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Expanded Indications in the Adult Cochlear Implant Population

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ClinicalTrials.gov Identifier: NCT03236909
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation

Brief Summary:
The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

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

Detailed Description:

Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. .

Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanded Indications in the Adult Cochlear Implant Population
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
    Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
    Other Names:
    • SYNCHRONY +FLEXSOFT
    • SYNCHRONY +FLEX28


Primary Outcome Measures :
  1. Percent correct words recognition in quiet in implanted ear [ Time Frame: Up to twelve (12 months) post-activation ]
    CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline through 6 months and reported as percentage points improved.

  2. Percent correct of words identified for sentences in noise in implanted ear [ Time Frame: Up to twelve (12 months) post-activation ]
    AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline through 6 months and reported as percentage points improved.


Secondary Outcome Measures :
  1. Patient reported improvement in everyday listening conditions [ Time Frame: Up to twelve (12 months) post -activation ]
    APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) and SSQ (Spatial and Qualities of Hearing) questionnaires will be used to assess subjective outcomes and reported as improvements from baseline to 6 months post-activation.

  2. Number and proportion of subjects experiencing device related adverse events [ Time Frame: Up to twelve (12 months) post-activation ]
    Adverse events will be collected and reported throughout the duration of the study.

  3. Residual low frequency hearing [ Time Frame: Up to twelve (12) months post-activation ]
    HEARRING scale will be used to calculate the percent of hearing preservation for each subject. This data will be summarized through 6 months post-activation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults, 18 years of age or older at the time of implantation
  • Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz)
  • Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB
  • Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear
  • CNC word score in quiet of greater than or equal to 10% in the ear to be implanted
  • Evidence of appropriately fit hearing aids as determined by the audiologist
  • Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal
  • Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification
  • If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study
  • Fluent in English
  • No radiological contraindications
  • Ability to undergo general anesthesia
  • Appropriate motivation and expectation levels
  • Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria:

  • Evidence that hearing loss is retrocochlear in origin
  • Active middle ear infection
  • Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction
  • History of prior use of a hearing implant

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): NCT03236909


Contacts
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Contact: Allison Racey, AuD 888-633-3524 allison.racey@medel.com
Contact: Jennifer Bulls 888-633-3524 jennifer.bulls@medel.com

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Matthew Fitzgerald, PhD       fitzmb@stanford.edu   
Contact: Janine Larky, MA       jlarky@stanford.edu   
Principal Investigator: Matthew Fitzgerald, PhD         
Sub-Investigator: Janine Larky, MA         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Sandy Prentiss, AuD    305-243-1667    s.prentiss@med.miami.edu   
Contact: Constanza Pelluso    305-243-7102    cpelusso@med.miami.edu   
Sub-Investigator: Fred Telischi, MD         
Principal Investigator: Sandy Prentiss, PhD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Margaret Dillon, AuD    650-723-5281    mdillon@med.unc.edu   
Principal Investigator: Margaret Dillon, AuD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sara Unrein, AuD    615-322-0333    Sara.c.unrein@vanderbilt.edu   
Contact: Kathleen M VonWahlde, MJ, CCRP    615-322-0333    kate.vonwahlde@Vanderbilt.Edu   
Principal Investigator: David Haynes, MD         
Principal Investigator: Sara Unrein, AuD         
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Kari Smilsky, M.CI.Sc    416-480-6100 ext 4148    Kari.smilsky@sunnybrook.ca   
Contact: Varia Sajeniouk, CRC    416-480-6100 ext 85392    varia.sajeniouk@sunnybrook.ca   
Principal Investigator: Kari Smilsky, M.Cl.Sc         
Sponsors and Collaborators
Med-El Corporation

Publications:

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Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT03236909     History of Changes
Other Study ID Numbers: G170111
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms