2019 BBOO5 BCI 602 Bonebridge Post-Market follow-up study

• Research type

  Research Study

• Full title

  2019BB005 The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study

• IRAS ID

  250051

• Contact name

  Severin Fürhapter

• Contact email

  severin.fuerhapter@medel.com

• Sponsor organisation

  MED-EL Elektromedizinische Geräte GmbH

• Clinicaltrials.gov Identifier

  NCT04427033

• Clinicaltrials.gov Identifier

  20191111-2132, https://ctc.tirol-kliniken.at/page.cfm?vpath=oeffentliche

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Research Summary
  The aim of this post market clinical follow up study is to confirm long-term audiological performance and safety of the routinely used BONEBRIDGE (implant) in patients with conductive hearing loss (CHL), mixed hearing loss (MHL) and single sided deafness (SSD). The primary objective is to investigate if hearing will improve when implanted with the BONEBRIDGE. Audiological performance is evaluated by change in aided hearing thresholds, speech intelligibility and quality of life scores. Safety is evaluated by monitoring complications with the implant.
  Patients with CHL, MHL and SSD 5 years of age indicated for the BONEBRIDGE treatment are eligible, and the research will be conducted in an Auditory Implant Centre, both in clinical room and soundproof booths.

  Summary of Results
  Plain Language Summary of the Research Findings Thank You First, we would like to thank everyone who took part in this study.

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

  Who Carried Out the Research?
  This research was sponsored and funded by MED-EL, a company specializing in medical devices for hearing loss.

  Where and When the Study Took Place:
  The study was conducted at several clinics in Germany, Austria, and the UK from January 2020 (first patient enrolled) to August 2023 (last patient in).

  Why Was the Research Needed?
  This study aimed to evaluate the safety and effectiveness of the Bonebridge BCI 602 hearing system for people with different types of hearing loss. The system is intended for individuals with conductive or mixed hearing loss (CHL/MHL) or single-sided deafness (SSD).

  Device Description:
  The Bonebridge augments hearing by providing acoustic input to the inner ear via bone conduction.
  The Bonebridge is a bone conduction hearing system that includes two main components:
  An externally worn audio processor (AP).
  A surgically implanted bone conduction implant (BCI).

  Main Questions Studied:
  • Does the BCI 602 improve hearing?
  • How well do participants understand speech with the implant?
  • Is the improvement stable up to 12 months after implantation?
  • Are there any safety concerns with the implant?

  Who Participated in the Study?
  The study included 52 participants ranging from children to adults who were already scheduled to receive Bonebridge as part of their standard treatment.
  Participants had either
  • Conductive Hearing Loss: Sound can’t get through the outer/middle ear to the inner ear.
  • Mixed Hearing Loss: Problems exist in both the outer/middle ear and the inner ear.
  • Single-Sided Deafness (SSD): One ear can’t hear well or at all, while the other ear hears normally.

  All participants met specific criteria and wanted to join the study.

  Treatments or Interventions:
  Participants received the Bonebridge BCI 602 implant, which involves surgery to place part of the device inside the head. The system includes an external audio processor worn outside the head.

  What Happened During the Study?
  Participants were followed for 12 months after the surgery. Their hearing and speech understanding were routinely tested before and after receiving the implant. No additional treatments were assigned because of the study.

  What Were the Results after 12 months?
  • Hearing Improvement: Significant improvement was observed in hearing across all groups:
  o Adults with conductive/mixed hearing loss improved by 23.07 dB.
  o Children with conductive/mixed hearing loss improved by 25.64 dB.
  o Those with single-sided deafness improved by 24.30 dB.
  • Speech Understanding: Participants improved in understanding speech in both quiet and noisy environments.
  • Safety: Side effects were minor and manageable, with no unexpected or serious device-related events.

  How Has This Study Helped Patients and Researchers?
  The Bonebridge BCI 602 helps patients to hear and understand speech better. It is safe, showing only minor and manageable side effects. This study shows that the BCI 602 as a beneficial and safe treatment.

  Further Research Planned:
  Future studies may look at the how patients perform after being implanted for a few years.

  Where Can I Learn More About This Study?
  For more information, you can visit:
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.hra.nhs.uk%252Fplanning-and-improving-research%252Fapplication-summaries%252Fresearch-summaries%252F2019-bboo5-bci-602-bonebridge-post-market-follow-up-study%252F%2FNBTI%2FirK2AQ%2FAQ%2F9596890b-9567-41e9-897b-d4a5b868416c%2F1%2FIZYDblwb2o&data=05%7C02%7Capprovals%40hra.nhs.uk%7C4805082a1dc349f7ac2c08dca5a43e00%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638567372040821799%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=TLa6Gmwd8po8hRgQVdi3Shq18VsC1ZNDAcwY4yjqAJM%3D&reserved=0

  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.clinicaltrials.gov%252Fstudy%252FNCT04427033%2FNBTI%2FirK2AQ%2FAQ%2F9596890b-9567-41e9-897b-d4a5b868416c%2F2%2FMU750DZtpU&data=05%7C02%7Capprovals%40hra.nhs.uk%7C4805082a1dc349f7ac2c08dca5a43e00%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638567372040837490%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=fnfuqO2EfVChb7%2BnVsJuumhW%2FJin%2BIr7HK2JhUX2Atg%3D&reserved=0

  What is dB and how was hearing improvement measured:
  A decibel (dB) is a unit used to measure the loudness of sound. It can be a bit tricky, so here’s an easy way to understand it:
  • Quiet Sounds: Soft sounds like a whisper are about 30 dB.
  • Normal Conversation: When you talk to someone at a normal volume, that's about 60 dB.
  • Loud Sounds: A lawnmower or loud music can be around 90 dB.
  Key Points:
  • Higher dB = Louder Sound: The bigger the number, the louder the sound.
  • Lower dB = Quieter Sound: The smaller the number, the quieter the sound.

  Decibels are important in hearing tests to see how well someone can hear different sounds. For example, if a hearing aid improves a person's hearing by 10 dB, it means they can hear sounds that are quieter than before.
  In our study, we measured in the sound field (SF) how much the Bonebridge hearing system improved people's hearing in decibels.

  SF PTA4 measures the average hearing ability at four key pitches (0.5, 1.0, 2.0, and 4.0 kHz) using natural sounds from speakers. It is recorded in decibels (dB), where a lower number means better hearing. In our study, an improvement in SF PTA4 in decibels indicates that the Bonebridge hearing system helped participants hear more softly spoken sounds.

• REC name

  HSC REC B

• REC reference

  20/NI/0020

• Date of REC Opinion

  27 Feb 2020

• REC opinion

  Further Information Favourable Opinion