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Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

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ClinicalTrials.gov Identifier: NCT03052920
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
Midwest Ear Institute
House Clinic, Inc.
New York University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This longitudinal study evaluates the possible benefit of cochlear implantation in the poor ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better hearing ear.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Cochlear implant Not Applicable

Detailed Description:

The study will be conducted as a multicenter, prospective, single-arm clinical trial, evaluating the efficacy and safety of cochlear implantation in patients with asymmetric hearing loss. A repeated-measures analysis will be employed whereby patients will act as their own controls. Participants will be recruited from surgeons and audiologists in Otolaryngology departments at the participating sites.

Participants will be evaluated at multiple intervals using a variety of test measures (addressing sound localization, understanding speech in noise, understanding speech in quiet, and quality of life).

Prior to receiving a cochlear implant (CI) in the poor hearing ear, participants will be evaluated as follows:

  • Hearing aid (HA) in the better ear alone
  • HA in the poor ear alone
  • Bilateral HAs

Participants who have not previously used a poor-ear hearing aid or BiCROS hearing aid will complete a 1-2 week trial and be evaluated at the end of the trial. If performance is better with the alternate therapy (bilateral hearing aids or BiCROS hearing aid) than the better ear alone performance and the participant prefers the alternate therapy, the participant will not continue in the study.

Participants who do continue in the study will be evaluated at several post-implant intervals. Post-implant evaluations will occur at 3, 6, 9, and 12 months after initial stimulation of the CI. Participants will be evaluated as follows:

  • HA in the better ear alone
  • CI in the poor ear alone
  • HA and CI together

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Actual Study Start Date : June 13, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cochlear Implantation
Cochlear implantation of the poor hearing ear
Device: Cochlear implant
Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Other Names:
  • Cochlear America
  • Advanced Bionics
  • MED-EL



Primary Outcome Measures :
  1. Poor ear alone CNC monosyllabic word understanding in quiet [ Time Frame: Pre-implant and 6 months post-implant ]
    CNC monosyllabic word understanding in quiet with the CI alone compared to pre-implant with a hearing aid.


Secondary Outcome Measures :
  1. Sound localization [ Time Frame: Pre-implant and 6 months post-implant ]
    Sound localization post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.

  2. AzBio Sentences at 50 decibels (dB) sound pressure level (SPL) [ Time Frame: Pre-implant and 6 months post-implant ]
    Understanding of sentences at a soft presentation level post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.

  3. AzBio Sentences at 60 dB SPL and 4-talker babble at +8 dB signal-to-noise ratio (SNR) [ Time Frame: Pre-implant and 6 months post-implant ]
    Understanding of sentences in noise post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.

  4. Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentences with noise to the better ear and with noise to the poor ear [ Time Frame: Pre-implant and 6 months post-implant ]
    Understanding of sentences in noise post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.

  5. AzBio Sentences at 60 dB SPL [ Time Frame: Pre-implant and 6 months post-implant ]
    AzBio sentence understanding in quiet with the CI alone compared to pre-implant with a hearing aid.

  6. Hearing Handicap Inventory (HHIE) [ Time Frame: Pre-implant and 6 months post-implant ]
    Inventory completed by participant regarding emotional and social consequences of hearing loss.

  7. Health Utility Index (HUI3) [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant regarding ability/disability across several health dimensions.

  8. Speech, Spatial and Sound Qualities (SSQ) [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant regarding impact of hearing loss on various listening situations.

  9. Speech, Spatial and Sound Qualities (SSQ) [ Time Frame: Pre-implant and 12 months post-implant ]
    Questionnaire completed by participant regarding impact of hearing loss on various listening situations.

  10. Glasgow Benefit Inventory (GBI) [ Time Frame: 6 months post-implant ]
    Inventory completed by participant regarding perceived benefit of cochlear implantation.

  11. Satisfaction with Amplification in Daily Use (SADL) [ Time Frame: 6 months post-implant ]
    Questionnaire completed by participant regarding satisfaction of bimodal (HA+CI) device use. The original questionnaire wording has been modified for bimodal listeners.

  12. Questions from the Communication Profile for the Hearing Impaired (CPHI) [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations.

  13. Hearing Impaired Impact - Significant Other Profile (HII-SOP) [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other.

  14. Number, type and degree of adverse events [ Time Frame: Up through 6 months post-implant ]
    Adverse event information through 6 months post-implant will be summarized by event type, severity/seriousness, and whether related to the device and/or implant procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • 18 years of age or older
  • English as the native language
  • Have a desire for functional binaural hearing
  • Have failed a previous hearing aid (HA) treatment for asymmetric hearing loss (BiCROS or poor ear HA) or willing to complete a trial if necessary
  • Willingness to comply with all study requirements
  • Ability to provide informed consent
  • Poor ear (ear to be implanted):

    • Pure-tone average (PTA) at .5, 1 and 2 kilohertz (kHz) > 70 dB HL (hereafter referred to as severe to profound hearing loss - SPHL)
    • Aided word recognition score (CNC Word Test) at 60 dB SPL ≤ 30%
    • Duration of SPHL ≥ 6 months
    • Onset of hearing loss ≥ 6 years of age
  • Better ear:

    • PTA at .5, 1, 2, 4 kHz of 40 to 70 dB HL
    • Currently using a HA
    • Aided word recognition score (CNC Word Test) at 60 dB SPL > 40%
    • Stable hearing for the previous 1-year period. "Stable" is defined as thresholds that have not changed by more than 10 dB at 2 or more octave interval audiometric frequencies

Exclusion Criteria:

  • Medical condition that contraindicates surgery
  • Actively using an implantable device in the ear to be implanted
  • Known cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted
  • Hearing loss of neural or central origin
  • Unrealistic expectations related to the benefits and limitations of cochlear implantation
  • Unwillingness or inability to comply with all investigational requirements

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): NCT03052920


Contacts
Contact: Noel Dwyer, AuD 800-437-5930 DwyerN@wustl.edu
Contact: Laura Holden, AuD 800-437-5930 laurakholden@wustl.edu

Locations
United States, California
House Clinic Recruiting
Los Angeles, California, United States, 90057
Contact: Dawna Mills, AuD    213-483-9930    dmills@houseclinic.com   
Principal Investigator: William Slattery, MD         
United States, Missouri
Saint Luke's Midwest Ear Institute Recruiting
Kansas City, Missouri, United States, 64111
Contact: Sarah Zlomke, AuD    816-932-1660    sking@saint-lukes.org   
Contact: Kristen Lewis, AuD    (816) 932-1660    kllewis@saint-lukes.org   
Principal Investigator: Kristen Lewis, AuD         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Noel Dwyer, AuD    800-437-5930    NDywer@wustl.edu   
Contact: Laura Holden, AuD    800-437-5930    laurakholden@wustl.edu   
Principal Investigator: Jill B Firszt, PhD         
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Bill Shapiro, AuD    212-263-3311    william.shapiro@nyumc.org   
Principal Investigator: Susan Waltzman, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Midwest Ear Institute
House Clinic, Inc.
New York University School of Medicine
Investigators
Principal Investigator: Jill B Firszt, PhD Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03052920     History of Changes
Other Study ID Numbers: 201612147
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Washington University School of Medicine:
cochlear implant
asymmetric hearing loss

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