STUDIES AT A GLANCE

Scientific studies summarized for you

Study:  Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window
(Laryngoscope. 2021 May;131(5):E1434-E1442. Sprinzl GM et al.)

Take home message:

The VIBRANT SOUNDBRIDGE active middle ear implant system coupled to the Round Window proved to be a safe and stable long-term implantation method for hearing improvement in patients within the device’s indication range.

Patients with cholesteatoma (with radical cavity) and pre-implantation middle ear surgeries have a higher risk of complications and require additional counselling.

Background:

The VIBRANT SOUNDBRIDGE (VSB), an active, transcutaneous middle ear implant, has become a well-established treatment method for sensorineural, conductive and mixed hearing losses. Attachment methods of the Floating Mass Transducer (FMT) have been refined, allowing for wider indications that can be treated with the Vibrant Soundbridge. Apart from placing the FMT onto the ossicular chain, a method to attach it to the Round Window membrane was developed in 2006.

Indications for the VSB thus expanded to include a variety of complicated middle ear conditions.

Aim of the study:

• Examine the audiological benefits, long-term safety and stability of the VSB when attached (“coupled”) to the Round Window.

Method:

• Retrospective study, 2013-2019
• 46 ears implanted with the VSB
  • 31 ears for short-term follow-up (1-9 months)
  • 15 ears for long-term follow-up (12-59 months)
• Coupling method: Round Window

Results:

• Patients without choleasteatoma needing revision surgery: 0%
• Patients with cholesteatoma with radical cavity and previous middle ear opertaions needing revision surgery: 15.2% à this clearly shows the correlation between the underlying pathology and revision rate.
• Post-implantation residual hearing remained stable
• Significant and stable long-term audiological improvements compared to untreated condition.
• No significant difference in hearing performance between the short-term and long-term groups.
• Long daily wearing time (> 13 hours) of the VSB is a sign for patient satisfaction and high wearing comfort.

Read the study here: Long-term stability and safety of the Soundbridge cou-pled to the Round Window (nih.gov)