<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03243097</url>
  </required_header>
  <id_info>
    <org_study_id>20170029</org_study_id>
    <nct_id>NCT03243097</nct_id>
  </id_info>
  <brief_title>CROS Application in CI</brief_title>
  <acronym>CROS</acronym>
  <official_title>Contralateral Routing of Signal in Unilateral Cochlear Implant Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear&#xD;
      Implants. The majority of bilaterally deafened patients, however, often only receive a&#xD;
      unilateral cochlear implant (CI), with resultant limitations related to monaural listening.&#xD;
      For unilateral CI users, the deficits inherently associated with monaural listening remain&#xD;
      despite the considerable benefits achieved through implantation. Providing bilateral input to&#xD;
      monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral&#xD;
      routing of signal (CROS) hearing aids, where the signal of interest is routed from the&#xD;
      impaired (deaf) ear to the normal cochlea for processing is a promising alternative in&#xD;
      unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology&#xD;
      provides a less invasive alternative for patients who are unable or unwilling to undergo a&#xD;
      second CI surgery and offers an innovative approach to resolving the auditory deficits&#xD;
      associated with monaural listening. CROS technology has been used to treat traditional&#xD;
      monaural listeners since 1965. When applied to unilateral CI users, this novel approach can&#xD;
      overcome a key limitation of current treatment by restoring access to sound from the&#xD;
      non-implanted ear and improving speech perception in noise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">March 26, 2021</completion_date>
  <primary_completion_date type="Actual">March 12, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speech perception in noise</measure>
    <time_frame>8 weeks</time_frame>
    <description>Speech perception in noise will be evaluated with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Benefit</measure>
    <time_frame>8 weeks</time_frame>
    <description>Benefit of wireless CROS technology with the cochlear implant will be assessed using a customized questionnaire with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Study Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects enrolled in the study are required to complete Phase I before entering Phase II, and Phase II before entering Phase III.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phase I - Standard Microphone Cros Input</intervention_name>
    <description>Subject will be fit with the research processor plus CROS microphone and wear for a 4 week period</description>
    <arm_group_label>Study Subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phase II - Automatic directional microphone Cros Input</intervention_name>
    <description>Automatic directional microphone technology will be activated in the research processor. Subjects will wear the CI+CROS configuration with directionality activated exclusively for 4-weeks.</description>
    <arm_group_label>Study Subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phase III - No Cros Input</intervention_name>
    <description>Subjects will return the research processor and CROS device and wear their own processor for a 2-week period</description>
    <arm_group_label>Study Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral Advanced Bionics CI recipient&#xD;
&#xD;
          -  ≥ 6 months CI-listening experience and/or better than 50%-word recognition on&#xD;
             Consonant-Nucleus-Consonant (CNC) word testing&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who do not meet one or more of the above mentioned inclusion criteria are&#xD;
             excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hillary Snapp, AuD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Department of Otolaryngology</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Hillary A Snapp</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03243097
org study id: 20170029
nct id: NCT03243097
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear
      Implants. The majority of bilaterally deafened patients, however, often only receive a
      unilateral cochlear implant (CI), with resultant limitations related to monaural listening.
      For unilateral CI users, the deficits inherently associated with monaural listening remain
      despite the considerable benefits achieved through implantation. Providing bilateral input to
      monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral
      routing of signal (CROS) hearing aids, where the signal of interest is routed from the
      impaired (deaf) ear to the normal cochlea for processing is a promising alternative in
      unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology
      provides a less invasive alternative for patients who are unable or unwilling to undergo a
      second CI surgery and offers an innovative approach to resolving the auditory deficits
      associated with monaural listening. CROS technology has been used to treat traditional
      monaural listeners since 1965. When applied to unilateral CI users, this novel approach can
      overcome a key limitation of current treatment by restoring access to sound from the
      non-implanted ear and improving speech perception in noise.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Speech perception in noise
time frame: 8 weeks
description: Speech perception in noise will be evaluated with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.
measure: Subjective Benefit
time frame: 8 weeks
description: Benefit of wireless CROS technology with the cochlear implant will be assessed using a customized questionnaire with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.
arm group label: Study Subjects
arm group type: Experimental
description: All subjects enrolled in the study are required to complete Phase I before entering Phase II, and Phase II before entering Phase III.
intervention type: Device
intervention name: Phase I - Standard Microphone Cros Input
description: Subject will be fit with the research processor plus CROS microphone and wear for a 4 week period
arm group label: Study Subjects
intervention type: Device
intervention name: Phase II - Automatic directional microphone Cros Input
description: Automatic directional microphone technology will be activated in the research processor. Subjects will wear the CI+CROS configuration with directionality activated exclusively for 4-weeks.
arm group label: Study Subjects
intervention type: Device
intervention name: Phase III - No Cros Input
description: Subjects will return the research processor and CROS device and wear their own processor for a 2-week period
arm group label: Study Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hillary Snapp, AuD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Hillary A Snapp
investigator title: Assistant Professor
mesh term: Hearing Loss
sharing ipd: No