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.