<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/NCT02204618</url>
  </required_header>
  <id_info>
    <org_study_id>13 7053 10</org_study_id>
    <secondary_id>PRME2013</secondary_id>
    <nct_id>NCT02204618</nct_id>
  </id_info>
  <brief_title>Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.</brief_title>
  <acronym>CISSD</acronym>
  <official_title>Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators assume that cochlear implants in this indication are not only effective but&#xD;
      also cost-effective. The investigators' experimental protocol relies on real life therapeutic&#xD;
      strategy, where a cochlear implant may be proposed once CROS and bone conductions systems&#xD;
      have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction&#xD;
      devices. If these trials are ineffective, the remaining subjects will be randomized between&#xD;
      two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A&#xD;
      comparative cost-utility analysis between the two arms, of medical consequences measured in&#xD;
      terms of quality of life will identify a preference for a strategy. Specific binaural hearing&#xD;
      measurements with respect to each treatment option (abstention, CROS, bone conduction device,&#xD;
      cochlear implant) will also be collected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single sided deafness and profound asymmetrical hearing loss are impairments that&#xD;
      significantly alter quality of life. Behavioural problems and scholar delays have been&#xD;
      reported in children. Speech recognition with background or competing noise and sound&#xD;
      localization are both impaired. 1/1000 new borns are affected and the incidence tends to rise&#xD;
      in the adult population. At the moment, there is no guideline regarding the treatment of&#xD;
      single sided deafness and asymmetrical hearing loss. Some patients don't even receive any&#xD;
      therapeutic proposition.&#xD;
&#xD;
      Three treatment options are available :&#xD;
&#xD;
        -  CROS (Contralateral Routing Of the Signal) systems that convey the auditory information&#xD;
           from the deaf ear to the good ear using wi-fi&#xD;
&#xD;
        -  bone conduction devices which use transcranial conduction to convey auditory information&#xD;
           from the poor ear to the good ear&#xD;
&#xD;
        -  cochlear implants that directly stimulate afferent fibers of auditory nerve in the poor&#xD;
           ear Cochlear implantation is therefore the only treatment which restores stimulation in&#xD;
           the poor ear. Its efficacy in single sided deafness associated with incapacitating&#xD;
           tinnitus have been demonstrated by Pr Van de Heyning (Leeuven, Be) and colleagues. Its&#xD;
           interest has been compared to CROS systems and bone conduction devices in a valuable&#xD;
           study conducted by S. Arndt (Pr Laszig, Freibourg, Ger). Cochlear implants provided&#xD;
           better speech in noise recognition scores in dichotic hearing, i.e when speech and noise&#xD;
           sources are spatially separated. Their first publication involved 11 patients but to&#xD;
           date, more than 110 patients with single sided deafness have been included in their&#xD;
           protocol. The efficacy of cochlear implantation has thus been validated in the treatment&#xD;
           of single sided deafness and asymmetrical hearing loss.&#xD;
&#xD;
      The investigators assume that cochlear implants in this indication are not only effective but&#xD;
      also cost-effective. The investigators' experimental protocol relies on real life therapeutic&#xD;
      strategy, where a cochlear implant may be proposed once CROS and bone conductions systems&#xD;
      have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction&#xD;
      devices. If these trials are ineffective, the remaining subjects will be randomized between&#xD;
      two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A&#xD;
      comparative cost-utility analysis between the two arms, of medical consequences measured in&#xD;
      terms of quality of life will identify a preference for a strategy. Specific binaural hearing&#xD;
      measurements with respect to each treatment option (abstention, CROS, bone conduction device,&#xD;
      cochlear implant) will also be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incremental cost-utility ratio</measure>
    <time_frame>6 months after cochlear implantation versus no treatment option</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global score of EuroQoL-5D</measure>
    <time_frame>before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global score of Nijmegen Cochlear implant Questionnaire (NCIQ)</measure>
    <time_frame>before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nijmegen Cochlear Implant Questionnaire (NCIQ): score in advanced auditory perception section</measure>
    <time_frame>before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Reception Thresholds</measure>
    <time_frame>before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6</time_frame>
    <description>Signal to noise ratio that allows 50% words recognition) in diotic hearing, dichotic hearing and reverse dichotic hearing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean error angle for sound localization</measure>
    <time_frame>before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Retrocochlear Pathology</condition>
  <condition>Auditory Processing Disorder, Central</condition>
  <condition>Major Cochlear Ossification or Malformation</condition>
  <arm_group>
    <arm_group_label>cochlear implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 months initial abstention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cochlear implantation</intervention_name>
    <arm_group_label>cochlear implantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>6 months initial abstention</intervention_name>
    <description>Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).</description>
    <arm_group_label>6 months initial abstention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Social security affiliation&#xD;
&#xD;
          -  Single sided deafness or profound asymmetrical hearing loss confirmed using pure tone&#xD;
             audiometry and auditory brainstem responses, with or without tinnitus&#xD;
&#xD;
          -  Written consent to the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Retrocochlear pathology (vestibular schwannoma, severe central auditory processing&#xD;
             disorder)&#xD;
&#xD;
          -  Major cochlear ossification or malformation&#xD;
&#xD;
          -  Subjects under juridical protections or tutelage measure&#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>Mathieu Marx, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Toulouse - Pierre Paul Riquet Hospital</name>
      <address>
        <city>Toulouse</city>
        <state>Midi-Pyrénées</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <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>Plontke SK, Heider C, Koesling S, Hess S, Bieseke L, Goetze G, Rahne T. Cochlear implantation in a child with posttraumatic single-sided deafness. Eur Arch Otorhinolaryngol. 2013 May;270(5):1757-61. doi: 10.1007/s00405-013-2350-2. Epub 2013 Jan 29.</citation>
    <PMID>23358584</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>
  <reference>
    <citation>Punte AK, Vermeire K, Hofkens A, De Bodt M, De Ridder D, Van de Heyning P. Cochlear implantation as a durable tinnitus treatment in single-sided deafness. Cochlear Implants Int. 2011 May;12 Suppl 1:S26-9. doi: 10.1179/146701011X13001035752336.</citation>
    <PMID>21756468</PMID>
  </reference>
  <reference>
    <citation>Lazard DS, Marozeau J, McDermott HJ. The sound sensation of apical electric stimulation in cochlear implant recipients with contralateral residual hearing. PLoS One. 2012;7(6):e38687. doi: 10.1371/journal.pone.0038687. Epub 2012 Jun 19.</citation>
    <PMID>22723876</PMID>
  </reference>
  <reference>
    <citation>Persson P, Harder H, Arlinger S, Magnuson B. Speech recognition in background noise: monaural versus binaural listening conditions in normal-hearing patients. Otol Neurotol. 2001 Sep;22(5):625-30. doi: 10.1097/00129492-200109000-00011.</citation>
    <PMID>11568669</PMID>
  </reference>
  <reference>
    <citation>Bess FH. The minimally hearing-impaired child. Ear Hear. 1985 Jan-Feb;6(1):43-7. doi: 10.1097/00003446-198501000-00012.</citation>
    <PMID>4038669</PMID>
  </reference>
  <reference>
    <citation>Bovo R, Martini A, Agnoletto M, Beghi A, Carmignoto D, Milani M, Zangaglia AM. Auditory and academic performance of children with unilateral hearing loss. Scand Audiol Suppl. 1988;30:71-4.</citation>
    <PMID>3227285</PMID>
  </reference>
  <reference>
    <citation>Lieu JE. Speech-language and educational consequences of unilateral hearing loss in children. Arch Otolaryngol Head Neck Surg. 2004 May;130(5):524-30. doi: 10.1001/archotol.130.5.524.</citation>
    <PMID>15148171</PMID>
  </reference>
  <reference>
    <citation>Giolas TG, Wark DJ. Communication problems associated with unilateral hearing loss. J Speech Hear Disord. 1967 Nov;32(4):336-43. doi: 10.1044/jshd.3204.336. No abstract available.</citation>
    <PMID>6074893</PMID>
  </reference>
  <reference>
