Overview

The Vibrant® Soundbridge® is an FDA approved, direct-drive, semi-implantable middle ear device intended to provide a level of useful sound perception to individuals with a moderate-to-severe sensorineural hearing loss. The Soundbridge converts sound into mechanical energy that is directly transferred to the middle ear bone (auditory ossicles).

Direct-drive means that the implant attaches directly to the incus (second of three middle ear bones) while resting on the stapes (third middle ear bone). This causes the stapes to vibrate. In this way, the Soundbridge brings sound very close to the inner ear (cochlea) and, therefore, maximizes mechanical coupling to the inner ear to improve the clarity of sound transmission. Nothing is worn in the ear canal and the Soundbridge is 100% digital.

The Vibrant® Soundbridge® is considered a semi-implantable device because there is both an internal (implanted) component and an outer or external component. The internal component consists of two parts. The internal component placed directly under the skin behind the ear is known as the Vibrating Ossicular Prosthesis™ (VORP™). The second portion of the internal component is the Floating Mass Transducer™ (FMT™). The FMT™ attaches to the incus and vibrates the stapes bone. (See photo below) (All photos courtesy of MED-EL).

Vibrant® Soundbridge® Implant System

Amadé Soundbridge Audio Processor.

The outer or external component is known as the Amadé Audio Processor. The Audio Processor contains a microphone that picks up sound from the environment and transmits it across the skin to the internal receiver in the VORP™. The signal is then delivered to the Floating Mass Transducer™ through a wire, which causes the FMT™ to vibrate. The FMT™ mechanically stimulates the auditory ossicles, mimicking the natural hearing process.

Vibrating Ossicular Prosthesis (VORP Internal Implant)

Floating Mass Transducer

Advantages

A direct drive system provides mechanical energy directly to the ossicles, bypassing the ear canal and the tympanic membrane. The Floating Mass Transducer™ of the Soundbridge® mechanically stimulates the ossicles, mimicking the natural hearing process. This eliminates many of the inherent issues of conventional hearing aids such as occlusion, feedback, discomfort, and the need for ear wax-related repairs. It also provides a measurable improvement in sound quality and clarity. Many patients also report improvement in noisy environments compared to conventional hearing aids.

Patient Selection

• Adults, 18 years of age or older
• Moderate-to-severe sensorineural hearing loss
• Unsuccessful with, or medically unable to wear, conventional hearing aids. (Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.)
• 50% or better word recognition score in the implant ear
• Hearing thresholds within the limits shown in drawing below
• Normal middle ear function

Audiologic indications for Vibrant® Soundbridge®: dark blue area represents unaided hearing level range for ideal candidates.

Examples of realistic expectations:

• Those desiring a more natural sound
• Those looking for better hearing in adverse listening environments such as background noise
• Those who have problems with feedback issues with a conventional hearing aid
• Those interested in a more comfortable hearing solution
• Those desiring a cosmetic solution
• Those who experience difficulty with their own voice quality due to occlusion with conventional hearing aids
• Those who experience multiple hearing aid repairs due to ear wax (cerumen) and debris.

Overview of Surgical Procedure and Postoperative Care

The internal device is surgically implanted during an outpatient (same day) surgical procedure. The procedure is conducted under general anesthesia and takes 1 1/2 to 2 hours to complete. The VORP™ is implanted under the skin in back of the ear, and the FMT™ is attached to the long process of the incus during the procedure. The middle ear structures are not modified. Therefore, there is no significant impact on the residual hearing of the patient. The risks of surgery are similar to that of routine ear surgery. After a few days rest, the patient can resume normal activities.

Eight weeks after the procedure, the patient is fitted with the external audio processor that attaches magnetically in back of the ear. The patient’s audiologist then performs the fitting, programming and ongoing care of the audio processor.