European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
Active piezoelectric bone conduction implant Osia® 2 - evaluation of surgery and one-year audiological and quality of life benefits.
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Gawęcki Wojciech, Gibasiewicz Renata, Błaszczyk Magdalena, Wierzbicka Małgorzata, Bartkowiak Ewelina
Аннотация
PURPOSE: To present the surgical outcomes and one-year audiological and quality of life results of implantation of the Osia® 2 active piezoelectric bone conduction implant.
METHODS: Twenty adults with mixed and conductive hearing loss were implanted with the Osia® 2 system and followed up for at least one year. The surgical course, healing, and soft tissue condition were assessed. Audiometric tests included pure tone audiometry, speech audiometry and direct bone conduction measurements. Participants completed the APHAB and SSQ questionnaires.
RESULTS: All surgeries were successful. No soft tissue problems were observed. Pure tone audiometry showed a mean functional gain of 47.4 ± 5.6 dB HL (p = 0.000089). The Polish Monosyllabic Word Test showed mean improvements for silent, medium and loud speech of 59.5 ± 1.8%, 46.5 ± 32.3% and 13.3 ± 20.9% in quiet and 38.5 ± 24.4%, 62.0 ± 9.1%, and 36.5 ± 34.4% in noise (all p < 0.05). The Polish Matrix Test indicated a mean SNR improvement of 8.78 ± 2.31 dB SPL (p = 0.000155). BC in situ measurements were significantly better post-implantation compared to preoperative levels with Baha® 6 Max on the Softband. APHAB scores showed significant improvements in global, ease of communication, background noise and reverberation scores (all p < 0.001). SSQ scores improved significantly in speech, spatial and quality subscales (all p < 0.000001).
CONCLUSION: The Osia® 2 implantation is an effective treatment for patients with mixed and conductive hearing loss. The surgery is relatively easy and safe, with no significant postoperative or magnet pressure-related complications. Osia® 2 significantly improves speech understanding in noise and reduces communication problems.
METHODS: Twenty adults with mixed and conductive hearing loss were implanted with the Osia® 2 system and followed up for at least one year. The surgical course, healing, and soft tissue condition were assessed. Audiometric tests included pure tone audiometry, speech audiometry and direct bone conduction measurements. Participants completed the APHAB and SSQ questionnaires.
RESULTS: All surgeries were successful. No soft tissue problems were observed. Pure tone audiometry showed a mean functional gain of 47.4 ± 5.6 dB HL (p = 0.000089). The Polish Monosyllabic Word Test showed mean improvements for silent, medium and loud speech of 59.5 ± 1.8%, 46.5 ± 32.3% and 13.3 ± 20.9% in quiet and 38.5 ± 24.4%, 62.0 ± 9.1%, and 36.5 ± 34.4% in noise (all p < 0.05). The Polish Matrix Test indicated a mean SNR improvement of 8.78 ± 2.31 dB SPL (p = 0.000155). BC in situ measurements were significantly better post-implantation compared to preoperative levels with Baha® 6 Max on the Softband. APHAB scores showed significant improvements in global, ease of communication, background noise and reverberation scores (all p < 0.001). SSQ scores improved significantly in speech, spatial and quality subscales (all p < 0.000001).
CONCLUSION: The Osia® 2 implantation is an effective treatment for patients with mixed and conductive hearing loss. The surgery is relatively easy and safe, with no significant postoperative or magnet pressure-related complications. Osia® 2 significantly improves speech understanding in noise and reduces communication problems.