<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/NCT04427033</url>
  </required_header>
  <id_info>
    <org_study_id>2019BB005</org_study_id>
    <nct_id>NCT04427033</nct_id>
  </id_info>
  <brief_title>The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study</brief_title>
  <official_title>The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MED-EL Elektromedizinische Geräte GesmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MED-EL Elektromedizinische Geräte GesmbH</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective,&#xD;
      multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and&#xD;
      paediatric populations have shown a significant improvement in terms of aided sound field&#xD;
      (SF) thresholds, word recognition scores (WRS), speech reception thresholds (SRT) and&#xD;
      subjective device satisfaction. Safety was established by stable residual hearing and low&#xD;
      complication rates. The Bonebridge, implanted in over 600 clinics worldwide, is the world's&#xD;
      first active transcutaneous bone conduction implant (BCI) system.&#xD;
&#xD;
      This study now focuses on the further developed BCI 602 (marketed since 2019) that has the&#xD;
      same indication criteria and performance characteristics.&#xD;
&#xD;
      The aim of this post-market clinical follow-up (PMCF) study is to provide clinical data for&#xD;
      the long-term performance and safety when implanted with the Bonebridge BCI 602 .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 6, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sound Field audiometry</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Investigate if the PTA4 sound field thresholds (SF) improve with the BCI 602 (aided) at 12 months post-operative compared to the unaided test situation.&#xD;
(PTA4 = average of audiometric test frequencies 0.5, 1.0, 2.0, 4.0 kHz)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Word Recognition Score (CHL/MHL)</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Investigate if speech intelligibility improves with the BCI 602 (aided) at 12 months post-operative compared to the unaided test situation in the following speech intelligibility test.&#xD;
Word Recognition Score (WRS): S0°, WRS correct @ 65 dB SPL Signal&#xD;
Monosyllabic (MS) word lists are presented from the front (0°) at 65 dB SPL (45 dB HL) and the percent correct score [%] (0 % to 100 %) is recorded.&#xD;
(SPL= Sound Pressure Level; Score: 0% to 100% words understood )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Reception Threshold in quiet (CHL/MHL)</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Investigate if speech intelligibility improves with the BCI 602 (aided) in CHL/MHL at 12 months post-operative compared to the unaided test situation in the following speech intelligibility test.&#xD;
Speech Reception Threshold in quiet (SRT) : S0°, SRT for 50% correct</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Reception Threshold in noise (CHL/MHL)</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Investigate if speech intelligibility improves with the BCI 602 (aided) in CHL/MHL at 12 months post-operative compared to the unaided test situation in the following speech intelligibility test.&#xD;
Speech Reception Threshold in noise (SNR): S0° N0°, SNR for 50% correct @ 65 dB SPL Noise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Reception Threshold in noise (SSD) Sssd Nnh</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Investigate if speech intelligibility improves with the BCI 602 (aided) in SSD at 12 months post-operative compared to the unaided test situation in the following speech intelligibility tests.&#xD;
Sssd Nnh, SNR for 50% correct @ 65 dB SPL Noise&#xD;
(S= Signal; N= Noise; ssd = single sided deaf ear; nh = normal hearing ear)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Reception Threshold in noise (SSD) S0° Nnh</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Investigate if speech intelligibility improves with the BCI 602 (aided) in SSD at 12 months post-operative compared to the unaided test situation in the following speech intelligibility tests.&#xD;
S0° Nnh, SNR for 50% correct @ 65 dB SPL Noise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual hearing</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Investigate whether residual hearing by means of bone conduction (BC) PTA4 thresholds of subjects implanted with the BCI 602 remains stable 12 months post-operative compared to the pre operative test situation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Monitor the long-term safety of subjects implanted with the BCI 602 by collecting and reviewing adverse events (AEs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Questionnaires</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Monitor the long-term safety of subjects implanted with the BCI 602 by administering a surgical evaluation questionnaire to the surgeon.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Spatial Qualities questionnaire</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Investigate the Quality of Life with the SSQ questionnaire of subjects implanted with the BCI 602 12 months post-operative.&#xD;
(SSQ = Speech Spatial Qualities)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment Quality of Life questionnaire</measure>
    <time_frame>12 months post-operative</time_frame>
    <description>Investigate the Quality of Life with the AQoL questionnaire of subjects implanted with the BCI 602 12 months post-operative.&#xD;
(AQoL= Assessment Quality of Life)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">51</enrollment>
  <condition>Hearing Loss</condition>
  <condition>Hearing Loss, Conductive</condition>
  <condition>Hearing Loss, Mixed</condition>
  <condition>Hearing Loss, Unilateral</condition>
  <condition>Hearing Loss, Bilateral</condition>
  <condition>Hearing Loss, Sensorineural</condition>
  <arm_group>
    <arm_group_label>CHL &amp; MHL (18 years and older)</arm_group_label>
    <description>CHL= conductive hearing loss, MHL= mixed hearing loss</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHL &amp; MHL (5 to 17 years)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>SSD (5 years and older)</arm_group_label>
    <description>SSD= single sided deafness</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bone Conduction Implant</intervention_name>
    <description>Bonebridge system BCI 602</description>
    <arm_group_label>CHL &amp; MHL (18 years and older)</arm_group_label>
    <arm_group_label>CHL &amp; MHL (5 to 17 years)</arm_group_label>
    <arm_group_label>SSD (5 years and older)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will only enrol subjects who represent the target population and meet the&#xD;
        inclusion/exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Geographically and physically able to return to the investigational site for scheduled&#xD;
             evaluations and follow-up appointments&#xD;
&#xD;
          -  Fluent in the language used in the investigational site and used for evaluation&#xD;
&#xD;
          -  Signed and dated informed consent before the start of any study-specific procedure and&#xD;
             collection of any retrospective data.&#xD;
&#xD;
          -  Subjects meet the indication criteria according to the instructions for use (IFU):&#xD;
&#xD;
               -  Subject 5 years of age and older&#xD;
&#xD;
               -  The physician must fully assess the potential risks and benefits for the patient&#xD;
                  and his/her realistic expectations with the device prior to the decision to&#xD;
                  implant the BCI 602. The physician must exercise medical judgement and consider&#xD;
                  the patient's complete medical history.&#xD;
&#xD;
               -  Bonebridge candidates suffer from either&#xD;
&#xD;
               -  • conductive or mixed hearing loss as indicated by audiometric testing with bone&#xD;
                  conduction thresholds better than or equal to 45 dB HL at 0.5, 1.0, 2.0 and 3.0&#xD;
                  kHz.&#xD;
&#xD;
               -  • single-sided sensorineural deafness, that is severe-to-profound sensorineural&#xD;
                  hearing loss in one ear while the other ear has normal hearing (air conduction&#xD;
                  (AC) should be better than or equal to 20 dB HL measured at 0.5, 1.0, 2.0 and 3.0&#xD;
                  kHz).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A subject whose hearing loss has demonstrated an improving and decreasing fluctuation&#xD;
             over a two-year period of &gt;15 dB HL in either direction&#xD;
&#xD;
          -  Severe, chronic, non-revisable diseases or disorders (vestibular disorder, cancer&#xD;
             etc.)&#xD;
&#xD;
          -  A subject with any psychological (anxiety, depression, hallucinations etc.), emotional&#xD;
             (schizophrenia, mania, melancholia etc.) or from that originating physical disorder&#xD;
             that would interfere with the ability to perform on test procedures&#xD;
&#xD;
          -  Simultaneous participation in another clinical trial (on device or on drug) which&#xD;
             would interfere with the results of the study.&#xD;
&#xD;
          -  Any active ear infection&#xD;
&#xD;
          -  Subjects who meet any of the contraindications in the IFU:&#xD;
&#xD;
               -  Evidence that hearing loss is of retrocochlear or central origin (ipsilateral CHL&#xD;
                  /MHL; contralateral SSD)&#xD;
&#xD;
               -  Skin or scalp conditions that may preclude attachment of the Audio Processor (AP)&#xD;
                  or that may interfere with the use of the AP&#xD;
&#xD;
               -  Skull size or abnormality would preclude appropriate placement of the BCI 602&#xD;
                  implant&#xD;
&#xD;
               -  Intolerant to the materials in the BCI 602 implant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Assen Koitschev, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum Stuttgart - Olgahospital and Eberhard-Karls-Universität Tübingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinik Innsbruck für Hals-, Nasen- und Ohrenheilkunde</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum St. Pölten - Lilienfeld, Hals-Nasen-Ohren-Abteilung</name>
