The bone conduction implant – a review and 1-year follow-up

Bo Håkansson,Sabine Reinfeldt,Ann-Charlotte Persson,Karl-Johan Fredén Jansson,Cristina Rigato,Malou Hultcrantz,Måns Eeg-Olofsson

doi:10.1080/14992027.2019.1657243

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.

Highlights

There is a long history of treatment options for patients who suffer from a conduction hearing loss due to middle ear infection or syndromic malformations of the outer or middle ear
All implants were tested for nasal sound pressure (NSP) transmission and the implanted device was found to be functioning as expected before the wound was closed
It was shown that the procedure for implanting the bone conduction implant (BCI) is safe and that the transmission condition is stable over the follow-up time

Summary

Introduction

There is a long history of treatment options for patients who suffer from a conduction hearing loss due to middle ear infection or syndromic malformations of the outer or middle ear. We estimate from company sales information, that an accumulated number of up to 300,000 patients may have been treated (June 2019), where this estimated figure, not officially confirmed, includes a significant number of single sided deaf patients and passive/active transcutaneous bone-anchored implants This trend has catalysed new developments in other bone conduction applications such as for hearing and vertigo diagnostics (Håkansson 2003; Freden Jansson et al 2015a; Håkansson et al 2018) and in consumer applications (Everyday Hearing 2018). The hearing rehabilitation effect using the BAHA is significant and well documented, there are still some inherent drawbacks with the percutaneous solution These drawbacks include a lifelong commitment of everyday care and potential adverse events related to skin infections, skin overgrowth and implant loss. Secondary drawbacks are related to feedback when using head wear, and the stigma of having an implant sticking out through the skin

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