<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/NCT03036410</url>
  </required_header>
  <id_info>
    <org_study_id>AK-KEK-2016-01853</org_study_id>
    <nct_id>NCT03036410</nct_id>
  </id_info>
  <brief_title>Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients</brief_title>
  <acronym>PhoneCIHA</acronym>
  <official_title>Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advanced Bionics AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Advanced Bionics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Advanced Bionics AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Communication on telephone is challenging for people with hearing loss. For hearing aid&#xD;
      users, for instance, the inventions for improving speech intelligibility on the phone range&#xD;
      from an integrated tele coil and individual hearing programs to specially designed phone&#xD;
      devices. No formal studies involving these devices have been carried out with CI users.&#xD;
&#xD;
      Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate&#xD;
      different hearing solutions for communication on telephone in terms of intelligibility and&#xD;
      ease of use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Communication on telephone is challenging for people with hearing loss, due to a number of&#xD;
      factors:&#xD;
&#xD;
        -  The lack of visual cues (lip-reading),&#xD;
&#xD;
        -  The lack of binaural abilities,&#xD;
&#xD;
        -  The presence of (loud) background noise in a variety of listening situations,&#xD;
&#xD;
        -  A modified speech signal due to reduced frequency bandwidth and&#xD;
&#xD;
        -  Difficulties coupling the phone to the CI. For hearing aid users, for instance, the&#xD;
           inventions for improving speech intelligibility on the phone range from an integrated&#xD;
           tele coil and individual hearing programs to specially designed phone devices.&#xD;
&#xD;
      No formal studies involving these devices have been carried out with CI users.&#xD;
&#xD;
      Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate&#xD;
      the different hearing solutions for communication on telephone in terms of intelligibility&#xD;
      and ease of use:&#xD;
&#xD;
        -  Phonak DECT - cordless telephone for HA-, CI- users and bimodal users&#xD;
&#xD;
        -  Phonak EasyCall - accessories for Bluetooth capable mobile telephones for HA-, CI- and&#xD;
           bimodal users&#xD;
&#xD;
        -  Phonak DuoPhone - streaming function, which provides the speech signal to both ears&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">August 21, 2017</completion_date>
  <primary_completion_date type="Actual">August 21, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>speech reception threshold (SRT) assessment with audiological measures</measure>
    <time_frame>6 months</time_frame>
    <description>differences in speech reception threshold (SRT) on the phone in the presence of background noise between the Phonak DECT phone and a standard phone will be assessed with audiological measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective ratings assessment with scaling</measure>
    <time_frame>6 months</time_frame>
    <description>differences in preference ratings in the presence of background noise between a standard phone, a standard phone + DuoPhone algorithm, the DECT-telephone&#xD;
differences in preference ratings in the presence of background noise between a standard mobile phone, a standard mobile phone + DuoPhone algorithm and a standard mobile phone + EasyCall accessory</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Hearing Loss, Binaural</condition>
  <condition>Hearing Loss, Monaural</condition>
  <arm_group>
    <arm_group_label>bimodal user</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>unilateral hearing aid users</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>wearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bilateral hearing aid users</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CI users</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>standard telephone setting</intervention_name>
    <description>without streaming function</description>
    <arm_group_label>CI users</arm_group_label>
    <arm_group_label>bilateral hearing aid users</arm_group_label>
    <arm_group_label>bimodal user</arm_group_label>
    <arm_group_label>unilateral hearing aid users</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DECT</intervention_name>
    <description>cordless telephone (streaming to both hearing devices)</description>
    <arm_group_label>CI users</arm_group_label>
    <arm_group_label>bilateral hearing aid users</arm_group_label>
    <arm_group_label>bimodal user</arm_group_label>
    <arm_group_label>unilateral hearing aid users</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EasyCall</intervention_name>
    <description>accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)</description>
    <arm_group_label>CI users</arm_group_label>
    <arm_group_label>bilateral hearing aid users</arm_group_label>
    <arm_group_label>bimodal user</arm_group_label>
    <arm_group_label>unilateral hearing aid users</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DuoPhone</intervention_name>
    <description>streaming function, which provides the speech signal to both ears</description>
    <arm_group_label>CI users</arm_group_label>
    <arm_group_label>bilateral hearing aid users</arm_group_label>
    <arm_group_label>bimodal user</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral HA users with SRT of better (lower) than + 3 dB&#xD;
&#xD;
          -  Bilateral HA users with SRT of better (lower) than 0 dB&#xD;
&#xD;
          -  Unilateral CI users:&#xD;
&#xD;
        Unilaterally implanted with an Advanced Bionics CII, HiRes90k or Advantage implant&#xD;
&#xD;
        1-year acclimatization time after implantation at least 20% correct for a sentence test&#xD;
        delivered with a SNR of + 10 dB, or a SRT of better (lower) than + 15 dB&#xD;
&#xD;
          -  Bimodal (CI + HA) users:&#xD;
&#xD;
        Unilaterally implanted with an Advanced Bionics CII, HiRes90k or Advantage implant CI side:&#xD;
        at least 20% correct for a sentence test delivered with a SNR of + 10 dB, or a SRT of&#xD;
        better (lower) than + 15 dB HA side: unaided threshold ≤ 80 dB at least for frequencies up&#xD;
        to 500 Hz&#xD;
&#xD;
          -  All users:&#xD;
&#xD;
        Informed Consent as documented by signature Ability for speech understanding in the&#xD;
        presence of competing noise without any assistance from lip-reading Ability to give&#xD;
        subjective feedback in a certain listening situation First language: German or Swiss-German&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All users:&#xD;
&#xD;
        Difficulties additional to hearing impairment that would interfere with the study&#xD;
        procedures Acute inflammation or pain in head-/neck area Dizziness Age of participants &lt; 18&#xD;
        years Age of participants &gt; 80 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital Zurich, Department of Otorhinolaryngology, Head and Neck Surgery</name>
      <address>
        <city>Zurich</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Cray JW, Allen RL, Stuart A, Hudson S, Layman E, Givens GD. An investigation of telephone use among cochlear implant recipients. Am J Audiol. 2004 Dec;13(2):200-12. doi: 10.1044/1059-0889(2004/025).</citation>
    <PMID>15903146</PMID>
  </reference>
  <reference>
    <citation>Anderson I, Baumgartner WD, Boheim K, Nahler A, Arnoldner C, D'Haese P. Telephone use: what benefit do cochlear implant users receive? Int J Audiol. 2006 Aug;45(8):446-53. doi: 10.1080/14992020600690969. Erratum In: Int J Audiol. 2006 Oct;45(10):617. Arnolder, Christoph [corrected to Arnoldner, Christoph].</citation>
    <PMID>17005487</PMID>
  </reference>
  <reference>
    <citation>Adams JS, Hasenstab MS, Pippin GW, Sismanis A. Telephone use and understanding in patients with cochlear implants. Ear Nose Throat J. 2004 Feb;83(2):96, 99-100, 102-3.</citation>
    <PMID>15008443</PMID>
  </reference>
  <reference>
    <citation>Picou EM, Ricketts TA. Comparison of wireless and acoustic hearing aid-based telephone listening strategies. Ear Hear. 2011 Mar-Apr;32(2):209-20. doi: 10.1097/AUD.0b013e3181f53737.</citation>
    <PMID>20808225</PMID>
  </reference>
  <reference>
    <citation>Picou EM, Ricketts TA. Efficacy of hearing-aid based telephone strategies for listeners with moderate-to-severe hearing loss. J Am Acad Audiol. 2013 Jan;24(1):59-70. doi: 10.3766/jaaa.24.1.7.</citation>
    <PMID>23231817</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hearing Aid Usage (monaural, binaural)</keyword>
  <keyword>Cochlear Implant Usage (monaural, binaural)</keyword>
  <keyword>Hearing Aid and Cochlear Implant Usage (monaural)</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>
  </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/NCT03036410
org study id: AK-KEK-2016-01853
nct id: NCT03036410
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Communication on telephone is challenging for people with hearing loss. For hearing aid
      users, for instance, the inventions for improving speech intelligibility on the phone range
      from an integrated tele coil and individual hearing programs to specially designed phone
      devices. No formal studies involving these devices have been carried out with CI users.

      Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate
      different hearing solutions for communication on telephone in terms of intelligibility and
      ease of use.
Communication on telephone is challenging for people with hearing loss, due to a number of
      factors:

        -  The lack of visual cues (lip-reading),

        -  The lack of binaural abilities,

        -  The presence of (loud) background noise in a variety of listening situations,

        -  A modified speech signal due to reduced frequency bandwidth and

        -  Difficulties coupling the phone to the CI. For hearing aid users, for instance, the
           inventions for improving speech intelligibility on the phone range from an integrated
           tele coil and individual hearing programs to specially designed phone devices.

      No formal studies involving these devices have been carried out with CI users.

      Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate
      the different hearing solutions for communication on telephone in terms of intelligibility
      and ease of use:

        -  Phonak DECT - cordless telephone for HA-, CI- users and bimodal users

        -  Phonak EasyCall - accessories for Bluetooth capable mobile telephones for HA-, CI- and
           bimodal users

        -  Phonak DuoPhone - streaming function, which provides the speech signal to both ears
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: speech reception threshold (SRT) assessment with audiological measures
time frame: 6 months
description: differences in speech reception threshold (SRT) on the phone in the presence of background noise between the Phonak DECT phone and a standard phone will be assessed with audiological measures.
measure: Subjective ratings assessment with scaling
time frame: 6 months
description: differences in preference ratings in the presence of background noise between a standard phone, a standard phone + DuoPhone algorithm, the DECT-telephone
differences in preference ratings in the presence of background noise between a standard mobile phone, a standard mobile phone + DuoPhone algorithm and a standard mobile phone + EasyCall accessory
arm group label: bimodal user
arm group type: Other
description: wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
arm group label: unilateral hearing aid users
arm group type: Other
description: wearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
arm group label: bilateral hearing aid users
arm group type: Other
description: wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
arm group label: CI users
arm group type: Other
description: wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
intervention type: Device
intervention name: standard telephone setting
description: without streaming function
arm group label: CI users
arm group label: bilateral hearing aid users
arm group label: bimodal user
arm group label: unilateral hearing aid users
intervention type: Device
intervention name: DECT
description: cordless telephone (streaming to both hearing devices)
arm group label: CI users
arm group label: bilateral hearing aid users
arm group label: bimodal user
arm group label: unilateral hearing aid users
intervention type: Device
intervention name: EasyCall
description: accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)
arm group label: CI users
arm group label: bilateral hearing aid users
arm group label: bimodal user
arm group label: unilateral hearing aid users
intervention type: Device
intervention name: DuoPhone
description: streaming function, which provides the speech signal to both ears
arm group label: CI users
arm group label: bilateral hearing aid users
arm group label: bimodal user
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Switzerland
citation: Cray JW, Allen RL, Stuart A, Hudson S, Layman E, Givens GD. An investigation of telephone use among cochlear implant recipients. Am J Audiol. 2004 Dec;13(2):200-12. doi: 10.1044/1059-0889(2004/025).
PMID: 15903146
citation: Anderson I, Baumgartner WD, Boheim K, Nahler A, Arnoldner C, D'Haese P. Telephone use: what benefit do cochlear implant users receive? Int J Audiol. 2006 Aug;45(8):446-53. doi: 10.1080/14992020600690969. Erratum In: Int J Audiol. 2006 Oct;45(10):617. Arnolder, Christoph [corrected to Arnoldner, Christoph].
PMID: 17005487
citation: Adams JS, Hasenstab MS, Pippin GW, Sismanis A. Telephone use and understanding in patients with cochlear implants. Ear Nose Throat J. 2004 Feb;83(2):96, 99-100, 102-3.
PMID: 15008443
citation: Picou EM, Ricketts TA. Comparison of wireless and acoustic hearing aid-based telephone listening strategies. Ear Hear. 2011 Mar-Apr;32(2):209-20. doi: 10.1097/AUD.0b013e3181f53737.
PMID: 20808225
citation: Picou EM, Ricketts TA. Efficacy of hearing-aid based telephone strategies for listeners with moderate-to-severe hearing loss. J Am Acad Audiol. 2013 Jan;24(1):59-70. doi: 10.3766/jaaa.24.1.7.
PMID: 23231817
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness