VIBRANT SOUNDBRIDGE VORP 503
Active Middle Ear Implant
Over 25 Years of Proven Results & Reliability
VIBRANT SOUNDBRIDGE (VORP 503) is a unique active middle ear implant that combines excellent hearing outcomes with flexible surgical handling and proven long-term reliability. SOUNDBRIDGE has the longest track record of all active middle ear implants on the market—over 25 years—and is an ideal option for patients five years or older with:
- Mild-to-severe sensorineural hearing loss resulting from inner ear pathologies when acoustic hearing aids are contraindicated.
- Mixed hearing loss resulting from middle ear pathologies, including conductive hearing loss.
- Excellent hearing outcomes
- Flexible surgical placement
- Proven long-term reliability
Hearing Performance
SOUNDBRIDGE provides recipients with natural sound quality without feedback. That’s thanks to its unique design with a Floating Mass Transducer (FMT) that can be coupled to the most appropriate middle ear structure to suit each individual recipient’s specific anatomy.
For patients with sensorineural hearing loss, the FMT is attached to the incus, allowing stimulation of the inner ear via the ossicles, making hearing with SOUNDBRIDGE very similar to hearing naturally. In 127 studies with over 1,600 patients, SOUNDBRIDGE has shown to be an effective treatment for sensorineural hearing loss in its indication criteria. Combined data from these studies show improvements from 43.6% to 78.6% in word recognition scores at 65dB SPL for patients with sensorineural hearing loss. [ft]
- Flexible FMT design
- Natural sound quality
- Feedback free
For patients with mixed hearing loss, SOUNDBRIDGE bypasses middle ear issues and directly stimulates either the oval window (via the stapes) or the round window. When preoperative results with a hearing aid were compared to postoperative outcomes, the same patients obtained significantly better outcomes with SOUNDBRIDGE than with hearing aids. This was the case in pure-tone audiometry in four out of six frequencies, both the one-syllable test and the sentence test (WRS and SRT in quiet), and subjective perception. [ft] Additionally, hearing improvements with SOUNDBRIDGE remain stable in the long term. [ft]
Flexible FMT Design
The FMT, the core of SOUNDBRIDGE’s technology, provides maximum surgical flexibility when it comes to application—without the need to choose between a left or right version. Since the FMT is incredibly small (2.3 mm in length) and lightweight (25 mg), it can be placed on the optimal middle ear structure with a Vibroplasty Coupler. This provides the flexibility to select the optimal solution for each case based on individual anatomy and hearing loss type to achieve the best hearing outcome.
Natural Sound Quality
An unobstructed auditory canal and the active stimulation of middle ear structures with mechanical vibrations produce a natural listening experience. In addition, recipients can enjoy a full range of frequencies—including higher frequencies above 5 kHz often not covered by hearing aids. This is critical in patients with presbycusis because hearing loss is more profound in higher frequencies.
Feedback Free
Unlike hearing aids or high-power bone conduction devices that are prone to feedback due to microphone placement, SOUNDBRIDGE uses wireless signal transmission between the SAMBA 2 audio processor and the active middle ear implant. Since SAMBA 2’s dual microphones are separated from the mechanical output of the implant, feedback is minimized—even at high gain levels.
Bypass Challenging Anatomies
SOUNDBRIDGE’s unique design enables bypassing a variety of middle and outer ear conditions. Off the ear and without occlusion, SOUNDBRIDGE provides excellent audiological outcomes even in patients with chronic otitis externa, atresia, or radical cavities. By implanting SOUNDBRIDGE, patients can still undergo outer ear reconstruction.
Ease of Use
Standardized single-point FMT attachment and self-drilling screws make SOUNDBRIDGE implantation fast and straightforward—while maximizing surgical flexibility. SOUNDBRIDGE is suitable for implantation for recipients age five or older because the FMT is attached at a single point, making it independent from skull growth. In fact, it is the only middle ear implant on the market featuring single-point attachment.
In addition, the SAMBA 2 audio processor for SOUNDBRIDGE combines intelligent hearing technology with easy handling, a variety of connectivity options, and intuitive fitting software to make hearing as simple as possible—for both hearing implant recipients and professionals.
- Surgical flexibility
- Independent of growth
- Straightforward surgery
Made for Surgical Flexibility
Flexibility during surgery is important since every individual has unique middle ear anatomy. Therefore, we have developed standardized coupling options for various middle ear structures to allow the FMT to be attached to a single, optimal point, or middle ear structure, to suit each individual recipient’s specific anatomy.
Systematic Review and Meta-Analysis of Audiological and Patient-Reported Outcomes With the Vibrant SOUNDBRIDGE Active Middle Ear Implant. 2021.
