Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System.

OBJECTIVE

A new active transcutaneous bone conduction hearing implant system that uses piezoelectric technology has been developed: an active osseointegrated steady-state implant system (OSI). This was the first clinical investigation undertaken to demonstrate clinical performance, safety, and benefit of the new implant system.

STUDY DESIGN AND SETTING

A multicenter prospective within-subject clinical investigation was conducted.

PATIENTS

Fifty-one adult subjects with mixed and conductive hearing loss (MHL/CHL, n = 37) and single-sided sensorineural deafness (SSD, n = 14) were included.

MAIN OUTCOME MEASURE

Audiological evaluations included audiometric thresholds, speech recognition in noise, and quiet. Hearing and health-related patient-reported outcomes (PROs; health utilities index [HUI], abbreviated profile of hearing aid benefit [APHAB], and speech, spatial of qualities of hearing scale [SSQ]), daily use, surgical and safety parameters were collected.

RESULTS

Intra- and postoperative complications were few. One implant was removed before activation due to post-surgical infection. Compared with the preoperative softband tests, a significant improvement in speech recognition-in-noise was observed in the MHL/CHL group (-7.3 dB, p ≤ 0.0001) and the SSD group (-8.1 dB, p = 0.0008). In quiet, word recognition improved in the MHL/CHL group, most markedly at lower intensity input of 50 dB SPL (26.7%, p ≤ 0.0001). The results of all PROs showed a significant improvement with the new device compared with preoperative softband in the MHL/CHL group. In the SSD group significant improvements were observed in the APHAB and SSQ questionnaires.

DISCUSSION

The results confirmed the clinical safety, performance, and benefit of this new treatment modality for subjects with CHL, MHL, and SSD.