Clinical trial NCT04427033: The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study
Official title: The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Mixed
Hearing Loss, Unilateral
Hearing Loss, Bilateral
Hearing Loss, Sensorineural
Keywords: Bonebridge system
BCI 601
BCI 602
bone conduction
bone conduction implant
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This study will only enrol subjects who represent the target population and meet the inclusion/exclusion criteria.

Brief 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 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 .


Eligibility criteria: 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.

Primary outcomes:
measure: Sound Field audiometry
timeFrame: 12 months post-operative
Secondary outcomes:
measure: Word Recognition Score (CHL/MHL)
timeFrame: 12 months post-operative
measure: Speech Reception Threshold in quiet (CHL/MHL)
timeFrame: 12 months post-operative
measure: Speech Reception Threshold in noise (CHL/MHL)
timeFrame: 12 months post-operative
measure: Speech Reception Threshold in noise (SSD) Sssd Nnh
timeFrame: 12 months post-operative
measure: Speech Reception Threshold in noise (SSD) S0° Nnh
timeFrame: 12 months post-operative
measure: Residual hearing
timeFrame: 12 months post-operative
measure: Adverse Events
timeFrame: 12 months post-operative
measure: Surgical Questionnaires
timeFrame: 12 months post-operative
measure: Speech Spatial Qualities questionnaire
timeFrame: 12 months post-operative
measure: Assessment Quality of Life questionnaire
timeFrame: 12 months post-operative
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck für Hals-, Nasen- und Ohrenheilkunde
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten - Lilienfeld, Hals-Nasen-Ohren-Abteilung
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen, Abteilung für Hals-, Nasen-, Ohrenkrankheiten
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
city: Halle/Saale
country: Germany
facility: Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie
city: Hannover
country: Germany
facility: Klinik u. Poliklinik f. HNO-Heilkunde
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart - Olgahospital, Klinik für HNO-Krankheiten, Plastische Operationen
city: Belfast
country: United Kingdom
facility: Regional Auditory Implant Centre, Beech Hall Centre, Belfast HSC Trust
Study officials:
affiliation: Klinikum Stuttgart - Olgahospital and Eberhard-Karls-Universität Tübingen
name: Assen Koitschev, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.