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Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052920
Recruitment Status : Completed
First Posted : February 14, 2017
Results First Posted : October 18, 2021
Last Update Posted : January 12, 2022
Sponsor:
Collaborators:
Midwest Ear Institute
House Clinic, Inc.
NYU Langone Health
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
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 : July 28, 2017
Actual Primary Completion Date : November 17, 2020
Actual Study Completion Date : March 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet [ Time Frame: Pre-implant and 6 months post-implant ]
    Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.)

  2. Change in Poor Ear Alone Soundfield Thresholds [ Time Frame: Pre-implant and 6 months post-implant ]
    Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.)


Secondary Outcome Measures :
  1. Change in Sound Localization [ Time Frame: Pre-implant and 6 months post-implant ]
    Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.)

  2. Change in 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 at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.)

  3. Change in AzBio Sentence Scores 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 ]
    Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.)

  4. Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear [ Time Frame: Pre-implant and 6 months post-implant ]
    Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)

  5. Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone [ Time Frame: Pre-implant and 6 months post-implant ]
    Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.)

  6. Change in 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. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.)

  7. Change in Health Utility Index (HUI3) Ratings [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.)

  8. Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)

  9. Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant [ Time Frame: Pre-implant and 12 months post-implant ]
    Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)

  10. Change in Satisfaction With Amplification in Daily Use (SADL) [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.)

  11. Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) [ Time Frame: Pre-implant and 6 months post-implant ]
    The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.)

  12. Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant [ 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. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.)

  13. Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear [ Time Frame: Pre-implant and 6 months post-implant ]
    Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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


Locations
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United States, California
House Clinic
Los Angeles, California, United States, 90057
United States, Missouri
Saint Luke's Midwest Ear Institute
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Washington University School of Medicine
Midwest Ear Institute
House Clinic, Inc.
NYU Langone Health
Investigators
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Principal Investigator: Jill B Firszt, PhD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Study Protocol and Statistical Analysis Plan  [PDF] April 27, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03052920    
Other Study ID Numbers: 201612147
First Posted: February 14, 2017    Key Record Dates
Results First Posted: October 18, 2021
Last Update Posted: January 12, 2022
Last Verified: December 2021
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
Keywords provided by Washington University School of Medicine:
cochlear implant
asymmetric hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases