<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/NCT04506853</url>
  </required_header>
  <id_info>
    <org_study_id>P000025/S113</org_study_id>
    <nct_id>NCT04506853</nct_id>
  </id_info>
  <brief_title>Single-Sided Deafness and Asymmetric Hearing Loss</brief_title>
  <official_title>Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear&#xD;
      implantation of the approved population in adults and children with single-sided deafness and&#xD;
      asymmetric hearing loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted as a single-subject, repeated measures, multi center study at 6&#xD;
      sites. Sixty-five subjects will be enrolled in this study. Six centers across the United&#xD;
      States and Canada will recruit subjects into this study. Study subjects will be followed for&#xD;
      a minimum of 3 years post-implantation of the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 22, 2021</start_date>
  <completion_date type="Anticipated">September 2026</completion_date>
  <primary_completion_date type="Anticipated">September 2026</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation</measure>
    <time_frame>Three years (36 months) post implantation</time_frame>
    <description>The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12-month and 36-month CI score for AzBio sentences in noise(range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation</measure>
    <time_frame>Three years (36 months) post implantation</time_frame>
    <description>Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 12 and 36 months post-activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear.(Range of score 0-100, higher score is better)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation</measure>
    <time_frame>Three years (36 months) post implantation</time_frame>
    <description>Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 12-month, and 36-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation</measure>
    <time_frame>Three years (36 months) post implantation</time_frame>
    <description>Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 12-month, and 36-month intervals.(Range of score 0-10, lower score is better)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term safety will be evaluated for all study subjects through three (36 months) years post implantation</measure>
    <time_frame>Three years (36 months) post implantation</time_frame>
    <description>Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Hearing Loss, Unilateral</condition>
  <condition>Hearing Loss, Sensorineural</condition>
  <arm_group>
    <arm_group_label>Study Procedure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MED-EL Cochlear Implant System</intervention_name>
    <description>Cochlear implant and audio processor</description>
    <arm_group_label>Study Procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Five years of age or older at the time of implantation&#xD;
&#xD;
          -  Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000,&#xD;
             and 4000 Hz) of 90 dB or greater in the ear to be implanted&#xD;
&#xD;
          -  Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap&#xD;
             less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and&#xD;
             4000 Hz and a diagnosed pathology of the outer or middle ear&#xD;
&#xD;
          -  Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined&#xD;
             by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less&#xD;
&#xD;
          -  Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet&#xD;
&#xD;
          -  Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS)&#xD;
             hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction,&#xD;
             or traditional hearing aid, as deemed appropriate by investigator&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Duration of profound hearing loss of 10 years or more&#xD;
&#xD;
          -  Absence of cochlear development or non-functionality of cochlear nerve&#xD;
&#xD;
          -  Other retrocochlear hearing loss&#xD;
&#xD;
          -  Evidence of severe cochlear malformation (i.e., common cavity or ossification)&#xD;
&#xD;
          -  External or middle ear infection&#xD;
&#xD;
          -  Suspected developmental or cognitive concern&#xD;
&#xD;
          -  Other medical contraindication for surgery or anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denise Thomas, AuD</last_name>
      <phone>312-227-3075</phone>
      <email>dthomas@luriechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Nancy Young, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242-1078</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Camille Dunn, PhD</last_name>
      <phone>319-353-8776</phone>
      <email>camille_dunn@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>Camille Dunn, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York Eye and Ear Infirmary</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samantha Udondem, MPH</last_name>
      <phone>347-978-3973</phone>
      <email>samantha.udondem@mountsinai.org</email>
    </contact>
    <investigator>
      <last_name>Maura Cosetti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Margaret Dillon, Au.D</last_name>
      <phone>984-974-2255</phone>
      <email>mdillon@med.unc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Meredith Rooth, AuD</last_name>
      <email>Meredith_Rooth@med.unc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Kevin Brown, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Robertson</last_name>
      <phone>206-287-6263</phone>
      <email>Kelly.Robertson@virginiamason.org</email>
    </contact>
    <investigator>
      <last_name>Daniel Zietler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kari Smilsky, M.CI.Sc.</last_name>
      <phone>416-480-6100</phone>
      <email>kari.smilsky@sunnybrook.ca</email>
    </contact>
    <investigator>