    <citation>Dalzell L, Orlando M, MacDonald M, Berg A, Bradley M, Cacace A, Campbell D, DeCristofaro J, Gravel J, Greenberg E, Gross S, Pinheiro J, Regan J, Spivak L, Stevens F, Prieve B. The New York State universal newborn hearing screening demonstration project: ages of hearing loss identification, hearing aid fitting, and enrollment in early intervention. Ear Hear. 2000 Apr;21(2):118-30. doi: 10.1097/00003446-200004000-00006.</citation>
    <PMID>10777019</PMID>
  </reference>
  <reference>
    <citation>Chapman DA, Stampfel CC, Bodurtha JN, Dodson KM, Pandya A, Lynch KB, Kirby RS. Impact of co-occurring birth defects on the timing of newborn hearing screening and diagnosis. Am J Audiol. 2011 Dec;20(2):132-9. doi: 10.1044/1059-0889(2011/10-0049). Epub 2011 Sep 22.</citation>
    <PMID>21940980</PMID>
  </reference>
  <reference>
    <citation>Byl FM Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope. 1984 May;94(5 Pt 1):647-61.</citation>
    <PMID>6325838</PMID>
  </reference>
  <reference>
    <citation>Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.</citation>
    <PMID>21068690</PMID>
  </reference>
  <reference>
    <citation>Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.</citation>
    <PMID>22935813</PMID>
  </reference>
  <reference>
    <citation>Hassepass F, Aschendorff A, Wesarg T, Kroger S, Laszig R, Beck RL, Schild C, Arndt S. Unilateral deafness in children: audiologic and subjective assessment of hearing ability after cochlear implantation. Otol Neurotol. 2013 Jan;34(1):53-60. doi: 10.1097/MAO.0b013e31827850f0.</citation>
    <PMID>23202150</PMID>
  </reference>
  <reference>
    <citation>Bishop CE, Eby TL. The current status of audiologic rehabilitation for profound unilateral sensorineural hearing loss. Laryngoscope. 2010 Mar;120(3):552-6. doi: 10.1002/lary.20735.</citation>
    <PMID>20014322</PMID>
  </reference>
  <reference>
    <citation>Essink-Bot ML, Stouthard ME, Bonsel GJ. Generalizability of valuations on health states collected with the EuroQolc-questionnaire. Health Econ. 1993 Oct;2(3):237-46. doi: 10.1002/hec.4730020307.</citation>
    <PMID>8275169</PMID>
  </reference>
  <reference>
    <citation>Chevalier J, de Pouvourville G. Valuing EQ-5D using time trade-off in France. Eur J Health Econ. 2013 Feb;14(1):57-66. doi: 10.1007/s10198-011-0351-x. Epub 2011 Sep 21.</citation>
    <PMID>21935715</PMID>
  </reference>
  <reference>
    <citation>Gaylor JM, Raman G, Chung M, Lee J, Rao M, Lau J, Poe DS. Cochlear implantation in adults: a systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. 2013 Mar;139(3):265-72. doi: 10.1001/jamaoto.2013.1744.</citation>
    <PMID>23429927</PMID>
  </reference>
  <reference>
    <citation>Drummond M, O' brien B, Stodart G et al. 1998. Méthodes d'évaluation économique des programmes de santé. Paris : Economica, 1998.</citation>
  </reference>
  <results_reference>
    <citation>Marx M, Costa N, Lepage B, Taoui S, Molinier L, Deguine O, Fraysse B. Cochlear implantation as a treatment for single-sided deafness and asymmetric hearing loss: a randomized controlled evaluation of cost-utility. BMC Ear Nose Throat Disord. 2019 Feb 4;19:1. doi: 10.1186/s12901-019-0066-7. eCollection 2019.</citation>
    <PMID>30766449</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>single sided deafness</keyword>
  <keyword>Asymmetrical hearing loss</keyword>
  <keyword>Cost-utility</keyword>
  <keyword>Tinnitus</keyword>
  <keyword>Cochlear implants</keyword>
  <keyword>Bone conduction device</keyword>
  <keyword>Dichotic hearing</keyword>
  <keyword>Squelch effect.</keyword>
  <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>Auditory Perceptual Disorders</mesh_term>
    <mesh_term>Language Development Disorders</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/NCT02204618
org study id: 13 7053 10
secondary id: PRME2013
nct id: NCT02204618
lead sponsor: 
has dmc: Yes
The investigators assume that cochlear implants in this indication are not only effective but
      also cost-effective. The investigators' experimental protocol relies on real life therapeutic
      strategy, where a cochlear implant may be proposed once CROS and bone conductions systems
      have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction
      devices. If these trials are ineffective, the remaining subjects will be randomized between
      two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A
      comparative cost-utility analysis between the two arms, of medical consequences measured in
      terms of quality of life will identify a preference for a strategy. Specific binaural hearing
      measurements with respect to each treatment option (abstention, CROS, bone conduction device,
      cochlear implant) will also be collected.
