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

NCT04427033 | Completed

• 1 other identifier: 2019BB005
• Study Type: observational
• Target: 52
• Locations: 3 countries
• Sites: 8

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 .

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

Outcome Measures

Primary Outcomes (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)

  12 months post-operative

Secondary Outcomes (10)

• Word Recognition Score (CHL/MHL)

  12 months post-operative

• Speech Reception Threshold in quiet (CHL/MHL)

  12 months post-operative

• Speech Reception Threshold in noise (CHL/MHL)

  12 months post-operative

• Speech Reception Threshold in noise (SSD) Sssd Nnh

  12 months post-operative

• Speech Reception Threshold in noise (SSD) S0° Nnh

  12 months post-operative

Study Arms (3)

CHL & MHL (18 years and older)

CHL= conductive hearing loss, MHL= mixed hearing loss

Device: Bone Conduction Implant

CHL & MHL (5 to 17 years)

Device: Bone Conduction Implant

SSD (5 years and older)

SSD= single sided deafness

Device: Bone Conduction Implant

Interventions

Bone Conduction Implant DEVICE

Bonebridge system BCI 602

CHL & MHL (18 years and older); CHL & MHL (5 to 17 years); SSD (5 years and older)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (8)

Universitätsklinik Innsbruck für Hals-, Nasen- und Ohrenheilkunde

Innsbruck, 6020, Austria

Location

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

Sankt Pölten, 3100, Austria

Location

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

Vienna, 1090, Austria

Location

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

Wels, 4600, Austria

Location

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

Halle, 06120, Germany

Location

Klinik u. Poliklinik f. HNO-Heilkunde

Hanover, 30625, Germany

Location

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

Stuttgart, 70174, Germany

Location

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

Belfast, BT11 9AF, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 23714710 BACKGROUND

• 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.

  PMID: 27153327 BACKGROUND

• 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.

  PMID: 36625869 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Assen Koitschev, Prof. Dr.

  Klinikum Stuttgart - Olgahospital and Eberhard-Karls-Universität Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 11, 2020
• Study Start: December 6, 2019
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); DE (3); GB (1)