Incus-SP-Coupler
Incus-LP-Coupler
Stapes-SH-Coupler
Vibroplasty-CliP-Coupler
RW-Soft-Coupler
Incus-SP-Coupler
- The FMT is placed on the short process of the incus.
- Safely performed away from facial nerve and chorda tympani since only a posterior epitympanotomy is needed.
- 35% shorter surgery time. [ft]
Incus-LP-Coupler
- The FMT is placed onto the long process of the incus via a posterior tympanotomy.
- A left and a right version of the Incus-LP-Coupler are available.
Stapes-SH-Coupler
- The FMT is placed onto the head of the stapes.
- Allows for standardized coupling in cases where the incus is not present.
- Selection of this or Vibroplasty-CliP-Coupler can be made based on anatomical conditions.
Vibroplasty-CliP-Coupler
- The FMT is placed onto the head of the stapes.
- Allows for standardized coupling in cases where the incus is not present.
- Selection of this or Stapes-SH-Coupler can be made based on anatomical conditions.
RW-Soft-Coupler
- The FMT is placed on the round window membrane.
- Features an anatomically optimized shape.
- Made from silicon to protect the round window membrane.
- Attached to the FMT via adhesive pad.
Straightforward Standardized Coupling
Straightforward and standardized coupling procedures exist for each of the Vibroplasty Couplers. Watch as experienced surgeons demonstrate these simple surgical placements of the Floating Mass Transducer, coupling it to the most appropriate middle ear structure to suit each individual recipient’s specific anatomy.
Prof. Dr. med. Robert Mlynski
Prof. Dr. med. Stefan Plontke
PD Dr. med Henning Frenzel
Assoz. Prof. Priv.-Doz. Dr.med.univ. Joachim Schmutzhard
MED-EL surgical videos are for educational purposes only. Not all medical devices, surgical techniques or indications shown are approved in all countries. The videos are produced in countries in which the demonstrated content is authorized under applicable regulatory provisions. Please always follow the approved labelling and surgical information for your market. Please contact your local MED-EL representative for queries on the status of regulatory approval in your market.
Fast and Easy Fixation
SOUNDBRIDGE is anchored to the bone via two titanium fixation wings. With self-drilling screws for fast and secure implant fixation, surgical handling is simple and surgical procedures are shortened. Everything needed for implantation is included in the VORP 503 Implant Kit – including the sizer kit, screwdriver, screws and an optional Vibroplasty Coupler of your choice.
Innovative Integrity Testing
The VSB QuickCheck 2 can be quickly and easily used to test the integrity of the implant in seconds—both intraoperatively (when placed in a sterile sleeve), or during follow-up care. Simply switch it on, select the implant type and place it above the coil section of the implant. The result is shown with either a red or green light.
SAMBA 2: Hearing Made Simple
SAMBA 2 is an all-in-one audio processor for VIBRANT SOUNDBRIDGE implant recipients. With a lightweight design, snap-on attachment clips, and quick-change batteries, everyday handling is easy and intuitive. SAMBA 2 is so comfortable to wear and easy to handle that recipients might even forget they’re wearing it.
Long-Lasting Battery
With a battery life of approximately 8-10 days, SAMBA 2 provides reliable, long-lasting power.
Easy Streaming
SAMBA 2 GO easily connects phones and other devices to SAMBA 2 for wireless streaming and hands-free calls.
Discreet Design
SAMBA 2 has both the lightest weight and the lowest profile height of any audio processor on the market, making it easy to hide.
Long Average Wearing Time
A successful hearing device should be both comfortable and used all day. With an average daily usage time of 11.9 hours per day, SOUNDBRIDGE users enjoy comfortable hearing all day long. [ft]
Hours Per Day
Peace of Mind
SOUNDBRIDGE provides stable audiological results in the long term with an exceptionally low rate of complications. Thanks to the intact skin design, SOUNDBRIDGE avoids issues such as infections and additional clinic visits common with BAHA devices. In addition, recipients and their radiologists get peace of mind knowing that the VORP 503 may be safely MRI scanned at 1.5 Tesla.*
- Long-term reliability
- Exceptionally low complication rate
- Straightforward surgery
MR Conditional at 1.5 Tesla
The VORP 503 magnet was designed with MRI scans in mind. This allows the implant to be exposed to MRI scans at 1.5 Tesla without magnet removal.* Because of our long and positive experience with MRIs and hearing implants, we offer a life-long MRI guarantee. In the very unlikely event that it’s damaged during an MRI scan we will replace the implant.**
For the patient, this means no surgery is necessary for an MRI scan, and of course, there is no hearing downtime—patients can use the implant immediately after scans.***
- No surgery***
- No hearing downtime
- No discomfort
Why MED-EL:
A Trusted Partner
For more than 30 years, MED-EL has been a trusted partner and innovation leader in hearing implants. We’re here to work together with you, and we’re committed to providing outstanding service and support for our professional partners.
