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Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss

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ClinicalTrials.gov Identifier: NCT02004535
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE November 26, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date September 6, 2019
Study Start Date  ICMJE April 2006
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Sound localization using a 140 degree, horizontal plane loudspeaker arc [ Time Frame: Change from Pre-implant baseline localization at 12 months post-implant ]
Sound localization using a 140 degree, horizontal plane loudspeaker arc
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Sound localization using a 140 degree, horizontal plane loudspeaker arc [ Time Frame: Change from Pre-implant baseline localization at 12 months post-implant ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
  • Speech recognition [ Time Frame: Pre-implant and 1, 3, 6, 9, 12, and 24 months post-implant ]
    Speech recognition will be assessed with word and sentence material for the each ear individually as well as bilaterally (both ears together). Testing will be completed in quiet and in the presence of background noise.
  • Perceived benefit questionnaire [ Time Frame: Pre-implant and 1, 3, 6, 12, and 24 months post-implant ]
    Speech, Spatial and Qualities of Hearing scale (SSQ; Gatehouse and Noble,2004) will be completed by participants. The SSQ is a 49-item questionnaire that uses a 10-point rating scale (where a 0 rating reflects least ability and 10 reflects greatest ability) to evaluate the effects of hearing loss in terms of disability and function across three domains: Speech Hearing, Spatial Hearing, and Qualities of Hearing.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 8, 2018)
Cognitive ability (processing speed, visuospatial working memory, and perceptual effort) [ Time Frame: Pre-implant and 12 months post-implant ]
processing speed, visuospatial working memory, and perceptual effort
Original Other Pre-specified Outcome Measures
 (submitted: December 4, 2013)
Cognitive ability (processing speed, visuospatial working memory, and perceptual effort) [ Time Frame: Pre-implant and 12 months post-implant ]
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss
Official Title  ICMJE Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss
Brief Summary The objective of this study is to investigate benefits of binaural hearing for non-traditional cochlear implant candidates (with Asymmetric Hearing Loss). Asymmetric candidates are patients with severe to profound hearing loss in one ear and better hearing in the other ear. (One ear is deaf and the other ear has better hearing and in most cases uses a hearing aid.) The investigators hypothesize that cochlear implantation of the poorer ear provides a functional increase in word and sentence understanding in quiet or noise, perceived benefit, localization ability, and other measures of auditory performance relative to use of the better hearing ear alone.
Detailed Description

Multichannel cochlear implants have been highly successful in restoring speech understanding in adults and children who have congenital or acquired bilateral profound or severe-to-profound sensorineural (permanent) hearing loss. As implant technology has continued to develop and post-implant performance of patients has improved, the patient selection criteria has broadened to include patients with less severe hearing loss. Further, results from studies where patients received bilateral cochlear implants have demonstrated not only improved performance but the feasibility of integrating signals from both ears.

In contrast to persons with bilateral severe-to-profound hearing loss, persons who have only one ear with profound or severe-to-profound hearing loss and the other ear with substantially less hearing loss have not, to date, been considered cochlear implant candidates. This is because it has been assumed they will do well enough with a conventional hearing aid in the better ear. A problem with this assumption is that even with an appropriately fit better ear hearing aid, many of these hearing-impaired individuals still experience significant difficulties in speech understanding in their everyday listening environments, along with significant communication handicaps that interfere with their employment and quality of life.

Previous studies that have examined the performance of patients who have more symmetrical hearing loss and who wear a cochlear implant on one ear and a power hearing aid on the other ear, have illustrated that the two inputs can be combined and provide binaural hearing benefits. It is hypothesized in this study that patients with an asymmetrical sensorineural hearing loss may also receive significant binaural benefit from having a cochlear implant on the poorer ear along with an appropriately fit hearing aid on the better ear. That is, this study examines whether patients with asymmetrical sensorineural hearing loss can utilize both types of input (acoustic to one ear and electric to the other) effectively, and combine them to receive binaural hearing assistance for improving speech understanding, localization ability, and patient satisfaction.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss
Intervention  ICMJE Procedure: Cochlear Implantation
The standard surgical procedure for a cochlear implant will be used. The asymmetric participant will receive the cochlear implant in the deaf ear.
Study Arms  ICMJE Experimental: Cochlear implantation
Cochlear implantation of the ear with severe to profound hearing loss
Intervention: Procedure: Cochlear Implantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2017)
59
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2013)
60
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older at time of surgery
  • The poorer ear (implant ear) will have a severe-to-profound hearing loss and meet current cochlear implant candidacy criteria.
  • The better ear (contralateral ear) will have hearing levels less than current cochlear implant candidacy criteria and stable/non-fluctuating hearing levels for at least the previous year
  • Normal/patent cochlear anatomy
  • Fluent in English
  • Desire to have more functional binaural hearing and willingness to comply with all of the study requirements

Exclusion Criteria:

  • Medical or psychological conditions that contraindicate undergoing surgery
  • Additional handicaps that would prevent or restrict participation in the audiological evaluations
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Hearing loss of neural or central origin, including auditory neuropathy
  • Chronic and severe tinnitus in the ear to be implanted
  • Unwillingness or inability to comply with all investigational requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004535
Other Study ID Numbers  ICMJE 201605131
R01DC009010 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Jill B Firszt, PhD Washington University School of Medicine in St. Louis
PRS Account Washington University School of Medicine
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP