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

MED-EL Elektromedizinische Geräte GesmbH52 enrolled

Overview

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 .

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Hearing Loss, Bilateral Hearing Loss, Sensorineural

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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.

Locations (8)

Universitätsklinik Innsbruck für Hals-, Nasen- und Ohrenheilkunde

Innsbruck, Austria

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

Sankt Pölten, Austria

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

Vienna, Austria

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

Wels, Austria

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

Halle, Germany

Klinik u. Poliklinik f. HNO-Heilkunde

Hanover, Germany

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

Stuttgart, Germany

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

Belfast, United Kingdom

Outcomes

Primary Outcomes

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)