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Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants

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ClinicalTrials.gov Identifier: NCT03929809
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Camille Dunn, University of Iowa

Tracking Information
First Submitted Date April 22, 2019
First Posted Date April 29, 2019
Last Update Posted Date April 29, 2019
Estimated Study Start Date May 1, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants
Official Title Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants
Brief Summary The purpose of this study is to understand the speech perception in noise and in quiet and localization benefits in a laboratory setting in listeners that receive a cochlear implant in an ear with severe to profound hearing loss and have normal, or near-normal hearing in the opposite ear. We will also evaluate the functional benefit of restoring hearing to the impaired ear via questionnaires that subjects will be answering while listening in their natural environment.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be adults 18 years of age or older who utilize English as their primary language. These adults will have unilateral severe to profound sensorineural hearing loss in one ear for a duration of at least 6 months (to ensure stability of hearing loss), but no greater than 10 years. The contralateral ear will present with with normal, or near-normal, hearing.
Condition
  • Hearing Loss, Unilateral
  • Hearing Loss, Profound
Intervention 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
Study Groups/Cohorts 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.
Intervention: Device: Cochlear Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 25, 2019)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Participants will be adults who utilize English as their primary language.
  2. Unilateral severe to profound sensorineural hearing loss for a duration of at least 6 months (to ensure stability of hearing loss), but no greater than 10 years.
  3. Contralateral ear with normal, or near-normal, hearing.
  4. Poorer ear (ear to be implanted): severe to profound sensorineural hearing loss, defined as pure-tone thresholds 70 dB HL or greater for the frequencies 500, 1000, 2000, 3000, and 4000 Hz with monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, less than or equal to 20%
  5. Better ear (contralateral ear): normal or near-normal hearing defined as pure-tone thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB HL at 4000 Hz with monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, of greater than or equal to 85%.
  6. Willingness to comply with all study requirements.
  7. Patent cochlea and normal cochlear anatomy.

Exclusion Criteria:

  1. Medical or psychological conditions that contraindicate undergoing surgery.
  2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
  3. Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
  4. Unwillingness or inability of the candidate to comply with all investigational requirements.
  5. Active middle ear infection.
  6. Tinnitus primary motivation for implantation.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Camille Dunn, PhD 319-353-8776 camille-dunn@uiowa.edu
Contact: Diane Burke, RN 319-356-1765 diane-burke@uiowa.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03929809
Other Study ID Numbers 201901735
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Camille Dunn, University of Iowa
Study Sponsor University of Iowa
Collaborators Not Provided
Investigators
Principal Investigator: Camille Dunn, PhD University of Iowa
PRS Account University of Iowa
Verification Date April 2019