<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/NCT03031678</url>
  </required_header>
  <id_info>
    <org_study_id>P000025/PAS001</org_study_id>
    <nct_id>NCT03031678</nct_id>
  </id_info>
  <brief_title>Electric-Acoustic Stimulation Extended Follow-up Post Approval Study</brief_title>
  <official_title>Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Med-El Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Med-El Corporation</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were&#xD;
      enrolled in the pivotal study to assess long-term safety and device performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted as a prospective, non-controlled, non-randomized, multicenter&#xD;
      study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study&#xD;
      will be invited to participate in the extended follow-up. Study subjects will be followed for&#xD;
      a minimum of 5 years post-implantation of the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Words Correct As Assessed by CUNY Sentence Test.</measure>
    <time_frame>Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial</time_frame>
    <description>Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.</measure>
    <time_frame>Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial</time_frame>
    <description>The HEARRING Scale was developed by the HEARRING Research Group, a collaboration of surgeons and audiologists in the hearing implant field who work together to develop consensus statements. The Scale was published in 2013 by Skarzynski et al. as means to classify post-operative residual hearing thresholds. Residual hearing is classified as complete (100-76%), partial (26-75%), minimal (1-25%), or none (0%) according to an equation which takes into account pre-operative thresholds, post-operative thresholds, and the limits of the audiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Words Correct as Assessed by CNC Words in Quiet.</measure>
    <time_frame>Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial</time_frame>
    <description>Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in quiet with CNC words completed through five years post-implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.</measure>
    <time_frame>Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial</time_frame>
    <description>The APHAB Questionnaire measures percentage of listening difficulty on a scale from 100% (very difficult) to 0% (not difficult at all). Results are reported as the average listening difficulty across subjects.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Hearing Loss, Sensorineural</condition>
  <arm_group>
    <arm_group_label>Study procedures</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electric-Acoustic Stimulation (EAS) Cochlear Implant System</intervention_name>
    <description>Combination of a cochlear implant and a hearing aid</description>
    <arm_group_label>Study procedures</arm_group_label>
    <other_name>EAS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older at the time of implantation&#xD;
&#xD;
          -  Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz&#xD;
             (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)&#xD;
&#xD;
          -  Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL&#xD;
&#xD;
          -  CNC word recognition score less than or equal to 60% in the ear to be implanted&#xD;
&#xD;
          -  CNC word recognition score less than or equal to 60% in the contralateral ear&#xD;
&#xD;
          -  English spoken as the primary language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conductive, retrocochlear, or central auditory disorder&#xD;
&#xD;
          -  Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at&#xD;
             two or more frequencies of 15 dB in either direction in the last 2 years&#xD;
&#xD;
          -  Any physical, psychological, or emotional disorder that interferes with surgery or the&#xD;
             ability to perform on test and rehabilitation procedures&#xD;
&#xD;
          -  Developmental delays or organic brain dysfunction&#xD;
&#xD;
          -  Unrealistic expectations on the part of the subject, regarding the possible benefits,&#xD;
             risks, and limitations&#xD;
&#xD;
          -  Unwillingness or inability of the candidate to comply with all investigational&#xD;
             requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford Unversity</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas University Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Skarzynski H, van de Heyning P, Agrawal S, Arauz SL, Atlas M, Baumgartner W, Caversaccio M, de Bodt M, Gavilan J, Godey B, Green K, Gstoettner W, Hagen R, Han DM, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Levevre F, Li Y, Manikoth M, Martin J, Mlynski R, Mueller J, O'Driscoll M, Parnes L, Prentiss S, Pulibalathingal S, Raine CH, Rajan G, Rajeswaran R, Rivas JA, Rivas A, Skarzynski PH, Sprinzl G, Staecker H, Stephan K, Usami S, Yanov Y, Zernotti ME, Zimmermann K, Lorens A, Mertens G. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;(564):3-13. doi: 10.3109/00016489.2013.869059.</citation>
    <PMID>24328756</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <results_first_submitted>August 6, 2020</results_first_submitted>
  <results_first_submitted_qc>August 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 10, 2020</results_first_posted>
  <last_update_submitted>August 24, 2020</last_update_submitted>
  <last_update_submitted_qc>August 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 5, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03031678/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Study Procedures</title>
          <description>Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>EAS Test Condition Complete</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>CI Alone Test Condition Complete</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study closed prior to completion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Procedures</title>
          <description>Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.58" spread="13.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ear Implanted</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Right</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Left</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Words Correct As Assessed by CUNY Sentence Test.</title>
        <description>Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.</description>
        <time_frame>Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electric Acoustic Stimulation</title>
            <description>Subjects tested with a combination of electric and acoustic stimulation</description>
          </group>
          <group group_id="O2">
            <title>CI Alone</title>
            <description>Subjects testing with electric stimulation only</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Words Correct As Assessed by CUNY Sentence Test.</title>
          <description>Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.</description>
          <units>percentage of words correct</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.33" spread="27.05"/>
                    <measurement group_id="O2" value="43.30" spread="33.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.</title>
