Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss
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|ClinicalTrials.gov Identifier: NCT02004535|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Procedure: Cochlear Implantation||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss|
|Study Start Date :||April 2006|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: Cochlear implantation
Cochlear implantation of the ear with severe to profound hearing loss
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.
- 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
- 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.
- 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
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): NCT02004535
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Jill B Firszt, PhD||Washington University School of Medicine in St. Louis|