Active Middle Ear Implantation

Zwartenkot, Joost W.; Mulder, Jef J. S.; Snik, A.F.M.; Cremers, C.W.R.J.; Mylanus, Emmanuel A. M.

doi:10.1097/mao.0000000000001015

Cited by 34 publications

(14 citation statements)

References 29 publications

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“…Previous publications on the MET device have reported adverse events [13,16], although most of the events related to the 1st generation implant. Prenzeler et al [13] investigated implant survival in MET devices for 1st (T1) and 2nd (T2) generation transducers separately over an extended period of time.…”

Section: Discussionmentioning

confidence: 98%

“…In general, previously published experience [13,16] has been that the medical and technical complications and device failures in 2nd generation MET devices are not uncommon. Those findings are in line with our long-term observations in relation to the latest generation MET.…”

Section: Discussionmentioning

confidence: 99%

“…Audiological indications include both SNHL and mixed hearing loss (MHL). To the best of our knowledge, only two papers [13,16] have scrutinized the safety and efficacy of the latest generation of MET (known as Cochlear MET).…”

Section: Introductionmentioning

confidence: 99%

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Three-year audiological outcomes of the latest generation middle ear transducer (MET) implant

Skarżyńśki

Dziendziel

Włodarczyk

et al. 2020

Eur Arch Otorhinolaryngol

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Purpose To evaluate the long-term audiological outcomes and safety of the latest generation of middle ear transducer (MET) among a group of Polish patients. Methods Ten patients aged 48–72 years with bilateral sensorineural hearing loss (n = 8) and mixed hearing loss (n = 2) were included in this study. Pure tone audiometry, sound thresholds, word recognition scores in quiet and speech reception thresholds in noise were assessed. Medical and technical complication information was gathered. Results All the patients underwent unilateral implantation with the latest generation Cochlear MET between 2014 and 2016. Mean length of follow-up was 3.7 years. Compared to the unaided condition, the implant provided significant functional gain (mean M = 26.1 dB) at 12 months follow-up. Compared to before surgery, average word recognition in quiet at 65 dB and at 80 dB SPL, as well as speech reception threshold in noise, were significantly better at 12 months. However, postoperative air conduction thresholds 6 months after implantation worsened by 10.3 dB (standard deviation SD = 5.8 dB). Postoperatively, three patients had skin problems around the processor, and one of them completely resigned from using the device 5 months after activation. Technical failures occurred in 4 cases. There were 9 out of 10 patients who still used the MET, but only 5 of them used the processor regularly (every day). Conclusion Despite changes in the transducer implemented by the manufacturer, we observed a significant number of adverse events in users of the latest generation of MET.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

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Three-year audiological outcomes of the latest generation middle ear transducer (MET) implant

Skarżyńśki

Dziendziel

Włodarczyk

et al. 2020

Eur Arch Otorhinolaryngol

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“…The MET transducer is used in two different devices: the semi-implantable MET that is commercially not available anymore and the fully implantable device Carina®. The rare articles that report on the semi-implantable MET state technical problems of the earlier MET T1 generation but only few cases are mentioned regarding the latest generation devices [3, 7]. Debeaupte et al [11] make a clear distinction between different generations of Carina implants and report on implant survival after 2 years in a multicenter setting.…”

Section: Discussionmentioning

confidence: 99%

“…Over the course of time, more and more data emerged that constituted frequent technical failure of the device. Zwartenkot et al [3] reported on a technical failure rate of 9/32 over a follow-up period of up to 13 years, whereby all failures occurred within the first 2 years after implantation. Four of the 32 patients in that publication had been implanted with a Cochlear® MET (T2) since 2014, where no failure occurred so far, insinuating an improved technical long term stability of the T2 transducer compared to the T1.…”

Section: Introductionmentioning

confidence: 99%

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

Prenzler

Kludt

Giere

et al. 2019

BioMed Research International

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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.

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Totally implantable hearing system: Five‐year hearing results

et al. 2017

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Objectives/Hypothesis: 1) To provide long-term hearing outcome measures of a totally implantable hearing system (implant) and compare to the baseline unaided (BLU) and baseline aided (BLA) conditions, and 2) discuss relevant safety measures.Study Design: Prospective, nonrandomized, multicenter, single-subject-as-own-control design. Methods: Fifty-one subjects with mild to severe sensorineural hearing loss were implanted between 2008 and 2009 and enrolled in this postmarket approval study in the setting of private and hospital-based practices. Forty-nine of these subjects completed the 5-year study, which included annual follow-ups. Primary effectiveness endpoints were speech reception threshold (SRT) and word recognition scores at 50 dB (WRS50s). Secondary effectiveness endpoints were WRSs and the Abbreviated Profile of Hearing Aid Benefit (APHAB) scores. Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) reported during the study period and a comparison of bone conduction scores are submitted as safety measures.Results: Compared to the BLA condition, 1) SRT scores were improved at every annual follow-up; 2) WRS50s were better in 49%, and the same in 41% at the 5-year follow-up; 3) WRSs were improved by 17% at the 5-year follow-up; and 4) APHAB scores were improved in most subscales at every annual follow-up. There were three SADEs in three subjects and 15 ADEs in 11 subjects. Bone conduction scores increased by 3.7 dB at the 5-year follow-up. Average battery life was 4.9 years.Conclusions: The implant compared favorably to the subjects' hearing aid throughout the 5-year period in all of the areas measured and was found to be safe.

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Active Middle Ear Implantation

Cited by 34 publications

References 29 publications

Three-year audiological outcomes of the latest generation middle ear transducer (MET) implant

Three-year audiological outcomes of the latest generation middle ear transducer (MET) implant

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

Totally implantable hearing system: Five‐year hearing results

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