- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02004535
Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Cochlear implantation
Cochlear implantation of the ear with severe to profound hearing loss
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The standard surgical procedure for a cochlear implant will be used.
The asymmetric participant will receive the cochlear implant in the deaf ear.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sound localization using a 140 degree, horizontal plane loudspeaker arc
Time Frame: Change from Pre-implant baseline localization at 12 months post-implant
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Sound localization using a 140 degree, horizontal plane loudspeaker arc
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Change from Pre-implant baseline localization at 12 months post-implant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech recognition
Time Frame: Pre-implant and 1, 3, 6, 9, 12, and 24 months post-implant
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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.
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Pre-implant and 1, 3, 6, 9, 12, and 24 months post-implant
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Perceived benefit questionnaire
Time Frame: Pre-implant and 1, 3, 6, 12, and 24 months post-implant
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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.
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Pre-implant and 1, 3, 6, 12, and 24 months post-implant
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive ability (processing speed, visuospatial working memory, and perceptual effort)
Time Frame: Pre-implant and 12 months post-implant
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processing speed, visuospatial working memory, and perceptual effort
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Pre-implant and 12 months post-implant
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Collaborators and Investigators
Investigators
- Principal Investigator: Jill B Firszt, PhD, Washington University School of Medicine in St. Louis
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201605131
- R01DC009010 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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