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. 2014 Oct 17;9(10):e110636. doi: 10.1371/journal.pone.0110636

Table 2. Complications related to the fully implantable middle ear devices.

Study Year MED Patients(n) AdverseEffects (n) SurgicalComplications(n) DeviceAdverseEffects (n) Revisions(n)
Bruschini et al. 2009 Carina 5 NR None Feedback (5) 1
Bruschini et al. 2010 Carina 8 Extrusion of the cable of microphone (1),Psychologicalproblems andexplantation (1) NR Feedback (1),Device failure (1) 2
Chen et al. 2004 Esteem 7 Woundcomplication (1) Temporary swelling ofthe lower eyelid, sorejaw, nausea, diarrhea,elbow pain, arm andhand pain, andnumbness (2) No benefit (3),Low gain (3) 3
Gerard et al. 2012 Esteem 13 Secondaryhealing difficulty(1), recurrenttissue edema (1),S aureus woundinfection (2) Temporary partialfacial palsy (1),rupture of chordatympani nerve (8), Poor anddeterioratingfunctionalresults (4) 4
Jenkins 2007 and 208 Carina 20 fullness orpressure sensation(2), conductivehearing loss (4),lightheadedness(1), tinnitus (1),partial deviceextrusion (3), andmiddle eareffusion (3) partial deviceextrusion (3),inability tocharge orestablishcommunication(2),increasedcharging timesbeyond 1.5 hours
Kam et al. 2012 6 None None feedback 1
Kraus et al. 2011 Esteem 57 Taste disturbance(24), middle eareffusion (18),pain (8), dizziness(9), tinnitus (7),headache (3),infection (2) Facialparesis/paralysis (4) Limitedbenefit (4) 3
Martin et al. 2009 Carina 11 Infection (2),vertigo (1),tinnitus (1) NR Hearing loss(1), poor soundtransmission (1) 1
Memari et al. 2011 Esteem 10 NR Temporary facialweakness (1) Nobenefit (2) NR
Murali et al. 2009 Esteem 3 None transient facialparesis (1) NR 0

n – number; MED – middle ear device; NR – not reported.