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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427033
• Other study ID #: 2019BB005
• Status: Completed
• Start date: December 6, 2019
• Est. completion date: January 18, 2024

Study information

• Verified date: January 2024
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Conductive
• Hearing Loss, Mixed
• Hearing Loss, Mixed Conductive-Sensorineural
• Hearing Loss, Sensorineural
• Hearing Loss, Unilateral

Intervention

Device:
• Bone Conduction Implant
Bonebridge system BCI 602

Locations

Country	Name	City	State
Austria	Universitätsklinik Innsbruck für Hals-, Nasen- und Ohrenheilkunde	Innsbruck
Austria	Universitätsklinikum St. Pölten - Lilienfeld, Hals-Nasen-Ohren-Abteilung	St. Pölten
Austria	Klinikum Wels-Grieskirchen, Abteilung für Hals-, Nasen-, Ohrenkrankheiten	Wels
Austria	Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten	Wien
Germany	Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie	Halle/Saale
Germany	Klinik u. Poliklinik f. HNO-Heilkunde	Hannover
Germany	Klinikum Stuttgart - Olgahospital, Klinik für HNO-Krankheiten, Plastische Operationen	Stuttgart
United Kingdom	Regional Auditory Implant Centre, Beech Hall Centre, Belfast HSC Trust	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Countries where clinical trial is conducted

Austria,  Germany,  United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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