In Products & Updates, Surgical

With a surgical accessory as small as it is innovative—the Stapes-SH-Coupler—MED-EL is expanding its middle ear implant system, VIBRANT SOUNDBRIDGE (VSB). It can be used for quick, gentle, and stable coupling of the SOUNDBRIDGE’s Floating Mass Transducer (FMT) to the head of the stapes. As with the VSB’s other couplers, fixation is simple and performed without crimping. The Stapes-SH-Coupler is simply placed onto the stapes and attached to it with clips.

Like the Bell-Coupler and the CliP-Coupler, the new addition to the VSB coupler family is placed on the head of the stapes, making it vibrate with the FMT secured inside the coupler’s FMT cage.

 

More Anatomies, More Applications

So why is there a new third coupler for the head of the stapes? The Stapes-SH-Coupler solves a problem that has arisen in the past with certain anatomies. Surgeons reported that CliP-Coupler and Bell-Coupler were too tall for some patients; therefore, in some cases, there was not enough space for the coupler to be placed due to the very small anatomical distance between the stapes head and the tympanic membrane.

Lack of space is no longer a limiting factor with the new coupler, which has a significantly lower profile. This increases the range of suitable anatomies and the pre- and intraoperative flexibility of the VSB system.

Stapes-SH-Coupler

New in the VSB portfolio: Stapes-SH-Coupler

 

 

Developed With Leading ENT Surgeons

The Stapes-SH-Coupler was developed in close collaboration with Prof. Dr. Dirk Beutner (University Medical Center Göttingen) as well as Prof. Dr. Alexander Huber and PD Dr. Jae Hoon Sim (both from University Hospital Zurich). Selection of one of the three stapes head couplers depends—as is generally the case when choosing a Vibroplasty Coupler—on the personal preferences of the surgeon and the anatomical requirements. The audiological indication criteria are identical for all three of these couplers.

 

Advantages of the Stapes-SH-Coupler

1. More Distance From the Eardrum

Unlike the other couplers that attach to the stapes head, the FMT cage is offset beside the coupler itself, so the FMT is positioned next to the stapes head rather than on top of it. This position provides a significant reduction in the functional height of the coupler and increases its distance from the eardrum by approximately 0.5 mm. In addition, the FMT cage is tilted 30° to avoid colliding with the promontorium tympani.

Stapes-SH-Coupler

Stapes-SH-Coupler on the head of the stapes

2. Simple Surgical Handling

For optimal surgical handling and rapid, standardized assembly of the coupler and FMT, the same holding frame is used for the Stapes-SH-Coupler as with other MED-EL Vibroplasty Couplers. The Stapes-SH-Coupler is made of titanium and can be used on either side.

Holding Frame

Standardized holding frame

3. Secure and Stable Connection

The innovative Stapes-SH-Coupler has been designed to provide maximum long-term stability. Four corrugated legs wrap around the stapes and hold the coupler securely in place, while two additional legs provide the right amount of spring tension. In addition, the FMT cage, which grips the FMT from the side rather than from below, ensures an extremely stable connection between the coupler and the FMT.

 

Proven Experience: “High Flexibility” and “Very Good Fixation”

The Stapes-SH-Coupler has CE approval and has been used in several ENT centers for nearly a year. One of the first surgeons to use the new coupler in multiple occasions is PD Dr. Kristen Rak at the University Hospital Würzburg. He summarizes his experience and findings as follows:

“The Stapes-SH-Coupler can be used in cases with an intact ear canal wall or in mastoid cavities. The indication spectrum here is conductive or combined hearing loss. Due to its lower height when compared to the Bell or CliP couplers, it facilitates reconstruction of tympanic membrane. In addition, it provides high coupling flexibility. The FMT can either be placed over the facial nerve or the promotorium to provide the optimal angle towards the reconstructed tympanic membrane. The spring-loaded grips for fixation allow it to be clipped onto the stapes with very little force. After clipping, the design provides very strong retention. Thanks to its coupling flexibility, guiding the cable along the bony structures of the mastoid cavity can always be performed very well, which facilitates subsequent reconstruction.”

Dr. Kristen Rak

 

Surgery Online: Surgical Demonstration of the Stapes-SH-Coupler

On Wednesday, December 22, 2021, Dr. Kristen Rak will present on the Stapes-SH-Coupler as part of MED-EL’s SurgeryONLINE lecture series, demonstrating the surgical steps involved in coupling and sharing his personal insights from previous implantations.

The New Stapes-SH-Coupler for VIBRANT SOUNDBRIDGE: First Surgical Experiences

December 22, 2021, 15:00 – 16:00 (UTC +1:00)

Register now for the online event!

>>Register Here<<

VIBRANT SOUNDBRIDGE and flexible coupling options

Take the Next Step: Get the Stapes-SH-Coupler at Your Clinic

Would you like to use the Stapes-SH-Coupler at your clinic? Or would you like to know more about this new coupler for the VIBRANT SOUNDBRIDGE middle ear implant system? Contact us!

You can also check out our previous articles on the SOUNDBRIDGE here:

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Not all products, features, or indications shown are approved in all countries. Please contact your local MED-EL representative for more information.

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