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Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cochlear Implantation
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing loss, Asymmetric hearing loss, Cochlear implantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cochlear implantation

Arm Description

Cochlear implantation of the ear with severe to profound hearing loss

Outcomes

Primary Outcome Measures

Sound localization using a 140 degree, horizontal plane loudspeaker arc
Sound localization using a 140 degree, horizontal plane loudspeaker arc

Secondary Outcome Measures

Speech recognition
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
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.

Full Information

First Posted
November 26, 2013
Last Updated
September 5, 2019
Sponsor
Washington University School of Medicine
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT02004535
Brief Title
Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss
Official Title
Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing loss, Asymmetric hearing loss, Cochlear implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cochlear implantation
Arm Type
Experimental
Arm Description
Cochlear implantation of the ear with severe to profound hearing loss
Intervention Type
Procedure
Intervention Name(s)
Cochlear Implantation
Intervention Description
The standard surgical procedure for a cochlear implant will be used. The asymmetric participant will receive the cochlear implant in the deaf ear.
Primary Outcome Measure Information:
Title
Sound localization using a 140 degree, horizontal plane loudspeaker arc
Description
Sound localization using a 140 degree, horizontal plane loudspeaker arc
Time Frame
Change from Pre-implant baseline localization at 12 months post-implant
Secondary Outcome Measure Information:
Title
Speech recognition
Description
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.
Time Frame
Pre-implant and 1, 3, 6, 9, 12, and 24 months post-implant
Title
Perceived benefit questionnaire
Description
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.
Time Frame
Pre-implant and 1, 3, 6, 12, and 24 months post-implant
Other Pre-specified Outcome Measures:
Title
Cognitive ability (processing speed, visuospatial working memory, and perceptual effort)
Description
processing speed, visuospatial working memory, and perceptual effort
Time Frame
Pre-implant and 12 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill B Firszt, PhD
Organizational Affiliation
Washington University School of Medicine in St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22441359
Citation
Firszt JB, Holden LK, Reeder RM, Cowdrey L, King S. Cochlear implantation in adults with asymmetric hearing loss. Ear Hear. 2012 Jul-Aug;33(4):521-33. doi: 10.1097/AUD.0b013e31824b9dfc.
Results Reference
result
PubMed Identifier
21527825
Citation
Asymmetric hearing loss. Extended abstracts from the Cochlear Science and Research Seminar. Interlaken, Switzerland. February 10-11, 2011. Audiol Neurootol. 2011;16 Suppl 1:1-26. doi: 10.1159/000327759. No abstract available.
Results Reference
result

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Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss

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