Single sided deafness and profound asymmetrical hearing loss are impairments that
      significantly alter quality of life. Behavioural problems and scholar delays have been
      reported in children. Speech recognition with background or competing noise and sound
      localization are both impaired. 1/1000 new borns are affected and the incidence tends to rise
      in the adult population. At the moment, there is no guideline regarding the treatment of
      single sided deafness and asymmetrical hearing loss. Some patients don't even receive any
      therapeutic proposition.

      Three treatment options are available :

        -  CROS (Contralateral Routing Of the Signal) systems that convey the auditory information
           from the deaf ear to the good ear using wi-fi

        -  bone conduction devices which use transcranial conduction to convey auditory information
           from the poor ear to the good ear

        -  cochlear implants that directly stimulate afferent fibers of auditory nerve in the poor
           ear Cochlear implantation is therefore the only treatment which restores stimulation in
           the poor ear. Its efficacy in single sided deafness associated with incapacitating
           tinnitus have been demonstrated by Pr Van de Heyning (Leeuven, Be) and colleagues. Its
           interest has been compared to CROS systems and bone conduction devices in a valuable
           study conducted by S. Arndt (Pr Laszig, Freibourg, Ger). Cochlear implants provided
           better speech in noise recognition scores in dichotic hearing, i.e when speech and noise
           sources are spatially separated. Their first publication involved 11 patients but to
           date, more than 110 patients with single sided deafness have been included in their
           protocol. The efficacy of cochlear implantation has thus been validated in the treatment
           of single sided deafness and asymmetrical hearing loss.

      The investigators assume that cochlear implants in this indication are not only effective but
      also cost-effective. The investigators' experimental protocol relies on real life therapeutic
      strategy, where a cochlear implant may be proposed once CROS and bone conductions systems
      have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction
      devices. If these trials are ineffective, the remaining subjects will be randomized between
      two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A
      comparative cost-utility analysis between the two arms, of medical consequences measured in
      terms of quality of life will identify a preference for a strategy. Specific binaural hearing
      measurements with respect to each treatment option (abstention, CROS, bone conduction device,
      cochlear implant) will also be collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: incremental cost-utility ratio
time frame: 6 months after cochlear implantation versus no treatment option
measure: Global score of EuroQoL-5D
time frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6
measure: Global score of Nijmegen Cochlear implant Questionnaire (NCIQ)
time frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6
measure: Nijmegen Cochlear Implant Questionnaire (NCIQ): score in advanced auditory perception section
time frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6
measure: Speech Reception Thresholds
time frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6
description: Signal to noise ratio that allows 50% words recognition) in diotic hearing, dichotic hearing and reverse dichotic hearing
measure: Mean error angle for sound localization
time frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6
arm group label: cochlear implantation
arm group type: Experimental
description: Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).
arm group label: 6 months initial abstention
arm group type: Other
description: Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).
intervention type: Device
intervention name: cochlear implantation
arm group label: cochlear implantation
intervention type: Other
intervention name: 6 months initial abstention
description: Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).
arm group label: 6 months initial abstention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mathieu Marx, MD
role: Principal Investigator
affiliation: University Hospital of Toulouse
facility: 
country: France
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: Plontke SK, Heider C, Koesling S, Hess S, Bieseke L, Goetze G, Rahne T. Cochlear implantation in a child with posttraumatic single-sided deafness. Eur Arch Otorhinolaryngol. 2013 May;270(5):1757-61. doi: 10.1007/s00405-013-2350-2. Epub 2013 Jan 29.
PMID: 23358584
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
citation: Punte AK, Vermeire K, Hofkens A, De Bodt M, De Ridder D, Van de Heyning P. Cochlear implantation as a durable tinnitus treatment in single-sided deafness. Cochlear Implants Int. 2011 May;12 Suppl 1:S26-9. doi: 10.1179/146701011X13001035752336.
PMID: 21756468
citation: Lazard DS, Marozeau J, McDermott HJ. The sound sensation of apical electric stimulation in cochlear implant recipients with contralateral residual hearing. PLoS One. 2012;7(6):e38687. doi: 10.1371/journal.pone.0038687. Epub 2012 Jun 19.
