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Completed

NCT Number: NCT04427033

The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study

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 .

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss, Bilateral Hearing Loss, Conductive Hearing Loss, Mixed Hearing Loss, Mixed Conductive-Sensorineural Hearing Loss, Sensorineural Hearing Loss, Unilateral Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik Innsbruck für Hals-, Nasen- und Ohrenheilkunde, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Geographically and physically able to return to the investigational site for scheduled evaluations and follow-up appointments
  • Fluent in the language used in the investigational site and used for evaluation
  • Signed and dated informed consent before the start of any study-specific procedure and collection of any retrospective data.
  • Subjects meet the indication criteria according to the instructions for use (IFU):
  • Subject 5 years of age and older
  • The physician must fully assess the potential risks and benefits for the patient and his/her realistic expectations with the device prior to the decision to implant the BCI 602. The physician must exercise medical judgement and consider the patient's complete medical history.
  • Bonebridge candidates suffer from either
  • • conductive or mixed hearing loss as indicated by audiometric testing with bone conduction thresholds better than or equal to 45 dB HL at 0.5, 1.0, 2.0 and 3.0 kHz.
  • • single-sided sensorineural deafness, that is severe-to-profound sensorineural hearing loss in one ear while the other ear has normal hearing (air conduction (AC) should be better than or equal to 20 dB HL measured at 0.5, 1.0, 2.0 and 3.0 kHz).

Exclusion criteria

  • A subject whose hearing loss has demonstrated an improving and decreasing fluctuation over a two-year period of >15 dB HL in either direction
  • Severe, chronic, non-revisable diseases or disorders (vestibular disorder, cancer etc.)
  • A subject with any psychological (anxiety, depression, hallucinations etc.), emotional (schizophrenia, mania, melancholia etc.) or from that originating physical disorder that would interfere with the ability to perform on test procedures
  • Simultaneous participation in another clinical trial (on device or on drug) which would interfere with the results of the study.
  • Any active ear infection
  • Subjects who meet any of the contraindications in the IFU:
  • Evidence that hearing loss is of retrocochlear or central origin (ipsilateral CHL /MHL; contralateral SSD)
  • Skin or scalp conditions that may preclude attachment of the Audio Processor (AP) or that may interfere with the use of the AP
  • Skull size or abnormality would preclude appropriate placement of the BCI 602 implant
  • Intolerant to the materials in the BCI 602 implant.

Treatment and study plan

Bone Conduction Implant

Device

Bonebridge system BCI 602

Primary outcomes

  1. Sound Field audiometry

    Time frame: 12 months post-operative

    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)

Secondary outcomes

  1. Word Recognition Score (CHL/MHL)

    Time frame: 12 months post-operative

    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 )

  2. Speech Reception Threshold in quiet (CHL/MHL)

    Time frame: 12 months post-operative

    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

  3. Speech Reception Threshold in noise (CHL/MHL)

    Time frame: 12 months post-operative

    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

  4. Speech Reception Threshold in noise (SSD) Sssd Nnh

    Time frame: 12 months post-operative

    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)

  5. Speech Reception Threshold in noise (SSD) S0° Nnh

    Time frame: 12 months post-operative

    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

  6. Residual hearing

    Time frame: 12 months post-operative

    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.

  7. Adverse Events

    Time frame: 12 months post-operative

    Monitor the long-term safety of subjects implanted with the BCI 602 by collecting and reviewing adverse events (AEs).

  8. Surgical Questionnaires

    Time frame: 12 months post-operative

    Monitor the long-term safety of subjects implanted with the BCI 602 by administering a surgical evaluation questionnaire to the surgeon.

  9. Speech Spatial Qualities questionnaire

    Time frame: 12 months post-operative

    Investigate the Quality of Life with the SSQ questionnaire of subjects implanted with the BCI 602 12 months post-operative.

    (SSQ = Speech Spatial Qualities)

  10. Assessment Quality of Life questionnaire

    Time frame: 12 months post-operative

    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)

Sponsors and collaborators

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Industry

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2020
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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