International consensus paper on implantable devices for conductive or mixed loss
Reviewed by Aileen Lambert

This is a weighty but insightful ‘Special Feature’ paper in the June edition of Otology and Neurotology. It has the broad aim to gather current opinion from otologists, audiologists, manufacturers and health-economists from around the world on unilateral hearing implantation devices for use in patients with bilateral conductive or mixed loss who have had no success with conventional hearing aids or for whom surgical reconstruction is not an option. This includes implantable and transcutaneous bone-conduction devices as well as active middle ear implants. A series of round-table discussions at the main otology/implant conferences was the platform on which the included efficacy statements are based. It provides an in-depth review of the current range of devices available globally, with a focus on aspects of how to optimise/standardise the process, matching patients with the device that will best serve their needs. Standardised methods, equipment and procedures to measure the characteristics of all devices were identified as critical going forward. The areas that are covered in detail include selection and fitting of the device, with explanation for the recommendation of using ‘effective gain’ (advocated as it is independent of the air-bone gap and assesses the effectiveness of the treatment). Surgical aspects are discussed, including adequate patient counselling and maintaining surgical technical skills with newer devices. The role and responsibilities of device manufacturers is outlined, from market release to technical specifications and aftercare. There is considerable discussion of the wider concepts of overall health policy in the context of device benefit, particularly in the era of the newer AMEIs. It highlights the need for agreed patient-relevant endpoints as well as audiological measurements of outcome. The challenges of implant and application-specific registries are acknowledged but no real detail is given in this document on how these could be feasibly overcome. Although a range of stakeholders were involved in the consensus document, the authors acknowledge the absence of patients in the process, as well as the need for greater diversity of global representation.

Consensus Statement on Bone Conduction Devices and Active Middle Ear Implants in Conductive and Mixed Hearing Loss.
Maier H, Lenarz T, Agha-Mir-Salim P, et al.
OTOL NEUROTOL
2022;43(5):513-29.