      <address>
        <city>St. Pölten</city>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen, Abteilung für Hals-, Nasen-, Ohrenkrankheiten</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie</name>
      <address>
        <city>Halle/Saale</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik u. Poliklinik f. HNO-Heilkunde</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Stuttgart - Olgahospital, Klinik für HNO-Krankheiten, Plastische Operationen</name>
      <address>
        <city>Stuttgart</city>
        <zip>70174</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Auditory Implant Centre, Beech Hall Centre, Belfast HSC Trust</name>
      <address>
        <city>Belfast</city>
        <zip>BT11 9AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Sprinzl G, Lenarz T, Ernst A, Hagen R, Wolf-Magele A, Mojallal H, Todt I, Mlynski R, Wolframm MD. First European multicenter results with a new transcutaneous bone conduction hearing implant system: short-term safety and efficacy. Otol Neurotol. 2013 Aug;34(6):1076-83. doi: 10.1097/MAO.0b013e31828bb541.</citation>
    <PMID>23714710</PMID>
  </reference>
  <reference>
    <citation>Baumgartner WD, Hamzavi JS, Boheim K, Wolf-Magele A, Schlogel M, Riechelmann H, Zorowka P, Koci V, Keck T, Potzinger P, Sprinzl G. A New Transcutaneous Bone Conduction Hearing Implant: Short-term Safety and Efficacy in Children. Otol Neurotol. 2016 Jul;37(6):713-20. doi: 10.1097/MAO.0000000000001038.</citation>
    <PMID>27153327</PMID>
  </reference>
  <reference>
    <citation>Sprinzl G, Toner J, Koitschev A, Berger N, Keintzel T, Rasse T, Baumgartner WD, Honeder C, Magele A, Plontke S, Gotze G, Schmutzhard J, Zelger P, Corkill S, Lenarz T, Salcher R. Multicentric study on surgical information and early safety and performance results with the Bonebridge BCI 602: an active transcutaneous bone conduction hearing implant. Eur Arch Otorhinolaryngol. 2023 Apr;280(4):1565-1579. doi: 10.1007/s00405-022-07792-y. Epub 2023 Jan 10.</citation>
    <PMID>36625869</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bonebridge system</keyword>
  <keyword>BCI 601</keyword>
  <keyword>BCI 602</keyword>
  <keyword>bone conduction</keyword>
  <keyword>bone conduction implant</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>Hearing Loss, Sensorineural</mesh_term>
    <mesh_term>Hearing Loss, Bilateral</mesh_term>
    <mesh_term>Hearing Loss, Conductive</mesh_term>
    <mesh_term>Hearing Loss, Unilateral</mesh_term>
    <mesh_term>Hearing Loss, Mixed Conductive-Sensorineural</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/NCT04427033
org study id: 2019BB005
nct id: NCT04427033
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective,
      multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and
      paediatric populations have shown a significant improvement in terms of aided sound field
      (SF) thresholds, word recognition scores (WRS), speech reception thresholds (SRT) and
      subjective device satisfaction. Safety was established by stable residual hearing and low
      complication rates. The Bonebridge, implanted in over 600 clinics worldwide, is the world's
      first active transcutaneous bone conduction implant (BCI) system.

      This study now focuses on the further developed BCI 602 (marketed since 2019) that has the
      same indication criteria and performance characteristics.

      The aim of this post-market clinical follow-up (PMCF) study is to provide clinical data for
      the long-term performance and safety when implanted with the Bonebridge BCI 602 .
observational model: Other
time perspective: Other
measure: Sound Field audiometry
time frame: 12 months post-operative
description: Investigate if the PTA4 sound field thresholds (SF) improve with the BCI 602 (aided) at 12 months post-operative compared to the unaided test situation.
(PTA4 = average of audiometric test frequencies 0.5, 1.0, 2.0, 4.0 kHz)
measure: Word Recognition Score (CHL/MHL)
time frame: 12 months post-operative
description: Investigate if speech intelligibility improves with the BCI 602 (aided) at 12 months post-operative compared to the unaided test situation in the following speech intelligibility test.
Word Recognition Score (WRS): S0°, WRS correct @ 65 dB SPL Signal
Monosyllabic (MS) word lists are presented from the front (0°) at 65 dB SPL (45 dB HL) and the percent correct score [%] (0 % to 100 %) is recorded.
(SPL= Sound Pressure Level; Score: 0% to 100% words understood )
measure: Speech Reception Threshold in quiet (CHL/MHL)
time frame: 12 months post-operative
description: Investigate if speech intelligibility improves with the BCI 602 (aided) in CHL/MHL at 12 months post-operative compared to the unaided test situation in the following speech intelligibility test.
Speech Reception Threshold in quiet (SRT) : S0°, SRT for 50% correct
measure: Speech Reception Threshold in noise (CHL/MHL)
time frame: 12 months post-operative
description: Investigate if speech intelligibility improves with the BCI 602 (aided) in CHL/MHL at 12 months post-operative compared to the unaided test situation in the following speech intelligibility test.