With the most advanced cochlear implant systems, we offer the best hearing experience for your patients and the best clinical experience for you.
- Closest to Natural Hearing
- Superior Ease-of-Use
- True Peace of Mind
Contact Us
Ready to learn more about VIBRANT SOUNDBRIDGE?
Fill out our simple contact form and we’ll get in touch with you.
SYMFIT 8.0
The SYMFIT 8.0 software makes fitting SAMBA 2 easy and efficient. Its straightforward guided workflow includes precise Vibrograms and fitting tools to help you get the most out of SAMBA 2.
SAMBA 2
SAMBA 2 for VIBRANT SOUNDBRIDGE and BONEBRIDGE combines intelligent hearing technology with easy handling, intuitive connectivity options and improved fitting software to make hearing as simple as possible—for both hearing implant recipients and their audiologists.
Technical Data
VORP 503 Active Middle Ear Implant
VIBRANT SOUNDBRIDGE System
Contents of Implant Kit
- 1 VORP 503 middle ear implant
- 3 self-drilling cortical screws
- 1 single-use screwdriver
Weight
- 10.6 g
Materials in Contact With Tissue
Implant: medical grade silicone elastomers, titanium, medical grade epoxy Screws: titanium alloy Ti 6Al 7Nb
Recommended Bone Bed Depth for Demodulator
1.9 mm
Safety Features
Overvoltage protection
MRI Conditions
MR-conditional at 1.5 Tesla*
Screw Penetration in Bone
3.5 mm (max.)
Maximum Immersion Depth
50 m in salt water (6 bar)
Biocompatible in Accordance With ISO 10993-1
Latex-free****
Delivered sterile
Not for Reuse
Vibroplasty Couplers
Incus-SP-Coupler
- For placement onto the short process of the incus
- Material in contact with tissue: titanium grade 5 ELI (ASTM F136)
- Contents of kit: 1 Coupler, 1 holding frame, 1 retainer
Incus-LP-Coupler
- For placement onto the long process of the incus
- Material in contact with tissue: titanium grade 5 ELI (ASTM F136), titanium grade 2 (ASTM F67)
- Contents of kit: 1 Coupler, 1 holding frame, 1 retainer
RW-Soft-Coupler
- For placement onto the round window membrane
- Material in contact with tissue: Medical silicone and silicone gel
- Contents of kit: 2 Couplers, 1 holding frame, 2 retainers
Vibroplasty-CliP-Coupler
- For placement onto the stapes head
- Material in contact with tissue: titanium grade 2, titanium grade 1
- Contents of kit: 1 Coupler
Stapes-SH-Coupler
- For placement onto the stapes head
- Material in contact with tissue: Titanium Grade 2 (ASTM F67) and Titanium Grade 5 (ASTM F136)
- Contents of kit: 1 coupler, 1 holding frame, 1 retainer
Frequency Response Curves
SAMBA 2 Hi
Maximum OSPL90: 109 dB SPLeq
HFA-OSPL90: 109 dB SPLeq
Maximum full-on gain: 53 dB
HFA-FOG: 52 dB
Equivalent input noise: 23 dB SPL
Total harmonic distortion, 70 dB SPL input level, 500 Hz distortion test frequency: < 5 %
Total harmonic distortion, 70 dB SPL input level, 800 Hz distortion test frequency: < 5 %
Total harmonic distortion, 65 dB SPL input level, 1600 Hz distortion test frequency: < 3 %
Total harmonic distortion, 60 dB SPL input level,
3200 Hz distortion test frequency: < 3 %
Frequency response curves for SAMBA 2 Hi:
Click on the thumbnail to enlarge the picture.
SAMBA 2 Lo
Maximum OSPL90: 91 dB SPLeq
HFA-OSPL90: 91 dB SPLeq
Maximum full-on gain: 38 dB
HFA-FOG: 38 dB
Equivalent input noise: 23 dB SPL
Frequency response curves for SAMBA 2 Lo:
Click on the thumbnail to enlarge the picture.
* The SOUNDBRIDGE VORP 503 implant is MR conditional. Recipients with the SOUNDBRIDGE VORP 503 implant may be safely MRI scanned
at 1.5 Tesla following the conditions detailed in the instructions for use.
The previous generations, VORP 502 and VORP 501, are MR unsafe and should not be scanned.
** Provided that the MRI is conducted according to the IFU or the medical procedures manuals.
*** No surgery unless required for diagnostic reasons.
**** Where “latex-free” means “not made with latex” in accordance with the latest FDA “Recommendations for Labeling Medical Products
to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex” guideline, 2014
Please find detailed information and specific conditions for use for each product in the respective instructions for use.
