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

Does the bone-anchored hearing aid have a complementary effect on audiological and subjective outcomes in patients with unilateral conductive hearing loss?

Item does not contain fulltextOBJECTIVES: To study the effect of a bone-anchored hearing aid (BAHA) in patients with unilateral conductive hearing loss. STUDY DESIGN: Prospective evaluation on 18 subjects. METHODS: Aided and unaided binaural hearing was assessed in the sound field using a sound localization test and a speech recognition in noise test with spatially separated sound and noise sources. The patients also filled out a disability-specific questionnaire. PATIENTS: 13 out of the 18 subjects had normal hearing on one side and acquired conductive hearing loss in the other ear. The remaining 5 patients had a unilateral air-bone gap and mild symmetrical sensorineural hearing loss. RESULTS: Sound localization with the BAHA improved significantly. Speech recognition in noise with spatially separated speech and noise sources also improved with the BAHA. Fitting a BAHA to patients with unilateral conductive hearing loss had a complementary effect on hearing. Questionnaire results showed that the BAHA was of obvious benefit in daily life. CONCLUSIONS: The BAHA proved to be a beneficial means to optimize binaural hearing in patients with severe (40-60 dB) unilateral conductive hearing loss according to audiometric data and patient outcome measures