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 .

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Bilateral; Hearing Loss, Conductive; Hearing Loss, Unilateral; Hearing Loss, Mixed
• Intervention / Treatment: Device: Bone Conduction Implant

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

• Study Contact: Name: Robert Wiek, PhD; Phone Number: +43 (0) 57788; Email: allclinicalresearchvibrant@medel.com
• Study Contact Backup: Name: Severin Fürhapter, PhD; Phone Number: +43 (0) 57788; Email: allclinicalresearchvibrant@medel.com

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Universitätsklinik Innsbruck für Hals-, Nasen- und Ohrenheilkunde
  • St. Pölten, Austria, 3100
    • Universitätsklinikum St. Pölten - Lilienfeld, Hals-Nasen-Ohren-Abteilung
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen, Abteilung für Hals-, Nasen-, Ohrenkrankheiten
  • Wien, Austria, 1090
    • Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
• Germany
  • Halle/Saale, Germany, 06120
    • Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie
  • Hannover, Germany, 30625
    • Klinik u. Poliklinik f. HNO-Heilkunde
  • Stuttgart, Germany, 70174
    • Klinikum Stuttgart - Olgahospital, Klinik für HNO-Krankheiten, Plastische Operationen
• United Kingdom
  • Belfast, United Kingdom, BT11 9AF
    • Regional Auditory Implant Centre, Beech Hall Centre, Belfast HSC Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CHL & MHL (5 to 17 years)	Device: Bone Conduction Implant; Bonebridge system BCI 602
CHL & MHL (18 years and older); CHL= conductive hearing loss, MHL= mixed hearing loss	Device: Bone Conduction Implant; Bonebridge system BCI 602
SSD (5 years and older); SSD= single sided deafness	Device: Bone Conduction Implant; Bonebridge system BCI 602

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 )	12 months post-operative
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	12 months post-operative
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	12 months post-operative
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)	12 months post-operative
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	12 months post-operative
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.	12 months post-operative
Adverse Events	Monitor the long-term safety of subjects implanted with the BCI 602 by collecting and reviewing adverse events (AEs).	12 months post-operative
Surgical Questionnaires	Monitor the long-term safety of subjects implanted with the BCI 602 by administering a surgical evaluation questionnaire to the surgeon.	12 months post-operative
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)	12 months post-operative
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)	12 months post-operative

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH
• Investigators: Principal Investigator: Assen Koitschev, Prof. Dr., Klinikum Stuttgart - Olgahospital and Eberhard-Karls-Universität Tübingen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Actual): January 18, 2024
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: bone conduction; Bonebridge system; BCI 601; BCI 602; bone conduction implant
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral; Hearing Loss, Conductive; Hearing Loss, Unilateral; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: 2019BB005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No