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reconstruction using the Omega Connector was evaluated. Vincent R., Bittermann A. J. N., Wenzel G. Oates J., Sperling
N., Lenarz T., Grolman W.
Study Design: Prospective cohort study and experimental measurements
with a fresh human temporal bone. Setting: Tertiary referral center. Published: Otol Neurotol. 2013; 34 (1): 83-90
DOI: 10.1097/MAO.0b013e318277a2bd
Patients: Seventeen consecutive patients receiving total ossicular recon-
struction were included. Historical control group composed of 36 patients. Objectives: To present the preliminary results of new malleus replacement
Interventions: Total ossicular reconstruction using the Omega Connector. prosthesis combined with a total ossicular prosthesis in middle ear recon-
struction in patients missing the malleus and stapes.
Main outcome Measures: (a) Handling of the TORP and Omega Con-
nector intraoperatively, (b) functional short-term results compared with a Study Design: Prospective experimental and nonrandomized clinical
historical control group, (c) sound transmission properties with 3 different study. Setting: Tertiary referral center.
connective positions between the TORP and the Omega Connector.
Methods: An original titanium malleus replacement prosthesis (MRP) was
Results: Placing the Omega Connector on the footplate and coupling the designed to be inserted into the external auditory canal and to replace a
Omega Connector to the TORP was straightforward in 65% of cases. A missing malleus for various middle ear pathologies. The MRP was tested
stable final position of the TORP was obtained in 88% of cases. Mean (SD) experimentally and clinically. The vibratory properties of the new prosthe-
preoperative and postoperative air-bone gaps were 36.00 (11.05) and 25.29 sis were measured using laser Doppler vibrometry. Ninety patients with
(12.25) dB and were almost identical with those in the historical control group missing malleus and stapes, undergoing 92 ossicular reconstructions were
(p = 0.9). In the experimental measurements, functional outcomes with enrolled in this study from September 1994 to March 2012. Comparative
"partial connection" showed almost the same results as those with "full analyses were made between a group of 34 cases of ossicular reconstruc-
connection." tions with total prosthesis (TORP) positioned from the tympanic mem-
brane to the stapes footplate (TM-to-footplate assembly) and a group of
Conclusions: The Omega Connector provides easy handling of the TORP. 58 cases of ossicular reconstructions with TORP positioned from a newly
The short-term functional results were comparable to those achieved pre- designed malleus replacement prosthesis (MRP) to the stapes footplate
viously without the Omega Connector. The temporal bone measurement (MRP-to-footplate assembly). Preoperative and postoperative audiometric
supports tolerance in connective position between the TORP and the evaluation using conventional audiometry, that is, air-bone gap (ABG),
Omega Connector. bone-conduction thresholds (BC), and air-conduction thresholds (AC)
were assessed.
The Ω Connector - A Module for Jointed Coupling of Results: Experimentally, the vibratory properties of the MRP are promising
Titanium Total Prostheses in the Middle Ear and remain very good even when the MRP is cemented into the bony canal
wall mimicking its complete osseous-integration, if this were to occur. This
Schmid G., Steinhardt U., Heckmann W. finding supports the short-term clinical results as in the TM-to-footplate
group; the 3-month postoperative mean ABG was 23.3 dB compared with
Published: Laryngo-Rhino-Otologie 2009, vol. 88, no (12), pp. 782-788 12.5 dB in the MRP-to-footplate group (difference, 10.8; 95% confidence
DOI: 10.1055/s-0029-1231047 interval, 4.0 - 17.6); 37.0% of patients from the TM-to-footplate group had
a postoperative ABG of 10 dB or less, and 48.1% of patients had a postop-
Background: Hearing improvement after reconstruction of a defect os- erative ABG of 20 dB or less, as compared with 58.1% and 79.1%, respec-
sicular chain depends on material, design and - crucially - coupling of the tively, in the MRP-to-footplate group. The average gain in AC was 11.0 dB
prosthesis. Coupling a total ossicular replacement prosthesis to the stapes in the TM-to-footplate group as compared with 21.3 dB in the MRP-to-
footplate can be problematic and lead to prosthesis instability. In order to footplate group (difference, -10.3; 95% confidence interval, -18.2 to - 2.4).
solve this problem, the Ω Connector was developed, a module allowing
the middle ear surgeon to couple a titanium total prosthesis to the stapes Conclusion: The results of this study indicate that superior postoperative
footplate in a flexible, angle-variable manner. hearing thresholds could be achieved using a MRP-to-footplate assem-
bly, compared with a TM-to-footplate assembly in patients with an absent
Material and Method: The Ω Connector is made of pure titanium and malleus undergoing ossiculoplasty. The postoperative AC thresholds, after
consists of three components: head, neck and base plate. The head allows 3 months and 1 year, are significantly lower in patients treated with the
a jointed coupling to the steam of a titanium total prosthesis. Positioned MRP-to-footplate assembly.
between the remnants of the stapes crura, the bas plate proves for a stable
connection with the stapes footplate.

Results: The Ω Connector was implanted during 14 revisions surgeries. In CLIP PARTIAL FLEXIB AL
10 of these surgeries a total ossicular replacement prosthesis was removed
which was implanted at an earlier date and which was fixed and no longer
functioning. In all 14 cases it was possible intraoperatively to position the Ω Long-term hearing results and patient satisfaction after
Connector correctly and to couple it to a titanium total prosthesis. The post- tympanoplasty with Titanium-CliP Prostheses
operative hearing gain was between 10 to 25 dB, with an average of 18 dB.
Wolferts G., Schicke D., Delank K.W.
Conclusion: For the first time, the Ω Connector offers to the surgeon the
option to couple a titanium total prosthesis via a micro ball joint. Hearing Published: 86th Annual Meeting of the German Society for Oto-, Rhino-,
results achieved so far are satisfying. The results confirm the advantages of Laryngology, Head and Neck Surgery. Berlin, May 13-16, 2015. Düsseldorf:
the Ω Connector during implantation of a titanium total prosthesis. For a German Medical Science GMS Publishing House; 2015. Doc15hnod526,
final evaluation, long-term studies have yet to be made. March 26, 2015. Poster Abstract (German). DOI: 10.3205/15hnod526

Introduction: Titanium-CliP® Prostheses (Dresden or FlexiBal® type,
Kurz) have been in use for reconstruction of the ossicle chain for several
MRP MALLEUS REPL A CEMENT PROS THESIS years. So far only a few studies of the long-term audiological and otologi-
cal results have been published. The quality of life of patients has not been
analyzed.
Ossiculoplasty in Missing Malleus and
Stapes Patients: Experimental and Preliminary Clinical Methods: From 2003-2013 140 patients received a tympanoplasty with im-
Results With a New Malleus Replacement Prosthesis With the plantation of a Titanium-CliP® Prosthesis in this hospital. We conducted a
Otology-Neurotology Database retrospective, monocentric study with prospective follow-up of up to eleven

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