To assess the audiological and longterm medical and technical followup outcomes of an active middle ear implant.
This was a retrospective medical chart analysis of all patients provided with an active middle ear implant in a tertiary academic medical referral center between September 1, 1998, and July 31, 2015. Main outcome measures were medical and technical complications, revisions, reimplantations, explantations, coupling approaches, mean time of use, pre and postoperative hearing thresholds, functional hearing gain across frequencies (2504,000 Hz), and Freiburg monosyllablic word test at 65 dB.
One hundred and three patients were identified. Fifteen were implanted bilaterally (n = 118 Vibrant Soundbridge devices [MEDEL, Innsbruck, Austria]). Seventyseven devices were implanted for sensorineural and 41 for mixed and conductive hearing loss. Patients used the implant for 6.7 years (range 0.7 months17.9 years) on average. Ninetyone patients (77.12%) were using the device at the end of the observation period. An overall complication rate of 16.1% was observed. The revision and explantation rates were higher for devices implanted between 2004 and 2006. The device failure rate was 3.4%. Audiological evaluation showed significant hearing gains for both hearing loss patient groups.
This longterm followup reveals the reliability of the active middle ear implant in a single center. Overall complication rate and device failure rate are acceptable. The complication rate was higher during implementation of alternative coupling approaches. The audiological benefit was satisfactory in patients with all hearing loss types. The majority of implanted patients used the implant at the end of the observation period.