Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03929809|
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment|
|Hearing Loss, Unilateral Hearing Loss, Profound||Device: Cochlear Implant|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2021|
Adult Single-sided deafness
Adult subjects with unilateral single-sided deafness at least 6 months (to ensure stability of hearing loss), but no greater than 10 years will be implanted with a MED-EL Synchrony Cochlear Implant.
Device: Cochlear Implant
adults with unilateral hearing loss who wish to regain bilateral hearing will be implanted with a cochlear implant on their deafened ear.
Other Name: MED-EL Synchrony
- Change in AzBio Sentences in Noise [ Time Frame: Pre-operative baseline, 3, 6, 12 months post-activation ]The percent correct of words from a list of 20 Target AzBio sentences will be played from 0° azimuth. A list of AzBio sentences will be played in multitalker babble which will be presented in three different conditions: 0° azimuth, S0N90, or S0N270°.
- Change in Localization [ Time Frame: Pre-operative baseline, 3, 6, 12 months post-activation ]Testing with 16 sounds played randomly from 1 of 8 loudspeakers in a 108 degree arc will be completed with non-implanted ear alone and everyday listening condition at 60 dBA. Subjects will be asked to identify which loudspeaker presented the sound. The RMS error in degrees will be calculated. A lower number indicates better localization ability.
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): NCT03929809
|Contact: Camille Dunn, PhDemail@example.com|
|Contact: Diane Burke, RNfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52241|
|Contact: Camille C Dunn, Phd 319-353-8776 email@example.com|
|Principal Investigator:||Camille Dunn, PhD||University of Iowa|