      <last_name>Kari Smilsky, M.CI.Sc.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Arndt S, Laszig R, Aschendorff A, Hassepass F, Beck R, Wesarg T. Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss. HNO. 2017 Aug;65(Suppl 2):98-108. doi: 10.1007/s00106-016-0297-5.</citation>
    <PMID>28188428</PMID>
  </reference>
  <reference>
    <citation>Arndt S, Prosse S, Laszig R, Wesarg T, Aschendorff A, Hassepass F. Cochlear implantation in children with single-sided deafness: does aetiology and duration of deafness matter? Audiol Neurootol. 2015;20 Suppl 1:21-30. doi: 10.1159/000380744. Epub 2015 May 19.</citation>
    <PMID>25999052</PMID>
  </reference>
  <reference>
    <citation>Buss E, Dillon MT, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effects of Cochlear Implantation on Binaural Hearing in Adults With Unilateral Hearing Loss. Trends Hear. 2018 Jan-Dec;22:2331216518771173. doi: 10.1177/2331216518771173.</citation>
    <PMID>29732951</PMID>
  </reference>
  <reference>
    <citation>Dillon MT, Buss E, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effect of Cochlear Implantation on Quality of Life in Adults with Unilateral Hearing Loss. Audiol Neurootol. 2017;22(4-5):259-271. doi: 10.1159/000484079. Epub 2018 Jan 4.</citation>
    <PMID>29298446</PMID>
  </reference>
  <reference>
    <citation>Niparko JK, Cox KM, Lustig LR. Comparison of the bone anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral deafness. Otol Neurotol. 2003 Jan;24(1):73-8. doi: 10.1097/00129492-200301000-00015.</citation>
    <PMID>12544032</PMID>
  </reference>
  <reference>
    <citation>Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):645-52. doi: 10.1177/000348940811700903.</citation>
    <PMID>18834065</PMID>
  </reference>
  <reference>
    <citation>Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.</citation>
    <PMID>19005250</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</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>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
    <mesh_term>Hearing Loss, Unilateral</mesh_term>
  </condition_browse>
  <!-- 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/NCT04506853
org study id: P000025/S113
nct id: NCT04506853
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear
      implantation of the approved population in adults and children with single-sided deafness and
      asymmetric hearing loss.
The study will be conducted as a single-subject, repeated measures, multi center study at 6
      sites. Sixty-five subjects will be enrolled in this study. Six centers across the United
      States and Canada will recruit subjects into this study. Study subjects will be followed for
      a minimum of 3 years post-implantation of the device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation
time frame: Three years (36 months) post implantation
description: The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12-month and 36-month CI score for AzBio sentences in noise(range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.
measure: Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation
time frame: Three years (36 months) post implantation
description: Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 12 and 36 months post-activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear.(Range of score 0-100, higher score is better)
measure: Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation
time frame: Three years (36 months) post implantation
description: Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 12-month, and 36-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better)
measure: Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation
time frame: Three years (36 months) post implantation
description: Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 12-month, and 36-month intervals.(Range of score 0-10, lower score is better)
measure: Long term safety will be evaluated for all study subjects through three (36 months) years post implantation
time frame: Three years (36 months) post implantation
description: Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event.
arm group label: Study Procedure
arm group type: Other
intervention type: Device
intervention name: MED-EL Cochlear Implant System
description: Cochlear implant and audio processor
arm group label: Study Procedure
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
country: United States
citation: Arndt S, Laszig R, Aschendorff A, Hassepass F, Beck R, Wesarg T. Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss. HNO. 2017 Aug;65(Suppl 2):98-108. doi: 10.1007/s00106-016-0297-5.
PMID: 28188428
citation: Arndt S, Prosse S, Laszig R, Wesarg T, Aschendorff A, Hassepass F. Cochlear implantation in children with single-sided deafness: does aetiology and duration of deafness matter? Audiol Neurootol. 2015;20 Suppl 1:21-30. doi: 10.1159/000380744. Epub 2015 May 19.
PMID: 25999052
citation: Buss E, Dillon MT, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effects of Cochlear Implantation on Binaural Hearing in Adults With Unilateral Hearing Loss. Trends Hear. 2018 Jan-Dec;22:2331216518771173. doi: 10.1177/2331216518771173.
PMID: 29732951
citation: Dillon MT, Buss E, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effect of Cochlear Implantation on Quality of Life in Adults with Unilateral Hearing Loss. Audiol Neurootol. 2017;22(4-5):259-271. doi: 10.1159/000484079. Epub 2018 Jan 4.
PMID: 29298446
citation: Niparko JK, Cox KM, Lustig LR. Comparison of the bone anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral deafness. Otol Neurotol. 2003 Jan;24(1):73-8. doi: 10.1097/00129492-200301000-00015.
PMID: 12544032
citation: Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):645-52. doi: 10.1177/000348940811700903.
PMID: 18834065
citation: Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.
PMID: 19005250
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Sensorineural
mesh term: Hearing Loss, Unilateral