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Single-Sided Deafness and Asymmetric Hearing Loss

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ClinicalTrials.gov Identifier: NCT04506853
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation

Brief Summary:
The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.

Condition or disease Intervention/treatment Phase
Hearing Loss, Unilateral Hearing Loss, Sensorineural Device: MED-EL Cochlear Implant System Not Applicable

Detailed Description:
The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study
Actual Study Start Date : February 22, 2021
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study Procedure Device: MED-EL Cochlear Implant System
Cochlear implant and audio processor




Primary Outcome Measures :
  1. Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation [ Time Frame: Three years (36 months) post implantation ]
    The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12-month and 36-month CI score for AzBio sentences in noise(range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.


Secondary Outcome Measures :
  1. Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation [ Time Frame: Three years (36 months) post implantation ]
    Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 12 and 36 months post-activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear.(Range of score 0-100, higher score is better)

  2. Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation [ Time Frame: Three years (36 months) post implantation ]
    Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 12-month, and 36-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better)

  3. Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation [ Time Frame: Three years (36 months) post implantation ]
    Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 12-month, and 36-month intervals.(Range of score 0-10, lower score is better)

  4. Long term safety will be evaluated for all study subjects through three (36 months) years post implantation [ Time Frame: Three years (36 months) post implantation ]
    Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event.



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Five years of age or older at the time of implantation
  • Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
  • Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear
  • Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less
  • Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
  • Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
  • Fluent in English

Exclusion Criteria:

  • Duration of profound hearing loss of 10 years or more
  • Absence of cochlear development or non-functionality of cochlear nerve
  • Other retrocochlear hearing loss
  • Evidence of severe cochlear malformation (i.e., common cavity or ossification)
  • External or middle ear infection
  • Suspected developmental or cognitive concern
  • Other medical contraindication for surgery or anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04506853


Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Denise Thomas, AuD    312-227-3075    dthomas@luriechildrens.org   
Principal Investigator: Nancy Young, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1078
Contact: Camille Dunn, PhD    319-353-8776    camille_dunn@uiowa.edu   
Principal Investigator: Camille Dunn, PhD         
United States, New York
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Samantha Udondem, MPH    347-978-3973    samantha.udondem@mountsinai.org   
Principal Investigator: Maura Cosetti, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Margaret Dillon, Au.D    984-974-2255    mdillon@med.unc.edu   
Contact: Meredith Rooth, AuD       Meredith_Rooth@med.unc.edu   
Principal Investigator: Kevin Brown, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Kelly Robertson    206-287-6263    Kelly.Robertson@virginiamason.org   
Principal Investigator: Daniel Zietler, MD         
Canada, Ontario
Sunnybrook Health Sciences Center Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Kari Smilsky, M.CI.Sc.    416-480-6100    kari.smilsky@sunnybrook.ca   
Principal Investigator: Kari Smilsky, M.CI.Sc.         
Sponsors and Collaborators
Med-El Corporation
Publications:

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Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT04506853    
Other Study ID Numbers: P000025/S113
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Unilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases