<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/NCT03005912</url>
  </required_header>
  <id_info>
    <org_study_id>Bluetooth-Study</org_study_id>
    <secondary_id>2016-01935</secondary_id>
    <nct_id>NCT03005912</nct_id>
  </id_info>
  <brief_title>Telephone vs. Voice Over IP Speech Comprehension in Hearing Aided Subjects.</brief_title>
  <official_title>Clinical Single Centre Cohort Study Comparing Telephone vs. Voice Over Internet Protocol (VoIP) Speech Comprehension for Acoustical and Bluetooth Speech Signal Transmission in Hearing Aided Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cochlear</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stiftung Besser Hören</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      Despite modern hearing aids such as cochlear implants, speech comprehension during telephone&#xD;
      conversation is challenging for hearing-impaired patients. On the one hand, conventional&#xD;
      telephones transmit a limited spectrum of the acoustic signal compared to a normal&#xD;
      conversation. On the other hand, lip reading during a phone call is generally not possible.&#xD;
      As a result, speech comprehension during a telephone conversation is reduced. In previous&#xD;
      studies, the authors demonstrated an improved speech comprehension for hearing-impaired&#xD;
      patients using voice-over internet protocol (VoIP) telephony (Skype) compared to conventional&#xD;
      telephony.&#xD;
&#xD;
      New bluetooth-enabled hearing aids allow for direct transmission of the telephone signal to&#xD;
      the hearing device. As the direct transmission is expected to improve signal-to-noise ratio,&#xD;
      speech comprehension is tested in patients with bluetooth-enabled hearing aids for 4&#xD;
      different scenarios: 1. conventional telephony without bluetooth device 2. conventional&#xD;
      telephony with bluetooth device 3. VoIP telephony without bluetooth device 4. VoIP telephony&#xD;
      with bluetooth device&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Speech comprehension of hearing impaired individuals is limited in telephone conversations&#xD;
      due to the limited acoustic spectrum transmitted by conventional analogue telephones, such as&#xD;
      background noise, interferences with the hearing aid and the absent possibility of&#xD;
      lip-reading. This can provide an impact on quality of life as better speech comprehension&#xD;
      reduces exclusion from social interactions as well as potential professional occupations.&#xD;
      Furthermore, in elderly population an impaired hearing function is associated with a higher&#xD;
      risk of dementia, mortality rate and dependency in the daily activities.&#xD;
&#xD;
      Mantokoudis et al. recently demonstrated that the larger acoustic spectrum of internet&#xD;
      telephony (Voice over Internet Protocol [VoIP]) results in superior speech comprehension of&#xD;
      individuals with hearing aids compared to conventional telephones. Low signal quality during&#xD;
      internet telephony does not significantly attenuate speech understanding. Another study&#xD;
      revealed that internet telephony combined with a webcam further improves speech comprehension&#xD;
      as additional lip reading was possible.&#xD;
&#xD;
      New bluetooth audio streaming devices allow for pairing with smart phones or other devices&#xD;
      supporting bluetooth technology such as computers for direct routing of the audio signal to&#xD;
      the hearing aid. Current state of research shows significant benefits for hearing impaired&#xD;
      individuals using this technology for telephone conversations. The speech comprehension and&#xD;
      subjective satisfaction can be improved due to a better sound quality and accuracy and less&#xD;
      noise interference.&#xD;
&#xD;
      However, speech comprehension of these new bluetooth devices has not been investigated in&#xD;
      combination with internet telephony (VoIP) and it remains unclear whether hearing impaired&#xD;
      individuals could benefit of this possibility. This study investigates, whether bluetooth&#xD;
      audio streaming devices paired to hearing aids/implants combined with internet telephony&#xD;
      improves speech comprehension in hearing impaired individuals.&#xD;
&#xD;
      VoIP and conventional telephone speech comprehension will be compared with and without a&#xD;
      wireless bluetooth phone clip (Cochlear Wireless Phone Clip, Cochlear Ltd., 1 University&#xD;
      Avenue, Macquarie University, New South Wales 2109, Australia). The phone clip is capable to&#xD;
      directly connect to other bluetooth-enabled devices and transmits the audio signal directly&#xD;
      to the sound processor of the hearing implant. A microphone in the phone clip enables to&#xD;
      record and transmit the user's spoken words to the mobile phone therefore a hands-free use is&#xD;
      possible.&#xD;
&#xD;
      Bluetooth connection is a well-established wireless technology transmitting at 2.4 gigahertz&#xD;
      at distances up to approximately seven meters. The wireless technology is the same for most&#xD;
      of bluetooth and Wireless Local Area Network (WLAN) devices. According to the Swiss federal&#xD;
      health office the electromagnetic radiation of the bluetooth device as intended to be used in&#xD;
      the proposed study fulfils the requirements of the European Committee for Electrotechnical&#xD;
      Standardization (CENELEC).&#xD;
&#xD;
      Several previous studies demonstrated a significantly increased conventional telephone speech&#xD;
      perception with the Cochlear Wireless Phone Clip than without this device. On the other hand,&#xD;
      speech perception in hearing impaired people using internet telephony is improved compared to&#xD;
      conventional telephony. However, speech perception using the phone clip in connection to&#xD;
      internet telephony has not been studied to this date and remains unknown.&#xD;
&#xD;
      The purpose of the proposed study is to quantify VoIP vs. conventional telephone speech&#xD;
      comprehension in individuals with or without application of bluetooth phone clip. Potentially&#xD;
      better speech comprehension due to the application of the phone clip could alleviate the&#xD;
      handicap of communication in individuals with hearing aids. As a consequence the social life&#xD;
      and contacts of the affected individuals such as worsening of mental state and dependency in&#xD;
      the everyday life could be ameliorated only by using a simple device.&#xD;
&#xD;
      The goal of this study is to measure speech comprehension of individuals with hearing aids&#xD;
      using a bluetooth paired phone clip and VoIP telephony. To quantify a potential benefit of&#xD;
      this, speech comprehension has to be tested with and without the phone clip for VoIP and&#xD;
      conventional telephony in the same individuals. Speech comprehension will be quantified with&#xD;
      a signal/noise ratio of the HSM- sentence test (Hochmair, Schulz, Moser)&#xD;
&#xD;
      Upon agreement to participate, patients are invited to the audiological department at&#xD;
      Inselspital in Bern. After remaining questions are clarified, the patient has to sign a&#xD;
      written informed consent. The investigation will take approximately two hours and takes place&#xD;
      in the sound-proof hearing test chambers of the audiological department.&#xD;
&#xD;
      Four different speech comprehension scenarios are tested:&#xD;
&#xD;
        1. Conventional telephony without bluetooth device&#xD;
&#xD;
        2. Conventional telephony with bluetooth device&#xD;
&#xD;
        3. VoIP telephony without bluetooth device&#xD;
&#xD;
        4. VoIP telephony with bluetooth device&#xD;
&#xD;
      To evaluate speech comprehension, the HSM (Hochmair-Schulz-Moser) sentence test is used. This&#xD;
      is a test mainly applied to evaluate the speech comprehension in patients with cochlear&#xD;
      implants and consists of 30 lists each including 20 short sentences. After initial&#xD;
      presentation of exercise sentences without background noise, additional noise is added while&#xD;
      the speech signal is kept at a constant volume level. The percentage of speech comprehension&#xD;
      is determined by the quantity of correctly understood sentences at a certain signal-to-noise&#xD;
      ratio (S/N Ratio). In this study a S/N Ratio of 10dB, with a signal at 70dB and noise at&#xD;
      60dB, will be analysed.&#xD;
&#xD;
      For representativeness of speech comprehension results, participants will use their hearing&#xD;
      aids with their daily use volume settings. The phone clip will be programmed for a 1:1&#xD;
      transmission of the telephone conversation and the ambient noise. At the end, the patient has&#xD;
      to evaluate the subjective perception of the speech sound quality by means of the Mean&#xD;
      Opinion Score (MOS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">May 11, 2018</completion_date>
  <primary_completion_date type="Actual">May 11, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speech comprehension scores</measure>
    <time_frame>2 years</time_frame>
    <description>Speech comprehension scores of the HSM-sentence test for each patient with and without bluetooth connection will be measured and compared in conventional and internet telephony.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective perception of speech sound quality</measure>
    <time_frame>2 years</time_frame>
    <description>Subjective perception of speech sound quality by means of the Mean Opinion Score (MOS).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Hearing-Impairment</condition>
  <arm_group>
    <arm_group_label>Conventional acoustic telephony</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a conventional mobile phone call with acoustic transmission of the speech signal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional bluetooth telephony</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a conventional mobile phone call with direct bluetooth transmission of the speech signal to the cochlear implant or hearing aid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VoIP acoustic telephony</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a VoIP mobile phone call with acoustic transmission of the speech signal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VoIP bluetooth telephony</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a VoIP mobile phone call with direct bluetooth transmission of the speech signal to the cochlear implant or hearing aid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional acoustic telephony</intervention_name>
    <description>Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.</description>
    <arm_group_label>Conventional acoustic telephony</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional bluetooth telephony</intervention_name>
    <description>Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.</description>
    <arm_group_label>Conventional bluetooth telephony</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VoIP acoustic telephony</intervention_name>
    <description>Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.</description>
    <arm_group_label>VoIP acoustic telephony</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VoIP bluetooth telephony</intervention_name>
    <description>Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.</description>
    <arm_group_label>VoIP bluetooth telephony</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bluetooth enabled hearing aid (Nucleus 6 CI or a GN Resound hearing aid) compatible to&#xD;
             the phone clip&#xD;
&#xD;
          -  Use of hearing aid for ≥ 3 months.&#xD;
&#xD;
          -  Native German speaker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mentally or physically unfit to participate&#xD;
&#xD;
          -  Vulnerable Person&#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>Georgios Mantokoudis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Attending physician</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Tyler RS, Baker LJ, Armstrong-Bednall G. Difficulties experienced by hearing-aid candidates and hearing-aid users. Br J Audiol. 1983 Aug;17(3):191-201. doi: 10.3109/03005368309107884.</citation>
    <PMID>6357328</PMID>
  </reference>
  <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>Ito J, Nakatake M, Fujita S. Hearing ability by telephone of patients with cochlear implants. Otolaryngol Head Neck Surg. 1999 Dec;121(6):802-4. doi: 10.1053/hn.1999.v121.a93864.</citation>
    <PMID>10580241</PMID>
  </reference>
  <reference>
    <citation>Liu C, Fu QJ, Narayanan SS. Effect of bandwidth extension to telephone speech recognition in cochlear implant users. J Acoust Soc Am. 2009 Feb;125(2):EL77-83. doi: 10.1121/1.3062145.</citation>
    <PMID>19206836</PMID>
  </reference>
  <reference>
    <citation>Horng MJ, Chen HC, Hsu CJ, Fu QJ. Telephone speech perception by Mandarin-speaking cochlear implantees. Ear Hear. 2007 Apr;28(2 Suppl):66S-69S. doi: 10.1097/AUD.0b013e31803153bd.</citation>
    <PMID>17496651</PMID>
  </reference>
  <reference>
    <citation>Fu QJ, Galvin JJ 3rd. Recognition of simulated telephone speech by cochlear implant users. Am J Audiol. 2006 Dec;15(2):127-32. doi: 10.1044/1059-0889(2006/016).</citation>
    <PMID>17182877</PMID>
  </reference>
  <reference>
    <citation>Milchard AJ, Cullington HE. An investigation into the effect of limiting the frequency bandwidth of speech on speech recognition in adult cochlear implant users. Int J Audiol. 2004 Jun;43(6):356-62. doi: 10.1080/14992020400050045.</citation>
    <PMID>15457818</PMID>
  </reference>
  <reference>
    <citation>Kepler LJ, Terry M, Sweetman RH. Telephone usage in the hearing-impaired population. Ear Hear. 1992 Oct;13(5):311-9. doi: 10.1097/00003446-199210000-00009.</citation>
    <PMID>1487091</PMID>
  </reference>
  <reference>
    <citation>Rumeau C, Frere J, Montaut-Verient B, Lion A, Gauchard G, Parietti-Winkler C. Quality of life and audiologic performance through the ability to phone of cochlear implant users. Eur Arch Otorhinolaryngol. 2015 Dec;272(12):3685-92. doi: 10.1007/s00405-014-3448-x. Epub 2014 Dec 20.</citation>
    <PMID>25527411</PMID>
  </reference>
  <reference>
    <citation>Cacciatore F, Napoli C, Abete P, Marciano E, Triassi M, Rengo F. Quality of life determinants and hearing function in an elderly population: Osservatorio Geriatrico Campano Study Group. Gerontology. 1999 Nov-Dec;45(6):323-8. doi: 10.1159/000022113.</citation>
    <PMID>10559650</PMID>
  </reference>
  <reference>
    <citation>Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. Gerontologist. 2003 Oct;43(5):661-8. doi: 10.1093/geront/43.5.661.</citation>
    <PMID>14570962</PMID>
  </reference>
  <reference>
    <citation>Gates GA, Cobb JL, Linn RT, Rees T, Wolf PA, D'Agostino RB. Central auditory dysfunction, cognitive dysfunction, and dementia in older people. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):161-7. doi: 10.1001/archotol.1996.01890140047010.</citation>
    <PMID>8630210</PMID>
  </reference>
  <reference>
    <citation>Barnett S, Franks P. Deafness and mortality: analyses of linked data from the National Health Interview Survey and National Death Index. Public Health Rep. 1999 Jul-Aug;114(4):330-6. doi: 10.1093/phr/114.4.330.</citation>
    <PMID>10501133</PMID>
  </reference>
  <results_reference>
    <citation>Mantokoudis G, Kompis M, Dubach P, Caversaccio M, Senn P. How internet telephony could improve communication for hearing-impaired individuals. Otol Neurotol. 2010 Sep;31(7):1014-21. doi: 10.1097/MAO.0b013e3181ec1d46.</citation>
    <PMID>20634771</PMID>
  </results_reference>
  <results_reference>
    <citation>Mantokoudis G, Dubach P, Pfiffner F, Kompis M, Caversaccio M, Senn P. Speech perception benefits of internet versus conventional telephony for hearing-impaired individuals. J Med Internet Res. 2012 Jul 16;14(4):e102. doi: 10.2196/jmir.1818.</citation>
    <PMID>22805169</PMID>
  </results_reference>
  <results_reference>
    <citation>Mantokoudis G, Dahler C, Dubach P, Kompis M, Caversaccio MD, Senn P. Internet video telephony allows speech reading by deaf individuals and improves speech perception by cochlear implant users. PLoS One. 2013;8(1):e54770. doi: 10.1371/journal.pone.0054770. Epub 2013 Jan 24.</citation>
    <PMID>23359119</PMID>
  </results_reference>
  <results_reference>
    <citation>Wolfe J, Morais M, Schafer E. Improving Hearing Performance in Cochlear Nucleus 6 users with true wireless accessories. Cochlear Limited. 2015 May; D710887 ISS2</citation>
  </results_reference>
  <results_reference>
    <citation>Robier M, Bakhos D, Pawelczyk T, Lescanne E. Evaluation of benefit provided by the Cochlear Wireless Phone Clip. Cochlear Limited.2015 Dec; D785163 ISS1</citation>
  </results_reference>
  <results_reference>
    <citation>Martinez Basterra Z, Fernandez de Pinedo M, Rey JA, Palicio I, Soriano-Reixach MM, Urreta I, Altuna Mariezcurena X. Phone Speech Recognition Improvement in Noisy Environment: Use of a Bluetooth Accessory. Ear Nose Throat J. 2021 Aug;100(7):490-496. doi: 10.1177/0145561319880384. Epub 2019 Oct 9.</citation>
    <PMID>31597532</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim MB, Chung WH, Choi J, Hong SH, Cho YS, Park G, Lee S. Effect of a Bluetooth-implemented hearing aid on speech recognition performance: subjective and objective measurement. Ann Otol Rhinol Laryngol. 2014 Jun;123(6):395-401. doi: 10.1177/0003489414526847.</citation>
    <PMID>24687593</PMID>
  </results_reference>
  <results_reference>
    <citation>Marcrum SC. Wireless streaming with the Cochlear Wireless Phone Clip improves speech understanding and reduces listening effort during telephone use in noise. Cochlear Limited.2015 Dec; D785163 ISS1</citation>
  </results_reference>
  <results_reference>
    <citation>Gündüz B, Gökdoğan C, Orçan E, Fikret Çetik M, Tuncer Ü, Özdemiroğlu S. Hearing inventory with the Cochlear Wireless Phone Clip in experienced adult cochlear implant recipients at work and during daily life. Cochlear Limited.2015 Dec; D785163 ISS1</citation>
  </results_reference>
  <results_reference>
    <citation>Duke M, Wolfe J. Evaluation of speech recognition over the telephone with and without the Cochlear Wireless Phone Clip. Cochlear Limited.2015 Dec; D785163 ISS1</citation>
  </results_reference>
  <results_reference>
    <citation>Çiprut A, Derinsu U, Cesur S, Çiçek B, Özkan B, Yücel E. Speech intelligibility with the Cochlear Wireless Phone Clip in experienced cochlear implant recipients. Cochlear Limited.2015 Dec; D785163 ISS1</citation>
  </results_reference>
  <results_reference>
    <citation>Qian H, Loizou PC, Dorman MF. A phone-assistive device based on Bluetooth technology for cochlear implant users. IEEE Trans Neural Syst Rehabil Eng. 2003 Sep;11(3):282-7. doi: 10.1109/TNSRE.2003.816871.</citation>
    <PMID>14518792</PMID>
  </results_reference>
  <results_reference>
    <citation>Hochmair-Desoyer I, Schulz E, Moser L, Schmidt M. The HSM sentence test as a tool for evaluating the speech understanding in noise of cochlear implant users. Am J Otol. 1997 Nov;18(6 Suppl):S83.</citation>
    <PMID>9391610</PMID>
  </results_reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>June 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>May 16, 2018</last_update_submitted>
  <last_update_submitted_qc>May 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Insel Gruppe AG, University Hospital Bern</investigator_affiliation>
    <investigator_full_name>Markus Huth</investigator_full_name>
    <investigator_title>Oberarzt</investigator_title>
  </responsible_party>
  <keyword>Speech Comprehension</keyword>
  <keyword>Telephony</keyword>
  <keyword>VoIP</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005912
org study id: Bluetooth-Study
secondary id: 2016-01935
nct id: NCT03005912
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite modern hearing aids such as cochlear implants, speech comprehension during telephone
      conversation is challenging for hearing-impaired patients. On the one hand, conventional
      telephones transmit a limited spectrum of the acoustic signal compared to a normal
      conversation. On the other hand, lip reading during a phone call is generally not possible.
      As a result, speech comprehension during a telephone conversation is reduced. In previous
      studies, the authors demonstrated an improved speech comprehension for hearing-impaired
      patients using voice-over internet protocol (VoIP) telephony (Skype) compared to conventional
      telephony.

      New bluetooth-enabled hearing aids allow for direct transmission of the telephone signal to
      the hearing device. As the direct transmission is expected to improve signal-to-noise ratio,
      speech comprehension is tested in patients with bluetooth-enabled hearing aids for 4
      different scenarios: 1. conventional telephony without bluetooth device 2. conventional
      telephony with bluetooth device 3. VoIP telephony without bluetooth device 4. VoIP telephony
      with bluetooth device
Speech comprehension of hearing impaired individuals is limited in telephone conversations
      due to the limited acoustic spectrum transmitted by conventional analogue telephones, such as
      background noise, interferences with the hearing aid and the absent possibility of
      lip-reading. This can provide an impact on quality of life as better speech comprehension
      reduces exclusion from social interactions as well as potential professional occupations.
      Furthermore, in elderly population an impaired hearing function is associated with a higher
      risk of dementia, mortality rate and dependency in the daily activities.

      Mantokoudis et al. recently demonstrated that the larger acoustic spectrum of internet
      telephony (Voice over Internet Protocol [VoIP]) results in superior speech comprehension of
      individuals with hearing aids compared to conventional telephones. Low signal quality during
      internet telephony does not significantly attenuate speech understanding. Another study
      revealed that internet telephony combined with a webcam further improves speech comprehension
      as additional lip reading was possible.

      New bluetooth audio streaming devices allow for pairing with smart phones or other devices
      supporting bluetooth technology such as computers for direct routing of the audio signal to
      the hearing aid. Current state of research shows significant benefits for hearing impaired
      individuals using this technology for telephone conversations. The speech comprehension and
      subjective satisfaction can be improved due to a better sound quality and accuracy and less
      noise interference.

      However, speech comprehension of these new bluetooth devices has not been investigated in
      combination with internet telephony (VoIP) and it remains unclear whether hearing impaired
      individuals could benefit of this possibility. This study investigates, whether bluetooth
      audio streaming devices paired to hearing aids/implants combined with internet telephony
      improves speech comprehension in hearing impaired individuals.

      VoIP and conventional telephone speech comprehension will be compared with and without a
      wireless bluetooth phone clip (Cochlear Wireless Phone Clip, Cochlear Ltd., 1 University
      Avenue, Macquarie University, New South Wales 2109, Australia). The phone clip is capable to
      directly connect to other bluetooth-enabled devices and transmits the audio signal directly
      to the sound processor of the hearing implant. A microphone in the phone clip enables to
      record and transmit the user's spoken words to the mobile phone therefore a hands-free use is
      possible.

      Bluetooth connection is a well-established wireless technology transmitting at 2.4 gigahertz
      at distances up to approximately seven meters. The wireless technology is the same for most
      of bluetooth and Wireless Local Area Network (WLAN) devices. According to the Swiss federal
      health office the electromagnetic radiation of the bluetooth device as intended to be used in
      the proposed study fulfils the requirements of the European Committee for Electrotechnical
      Standardization (CENELEC).

      Several previous studies demonstrated a significantly increased conventional telephone speech
      perception with the Cochlear Wireless Phone Clip than without this device. On the other hand,
      speech perception in hearing impaired people using internet telephony is improved compared to
      conventional telephony. However, speech perception using the phone clip in connection to
      internet telephony has not been studied to this date and remains unknown.

      The purpose of the proposed study is to quantify VoIP vs. conventional telephone speech
      comprehension in individuals with or without application of bluetooth phone clip. Potentially
      better speech comprehension due to the application of the phone clip could alleviate the
      handicap of communication in individuals with hearing aids. As a consequence the social life
      and contacts of the affected individuals such as worsening of mental state and dependency in
      the everyday life could be ameliorated only by using a simple device.

      The goal of this study is to measure speech comprehension of individuals with hearing aids
      using a bluetooth paired phone clip and VoIP telephony. To quantify a potential benefit of
      this, speech comprehension has to be tested with and without the phone clip for VoIP and
      conventional telephony in the same individuals. Speech comprehension will be quantified with
      a signal/noise ratio of the HSM- sentence test (Hochmair, Schulz, Moser)

      Upon agreement to participate, patients are invited to the audiological department at
      Inselspital in Bern. After remaining questions are clarified, the patient has to sign a
      written informed consent. The investigation will take approximately two hours and takes place
      in the sound-proof hearing test chambers of the audiological department.

      Four different speech comprehension scenarios are tested:

        1. Conventional telephony without bluetooth device

        2. Conventional telephony with bluetooth device

        3. VoIP telephony without bluetooth device

        4. VoIP telephony with bluetooth device

      To evaluate speech comprehension, the HSM (Hochmair-Schulz-Moser) sentence test is used. This
      is a test mainly applied to evaluate the speech comprehension in patients with cochlear
      implants and consists of 30 lists each including 20 short sentences. After initial
      presentation of exercise sentences without background noise, additional noise is added while
      the speech signal is kept at a constant volume level. The percentage of speech comprehension
      is determined by the quantity of correctly understood sentences at a certain signal-to-noise
      ratio (S/N Ratio). In this study a S/N Ratio of 10dB, with a signal at 70dB and noise at
      60dB, will be analysed.

      For representativeness of speech comprehension results, participants will use their hearing
      aids with their daily use volume settings. The phone clip will be programmed for a 1:1
      transmission of the telephone conversation and the ambient noise. At the end, the patient has
      to evaluate the subjective perception of the speech sound quality by means of the Mean
      Opinion Score (MOS).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Speech comprehension scores
time frame: 2 years
description: Speech comprehension scores of the HSM-sentence test for each patient with and without bluetooth connection will be measured and compared in conventional and internet telephony.
measure: Subjective perception of speech sound quality
time frame: 2 years
description: Subjective perception of speech sound quality by means of the Mean Opinion Score (MOS).
arm group label: Conventional acoustic telephony
arm group type: Placebo Comparator
description: Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a conventional mobile phone call with acoustic transmission of the speech signal.
arm group label: Conventional bluetooth telephony
arm group type: Active Comparator
description: Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a conventional mobile phone call with direct bluetooth transmission of the speech signal to the cochlear implant or hearing aid.
arm group label: VoIP acoustic telephony
arm group type: Active Comparator
description: Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a VoIP mobile phone call with acoustic transmission of the speech signal.
arm group label: VoIP bluetooth telephony
arm group type: Active Comparator
description: Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a VoIP mobile phone call with direct bluetooth transmission of the speech signal to the cochlear implant or hearing aid.
intervention type: Device
intervention name: Conventional acoustic telephony
description: Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
arm group label: Conventional acoustic telephony
intervention type: Device
intervention name: Conventional bluetooth telephony
description: Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
arm group label: Conventional bluetooth telephony
intervention type: Device
intervention name: VoIP acoustic telephony
description: Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
arm group label: VoIP acoustic telephony
intervention type: Device
intervention name: VoIP bluetooth telephony
description: Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
arm group label: VoIP bluetooth telephony
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Georgios Mantokoudis, MD
role: Principal Investigator
affiliation: Attending physician
facility: 
country: Switzerland
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responsible party type: Principal Investigator
investigator affiliation: Insel Gruppe AG, University Hospital Bern
investigator full name: Markus Huth
investigator title: Oberarzt
mesh term: Hearing Loss
mesh term: Deafness
sharing ipd: No