PMID: 22723876
citation: Persson P, Harder H, Arlinger S, Magnuson B. Speech recognition in background noise: monaural versus binaural listening conditions in normal-hearing patients. Otol Neurotol. 2001 Sep;22(5):625-30. doi: 10.1097/00129492-200109000-00011.
PMID: 11568669
citation: Bess FH. The minimally hearing-impaired child. Ear Hear. 1985 Jan-Feb;6(1):43-7. doi: 10.1097/00003446-198501000-00012.
PMID: 4038669
citation: Bovo R, Martini A, Agnoletto M, Beghi A, Carmignoto D, Milani M, Zangaglia AM. Auditory and academic performance of children with unilateral hearing loss. Scand Audiol Suppl. 1988;30:71-4.
PMID: 3227285
citation: Lieu JE. Speech-language and educational consequences of unilateral hearing loss in children. Arch Otolaryngol Head Neck Surg. 2004 May;130(5):524-30. doi: 10.1001/archotol.130.5.524.
PMID: 15148171
citation: Giolas TG, Wark DJ. Communication problems associated with unilateral hearing loss. J Speech Hear Disord. 1967 Nov;32(4):336-43. doi: 10.1044/jshd.3204.336. No abstract available.
PMID: 6074893
citation: Dalzell L, Orlando M, MacDonald M, Berg A, Bradley M, Cacace A, Campbell D, DeCristofaro J, Gravel J, Greenberg E, Gross S, Pinheiro J, Regan J, Spivak L, Stevens F, Prieve B. The New York State universal newborn hearing screening demonstration project: ages of hearing loss identification, hearing aid fitting, and enrollment in early intervention. Ear Hear. 2000 Apr;21(2):118-30. doi: 10.1097/00003446-200004000-00006.
PMID: 10777019
citation: Chapman DA, Stampfel CC, Bodurtha JN, Dodson KM, Pandya A, Lynch KB, Kirby RS. Impact of co-occurring birth defects on the timing of newborn hearing screening and diagnosis. Am J Audiol. 2011 Dec;20(2):132-9. doi: 10.1044/1059-0889(2011/10-0049). Epub 2011 Sep 22.
PMID: 21940980
citation: Byl FM Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope. 1984 May;94(5 Pt 1):647-61.
PMID: 6325838
citation: Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.
PMID: 21068690
citation: Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.
PMID: 22935813
citation: Hassepass F, Aschendorff A, Wesarg T, Kroger S, Laszig R, Beck RL, Schild C, Arndt S. Unilateral deafness in children: audiologic and subjective assessment of hearing ability after cochlear implantation. Otol Neurotol. 2013 Jan;34(1):53-60. doi: 10.1097/MAO.0b013e31827850f0.
PMID: 23202150
citation: Bishop CE, Eby TL. The current status of audiologic rehabilitation for profound unilateral sensorineural hearing loss. Laryngoscope. 2010 Mar;120(3):552-6. doi: 10.1002/lary.20735.
PMID: 20014322
citation: Essink-Bot ML, Stouthard ME, Bonsel GJ. Generalizability of valuations on health states collected with the EuroQolc-questionnaire. Health Econ. 1993 Oct;2(3):237-46. doi: 10.1002/hec.4730020307.
PMID: 8275169
citation: Chevalier J, de Pouvourville G. Valuing EQ-5D using time trade-off in France. Eur J Health Econ. 2013 Feb;14(1):57-66. doi: 10.1007/s10198-011-0351-x. Epub 2011 Sep 21.
PMID: 21935715
citation: Gaylor JM, Raman G, Chung M, Lee J, Rao M, Lau J, Poe DS. Cochlear implantation in adults: a systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. 2013 Mar;139(3):265-72. doi: 10.1001/jamaoto.2013.1744.
PMID: 23429927
citation: Drummond M, O' brien B, Stodart G et al. 1998. Méthodes d'évaluation économique des programmes de santé. Paris : Economica, 1998.
citation: Marx M, Costa N, Lepage B, Taoui S, Molinier L, Deguine O, Fraysse B. Cochlear implantation as a treatment for single-sided deafness and asymmetric hearing loss: a randomized controlled evaluation of cost-utility. BMC Ear Nose Throat Disord. 2019 Feb 4;19:1. doi: 10.1186/s12901-019-0066-7. eCollection 2019.
PMID: 30766449
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Auditory Perceptual Disorders
mesh term: Language Development Disorders