Middle Ear Transducer: Long Term Stability of the Latest Generation T2.

OBJECTIVES/HYPOTHESIS: Comparing long term stability of the Middle Ear Transducers (MET) of the 1st generation T1 (Otologics LLC) with the current generation T2 (Cochlear Ltd.) in all our clinical cases with standard incus coupling.

STUDY DESIGN

Retrospective chart review.

METHODS

52 ears implanted with a MET device between 2008 and 2016 were analyzed retrospectively. All patients suffered from sensorineural hearing loss and the actuator was coupled to the body of the incus (standard coupling). 23 ears were implanted with the transducer T1 (Otologics LLC) between 2008 and 2011 and 29 ears were implanted with the current transducer T2 since 2011 (Otologics LLC/Cochlear Ltd.). Latest available in situ and bone conduction (BC) thresholds were exploited for a follow-up period of up to 7 years after first fitting. Long term stability of coupling and actuator performance was evaluated by tracking differences between in situ and BC thresholds.

RESULTS

In the T1 group, 9 out of 23 implants were still used by the patients at their last follow-up visit (average observation time 3.7 yrs.; min 1.0 yrs., max 7.4 yrs.). In 9 patients a technical failure identified by a decrease of in situ threshold of more than 15 dB compared to BC thresholds [Δ (in situ - BC)] lead to non-usage of the implant and 7 explantations. Five other explantations occurred due to medical reasons such as BC threshold decrease, infection, or insufficient speech intelligibility with the device. In the T2 group, 23 out of 29 implants were still used at the most current follow-up visit (average observation time 3.3 yrs.; min 1.0 yrs., max 4.8 yrs.). No technical failures were observed up to more than 4 years after implantation. Five T2 patients discontinued using the device due to insufficient benefit; two of these patients were explanted. One patient had to be explanted before the activation of the device due to disorders of wound healing. Nevertheless, a small but significant decrease of hearing loss corrected coupling efficiency [Δ (in situ - BC)] was seen in the T2 group.

CONCLUSIONS

In contrast to the T1 transducers of the earlier generation of MET systems where technical failures occurred frequently, no technical failures were detected after 29 implantations with the current T2 transducers. However, a small but significant decline of transmission efficiency was observable even in the T2 implanted group.