        <description>The HEARRING Scale was developed by the HEARRING Research Group, a collaboration of surgeons and audiologists in the hearing implant field who work together to develop consensus statements. The Scale was published in 2013 by Skarzynski et al. as means to classify post-operative residual hearing thresholds. Residual hearing is classified as complete (100-76%), partial (26-75%), minimal (1-25%), or none (0%) according to an equation which takes into account pre-operative thresholds, post-operative thresholds, and the limits of the audiometer.</description>
        <time_frame>Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Procedures</title>
            <description>Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid</description>
          </group>
        </group_list>
        <measure>
          <title>Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.</title>
          <description>The HEARRING Scale was developed by the HEARRING Research Group, a collaboration of surgeons and audiologists in the hearing implant field who work together to develop consensus statements. The Scale was published in 2013 by Skarzynski et al. as means to classify post-operative residual hearing thresholds. Residual hearing is classified as complete (100-76%), partial (26-75%), minimal (1-25%), or none (0%) according to an equation which takes into account pre-operative thresholds, post-operative thresholds, and the limits of the audiometer.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Hearing Preservation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Hearing Preservation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal Hearing Perservation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Hearing Preservation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Words Correct as Assessed by CNC Words in Quiet.</title>
        <description>Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in quiet with CNC words completed through five years post-implantation.</description>
        <time_frame>Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electric Acoustic Stimulation</title>
            <description>Subjects tested with electric and acoustic stimulation combined</description>
          </group>
          <group group_id="O2">
            <title>CI Alone</title>
            <description>Subjects tested with electric stimulation only</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Words Correct as Assessed by CNC Words in Quiet.</title>
          <description>Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in quiet with CNC words completed through five years post-implantation.</description>
          <units>percentage of words correct</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.59" spread="13.71"/>
                    <measurement group_id="O2" value="57.40" spread="23.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.</title>
        <description>The APHAB Questionnaire measures percentage of listening difficulty on a scale from 100% (very difficult) to 0% (not difficult at all). Results are reported as the average listening difficulty across subjects.</description>
        <time_frame>Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial</time_frame>
        <population>46 completed the questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Study Procedures</title>
            <description>Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.</title>
          <description>The APHAB Questionnaire measures percentage of listening difficulty on a scale from 100% (very difficult) to 0% (not difficult at all). Results are reported as the average listening difficulty across subjects.</description>
          <population>46 completed the questionnaire</population>
          <units>percentage of listening difficulty</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.39" spread="13.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 Years (Duration of the Study)</time_frame>
      <desc>Any adverse event reported by a subject over the duration of the study is included here. Subjects were monitored through at least five years post-implantation from the original clinical trial.</desc>
      <group_list>
        <group group_id="E1">
          <title>Study Procedures</title>
          <description>Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Loss of Residual Hearing</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Internal Device Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Allison Racey</name_or_title>
      <organization>MED-EL Corporation</organization>
      <phone>1-888-633-3524</phone>
      <email>research.us@medel.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03031678
org study id: P000025/PAS001
nct id: NCT03031678
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were
      enrolled in the pivotal study to assess long-term safety and device performance.
The study will be conducted as a prospective, non-controlled, non-randomized, multicenter
      study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study
      will be invited to participate in the extended follow-up. Study subjects will be followed for
      a minimum of 5 years post-implantation of the device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percentage of Words Correct As Assessed by CUNY Sentence Test.
time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
description: Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.
measure: Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.
time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
description: The HEARRING Scale was developed by the HEARRING Research Group, a collaboration of surgeons and audiologists in the hearing implant field who work together to develop consensus statements. The Scale was published in 2013 by Skarzynski et al. as means to classify post-operative residual hearing thresholds. Residual hearing is classified as complete (100-76%), partial (26-75%), minimal (1-25%), or none (0%) according to an equation which takes into account pre-operative thresholds, post-operative thresholds, and the limits of the audiometer.
measure: Percentage of Words Correct as Assessed by CNC Words in Quiet.
time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
description: Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in quiet with CNC words completed through five years post-implantation.
measure: Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.
time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
description: The APHAB Questionnaire measures percentage of listening difficulty on a scale from 100% (very difficult) to 0% (not difficult at all). Results are reported as the average listening difficulty across subjects.
arm group label: Study procedures
arm group type: Other
intervention type: Device
intervention name: Electric-Acoustic Stimulation (EAS) Cochlear Implant System
description: Combination of a cochlear implant and a hearing aid
arm group label: Study procedures
other name: EAS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Skarzynski H, van de Heyning P, Agrawal S, Arauz SL, Atlas M, Baumgartner W, Caversaccio M, de Bodt M, Gavilan J, Godey B, Green K, Gstoettner W, Hagen R, Han DM, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Levevre F, Li Y, Manikoth M, Martin J, Mlynski R, Mueller J, O'Driscoll M, Parnes L, Prentiss S, Pulibalathingal S, Raine CH, Rajan G, Rajeswaran R, Rivas JA, Rivas A, Skarzynski PH, Sprinzl G, Staecker H, Stephan K, Usami S, Yanov Y, Zernotti ME, Zimmermann K, Lorens A, Mertens G. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;(564):3-13. doi: 10.3109/00016489.2013.869059.
PMID: 24328756
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Hearing Loss, Sensorineural
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 