AzTrials
AzTrials

Hearing LossNCT04427033

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

An observational study of Hearing Loss and Hearing Loss, Conductive, run by MED-EL Elektromedizinische Geräte GmbH at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 5 years and older
What is being tested?
Bone Conduction Implant
Type of treatment
Medical device
How many people
52 participants
Where
8 sitesin 3 countries
Study dates
6 Dec 2019to 18 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This study will only enrol subjects who represent the target population and meet the inclusion/exclusion criteria.

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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).

Who cannot join

  • 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:
Show all 10Show fewer
  • 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.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Austria4 sites

  • Universitätsklinik Innsbruck für Hals-, Nasen- und Ohrenheilkunde

    Innsbruck, 6020

  • Universitätsklinikum St. Pölten - Lilienfeld, Hals-Nasen-Ohren-Abteilung

    Sankt Pölten, 3100

  • Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten

    Vienna, 1090

  • Klinikum Wels-Grieskirchen, Abteilung für Hals-, Nasen-, Ohrenkrankheiten

    Wels, 4600

Other trials in Austria

Germany3 sites

  • Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie

    Halle, 06120

  • Klinik u. Poliklinik f. HNO-Heilkunde

    Hanover, 30625

  • Klinikum Stuttgart - Olgahospital, Klinik für HNO-Krankheiten, Plastische Operationen

    Stuttgart, 70174

Other trials in Germany

United Kingdom1 site

  • Regional Auditory Implant Centre, Beech Hall Centre, Belfast HSC Trust

    Belfast, BT11 9AF

Other trials in United Kingdom

About this 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 .

Being tested
Bone Conduction Implant
Keywords
Bonebridge system, BCI 601, BCI 602, bone conduction, bone conduction implant
Medical subject headings
Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Unilateral, Hearing Loss, Bilateral, Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone Conduction ImplantDevice

    Bonebridge system BCI 602

Study groups in NCT04427033
Study groupRoleWhat they receive
CHL & MHL (18 years and older)CHL= conductive hearing loss, MHL= mixed hearing loss
Receives: Device: Bone Conduction Implant
CHL & MHL (5 to 17 years)Not described
Receives: Device: Bone Conduction Implant
SSD (5 years and older)SSD= single sided deafness
Receives: Device: Bone Conduction Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sound Field audiometry

    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)

    Measured: 12 months post-operative

Secondary outcomes (10)

  1. Word Recognition Score (CHL/MHL)

    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 )

    Measured: 12 months post-operative

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

    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

    Measured: 12 months post-operative

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

    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

    Measured: 12 months post-operative

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

    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)

    Measured: 12 months post-operative

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

    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

    Measured: 12 months post-operative

  6. Residual hearing

    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.

    Measured: 12 months post-operative

  7. Adverse Events

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

    Measured: 12 months post-operative

  8. Surgical Questionnaires

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

    Measured: 12 months post-operative

  9. Speech Spatial Qualities questionnaire

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

    (SSQ = Speech Spatial Qualities)

    Measured: 12 months post-operative

  10. Assessment Quality of Life questionnaire

    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)

    Measured: 12 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start6 Dec 2019
  3. Primary completion18 Jan 2024
  4. Study completion18 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04427033
Sponsor's protocol ID
2019BB005
Status last verified
Aug 2026
First submitted
4 Jun 2020
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Plontke SK, Lenarz T, Toner J, Keintzel T, Sprinzl G, Baumgartner WD, Koitschev A, Schmutzhard J, Gotze G, Rahne T, Knoelke N, Busch S, Corkill S, Raffelsberger T, Niederwanger L, Magele A, Schorg P, Honeder C, Liepins R, Berger N, Koci V, Wiek R. The Bonebridge BCI 602 Safety and Performance 1 Year Post-Implantation in Adults and Children: A Multicentric Post-Market Study. Otol Neurotol. 2026 Jan 1;47(1):175-184. doi: 10.1097/MAO.0000000000004688. Epub 2025 Nov 18.

    PubMed 41250191

  • 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.

    PubMed 36625869

Questions about this trial

What is this clinical trial studying?

An observational study of Hearing Loss and Hearing Loss, Conductive, run by MED-EL Elektromedizinische Geräte GmbH at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Austria, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sound Field audiometry (time frame: 12 months post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04427033, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in