  4. Study completion6 Mar 2020

Resources

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
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03007472
Sponsor's protocol ID
CLTD5685
Acronym
SME
Status last verified
Dec 2020
First submitted
27 Dec 2016
Last updated
30 Dec 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Grutters JP, Joore MA, van der Horst F, Verschuure H, Dreschler WA, Anteunis LJ. Choosing between measures: comparison of EQ-5D, HUI2 and HUI3 in persons with hearing complaints. Qual Life Res. 2007 Oct;16(8):1439-49. doi: 10.1007/s11136-007-9237-x. Epub 2007 Jul 24.

    PubMed 17647093

  • Hiller W, Goebel G. Factors influencing tinnitus loudness and annoyance. Arch Otolaryngol Head Neck Surg. 2006 Dec;132(12):1323-30. doi: 10.1001/archotol.132.12.1323.

    PubMed 17178943

  • Meinert,C(1986).ClinicalTrials:Design,Conduct,andAnalysis.OxfordUniversityPress,NewYork.

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.

    PubMed 14485785

  • Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.

    PubMed 21829134

  • Kelsall D, Lupo J, Biever A. Longitudinal outcomes of cochlear implantation and bimodal hearing in a large group of adults: A multicenter clinical study. Am J Otolaryngol. 2021 Jan-Feb;42(1):102773. doi: 10.1016/j.amjoto.2020.102773. Epub 2020 Oct 22.

    PubMed 33161258

  • Wick CC, Kallogjeri D, McJunkin JL, Durakovic N, Holden LK, Herzog JA, Firszt JB, Buchman CA; CI532 Study Group. Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older: A Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):925-932. doi: 10.1001/jamaoto.2020.1585.

    PubMed 32857114

  • Buchman CA, Herzog JA, McJunkin JL, Wick CC, Durakovic N, Firszt JB, Kallogjeri D; CI532 Study Group. Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):916-924. doi: 10.1001/jamaoto.2020.1584.

    PubMed 32857113

Questions about this trial

What is this clinical trial studying?

A study testing CI532 and Nucleus 7 in people with Hearing Loss, Sensorineural, run by Cochlear at 10 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 9 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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 3 Dec 2020). 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 From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone (time frame: Preoperatively and 6 months post sound processor activation). 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 NCT03007472, which also lists 9 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 30 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in