Bo Håkansson1, Sabine Reinfeldt1, Ann-Charlotte Persson2, Karl-Johan Fredén Jansson1, Cristina Rigato1, Malou Hultcrantz3, Måns Eeg-Olofsson4. 1. Department of Electrical Engineering, Chalmers University of Technology, Gothenburg, Sweden. 2. Department of Audiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. 3. Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden. 4. Department of Otolaryngology, Head and Neck Surgery, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Abstract
Objective: The objective of this study is to evaluate its safety and effectiveness of the bone conduction implant (BCI) having an implanted transducer and to review similar bone conduction devices.Design: This is a consecutive prospective case series study where the patients were evaluated after 1, 3, 6 and 12 months. Outcome measures were focussed on intraoperative and postoperative safety, the effectiveness of the device in terms of audiological performance and patient's experience.Study sample: Sixteen patients with average age of 40.2 (range 18-74) years have been included. Thirteen patients were operated in Gothenburg and three in Stockholm. Results: It was found that the procedure for installing the BCI is safe and the transmission condition was stable over the follow-up time. No serious adverse events or severe adverse device effects occurred. The hearing sensitivity, speech in noise and the self-assessment as compared with the unaided condition improved significantly with the BCI. These patients also performed similar or better than with a conventional bone conduction reference device on a softband.Conclusions: In summary, it was found that the BCI can provide a safe and effective hearing rehabilitation alternative for patients with mild-to-moderate conductive or mixed hearing impairments.
Objective: The objective of this study is to evaluate its safety and effectiveness of the bone conduction implant (BCI) having an implanted transducer and to review similar bone conduction devices.Design: This is a consecutive prospective case series study where the patients were evaluated after 1, 3, 6 and 12 months. Outcome measures were focussed on intraoperative and postoperative safety, the effectiveness of the device in terms of audiological performance and patient's experience.Study sample: Sixteen patients with average age of 40.2 (range 18-74) years have been included. Thirteen patients were operated in Gothenburg and three in Stockholm. Results: It was found that the procedure for installing the BCI is safe and the transmission condition was stable over the follow-up time. No serious adverse events or severe adverse device effects occurred. The hearing sensitivity, speech in noise and the self-assessment as compared with the unaided condition improved significantly with the BCI. These patients also performed similar or better than with a conventional bone conduction reference device on a softband.Conclusions: In summary, it was found that the BCI can provide a safe and effective hearing rehabilitation alternative for patients with mild-to-moderate conductive or mixed hearing impairments.
Entities:
Keywords:
Bone conduction; active transcutaneous; hearing aid; implanted transducer
Authors: Pietro Canzi; Irene Avato; Millo Beltrame; Giovanni Bianchin; Marco Perotti; Lorenzo Tribi; Barbara Gioia; Federico Aprile; Stefano Malpede; Andrea Scribante; Marco Manfrin; Marco Benazzo Journal: Acta Otorhinolaryngol Ital Date: 2021-02 Impact factor: 2.124