Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

NCT03007472 | Completed Results FDA Device

• 1 other identifier: CLTD5685
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Hearing Loss, Sensorineural

Keywords

cochlear implant, sound processor

Outcome Measures

Primary Outcomes (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.

  Preoperatively and 6 months post sound processor activation

Secondary Outcomes (2)

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

  Preoperatively and 6 months post sound processor activation

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

  Preoperatively and 6 months post sound processor activaton

Other Outcomes (2)

• Frequency Specific Thresholds and Speech Recognition in Noise or Quiet

  12 months post-activation

• Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming

  Following 12-month study visit but prior to 36-month interval.

Study Arms (1)

CI532/N7 study group

EXPERIMENTAL

All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor

Device: CI532; Device: Nucleus 7

Interventions

CI532 DEVICE

Cochlear implant

Also known as: Slim Modiolar Electrode, 532

CI532/N7 study group

Nucleus 7 DEVICE

Sound processor

Also known as: N7, CP1000

CI532/N7 study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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
• 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-

Sponsors & Collaborators

• Cochlear: lead

Study Sites (10)

Rocky Mountain Ear Center

Englewood, Colorado, 80113, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

The Center for Hearing and Balance Disorders

Chesterfield, Missouri, 63017, United States

Location

Midwest Ear Institute

Kansas City, Missouri, 64111, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York University

New York, New York, 10016, United States

Location

The Ohio State University

Columbus, Ohio, 13212, United States

Location

Hearts for Hearing

Oklahoma City, Oklahoma, 73120, United States

Location

Dallas Ear Institute

Dallas, Texas, 75230, United States

Location

Related Publications (9)

• 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.

  PMID: 17647093 BACKGROUND

• 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.

  PMID: 17178943 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 14485785 BACKGROUND

• 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.

  PMID: 21829134 BACKGROUND

• 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.

  PMID: 33161258 DERIVED

• 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.

  PMID: 32857114 DERIVED

• 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.

  PMID: 32857113 DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Cochlear Clinical Studies
• Organization: Cochlear

clinicalstudies@cochlear.com

(303) 790-9010

Study Officials

• Jillian Crosson, PhD

  Senior Manager of Clinical Services

  STUDY DIRECTOR

• Megan Mears, AuD

  Clinical Project Manager

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: December 27, 2016
• First Posted: January 2, 2017
• Study Start: February 15, 2017
• Primary Completion: December 3, 2018
• Study Completion: March 6, 2020
• Last Updated: December 30, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-12

Locations

US (10)