Speech Reception Threshold in noise (SNR): S0° N0°, SNR for 50% correct @ 65 dB SPL Noise
measure: Speech Reception Threshold in noise (SSD) Sssd Nnh
time frame: 12 months post-operative
description: Investigate if speech intelligibility improves with the BCI 602 (aided) in SSD at 12 months post-operative compared to the unaided test situation in the following speech intelligibility tests.
Sssd Nnh, SNR for 50% correct @ 65 dB SPL Noise
(S= Signal; N= Noise; ssd = single sided deaf ear; nh = normal hearing ear)
measure: Speech Reception Threshold in noise (SSD) S0° Nnh
time frame: 12 months post-operative
description: Investigate if speech intelligibility improves with the BCI 602 (aided) in SSD at 12 months post-operative compared to the unaided test situation in the following speech intelligibility tests.
S0° Nnh, SNR for 50% correct @ 65 dB SPL Noise
measure: Residual hearing
time frame: 12 months post-operative
description: Investigate whether residual hearing by means of bone conduction (BC) PTA4 thresholds of subjects implanted with the BCI 602 remains stable 12 months post-operative compared to the pre operative test situation.
measure: Adverse Events
time frame: 12 months post-operative
description: Monitor the long-term safety of subjects implanted with the BCI 602 by collecting and reviewing adverse events (AEs).
measure: Surgical Questionnaires
time frame: 12 months post-operative
description: Monitor the long-term safety of subjects implanted with the BCI 602 by administering a surgical evaluation questionnaire to the surgeon.
measure: Speech Spatial Qualities questionnaire
time frame: 12 months post-operative
description: Investigate the Quality of Life with the SSQ questionnaire of subjects implanted with the BCI 602 12 months post-operative.
(SSQ = Speech Spatial Qualities)
measure: Assessment Quality of Life questionnaire
time frame: 12 months post-operative
description: Investigate the Quality of Life with the AQoL questionnaire of subjects implanted with the BCI 602 12 months post-operative.
(AQoL= Assessment Quality of Life)
arm group label: CHL & MHL (18 years and older)
description: CHL= conductive hearing loss, MHL= mixed hearing loss
arm group label: CHL & MHL (5 to 17 years)
arm group label: SSD (5 years and older)
description: SSD= single sided deafness
intervention type: Device
intervention name: Bone Conduction Implant
description: Bonebridge system BCI 602
arm group label: CHL & MHL (18 years and older)
arm group label: CHL & MHL (5 to 17 years)
arm group label: SSD (5 years and older)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Assen Koitschev, Prof. Dr.
role: Principal Investigator
affiliation: Klinikum Stuttgart - Olgahospital and Eberhard-Karls-Universität Tübingen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
country: United Kingdom
citation: Sprinzl G, Lenarz T, Ernst A, Hagen R, Wolf-Magele A, Mojallal H, Todt I, Mlynski R, Wolframm MD. First European multicenter results with a new transcutaneous bone conduction hearing implant system: short-term safety and efficacy. Otol Neurotol. 2013 Aug;34(6):1076-83. doi: 10.1097/MAO.0b013e31828bb541.
PMID: 23714710
citation: Baumgartner WD, Hamzavi JS, Boheim K, Wolf-Magele A, Schlogel M, Riechelmann H, Zorowka P, Koci V, Keck T, Potzinger P, Sprinzl G. A New Transcutaneous Bone Conduction Hearing Implant: Short-term Safety and Efficacy in Children. Otol Neurotol. 2016 Jul;37(6):713-20. doi: 10.1097/MAO.0000000000001038.
PMID: 27153327
citation: Sprinzl G, Toner J, Koitschev A, Berger N, Keintzel T, Rasse T, Baumgartner WD, Honeder C, Magele A, Plontke S, Gotze G, Schmutzhard J, Zelger P, Corkill S, Lenarz T, Salcher R. Multicentric study on surgical information and early safety and performance results with the Bonebridge BCI 602: an active transcutaneous bone conduction hearing implant. Eur Arch Otorhinolaryngol. 2023 Apr;280(4):1565-1579. doi: 10.1007/s00405-022-07792-y. Epub 2023 Jan 10.
PMID: 36625869
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Sensorineural
mesh term: Hearing Loss, Bilateral
mesh term: Hearing Loss, Conductive
mesh term: Hearing Loss, Unilateral
mesh term: Hearing Loss, Mixed Conductive-Sensorineural
sharing ipd: No