Can a new bone conduction implant restore hearing for the long haul?
NCT ID NCT04427033
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This study looks at the Bonebridge BCI 602, a bone conduction implant designed to help people with certain types of hearing loss. The trial will measure how well the device improves hearing and speech understanding one year after implantation, compared to not using it. It also tracks safety and any complications over time. Participants include people aged 5 and older who meet the device's criteria for use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bonebridge BCI 602 bone conduction implant
- What this could lead to
- If successful, this could confirm the BCI 602 as a reliable long-term option for people with certain types of hearing loss, improving hearing and quality of life.
- What could go wrong
- This is a post-market study, so the device is already available. The trial focuses on long-term outcomes, and results may vary among individuals. Risks include surgical complications and device-related issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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52 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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Jan 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will only enrol subjects who represent the target population and meet the inclusion/exclusion criteria.
- Ages
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
Vienna, 1090, Austria
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Klinik u. Poliklinik f. HNO-Heilkunde
Hanover, 30625, Germany
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Klinikum Stuttgart - Olgahospital, Klinik für HNO-Krankheiten, Plastische Operationen
Stuttgart, 70174, Germany
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Klinikum Wels-Grieskirchen, Abteilung für Hals-, Nasen-, Ohrenkrankheiten
Wels, 4600, Austria
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Regional Auditory Implant Centre, Beech Hall Centre, Belfast HSC Trust
Belfast, BT11 9AF, United Kingdom
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Universitätsklinik Innsbruck für Hals-, Nasen- und Ohrenheilkunde
Innsbruck, 6020, Austria
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Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie
Halle, 06120, Germany
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Universitätsklinikum St. Pölten - Lilienfeld, Hals-Nasen-Ohren-Abteilung
Sankt Pölten, 3100, Austria
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